The Construction and Improvement of the Protection System for the Rights and Interests of Human Subjects in Trial Institutions from the Ethical Perspective: Taking a Hospital in Anhui Province as an Example / 中国医学伦理学

This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.

Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent / 中国医学伦理学

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.

Evaluation of anxiolytic effect of combination of tramadol with gabapentin and pregabalin in Wistar rats

Background: Anxiety is a widespread disorder that approximately 18% of the population experience at some stage in their lives. Pain is a common stimulus that induces anxiety in both animals and human beings. Combination of drugs with good anti-anxiety and analgesic effect can be used for the treatment of chronic pain induced anxiety, post-operative, and procedure-related pain-induced anxiety. Aims and Objectives: The study was conducted to evaluate the anxiolytic activity of combination of gabapentin with tramadol, pregabalin with tramadol compared to standard fluoxetine, in elevated plus maze (EPM) and light-dark arena (LDA) models of anxiety in Wistar albino rats. Materials and Methods: Twenty-four male or female albino Wistar rats from Central Animal House, MRMC, Kalaburagi, were utilized. Fluoxetine 10 mg/kg, gabapentin 30 mg/kg, tramadol 30 mg/kg, and pregabalin 30 mg/kg were used. Eddy’s hot plate method used for inducing anxiety. EPM and LDA models were used to study the effect of drugs in reducing the pain and anxiety. Results: The present study showed that the exposure to hot plate induces pain, creates anxiety, and reduces locomotor and explorative activity among the rats when exposed to hot plate. There was reduction in anxiety after drug administration, in fluoxetine and gabapentin with tramadol groups with >75% increase in entry into the light chamber or open arm at least once or more during the time period of 5 min when compared to hot plate post-exposure readings. Whereas in pregabalin and tramadol group, it was observed that 25% increase in entry of rats into open arm at least once during the time period of 5 min and 25% decrease in entry of rats into light chamber as compared to those rats after exposure to hot plate. Conclusion: Our study has demonstrated that tramadol, pregabalin, and gabapentin have got analgesic as well as anti-anxiety effects in rats when given in combination. All these experimental data, together with the previous experimental studies and the results reported in this work, suggest that combination of these drugs could be more effective in treating anxiety-related disorders such as chronic pain, pain-induced anxiety, post-operative, and procedure-related pain-induced anxiety with minimal side effects. Further dose ranging studies and models might be necessary to better understand the effects of these drugs in combination.

Retromolar canal diagnosed by cone-beam computed tomography and its influence in inferior alveolar nerve block / Canal retromolar diagnosticado por tomografía computarizada de haz cónico y su influencia en el bloqueo del nervio alveolar inferior

The aim of this study was to observed the anesthetic efficacy of the alveolar nerve block on nine patients that CBCT diagnosed unilateral retromolar canal on a double-blind, split-mouth approach. The assessments of patient response to thermal (pulp vitality test) and pressure (compression of soft tissue) stimuli were carried out before and 5 minutes after the inferior alveolar nerve block procedure, using both visual analog scale (VAS) and Mc Gill pain questionnaires (McG). The mean percentage of patient response decreased after alveolar nerve block, according to both VAS and McG, and was statistically similar among hemi mandibles with and without retromolar canal (Wilcoxon>0.05); however, those without retromolar canal presented greater reduction in patient response in 6 out of 9 cases. Therefore, the retromolar canal is not a determinant factor of inferior alveolar nerve block failure.

El objetivo de este estudio fue observar la eficacia anestésica del bloqueo del nervio alveolar en nueve pacientes que CBCT diagnosticó canal retromolar unilateral en un abordaje de boca dividida doble ciego. Las evaluaciones de la respuesta del paciente a los estímulos térmicos (prueba de vitalidad pulpar) y de presión (compresión de los tejidos blandos) se realizaron antes y 5 minutos después del procedimiento de bloqueo del nervio alveolar inferior, utilizando tanto la escala analógica visual (VAS) como los cuestionarios de dolor de Mc Gill ( McG). El porcentaje medio de respuesta de los pacientes disminuyó tras el bloqueo del nervio alveolar, según EVA y McG, y fue estadísticamente similar entre hemimandíbulas con y sin canal retromolar (Wilcoxon>0,05); sin embargo, aquellos sin canal retromolar presentaron mayor reducción en la respuesta del paciente en 6 de 9 casos. Por lo tanto, el canal retromolar no es un factor determinante del fracaso del bloqueo del nervio alveolar inferior.

