Ensayo controlado y aleatorizado del uso de Heberkinasa® en el derrame pleural paraneumónico en niños / Randomized Controlled Trial of the Use of Heberkinase® in Parapneumonic Pleural Effusion in Children

Introducción: El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural. Objetivo: Evaluar la eficacia y la seguridad de la Heberkinasa® en el tratamiento del derrame pleural paraneumónico complicado complejo y el empiema en niños. Métodos: Ensayo clínico fase III, abierto, aleatorizado (2:1), en grupos paralelos y controlado. Se concluyó la inclusión prevista de 48 niños (1-18 años de edad), que cumplieron los criterios de selección. Los progenitores otorgaron el consentimiento informado. Los pacientes se distribuyeron en dos grupos: I- experimental: terapia estándar y administración intrapleural diaria de 200 000 UI de Heberkinasa® durante 3-5 días y II-control: tratamiento estándar. Las variables principales: necesidad de cirugía y la estadía hospitalaria. Se evaluaron los eventos adversos. Resultados: Ningún paciente del grupo I-experimental requirió cirugía, a diferencia del grupo II-control en el que 37,5 por ciento necesitó cirugía video-toracoscópica, con diferencia altamente significativa. Se redujo la estadía hospitalaria (en cuatro días), las complicaciones intratorácicas y las infecciones asociadas a la asistencia sanitaria en el grupo que recibió Heberkinasa®. No se presentaron eventos adversos graves atribuibles al producto. Conclusiones: La Heberkinasa® en el derrame pleural paraneumónico complicado complejo y empiema resultó eficaz y segura para la evacuación del foco séptico, con reducción de la necesidad de tratamiento quirúrgico, de la estadía hospitalaria y de las complicaciones, sin eventos adversos relacionados con su administración(AU)

Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion. Objective: To evaluate the efficacy and safety of Heberkinase® in the treatment of complex complicated parapneumonic pleural effusion and empyema in children. Methods: Phase III, open-label, randomized (2:1), parallel-group, controlled clinical trial. The planned inclusion of 48 children (1-18 years of age), who met the selection criteria, was completed. Parents gave informed consent. The patients were divided into two groups: I-experimental: standard therapy and daily intrapleural administration of 200,000 IU of Heberkinase® for 3-5 days; and II-control: standard treatment. The main variables: need for surgery and hospital stay. Adverse events were evaluated. Results: No patient in group I-experimental required surgery, unlike group II-control in which 37.5 percent required video-assisted thoracoscopic surgery, with a highly significant difference. Hospital stay (to 4 days), intrathoracic complications and infections associated to healthcare in the group that received Heberkinase® was reduced. No serious adverse events attributable to the product occurred. Conclusions: Heberkinase® in complex complicated parapneumonic pleural effusion and empyema was effective and safe for the draining of the septic focus, with reduction of the need for surgical treatment, hospital stay and complications, with no adverse events related to its administration(AU)

Effect of the association of continuous shortwave diathermy and Pilates-based exercises on pain, depression, and anxiety in chronic non-specific low back pain: a randomized clinical trial

Chronic nonspecific low back pain (CNLBP) is the most common musculoskeletal condition, which can be influenced by nociceptive, psychosocial, cognitive, and affective aspects, causing vulnerabilities and impairing the individual's ability to manage pain. The association of continuous shortwave diathermy (CSWD) with Pilates-based exercises may contribute to reduce pain, depression, and anxiety in patients with CNLBP. A single-blind randomized clinical trial was performed in which 36 patients with CNLBP were divided into a control group that received placebo CSWD and an intervention group that received active CSWD. Both groups received 12 sessions of Pilates-based exercises. Pain, depression, and anxiety variables were evaluated using the McGill questionnaire, the Beck Depression Inventory, and the Visual Analog Anxiety Scale. Assessments were performed at baseline, after three and six weeks of treatment, and at the three-month follow-up. The Shapiro-Wilk test, Student's t-test, Mann-Whitney U test, chi-squared test, and repeated measures ANOVA, with α=0.05, were used to compare the outcomes, and indicated that active CSWD did not present additional improvement in the assessed variables in CNLBP patients compared to the placebo group. Both groups improved pain and depression at follow-up and reduced anxiety only during Pilates-based exercises. Therefore, only Pilates-based exercises seemed sufficient to manage patients with CNLBP.

A randomized controlled clinical study of 0.01% and 0.02% atropine eye drops on myopia development in adolescents / 中华实验眼科杂志

Objective:To compare the clinical efficacy and safety of 0.01% and 0.02% atropine eye drops on myopia development in adolescents.Methods:A randomized controlled double-blind study was carried out.Two hundred and eighty myopic adolescents (280 eyes) with spherical equivalent (SE) from -1.25 to -6.0 D were enrolled in The First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017.All the subjects wore full-correction single vision spectacle lenses before topical administration of atropine eye drops.The subjects were randomly divided into 0.01% atropine group (142 eyes) and 0.02% atropine group (138 eyes) according to the random number table method.Atropine 0.01% or 0.02% eye drops was topically used in the test eye once per night according to grouping, and the related parameters of the right eyes were collected for data analysis.The subjects were followed up at the 1st, 4th, 8th and 12th month following administration.The SE was measured with an autorefractor to evaluate the refractive change.The anterior chamber depth, corneal curvature and axial length (AL) were measured with an IOLMaster.The adverse responses of atropine eye drops were investigated via a questionnaire.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University (No.2016-35). Written informed consent was obtained from subjects and their guardian prior to entering the cohort.Results:The follow-up rate of 0.01% atropine group was 83.8%, and the follow-up rate of 0.02% atropine group was 84.8% at the end of following-up.SE and AL increased by (-0.47±0.32)D and (0.37±0.20)mm in 0.01% atropine group, and (-0.38±0.35)D and (0.30±0.17)mm in 0.02% atropine groups during the following-up, respectively, showing statistically significant differences between two groups ( P=0.040, 0.004). After adjusting age, body mass index and baseline SE, the analysis by generalized additive mixed model showed that the increase rate of SE was -0.039 D/month and -0.032 D/month in 0.01% and 0.02% atropine group, respectively ( Pinteraction=0.041). After adjusting age, body mass index and baseline AL, the analysis of mixed effect model showed that the increase rate of AL was 0.031 mm/month and 0.025 mm/month in 0.01% and 0.02% atropine group, respectively ( Pinteraction=0.032). In 0.01% and 0.02% atropine groups, 32 cases (26.9%) and 33 cases (28.2%) occurred photophobia from 1st to 4th week during administration, and 7 cases (5.9%) and 7 cases (6.0%) appeared near-vision blur from 2nd to 4th week.Allergic response occurred in 0.01% atropine group at 1 month of treatment, and the symptom disappeared after interruption of the medication for two days. Conclusions:The incidence of adverse resoponses of 0.01% and 0.02% atropine eye drops is similar.Atropine 0.02% eye drops is more effective in controlling myopia progression.

Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke: A Multicenter, Randomized, Controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on motor function and gait of the lower limbs in post-stroke hemiplegia patients.@*METHODS@#A total of 231 patients with post-stroke hemiplegia was randomly divided into IDSA (78 cases), SCT (78 cases), and TSA (75 cases) groups by a random number table. Scalp acupuncture (SA) and lower-limb robot training (LLRT) were both performed in the IDSA and SCT groups. The patients in the TSA group underwent SA and did not receive LLRT. The treatment was administered once daily and 6 times weekly for 8 continuous weeks, each session lasted for 30 min. The primary outcome measures included Fugl-Meyer assessment of the lower extremity (FMA-LE), berg balance scale (BBS), modified barthel index (MBI), and 6-min walking test (6MWT). The secondary outcome measures included stride frequency (SF), stride length (SL), stride width (SW), affected side foot angle (ASFA), passive range of motion (PROM) of the affected hip (PROM-H), knee (PROM-K) and ankle (PROM-A) joints. The patients were evaluated before treatment, at 1- and 2-month treatment, and 1-, and 2-month follow-up visits, respectively. Adverse events during 2-month treatment were observed.@*RESULTS@#Nineteen patients withdrew from the trial, with 8 in the IDSA and 5 in the SCT groups, 6 in the TSA group. The FMA-LE, BBS, 6MWT and MBI scores in the IDSA group were significantly increased after 8-week treatment and 2 follow-up visits compared with the SCT and TSA groups (P<0.05 or P<0.01). Compared with pre-treatment, the grade distribution of BBS and MBI scores in the 3 groups were significantly improved at 1, 2-month treatment and 2 follow-up visits (P<0.05 or P<0.01). The SF, PROM-H, PROM-K and PROM-A in the IDSA group was significantly increased compared with the SCT and TSA groups after 8-week of treatment (P<0.05 or P<0.01). Compared with the SCT group, ASFA of the IDSA group was significantly reduced after 8-week of treatment (P<0.05). SF, SL, PROM-K and PROM-A were significantly increased at the 2nd follow-up visit whereas the ASFA was significantly reduced in the IDSA group compared with the SCT groups at 1st follow-up visit (P<0.05 or P<0.01). The SF was significantly increased in the SCT group compared with the TSA group after 8-week treatment (P<0.05). Compared with the TSA group, PROM-K, PROM-A were significantly increased at the 2nd follow-up visit (P<0.05).@*CONCLUSIONS@#The effects of IDSA on lower-limb motor function and walking ability of post-stroke patients were superior to SCT and TSA. The SCT was comparable to TSA treatment, and appeared to be superior in improving the motion range of the lower extremities. (Registration No. ChiCTR1900027206).

Effect of music combined with swaddling on pain in full-term newborns: randomized clinical trial / Efecto de la música combinada com swaddling en el dolor en recién nacidos a término: ensayo clínico aleatorizado

ABSTRACT Objectives: to evaluate the effect of music applied within ten and 15 minutes, combined with swaddling, on behavioral (facial action) and physiological (heart rate) responses to pain in full-term newborns, before and during venipuncture for blood sampling. Methods: a randomized, triple-blind, clinical trial with 52 rooming in infants randomly assigned to four groups of 13: Experimental 1 (music [ten minutes] plus swaddling), Experimental 2 (music [15 minutes] plus swaddling), Control 1 (no music [ten minutes] plus swaddling), and Control 2 (no music [15 minutes] plus swaddling). Pain was measured using the Neonatal Facial Coding System in the basal and procedural moments. Results: experimental 2 group showed high pain absence (p < 0.05); low heart rate mean (p < 0.0001) in the basal and procedural (antisepsis, puncture, blood squeezing/aspiration, compression) moments. Conclusions: neonates who listened to 15 minutes of music plus swaddling showed a greater absence of facial pain actions.

RESUMEN Objetivos: evaluar el efecto de la música aplicada en 10 y 15 minutos, combinada con swaddling, en la respuesta comportamental al dolor (mímica facial) y fisiológica (frecuencia cardíaca) de los recién nacidos a término, antes y durante la punción venosa para la extracción de sangre. Métodos: ensayo clínico aleatorizado, triple ciego, realizado en alojamiento conjunto con 52 recién nacidos, dividido aleatoriamente en cuatro grupos de 13: Experimental 1 (música [10 minutos], swaddling), Experimental 2 (música [15 minutos], swaddling), Control 1 (sin música [10 minutos, swaddling) y Control 2 (sin música [15 minutos], swaddling,). El dolor se midió utilizando el Neonatal Facial Coding System en los momentos Basal y Procedimiento. Resultados: el grupo experimental 2 mostró alta ausencia de dolor (p <0.05); media de frecuencia cardíaca baja (p<0,0001) en los momentos Basal y Procedimiento (antisepsia, punción, ordeño/aspiración de sangre, compresión). Conclusiones: recién nacidos que escucharon 15 minutos de música más swaddling mostraron una mayor ausencia de reacciones faciales de dolor.

Systematic review and Meta-analysis of 26 randomized controlled clinical trials of Compound Danshen Dripping Pill for non-proliferating diabetic retinopathy / 中草药·英文版