Caracterización clínico-epidemiológica de pacientes pediátricos con intento suicida en el Hospital Pediátrico Provincial de Holguín

Fundamento los intentos de suicidio en edades pediátricas son un problema actual con tendencia creciente a nivel mundial. Este grupo es muy vulnerable a la acción de factores internos y externos que alteran su integridad. En Cuba, a pesar de los logros obtenidos en ese sentido, también se considera como un problema de salud mental. Objetivo caracterizar desde el punto de vista clínico y epidemiológico a pacientes pediátricos con intento suicida. Métodos se realizó un estudio descriptivo, retrospectivo y de corte transversal, en el Hospital Pediátrico Provincial Octavio Concepción y de la Pedraja, de la provincia de Holguín, en el periodo enero/2020-diciembre/2021. Se trabajó con la totalidad del universo, conformado por 397 pacientes atendidos en la institución hospitalaria por intento suicida en el periodo de estudio. Las variables estudiadas fueron: edad, sexo, procedencia y método utilizado. Se empleó la estadística descriptiva. Resultados predominaron los pacientes con edades entre 16 y 18 años (48,4 %), del sexo femenino (74,6 %) y de procedencia urbana (70,3 %). El 92,2 % utilizó como método de suicidio la ingestión de psicofármacos. Conclusiones las variables estudiadas se comportan de forma similar a lo descrito en otras poblaciones y contextos, en los cuales también predominaron las adolescentes de procedencia urbana que ingirieron psicofármacos.

Background suicide attempts in pediatric ages are a current problem with a growing trend worldwide. This group is very vulnerable to the action of internal and external factors that alter their integrity. In Cuba, despite the achievements in this regard, it is also considered a mental health problem. Objective to characterize, from the clinical and epidemiological point of view, pediatric patients with suicide attempts. Methods a descriptive, retrospective and cross-sectional study was carried out at the Octavio Concepción y de la Pedraja Provincial Pediatric Hospital, in the Holguín province, from January/2020 to December/2021. The entire universe was analyzed made up of 397 patients, treated at the hospital for suicide attempts during the studied period. The variables were: age, sex, origin and method used. Descriptive statistics were used. Results patients aged between 16 and 18 years old (48.4%), female (74.6%) and urban origin (70.3%) predominated. 92.2% used the ingestion of psychotropic drugs as a method of suicide. Conclusions the studied variables behave in a similar way to that described in other populations and contexts, in which adolescents from urban origin who ingested psychoactive drugs also predominated.

Clinical tolerability and pharmacokinetics of troxacitabine / 中华肿瘤杂志

Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).

Drafting reports of clinical studies / 上海预防医学

Clinical research reports serve as the presentation of scientific research findings and directly reflect the quality of the research. This article describes the writing of different types of clinical research reports， such as observational studies and randomized controlled trial studies， with a particular focus on randomized controlled trials. Each scientific research design has its reporting focus， and the writing of scientific research papers has uniform requirements and a specific writing format. Mastering the proper format of drafting research reports is of practical value and significant importance for conduction high-quality clinical research.

Qianjin Weijingtang in Treatment of Chronic Obstructive Pulmonary Disease： A Review / 中国实验方剂学杂志

Chronic obstructive pulmonary disease （COPD） is a chronic heterogeneous airway disease characterized by persistent and progressive airflow restriction， which can be divided into stable COPD and acute exacerbations of COPD （AECOPD）. Its morbidity and mortality remain high， posing a serious threat to human health. Traditional Chinese Medicine （TCM） believes that COPD belongs to the categories of "cough"， "dyspnea syndrome"， "lung distension"， etc. And its basic pathogenesis is intermingled phlegm and stasis with deficiency in origin and excess in superficiality. Qianjin Weijingtang， derived from the Records of Proved Prescriptions， Ancient and Modern （古今录验方）， consists of Phragmitis Caulis， Persicae Semen， Coicis Semen， and Benincasae Semen， with remarkable functions in clearing the lung， resolving phlegm and eliminating blood stasis， and has definite clinical efficacy in treating COPD and its syndromes. At present， in clinical studies， Qianjin Weijingtang has been used to treat COPD with modifications. It can be used alone or in combination with other prescriptions/western medicines to treat stable COPD， AECOPD， COPD complications， and other TCM syndromes of COPD such as phlegm-heat-stagnation obstructing the lung syndrome. It can significantly improve clinical symptoms， lung function， and blood gas indexes， and inhibit inflammatory response. Animal experiments mainly explored the mechanism of COPD from the level of pathological changes. Specifically， the underlying mechanism may be related to regulating T helper 17 （Th17）/regulatory T cells （Treg） balance， up-regulating single immunoglobulin IL-1-related receptor （SIGIRR） for resisting inflammation， up-regulating hyperplasia suppressor gene （HSG） and inhibiting Wnt signaling pathway activation to inhibit airway remodeling. It was found that there were many problems， such as low quality of clinical research， failure in sharing research standards， and the lack of mechanism research. This article systematically reviewed clinical studies of Qianjin Weijingtang in the treatment of COPD and its mechanism based on animal experiments in recent years， and put forward thoughts and suggestions according to the existing problems to provide references for the clinical application and further research on Qianjin Weijingtang.

Clinical Efficacy of Qihuang Jianpi Zishen Granules in Treating Cardiac Involvement in Systemic Lupus Erythematosus / 中国实验方剂学杂志

ObjectiveTo investigate the clinical efficacy and safety of Qihuang Jianpi Zishen granules in the treatment of cardiac involvement in systemic lupus erythematosus （SLE）. MethodA total of 62 SLE patients with cardiac involvement treated in the Department of Rheumatology and Immunology， the First Affiliated Hospital of Anhui University of Chinese Medicine from June 2021 to December 2022 were randomized into control and observation groups （n=31）. The control group was treated with methylprednisolone tablets and hydroxychloroquine sulfate tablets， and the observation group with Qihuang Jianpi Zishen granules on the basis of the therapy in the control group. After 12 weeks of treatment， the two groups were compared in terms of the therapeutic effect， cardiac function indicators ［left atrial end-diastolic diameter （LADd）， left ventricular end-diastolic diameter （LVDd）， left ventricular posterior wall thickness （LVPWTd）， peak blood flow velocity in early diastolic period （peak E）， peak blood flow velocity in late diastolic period （peak A）， E/A ratio， stroke volume （SV）， left ventricular ejection fraction （LVEF）， left ventricular short axis shortening rate （LVFS）， and B-type natriuretic peptide （BNP）］， vascular damage indicators ［nitric oxide （NO）， endothelin-1 （ET-1）， vascular endothelial growth factor （VEGF）， and homocysteine （Hcy）］， inflammation indicators ［erythrocyte sedimentation rate （ESR） and hypersensitive C-reactive protein （Hs-CRP）］， anti-double-stranded DNA （dsDNA） antibodies， disease activity index （SLEDAI） score， mitigation of symptoms and signs， and occurrence of adverse reactions. ResultThe total response rate in the observation group was 87.09%， which was higher than that （67.74%） in the control group （P<0.01）， and the incidence of adverse reactions had no significant difference between the two groups. After treatment， the control group showed lowered LVDd， LVPWTd， BNP， ET-1， VEGF， and Hcy （P<0.05） and increased E peak， E/A ratio， SV， LVEF， and LVFS （P<0.05）. In the observation group， LADd， LVDd， LVPWTd， peak A， BNP， NO， ET-1， VEGF， and Hcy decreased （P<0.05）， while peak E， E/A ratio， SV， LVEF and LVFS increased （P<0.05） after treatment. The treatment in both groups decreased the scores of palpitation， chest tightness， dyspnea， and edema （P<0.05）， reduced ESR， Hs-CRP， ds-DNA， and SLEDAI （P<0.05）. After treatment， the observation group had lower LADd， LVDd， LVPWTd， peak A， BNP， and scores of palpation， chest tightness， dyspnea， and edema （P<0.05） and higher peak E， E/A ratio， SV， LVEF， and LVFS （P<0.05） than the control group. In addition， the observation group had lower NO， ET-1， VEGF， Hcy， ESR， Hs-CRP， ds-DNA， and SLEDAI than the control group （P<0.05）. ConclusionQihuang Jianpi Zishen granules combined with hydroxychloroquine sulfate and methylprednisolone can improve multiple indicators and mitigate the symptoms and signs of SLE patients with cardiac involvement， demonstrating a clinical application value.