Objective: Diabetic retinopathy (DR) is the retinal consequence of chronic progressive diabetic microvascular leakage and occlusion. Non-proliferating diabetic retinopathy (NPDR) is the early stage of DR. It eventually occurs to some degree in all patients with diabetes mellitus. In recent years, many clinical trials have shown that Compound Danshen Dripping Pill (CDDP) may be associated with the improvement of NPDR symptoms. The aim of this study was to quantitatively summarize the association between CDDP and the therapeutic effects of NPDR. Methods: It was conducted that a systematic literature search of PubMed, Web of Science, CNKI, VIP and Wanfang Data updated in June 2020 with the following search terms: “diabetic retinopathy” or “retinopathy” or “DR” or “NPDR”, in combination with “Compound Danshen Dripping Pill” or “Salvia miltiorrhiza” or “Danshen”. Risk ratio (RR) and weighted mean difference (WMD) with their 95% confidence interval (CI) was calculated between treatment and control groups. The sensitivity analyses were undertaken by removing each individual study when high heterogeneity appeared. Subgroup analysis, Meta-regression, and publication bias analysis were also conducted. The strength of evidence was evaluated with the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) method. Results: Twenty-six RCTs involving 2047 subjects were included to conduct a Meta-analysis after screening the studies, extracting the data, and assessing the study quality. The Stata15.0 software was utilized for processing. Meta-analysis indicated that curative effects of treatment group with CDDP was significantly better than control [RR = 0.54, 95% CI (0.40, 0.73); moderate-quality evidence]. In addition, the results showed that CDDP was significantly associated with improving retinal hemorrhages [WMD = −0.62, 95% CI (−0.78, −0.46); low-quality evidence], the vision [WMD = 0.14, and 95% CI (0.09, 0.19), low-quality evidence], fundus fluorescence angiography [RR = 0.37 and 95% CI (0.23, 0.60); low-quality evidence], reduction of retinal microaneurysm [WMD = −3.74 and 95% CI (−4.38, −3.11); moderate-quality evidence], hemangioma volume [WMD = −3.15, 95%CI (−3.45, −2.85); moderate-quality evidence], macular thickness [WMD = −5.52, 95%CI = (−64.27, −48.78); low-quality evidence], mean defect [WMD = −1.65 and 95% CI (−1.95, −1.34); very low-quality evidence], fasting blooding glucose [WMD = −0.95, 95% CI (−1.19, −0.70); low-quality evidence), hemoglobin A1c [WMD = −0.62, 95% CI (−0.93, −0.30); low-quality evidence], high sensitive C reaction protein [WMD = −5.66, 95% CI (−8.01, −3.31); low-quality evidence]. Sensitivity, subgroup, and Meta-regression analyses were also assessed. Conclusion: The study demonstrated that CDDP has beneficial clinical effects for treating NPDR and improve the vision. Moreover, it indicated that oral CDDP in NPDR patients led to significant regulation of serum level of fasting blooding glucose, hemoglobin A1c and high sensitive C reaction protein, which was associated with the pathogenesis of NPDR. However, high-quality and large randomized clinical trials will be needed to prove the consequence in future.

Clinical Efficacy of Zishui Bugan Decoction on Perimenopausal Insomnia Patients with Liver-kidney Deficiency / 中国实验方剂学杂志

ObjectiveTo evaluate the efficacy of Zishui Bugan decoction on perimenopausal insomnia of liver-kidney deficiency type and the safety. MethodA randomized， double-blind， placebo-controlled trial was designed. To be specific， 72 patients of perimenopausal insomnia with Liver-kidney deficiency were randomized into the treatment group and the control group at the ratio of 1∶1 and they were respectively treated with Zishui Bugan decoction and placebo for 3 weeks. The Pittsburgh sleep quality index （PSQI）， modified Kupperman index， traditional Chinese medicine （TCM） syndrome score， self-rating anxiety scale （SAS） score， and self-rating depression scale （SDS） score， were compared before and after treatment to determine the clinical efficacy， with adverse effects recorded. ResultThe total effective rate for insomnia was 85.3%（29/34） in treatment group and 17.6%（6/34） in control group（Z=-5.582，P<0.01）. After treatment， PSQI score， modified Kupperman index， TCM syndrome score， and SAS score were improved in both groups （P<0.05， P<0.01）， particularly the treatment group which showed significant difference from the control group （P<0.05，P<0.01）. The safety indicators were insignificantly different between two groups before and after treatment. No related adverse effects were reported in both groups during the treatment. ConclusionZishui Bugan decoction can improve the sleep quality and alleviate the menopausal symptoms， such as depression and anxiety， which shows ideal efficacy and safety for the perimenopausal insomnia with liver-kidney deficiency type.

Taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana e hidrocoloide em pó: ensaio clínico randomizado / Healing rate in diabetic foot ulcers treated with biomembrane and hydrocolloid powder: randomized clinical trial / Tasa de curación en la úlceras de pie diabético tratados con biomembrana e hidrocoloide en polvo: ensayo clínico aleatorizado

Objetivo:avaliar taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana de proteínas do látex de Calotropis procera (BioMem CpLP) quando comparada ao hidrocoloide em pó. Método: ensaio clínico randomizado controlado, registrado pelo Registro Brasileiro de Ensaio Clínico (REBEC), conforme protocolo RBR-98f3j9, realizado junto a oito pessoas com pé diabético, em ambulatório de pé diabético, de março a julho de 2019. No grupo experimental (n=04), realizou-se a aplicação de biomembrana; no grupo controle (n=04), utilizou-se o pó de hidrocoloide. A taxa de cicatrização foi avaliada com 30 e 60 dias após início do tratamento. Resultados: não se constataram diferenças estatísticas entre taxas de cicatrização do grupo controle e do grupo experimental na análise temporal dos 30 dias iniciais (p=0,726) e nos 60 dias subsequentes ao início do tratamento (p=0,562). Conclusão: a BioMem CpLP apresentou taxas de cicatrização semelhantes ao produto convencional, configurando-se como alternativa eficaz e de baixo custo para o tratamento de pés diabéticos.

Objective:to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

Principios generales que rigen la investigación científica en contexto de gran altitud, caso Bolivia: diagnóstico de anemia en altitud / General principles governing scientific research in a high altitude context, case of Bolivia: diagnosis of anemia at altitude

La importancia de la investigación científica referida a la definición de la anemia por deficiencia de hierro en altitud, se relaciona con los hallazgos de los estudios realizados y que permiten avanzar al conocimiento científico, en poblaciones vulnerables, siendo que están dirigidos a mejorar la salud pública e influir en políticas de salud. Se presenta el análisis y reflexión de una innovadora modalidad para nuestro medio de altitud, basada en la suplementación con hierro y folatos para definir anemia en la población estudiada, situación que difiere de investigaciones previas sobre el tema en nuestro contexto de altitud. Estos estudios han tenido un escrutinio intenso de parte de los revisores que han valorado las publicaciones sobre anemia ferropénica a gran altitud. La claridad de los diseños de ensayos clínicos formales y controlados aleatorizados, pertinentes en tiempo y necesarios por su importancia fueron realizados, en regiones de altitud de Bolivia. La falta de reconocimiento por terceros de este nivel de evidencia logrado, equivaldría a sustituirlos por estudios de ensayos no formales y no controlados, es decir seguir aplicando diseños de tipo observacional, con contrastación teórica y lógica que solo incrementan el estado de incertidumbre sobre el tema en Bolivia. El sumario presentado de la historia sobre la anemia ferropénica en regiones de altitud en Bolivia nos permite reflexiones importantes, a saber: 1. Es importante resaltar, como claro ejemplo, que la observación simple puede llevar a la incertidumbre y lo costoso de sus consecuencias futuras por la persistencia de la anemia ferropénica en poblaciones de altitud, más aún si se mantiene el posible manejo de prueba y error en resultados difundidos. 2. Se demuestra la necesidad de los controles en la investigación científica, y finalmente 3. Los ensayos clínicos controlados aleatorizados son la mejor fuente de evidencia confiable.