Clinical analysis of 60 patients with pneumatosis cystoides intestinalis in the Tibetan Plateau / 中国基层医药

Objective:To analyze the clinical characteristics of pneumatosis cystoides intestinalis in the Tibet Plateau, and to explore the diagnosis and treatment method of this disease.Methods:The medical records of 60 patients with confirmed pneumatosis cystoides intestinalis who were admitted to Tibet Autonomous Region People's Hospital from January 2014 to July 2021 were retrospectively analyzed. A descriptive statistical analysis was made.Results:The male-to-female ratio of 60 patients with pneumatosis cystoides intestinalis was 2.2: 1. The average age of onset was (48.6 ± 14.5) years. The average living altitude was (3 832.3 ± 399.8) meters. All patients were admitted mainly because of gastrointestinal symptoms. Twenty patients had hemorrhoids, chronic hepatitis, and gallstones. Pneumatosis cystoides intestinalis was confirmed by endoscopic examination in 59 patients and by surgery in 1 patient. Among the patients, 43 patients had lesions involving the colon, 2 patients had lesions involving the small intestine, and 1 patient had lesions involving the duodenum. The specific lesion sites were not determined in the remaining 14 patients because of unclear descriptions of the examination results. Two patients were positive for fecal occult blood tests, with a median hemoglobin value of 156.0 g/L. Forty-nine patients were given hyperbaric oxygen therapy, medication, and diet adjustment. Eleven patients were treated surgically. Clinical symptoms were relieved in 43 patients, and 17 patients were lost to follow-up.Conclusion:Pneumatosis cystoides intestinalis is relatively common in Tibet Plateau, and more common in men than in women. It occurs at any age. Clinical manifestations are not specific. The lesions most often involve the colon. The disease is mainly diagnosed by endoscopy. Individualized treatment based on different causes can help improve the prognosis of pneumatosis cystoides intestinalis.

Research progress and considerations on non-clinical studies of the drugs administered through the ocular vitreous body / 药学学报

In recent years, with the development of ophthalmic therapeutic drugs, the vitreous body, as a channel for the treatment of ophthalmic diseases, especially fundus diseases, has opened up a new therapeutic approach for various choroidal neovascular diseases, macular edema, uveitis and other diseases associated with fundus diseases, which is represented by wet age-related macular degeneration (wAMD). The drugs administered through the vitreous body mainly include ocular anti-vascular endothelial growth factor (VEGF) injections, microplasmin and hormones. For this kind of ophthalmic products, there are no clear technical guidelines and norms for non-clinical research at home and abroad. This article combines review practices and cases of marketed products to sort out the research progress and considerations on non-clinical studies of ophthalmic drugs dosing through the ocular vitreous body, in order to provide references for the research and evaluation of such drugs.

Ethical considerations on placebo-controlled vaccine trials in pregnant women / Consideraciones éticas sobre los ensayos de vacunas controlados con placebo en mujeres embarazadas / Considerações éticas sobre estudos de vacina controlada com placebo em gestantes

Abstract Placebo use in clinical trials, whenever a proven effective treatment exists, is one of the most debated topics in contemporary research ethics. This article addresses the ethical framework for placebo use in clinical trials assessing vaccine efficacy in pregnant women. Vaccine trial participants are healthy at the outset and some must be infected during the study to demonstrate the product's efficacy, meaning that placebo-treated participants are under risk of serious and irreversible harm. If effective vaccines exist, such risk precludes placebo use. This interdiction should be extended to any clinical trial of vaccine efficacy in pregnant women, because a demonstration of clinical efficacy in nonpregnant individuals and comparable immunogenic responses in pregnant women are predictors of efficacy in pregnancy as well. Moreover, product effectiveness in real-world use scenarios can be ascertained by observational studies conducted after its inclusion in vaccination campaigns.