The importance of scientific research related to the definition of iron deficiency anemia at altitude is related to the findings of the studies carried out and that allow advancing scientific knowledge, in vulnerable populations, being that they are aimed at improving public health and influence health policies. The analysis and reflection of an innovative modality for our altitude environment is presented, based on supplementation with iron and folates to define anemia in the studied population, a situation that differs from previous research on the subject in our altitude context. These studies have received intense scrutiny from reviewers who have evaluated the publications on high altitude iron deficiency anemia. The clarity of the designs of formal and randomized controlled clinical trials, pertinent in time and necessary due to their importance, were carried out in highland regions of Bolivia. The lack of recognition by third parties of this level of evidence achieved, would be equivalent to replacing them with studies of non-formal and uncontrolled trials, that is, to continue applying observational designs, with theoretical and logical contrast that only increase the state of uncertainty on the subject in Bolivia. The summary presented of the history of iron deficiency anemia in high-altitude regions of Bolivia allows us important reflections, namely: 1. It is important to highlight, as a clear example, that simple observation can lead to uncertainty and the cost of its future consequences due to the persistence of iron deficiency anemia in high altitude populations, even more so if the possible trial and error management is maintained in disseminated results. 2. The need for controls in scientific research is demonstrated, and finally 3. Randomized controlled clinical trials are the best source of reliable evidence.

Efeito de um guia autoinstrucional para raciocínio clínico na acurácia diagnóstica de estudantes de bacharelado em enfermagem: ensaio clínico randomizado / Effect of a self-instructional guide to clinical reasoning on the diagnostic accuracy of undergraduate nursing students: a randomized clinical trial

Resumo: Objetivou-se avaliar o efeito de um Guia Autoinstrucional para Raciocínio Clínico na acurácia diagnóstica de estudantes de bacharelado em enfermagem durante a resolução de estudos de caso. Realizou-se ensaio clínico randomizado paralelo e cego, com duas fases, e grupo intervenção (que utilizou o guia) e controle (sem utilizar o guia). A coleta de dados ocorreu de fevereiro a junho de 2019 com estudantes de quatro turmas de dois cursos graduação em Enfermagem no Paraná. Foram incluídos acadêmicos regularmente matriculados, presentes na primeira fase da aplicação e que cursaram, com aprovação, as disciplinas de Fundamentos do Cuidado de Enfermagem e Enfermagem em Saúde do Adulto e do Idoso e correspondentes. Foram excluídos acadêmicos com diagnóstico médico de dislexia e que não completaram a resolução do estudo de caso na segunda fase. Utilizou-se dois estudos de caso validados e que simularam paciente com dificuldade respiratória. A atividade requeria que o estudante identificasse um diagnóstico/problema de enfermagem prioritário do paciente, a etiologia (causa) desse problema e as pistas (sinais e sintomas) que justificavam esse problema. Para avaliar a acurácia das respostas utilizou-se rubricas validadas e baseadas na Escala de Acurácia Diagnóstica de Lunney, sendo realizado consenso, pós avaliação, por duas pesquisadoras. Foi utilizada estatística descritiva para os dados demográficos; teste exato de Fisher para determinar similaridades na educação prévia, sexo e confiança do estudante quanto ao conhecimento e seu uso; teste de Mann-Whitney para análise da idade; teste Anova não paramétrico para medidas repetidas na avaliação da hipótese de existir diferença na evolução da pontuação dos estudantes, ao longo de tempo, nos dois grupos. Valores de p<0,05 foram considerados significativos. A amostra final foi composta por 51 estudantes, 24 alocados no grupo controle e 27 no grupo intervenção; 82,4% (n=42) do sexo feminino e 98% (n=50) cursando a primeira graduação; com média de idade de 22 anos e sem diferença entre os grupos. Foi identificado diminuição dos escores, com diferença estatística, entre primeira e segunda fase para acurácia diagnóstica (p=0,041) e para acurácia etiológica (p=0,0351) no grupo intervenção na fase 2. Houve redução na identificação de pistas relevante nos dois grupos, porém sem diferença estatística. Observou-se efeito negativo na utilização do Guia; infere-se que a aplicação única e não explicação prévia pode ter influenciado os resultados. Considerando o potencial do Guia no desenvolvimento do raciocínio clínico e acurácia diagnóstica de estudantes sugere-se sua aplicação, como ferramenta didática, ao longo do semestre, com explicação prévia do professor, com vistas a favorecer a qualidade na assistência e segurança do paciente

Abstract: This study aimed to evaluate the effect of a Self-instructional Guide for Clinical Reasoning on the diagnostic accuracy of baccalaureate nursing students during case study solving. A blind and parallel randomized clinical trial was performed, with two phases, and intervention (using the guide) and control (without using the guide) group. Data collection took place from February to June 2019 with students from four classes of two undergraduate Nursing courses in the State of Paraná, Brazil. Those who were regularly enrolled, present in the first phase of the application and attended, with approval, the subjects of Fundamentals of Nursing Care and Adult and Elderly Health and their correspondents were included; Those with a medical diagnosis of dyslexia or who did not complete the resolution of the second phase case study were excluded. Two validated case studies were used, which simulated patients with difficulty breathing. The activity required the student to identify a patient's priority nursing diagnosis/patient problem, the etiology of this problem and the clues (signs and symptoms) that justified this problem. To assess the accuracy of the answers, validated rubrics were used, based on the Lunney Diagnostic Accuracy Scale, with consensus, after evaluation, by two researchers. Descriptive statistics were used for demographic data; Fisher's exact test to determine similarities in prior education, gender, and student confidence in knowledge and use; Mann-Whitney test for age analysis; Nonparametric Anova test for repeated measures in the evaluation of the hypothesis that there is a difference in the evolution of students' scores over time in both groups. P values <0.05 were considered significant. The final sample consisted of 51 students, 24 in the control group and 27 in the intervention group; 82.4% (n = 42) female and 98% (n = 50) attending the first graduation; with an average age of 22 years and with no difference between groups. Decreased scores were identified, with statistical difference between phase 1 and 2 for diagnostic accuracy (p=0.041) and for etiological accuracy (p=0.0351) in the phase 2 intervention group. There was a reduction in the identification of relevant clues in both groups, however without statistical difference. There was a negative effect on the use of the Guide; It can be inferred that a single application without a previous explanation may have influenced the results. Considering the potential of the Guide in the development of clinical reasoning and diagnostic accuracy of students, its application is suggested as a didactic tool throughout the semester, with a prior explanation of the teacher, to favor quality care and patient safety.

Team-Based Learning: a randomized clinical trial in undergraduate nursing / Aprendizaje Basado en Equipos: un ensayo clínico randomizado en la graduación en enfermería / Aprendizagem baseada em equipes: um ensaio clínico randomizado na graduação em enfermagem

ABSTRACT Objectives: To compare the knowledge on surgical safety through the team-based learning methodology and lecture classes for undergraduate Nursing students, and evaluate the learning satisfaction with team-based learning. Methods: Randomized, controlled, parallel, two-arm, unblinded clinical trial developed in the Faculty of Medicine of a public university in Botucatu, Brazil. The groups included 14 students for team-based learning and 11 students for lecture classes. Results: Students' apprehension of knowledge in the team-based learning group was significantly higher compared to the control group (p<0.002) by considering the pre-test results. After 30 days, there was no significant difference between groups. The experience with the methodology was considered positive among students. Conclusions: Team-based learning is an important pedagogic tool available and has proven effective in education and learning with students playing the role of protagonists.

RESUMEN Objetivos: Comparar la aprehensión del conocimiento en seguridad quirúrgica por la metodología del aprendizaje basada en equipos y clase expositiva para alumnos de graduación en enfermería y evaluar la satisfacción del aprendizaje en el aprendizaje basado en equipos. Métodos: Ensayo clínico aleatorizado, controlado, paralelo, con dos brazos, no ciego, desarrollado en una universidad pública ubicada en Botucatu, Brasil. Los grupos fueron compuestos por 14 alumnos para el aprendizaje basado en equipos y 11 alumnos para clase expositiva. Resultados: La aprehensión del conocimiento de los alumnos del grupo aprendizaje basado en equipos fue significativamente mayor comparado al grupo control (p <0,002) considerados los resultados del pre-test. Después de los 30 días, no hubo diferencia significativa entre los grupos. La experiencia con la metodología fue considerada positiva entre los alumnos. Conclusiones: El aprendizaje basado en equipos es una importante herramienta pedagógica disponible y se muestra eficaz en el proceso de enseñanza-aprendizaje teniendo al alumno como su protagonista.

RESUMO Objetivos: Comparar a apreensão do conhecimento em segurança cirúrgica pela metodologia da aprendizagem baseada em equipes e aula expositiva dialogada para alunos de graduação em enfermagem e avaliar a satisfação do aprendizado na aprendizagem baseada em equipes. Métodos: Ensaio clínico randomizado, controlado, paralelo, com dois braços, sem cegamento, desenvolvido em uma universidade pública paulista. Os grupos foram compostos por 14 alunos para aprendizagem baseada em equipes e 11 alunos para aula expositiva dialogada. Resultados: A apreensão de conhecimento dos alunos do grupo aprendizagem baseada em equipes foi significativamente maior em comparação com o grupo controle (p<0,002) considerados os resultados do pré-teste. Após os 30 dias, não houve diferença significativa entre os grupos. A experiência com a metodologia foi considerada positiva entre os alunos. Conclusões: A aprendizagem baseada em equipes é uma importante ferramenta pedagógica disponível e mostra-se eficaz no processo de ensino-aprendizagem tendo o aluno como seu protagonista.

Team-Based Learning: a randomized clinical trial in undergraduate nursing / Aprendizaje Basado en Equipos: un ensayo clínico randomizado en la graduación en enfermería / Aprendizagem baseada em equipes: um ensaio clínico randomizado na graduação em enfermagem

ABSTRACT Objectives: To compare the knowledge on surgical safety through the team-based learning methodology and lecture classes for undergraduate Nursing students, and evaluate the learning satisfaction with team-based learning. Methods: Randomized, controlled, parallel, two-arm, unblinded clinical trial developed in the Faculty of Medicine of a public university in Botucatu, Brazil. The groups included 14 students for team-based learning and 11 students for lecture classes. Results: Students' apprehension of knowledge in the team-based learning group was significantly higher compared to the control group (p<0.002) by considering the pre-test results. After 30 days, there was no significant difference between groups. The experience with the methodology was considered positive among students. Conclusions: Team-based learning is an important pedagogic tool available and has proven effective in education and learning with students playing the role of protagonists.

RESUMEN Objetivos: Comparar la aprehensión del conocimiento en seguridad quirúrgica por la metodología del aprendizaje basada en equipos y clase expositiva para alumnos de graduación en enfermería y evaluar la satisfacción del aprendizaje en el aprendizaje basado en equipos. Métodos: Ensayo clínico aleatorizado, controlado, paralelo, con dos brazos, no ciego, desarrollado en una universidad pública ubicada en Botucatu, Brasil. Los grupos fueron compuestos por 14 alumnos para el aprendizaje basado en equipos y 11 alumnos para clase expositiva. Resultados: La aprehensión del conocimiento de los alumnos del grupo aprendizaje basado en equipos fue significativamente mayor comparado al grupo control (p <0,002) considerados los resultados del pre-test. Después de los 30 días, no hubo diferencia significativa entre los grupos. La experiencia con la metodología fue considerada positiva entre los alumnos. Conclusiones: El aprendizaje basado en equipos es una importante herramienta pedagógica disponible y se muestra eficaz en el proceso de enseñanza-aprendizaje teniendo al alumno como su protagonista.

RESUMO Objetivos: Comparar a apreensão do conhecimento em segurança cirúrgica pela metodologia da aprendizagem baseada em equipes e aula expositiva dialogada para alunos de graduação em enfermagem e avaliar a satisfação do aprendizado na aprendizagem baseada em equipes. Métodos: Ensaio clínico randomizado, controlado, paralelo, com dois braços, sem cegamento, desenvolvido em uma universidade pública paulista. Os grupos foram compostos por 14 alunos para aprendizagem baseada em equipes e 11 alunos para aula expositiva dialogada. Resultados: A apreensão de conhecimento dos alunos do grupo aprendizagem baseada em equipes foi significativamente maior em comparação com o grupo controle (p<0,002) considerados os resultados do pré-teste. Após os 30 dias, não houve diferença significativa entre os grupos. A experiência com a metodologia foi considerada positiva entre os alunos. Conclusões: A aprendizagem baseada em equipes é uma importante ferramenta pedagógica disponível e mostra-se eficaz no processo de ensino-aprendizagem tendo o aluno como seu protagonista.

Chinese Medicine Sequential Therapy Improves Pregnancy Outcomes after Surgery for Endometriosis-Associated Infertility: A Multicenter Randomized Double-blind Placebo Parallel Controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy and safety of Chinese medicine (CM) improving pregnancy outcomes after surgery for endometriosis-associated infertility.@*METHODS@#A multicenter, randomized, double-blind placebo parallel controlled clinical trial was designed. A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017, 101 patients in each group. The two groups received continuous intervention at 1-5 days after surgery, for 6 menstrual cycles. Before ovulation, the CM group was treated Huoxue Xiaoyi Granule (); after ovulation, Bushen Zhuyun Granule ( was involved. The control group was treated with placebo. Transvaginal ultrasonography was performed every menstrual cycle during the treatment, and female hormone levels in the follicular and luteal phases were measured during the 1st, 3rd and 6th menstrual cycles. The analysis was continued until pregnancy. The primary outcomes were clinical pregnancy rate and pregnancy outcome, and the secondary outcomes were follicular development and endometrial receptivity. Safety evaluations were performed before and after treatment.@*RESULTS@#(1) Clinical pregnancy and live birth rates: the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group [44.6% (45/101) vs. 29.7% (30/101), 34.7% (35/101) vs. 20.8% (21/101), both P0.05).@*CONCLUSION@#Strategies for activating blood circulation-regulating Gan (Liver)-tonifying Shen (Kidney) sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosis-associated infertility with qi stagnation and blood stasis after laparoscopy, improve follicular development, promote ovulation, improve endometrial receptivity, while being a safe treatment option. (Trial registration No. NCT02676713).