Resumen El uso de placebo en ensayos clínicos es uno de los principales temas debatidos sobre la ética en investigación contemporánea cuando existe un tratamiento eficaz probado. Este artículo aborda la ética en el uso de placebo en ensayos clínicos sobre la eficacia de vacuna en mujeres embarazadas. Las participantes en los ensayos de vacunas estaban sanas al inicio del estudio, y algunas fueron vacunadas durante el estudio para demostrar la eficacia del producto. Las participantes tratadas con placebo corren el riesgo de sufrir daños graves e irreversibles. Si existen vacunas efectivas, este riesgo impide el uso de placebo. Este impedimento debe extenderse a cualquier ensayo clínico de eficacia de vacuna en embarazadas, pues la eficacia clínica demostrada en mujeres no embarazadas y las respuestas inmunogénicas comparables con las embarazadas son predictores de eficacia en el embarazo. Además, la efectividad del producto se constata en estudios observacionales realizados tras las campañas de vacunación.

Resumo O uso de placebo em ensaios clínicos, quando um tratamento comprovadamente eficaz existe, é um dos principais tópicos debatidos na ética em pesquisa contemporânea. Este artigo aborda o quadro ético para o uso de placebo em ensaios clínicos que avaliam a eficácia de vacina em gestantes. Participantes em ensaios de vacina são saudáveis no início e alguns devem ser inoculados durante o estudo para demonstrar a eficácia do produto. Ou seja, participantes tratados com placebo estão sob risco de danos graves e irreversíveis. Se existirem vacinas eficazes, esse risco impede o uso de placebo. Essa interdição deve ser estendida a qualquer ensaio clínico de eficácia de vacina em gestantes, pois a demonstração de eficácia clínica em não gestantes e as respostas imunogênicas comparáveis em gestantes também são preditoras de eficácia na gravidez. Ademais, a eficácia do produto em cenários reais de uso pode ser verificada por estudos observacionais realizados após sua inclusão em campanhas de vacinação.

Esclerose lateral amiotrófica em Belo Horizonte, Brasil entre 2010 e 2020: um estudo clínico epidemiológico / Amyotrophic lateral sclerosis in Belo Horizont, Brazil between 2010 and 2020: a clinical epidemiological study

Objetivo: Descrever o perfil clínico de indivíduos com Esclerose Lateral Amiotrófica (ELA) de um hospital de referência na cidade de Belo Horizonte, Brasil. Métodos: Trata-se de um estudo transversal retrospectivo com coleta de dados de prontuários eletrônicos de indivíduos com diagnóstico definido de ELA entre 2010 e 2020, no setor de referência em Distrofias Musculares de um hospital de uma capital brasileira. Resultados: Foram incluídos 103 indivíduos com ELA, com idade média de 60±12 anos, idade média de diagnóstico de 56±12 anos e tempo médio de evolução da doença de 3±3 anos. Além disso, 70% eram do sexo masculino, 88% com ELA esporádica, com envolvimento bulbar semelhante entre leve (32%), moderado (27%) e grave (28%), e com maior taxa de diagnóstico de 50 a 70 anos de idade. Conclusão: Os dados epidemiológicos deste estudo são muito semelhantes aos da literatura. No entanto, a heterogeneidade da doença, a complexidade do diagnóstico e a diversidade de formas que cada estudo traz para a doença, e principalmente a rápida progressão, dificultam a discussão de um quadro mais extenso. Traçar esse perfil é importante para uma clínica mais focada e um manejo mais adequado, e para isso são necessários mais estudos.