Chinese medicine synthesis rehabilitation in treatment of neurogenic bladder urinary retention after incomplete spinal cord injury: A multicenter randomized controlled clinical trial / 吉林大学学报(医学版)

Objective: To discuss the curative effect of Chinese medicine synthesis rehabilitation in the treatment of neurogenic bladder dysfunction after incomplete spinal cord injury, and to provide the clinical evidences for its application. Methods: A total of 184 patients meeting the inclusion criteria were randonly divided into trial group ( n=89) and control group (n=95) with central area group method. The patients in two groups were given the intermittent catheterization and the urinary functional training. The patients in trial group were treated by the electricity needle (20 min/time, one time a day, 6 d per week) and the massage (20 min/time, one time a day, 6 d per week). All patients in two groups were treated for 4 courses (2 weeks for a course). The residual urine volumes, the bladder securiey capacities, and the intravesical pressures of the patients in two groups were measured before and after treatment, and the curative effects were evaluated. Results: Compared with before treatment the residual urine volume of the patients in trial group was reduced significantly after treatment ( P0. 05); the residual urine volume of the patients in control group was reduced significantly after treatment ( P0. 05). After treatment, the residual urine volume of the patients in trial group was significantly lower than that in control group ( P0. 05). Conclusion: Chinese medicine synthesis rehabilitation may reduce the residual urine volume of the patients with neurogenic bladder urinary retention after incomplete spinal cord injury, and its curative effect is superior to modern rehabilitation of intermittent catheterization and urinary bladder function training.

Chinese medicine synthesis rehabilitation in treatment of neurogenic bladder urinary retention after incomplete spinal cord injury:A multicenter randomized controlled clinical trial / 吉林大学学报(医学版)

Objective:To discuss the curative effect of Chinese medicine synthesis rehabilitation in the treatment of neurogenic bladder dysfunction after incomplete spinal cord injury, and to provide the clinical evidences for its application.Methods:A total of 184patients meeting the inclusion criteria were randonly divided into trial group (n=89) and control group (n=95) with central area group method.The patients in two groups were given the intermittent catheterization and the urinary functional training.The patients in trial group were treated by the electricity needle (20min/time, one time a day, 6dper week) and the massage (20min/time, one time a day, 6d per week) .All patients in two groups were treated for 4courses (2 weeks for a course) .The residual urine volumes, the bladder securiey capacities, and the intravesical pressures of the patients in two groups were measured before and after treatment, and the curative effects were evaluated.Results:Compared with before treatment the residual urine volume of the patients in trial group was reduced significantly after treatment (P＜0.01) , the bladder security capacity was significantly increased (P＜0.01) , and there was no significant change in intravesical pressure (P＞0.05) ;the residual urine volume of the patients in control group was reduced significantly after treatment (P＜0.01) , there were no significant changes in the bladder security capacity and intravesical pressure (P＞0.05) .After treatment, the residual urine volume of the patients in trial group was significantly lower than that in control group (P＜0.01) , while there were no significant differences in the bladder security capacities and intravesical pressures between two groups (P＞0.05) .Conclusion:Chinese medicine synthesis rehabilitation may reduce the residual urine volume of the patients with neurogenic bladder urinary retention after incomplete spinal cord injury, and its curative effect is superior to modern rehabilitation of intermittent catheterization and urinary bladder function training.

Stress of nursing students in clinical simulation: a randomized clinical trial / Tensión del estudiante de enfermería en la simulación clínica: ensayo clínico aleatorizado / Estresse do estudante de enfermagem na simulação clínica: ensaio clínico randomizado

ABSTRACT Objective: To evaluate and compare the perception of stressors by nursing students before and after a high-fidelity clinical simulation or conventional laboratory practice class. Method: This is a randomized clinical trial conducted with 52 nursing students. Both groups had theoretical classes about cardiothoracic physical examination, followed by practice class in skill laboratory. In addition, the experimental group took part in a high-fidelity simulation scenario. Stressors were evaluated before and after class, with the application of KEZKAK questionnaire. Results: The experimental group was significantly more worried about six factors related to lack of competence and to interpersonal relationships (p < 0.05), while the control group was significantly more worried about being in contact with suffering (p = 0.0315). Conclusion: The simulation affects students' perception of stressors and promotes their self-evaluation and critical thinking regarding the responsibility that comes with their learning.

RESUMEN Objetivo: Evaluar y comparar la percepción de los factores de tensión del estudiante de enfermería antes y después de la simulación clínica de la alta fidelidad o de la clase práctica convencional de laboratorio. Método: Ensayo clínico aleatorizado realizado con 52 estudiantes de enfermería. Ambos grupos tuvieron clase teórica sobre el análisis físico cardiotorácico, después de la clase práctica en laboratorio de habilidades. El grupo experimental participó todavía de un escenario de simulación de alta fidelidad. Los factores de tensión fueron evaluados antes y después de la clase, con la aplicación del cuestionario KEZKAK. Resultados: El grupo experimental se presentó significativamente más preocupado con seis factores relacionados a la falta de competencia y relación interpersonal (p < 0,05), mientras que en el grupo control solamente el factor contacto con el sufrimiento fue significativamente más relevante (p= 0,0315). Conclusión: La simulación interfiere en la percepción de los factores de tensión y promociona una autoevaluación y el reflejo crítico por el alumno delante de la responsabilidad con el aprendizaje.

RESUMO Objetivo: Avaliar e comparar a percepção dos fatores estressores do discente de enfermagem antes e depois da simulação clínica de alta fidelidade ou da aula prática convencional de laboratório. Método: Ensaio clínico randomizado realizado com 52 discentes de enfermagem. Ambos os grupos tiveram aula teórica sobre exame físico cardiotorácico, seguida de aula prática em laboratório de habilidades. O grupo experimental participou ainda de um cenário de simulação de alta fidelidade. Os fatores estressores foram avaliados antes e após a aula, com a aplicação do questionário KEZKAK. Resultados: O grupo experimental apresentou-se significativamente mais preocupado com seis fatores relacionados à falta de competência e relação interpessoal (p < 0,05), enquanto no grupo controle apenas o fator contato com o sofrimento foi significativamente mais relevante (p= 0,0315). Conclusão: A simulação interfere na percepção dos fatores estressores e promove uma autoavaliação e reflexão crítica pelo aluno frente à responsabilidade com o aprendizado.