Objective: To describe the clinical profile of individuals with Amyotrophic Lateral Sclerosis (ALS) from a reference hospital in the city of Belo Horizonte, Brazil. Method: This is a retrospective cross-sectional study with data collection from electronic medical records of individuals with a defined diagnosis of ALS between 2010 and 2020, in the Muscular Dystrophies reference sector of a hospital in a Brazilian capital. Results: A total of 103 individuals with ALS were included, with a mean age of 60±12 years, mean diagnostic age 56±12 years, and mean time of disease progression of 3±3 years. Furthermore, 70% were male, 88% with sporadic ALS, with a similar bulbar involvement between mild (32%), moderate (27%) and severe (28%), and with a higher rate of diagnosis from 50 to 70 years of age. Conclusion: The epidemiological data from this study are very similar to those in the literature. However, the heterogeneity of the disease, the complexity of the diagnosis and the diversity of forms that each study brings to the disease, and especially the rapid progression, make a more extensive picture difficult to be discussed. Tracing this profile is important for a more focused clinic and a more adequate management, and for that, further studies are needed.

Lingual supplementation may not be required after articaine buccal infiltration anesthesia for lower molar extraction: a clinical comparative study / La suplementación lingual opcional después de la anestesia por infiltración bucal con articaína para la extracción de molares inferiores: un estudio clínico comparativo

Purpose: To investigate the anesthetic effectiveness of buccal infiltration (BI) versus buccal plus lingual infiltration (BI+LI) of 4% articaine for intra-alveolar extraction of erupted mandibular molar teeth. Material and Methods: Eighty patients were included in this prospective clinical study. They were randomly divided into 1 of 2 equal groups: the 1st group received BI of 4% articaine 1.8 ml and LI of 0.5 ml, while the 2nd group received 4% articaine 1.8 ml BI plus 0.5 ml LI of normal saline. Another 1.8 ml articaine BI was given if initial anesthesia was inadequate. Outcome variables included pain, which was rated by patients at 3 intervals using visual analogue scale, and lingual anesthesia and patients' satisfaction which were measured using 5-score verbal rating scale. Data analyses used were descriptive statistics, t test, χ2 test, and Pearson's correlation coefficient. P-value value less than 0.05 was considered significant. Results: There were 46 females and 34 males and the mean age was 35.3 years. All outcome variables were comparable between the two study groups (p˃0.05). Anesthesia was successful in 78% and 88% of cases in the (BI) and (BI+LI) groups respectively with no significant difference (p=0.2392). The mean articaine volume used was 2.5 ml and 2.87 ml respectively without significant difference (p=0.090). Conclusion: The anesthetic efficacy of (BI) alone and (BI+LI) of 4% articaine was comparable. When given in an adequate dose, articaine (BI) alone could be justified as an anesthetic option for the intra-alveolar extraction of mandibular molar teeth.

Objetivo: Investigar la efectividad anestésica de la infiltración bucal (BI) versus la infiltración bucal más lingual (BI+LI) de articaína al 4% para la extracción intraalveolar de molares mandibulares erupcionados. Material y Métodos: Ochenta pacientes fueron incluidos en este estudio clínico prospectivo. Se dividieron aleatoriamente en 1 de 2 grupos iguales: el primer grupo recibió BI de articaína al 4% 1,8 ml y LI de 0,5 ml, mientras que el segundo grupo recibió articaína al 4% 1,8 ml BI más 0,5 ml LI de solución salina normal. Se administró otro BI de articaína de 1,8 ml si la anestesia inicial era inadecuada. Las variables de resultado incluyeron el dolor, que los pacientes calificaron en 3 intervalos mediante una escala analógica visual, y la anestesia lingual y la satisfacción de los pacientes, que se midieron mediante una escala de calificación verbal de 5 puntos. Los análisis de datos utilizados fueron estadística descriptiva, prueba t, prueba χ2 y coeficiente de correlación de Pearson. Se consideró significativo el valor del valor de pinferior a 0,05. Resultados: Hubo 46 mujeres y 34 hombres y la edad media fue de 35,3 años. Todas las variables de resultado fueron comparables entre los dos grupos de estudio (p=0,05). La anestesia fue exitosa en el 78% y 88% de los casos en los grupos (BI) y (BI+LI) respectivamente sin diferencia significativa (p=0,2392). El volumen medio de articaína utilizado fue de 2,5 ml y 2,87 ml respectivamente sin diferencia significativa (p=0,090). Conclusión: La eficacia anestésica de (BI) solo y (BI+LI) de articaína al 4% fue comparable. Cuando se administra en una dosis adecuada, la articaína (BI) sola podría estar justificada para la extracción intraalveolar de molares mandibulares.