Efetividade da solução de heparina na prevenção de oclusão do cateter de Hickman®: ensaio clínico randomizado / Effectiveness of heparin solution in preventing Hickman® catheter occlusion: randomized clinical trial

Resumo: O cateter de Hickman® é um cateter venoso central de longa permanência semi-implantado e tem sido utilizado na realização do transplante de células-tronco hematopoéticas por tolerar infusão parenteral intensa, comumente utilizada nesta modalidade terapêutica. Apesar dos seus benefícios, sua utilização não está isenta de complicações, incluindo a oclusão, caracterizada pela impossibilidade de infundir solução em seu lúmen, incapacidade de aspirar sangue do mesmo ou ambos. Manter a permeabilidade de um cateter venoso central é um desafio, pois depende da lavagem e bloqueio com técnicas adequadas. Além disso, há pouca evidência científica para determinar a melhor solução para o bloqueio do cateter. Objetivo: Avaliar a efetividade da solução de heparina 50 UI/mL comparada à solução salina isotônica 0,9%na prevenção de oclusão do Cateter de Hickman® em pacientes submetidos a transplante de células-tronco hematopoéticas. Método: Ensaio clínico randomizado triplo cego, realizado no serviço de transplante de medula óssea de um hospital público de ensino, no período de março a setembro/2017. Participaram pacientes submetidos a transplante de células-tronco hematopoéticas, os quais foram alocados aleatoriamente no grupo heparina (n=7) e no grupo solução salina isotônica 0,9% (n=10) para bloqueio do cateter. Resultados: Foram avaliados 17 cateteres duplo lúmen, em que as duas vias do cateter foram analisadas separadamente, totalizando 34 lumens. O grupo heparina foi composto de sete cateteres (41,17%) e o grupo solução salina isotônica 0,9%, de dez cateteres (58,83%). A média de dias até o desfecho oclusão foi de 52 no grupo heparina e 13,46 no grupo solução salina isotônica 0,9% na via branca do cateter (p<0,001). Na via vermelha, a média de dias de acompanhamento do grupo heparina foi de 35,29, sem ocorrência de oclusão e, de 22,30 no grupo solução salina isotônica 0,9% até a primeira oclusão (p=0,030). Uma análise secundária realizada de acordo com a via avaliou que a via branca teve 14,28% de oclusão (n=1) no grupo heparina, caracterizada como oclusão completa e 90% de oclusões (n=9) no grupo solução salina isotônica 0,9%, sendo três oclusões completas (30%) e seis oclusões sem refluxo (60%), mostrando diferença significativa entre os grupos (p=0,006). A via vermelha não apresentou oclusão no grupo heparina, já no grupo solução salina isotônica 0,9% ocorreram cinco oclusões (50%), sendo uma oclusão completa (10%) e quatro oclusões sem refluxo (40%) (p=0,084). Conclusões: Houve diferença significativa em relação ao número de dias até o desfecho oclusão da via branca do cateter, utilizando a solução de heparina 50UI/mL em relação à solução salina isotônica 0,9%(p<0,001). E, na via vermelha, apresentou cinco oclusões no grupo solução salina isotônica 0,9%, em uma amostra de dez cateteres versus nenhuma oclusão no grupo heparina. Os resultados da pesquisa evidenciaram que o bloqueio com solução de heparina 50 UI/mL é mais efetivo em relação à solução salina isotônica 0,9%, na prevenção da oclusão do CVCLP-SI de Hickman®.

Abstract: Hickman® catheter is a long-term, semi-implantable central venous catheter used to perform hematopoietic stem-cell transplantation as it takes large infusion volume of parenteral nutrition, commonly used for that therapeutics. Despite its benefits, its use holds some complications, including occlusion, characterized by the infusion blockage into its lumen, incapability to aspirate blood or both hindrances. Keeping the permeability of a central venous catheter is challenging, once it depends on proper techniques for flushing and locking. Moreover, there is scarce scientific evidence to determine the best solution to catheter obstruction. Objective: To assess the effectiveness of 50 IU/mL heparin flush compared to 0.9% isotonic saline solution in order to prevent the occlusion of the Hickman® catheter in patients undergoing hematopoietic stem-cell transplantation. Method: Triple-blinded randomized clinical trial, carried out in the bone-marrow transplantation service of a public teaching hospital between March and September/2017. The participants were patients undergoing hematopoietic stem-cell transplantation, randomly placed in the heparin flush group (n=7), and in the 0.9% isotonic saline solution group (n=10) for catheter patency. Results: 17 double-lumen catheters were assessed, with their two tubes being separately analyzed, totaling 34 lumens. The heparin flush group comprised seven catheters (41.17%), and the 0.9% isotonic saline solution group entailed ten catheters (58.83%). Mean catheter duration until occlusion was 52 days in the heparin group, and 13.46 days in the 0.9% isotonic saline solution group for the white lumen of the catheter (p<0.001), and 35.29 days in the heparin flush group, and 22.30 days in the 0.9% isotonic saline solution group without occlusion for the red lumen of the catheter (p=0.030). A secondary lumen analysis evidenced that the white lumen had 14.28% of occlusions (n=1) in the heparin flush group, featuring complete occlusion, and 90% of occlusions (n=9) in the 0.9% isotonic saline solution group, featuring three complete occlusions (30%), and six occlusions without reflux (60%), showing significant difference between the groups (p=0.006). The red lumen of the catheter did not evidence any occlusions in the heparin flush group, while in the 0.9% isotonic saline solution group, five occlusions occurred, that is, a complete occlusion (10%), and four occlusions without reflux (40%) (p=0.084). Conclusions: There was significant difference regarding the days of catheter duration until occlusion for the white lumen of the catheter, which used 50 IU/mL heparin flush, comparing to the use of 0.9% isotonic saline solution (p<0.001). As for the red lumen, it featured five occlusions in the 0.9% isotonic saline solution group for a sample of ten catheters versus no occlusions in the heparin flush group.The results in this research study evidenced that 50 IU/mL heparin flush patency is more effective than 0.9% isotonic saline solution in order to prevent the obstruction of the Hickman®'s long-term, semi-implantable central venous catheter.

Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial / Influencia del Juguete Terapéutico en la ansiedad de niños en edad escolar hospitalizados: Ensayo clínico / Influência do Brinquedo Terapêutico na ansiedade de crianças escolares hospitalizadas: Ensaio clínico

ABSTRACT Objective: To evaluate the effects of Dramatic Therapeutic Play (DTP) technique on the degree of anxiety in hospitalized school-age children. Method: Randomized clinical trial performed in two hospitals ofSão Paulo, between May and October 2015. The intervention consisted of the application of DTP and the outcome was evaluated through the Child Drawing: Hospital (CD: H) instrument. The Wilcoxon-Mann Whitney, Corrected t, Fisher's exact and Chi-square tests were used in the analysis. Statistical significance was set at 5%. Results: In all, 28 children participated in the study. The majority of children (75%) had a low anxiety score, with a mean CD: H score of 73.9 and 69.4 in the intervention and control groups respectively, and with no significant difference. Conclusion: Children submitted to DTP had the same degree of anxiety as those in the control group. However, it is suggested that new studies be performed with a larger number of children in different hospitalization scenarios.

RESUMEN Objetivo: Evaluar los efectos de la aplicación de la técnica del Juguete Terapéutico Dramático (BTD) en el grado de ansiedad en niños en edad escolar hospitalizados. Método: Ensayo clínico aleatorizado realizado en dos hospitales de São Paulo, entre mayo y octubre de 2015. La intervención consistió en la aplicación del BTD y el resultado fue evaluado por medio del instrumento Child Drawing: Hospital (CD:H). Se utilizó en el análisis los testesWilcoxon-Mann Whitney, T corregido, Exacto de Fisher y Qui-cuadrado con significancia de 5%. Resultados: Participaron del estudio 28 niños. La mayoría de los niños de ambos los grupos (75%) presentó clasificación de bajo grado de ansiedad, siendo la puntuación media del instrumento CD:H en el grupo intervención de 73,9 y en el grupo control de 69,4, sin diferencia significativa. Conclusión: Los niños sometidos al BTD presentaron el mismo grado de ansiedad que los del grupo control. Sin embargo, se sugiere que nuevos estudios sean realizados con mayor número de niños en variados escenarios de la hospitalización.

RESUMO Objetivo: Avaliar os efeitos da aplicação da técnica do Brinquedo Terapêutico Dramático (BTD) no grau de ansiedade em crianças escolares hospitalizadas. Método: Ensaio clínico randomizado realizado em dois hospitais de São Paulo, entre maio e outubro de 2015. A intervenção consistiu na aplicação do BTD e o desfecho foi avaliado por meio do instrumento Child Drawing: Hospital (CD:H). Utilizaram-se na análise os testes Wilcoxon-Mann Whitney, T corrigido, Exato de Fisher e Qui-quadrado com significância de 5%. Resultados: Participaram do estudo 28 crianças. A maioria das crianças de ambos os grupos (75%) apresentou classificação de baixo grau de ansiedade, sendo o escore médio do instrumento CD: H no grupo intervenção de 73,9 e no grupo controle de 69,4, sem diferença significativa. Conclusão: As crianças submetidas ao BTD apresentaram o mesmo grau de ansiedade que as do grupo controle. Entretanto, sugere-se que novos estudos sejam realizados com maior número de crianças em variados cenários da hospitalização.

A non-randomized controlled clinical trials：therapeutic effect of sanyrene on diabetic skin pruritus / 中国实用护理杂志

Objective To explore the role of sanyrene in decreasing skin itching and observe its therapeutic effect on skin pruritus in patients with diabetes. Methods According to the principle of voluntary patients, 221 cases were divided into three groups: conventional therapy plus calamine smear including 80 cases, conventional therapy plus sanyrene including 80 cases and the conventional treatment only control group including 61 cases. Results Generalized estimating equations were established. Referring to the control group, model one was established. The coefficients in sanyrene treatment and calamine control group were 2.20 and 1.29 respectively (P<0.01). The therapeutic efficacy was significantly increased with 9.03 (OR=e2.20) times in sanyrene group and 3.63 (OR=e1.29) times in calamine group compared to the blank control,indicating effect of sanyrene and calamine were better than the control group;Referring to calamine group, Model two was established,shows better efficacy of sanyrene in calamine. The coefficients in sanyrene treatment and blank control group were 0.91 and-1.29 respectively (P<0.01). The therapeutic efficacy was significantly increased 2.48 (OR = e0.91) times in sanyrene group and 0.28 (OR = e-1.29) times in blank group compared to calamine control. Conclusions Sanyrene is effective in improving in diabetic skin pruritus situation. And compared with calamine, the treatment efficacy of sanyrene is better, which suggesting that sanyrene can be used in the clinical treatment of diabetic skin pruritus.

Difference in Clinical Effect between Deep and Superficial Acupuncture Needle Insertion for Neck-shoulder Pain: a Randomized Controlled Clinical Trial Pilot Study / 日本温泉気候物理医学会雑誌

Objective: The purpose of this study was to compare the effects of superficial and deep insertion of acupuncture needles in the treatment of patients with neck-shoulder pain and to search for more effective acupuncture methods. Methods: The subjects were patients seen at the Meiji University of Integrative Medicine’s Department of Orthopedic Surgery Clinic. A randomized controlled clinical trial was conducted in which 20 patients with neck-shoulder pain were randomly allocated to either a superficial acupuncture group (n=10) or a deep acupuncture group (n=10). Treatment was applied to points where patients experienced the most pain. The maximum number of stimulation points for both groups was 10. In the superficial acupuncture group, the needle was only inserted to a depth of 5 millimeter. In the deep acupuncture group, the needle was inserted to a depth of 15 to 20 millimeter. Both groups were manually stimulated using a sparrow pecking method over 20 seconds, after which the needle was removed. Both groups were treated weekly for four weeks. The primary outcome measurement was intensity of pain evaluated using a Visual Analogue Scale (VAS). The secondary outcome measurement was the Neck Disability Index (NDI) for the purpose of evaluating the grade of disability in daily life due to neck-shoulder pain. Results: There were no significant differences in age, male-female ratio, disease duration, or the initial scores of VAS and NDI between the two groups. VAS and NDI scores indicated significant differences between the groups (VAS: <0.0001, NDI: p<0.0001) in change over time, with the deep acupuncture group having more favorable results than the superficial acupuncture group. The degree of change from the baseline at the time of each evaluation was calculated, and results for the two groups were compared. The deep acupuncture group showed significantly better improvement in the sustained effects after completion of treatment (VAS: p<0.05). There were no significant differences directly after the first treatment (VAS: p=0.72) or in cumulative effect after repeated treatment (VAS: p=0.24). Discussion and Conclusion: The results of this study suggested it would be more efficient to insert the needle to deep tissues when performing acupuncture treatment on subjective pain sites. The difference in the effects between the two acupuncture methods may be due to the difference in tissue stimulation received. The difference in effect is thought to be due to the differing influence of treatment on pain threshold, muscle blood flow, and muscle tones.