Análise comparativa entre técnicas cirúrgicas de enxertia óssea em reabilitação de maxila atrófica: transplante celular odontológico (TCO) e técnica convencional de enxertia óssea ­ relato de caso clínico / Comparative analysis between surgical techniques of bone grafting in rehabilitation of atrophic maxilla: dental cell transplantation (OCT) and conventional bone grafting technique - a case report

A reabilitação de maxila atrófica se apresenta ainda nos dias de hoje como um desafio anatômico/fisiológico para os profissionais da área odontológica que visam buscar a instalação de implantes para futuras reabilitações protéticas, tendo em vista o grau de dificuldade de reconstituição do rebordo alveolar perdido. Com o intuito de reabilitar essas maxilas frente às adversidades, diferentes técnicas são propostas tais como enxertos ósseos autógenos, homógenos, substitutos ósseos alógenos, xenógenos e aloplásticos e suas respectivas técnicas. O objetivo deste trabalho foi apresentar um relato de caso clínico, no qual duas técnicas de reconstituição de rebordo alveolar de hemi-arco foram realizadas na mesma maxila utilizando biomaterial em bloco, visando comparar os resultados histológicos e clínicos. Após 5 meses da realização da enxertia, foi coletado material dos enxertos alveolares bilateralmente utilizando-se brocas trefinas para estudo histológico. Através da metodologia empregada, pode-se observar maior formação de estrutura óssea no lado em que foi praticada a metodologia transplantes celular odontológico (TCO), que preconiza a associação de sangue medular mandibular ao biomaterial, em relação a técnica contralateral em que utilizou a metodologia convencional, que preconiza a associação ao biomaterial do sangue periférico. Pode-se observar através da metodologia empregada que a utilização de biomateriais potencializados com sangue medular mandibular apresentou maior crescimento de estrutura óssea, incrementando em torno de 35% a mais na neoformação.de osso vital.

The rehabilitation of atrophic maxilla is still presented today as an anatomical/physiological challenge for professionals in the dental field who aim to seek the installation of implants for future prosthetic rehabilitations, in view of the degree of difficulty in reconstituting the lost alveolar ridge. In order to rehabilitate these jaws in the face of adversity, different techniques are proposed such as autogenous, homogenous bone grafts, allogeneic, xenogenous and alloplastic bone substitutes and their respective techniques. The aim of this study was to present a clinical case report, in which two hemi-arch alveolar ridge reconstruction techniques were performed in the same maxilla using biomaterial en bloc, in order to compare the histological and clinical results. After 5 months of grafting, material was collected from the alveolar grafts bilaterally using trephine burs for histological study. Through the used methodology, it was possible to see greater bone formation of structure on the side in which the dental cell transplantation (TCO) methodology was practiced, which advocates the association of mandibular medullary blood to the biomaterial, in relation to the contralateral technique in which the methodology was used conventional method, which advocates the association with peripheral blood biomaterial. It can be observed through the used methodology that the use of biomaterials potentiated with mandibular medullary blood showed greater growth of bone structure, increasing around 35% more in the neoformation of vital bone.

Promoting best practices and quality improvement based on real-world clinical study in neonatology / 中华围产医学杂志

Real-world evidence has become the basis for approval and regulation of drugs and medical devices. Real-world study has played a more and more important role with the continuous updating and iteration of medical technologies. The diseases and their underlying mechanisms in the neonatal period, the early stage of life, are significantly different from other stages of life and early high-quality clinical management has a profound impact on the long-term outcomes. Therefore, it is necessary to provide robust evidence for clinical diagnosis and treatment through real-world study. This paper explores the access to high-quality medical care in the neonatal period based on the application, challenges, and thinking of the China Neonatal Network (CHNN) in the real world and the integration of the China Neonatal Genome Project and other multi-omics data.

Compound oleum lithospermi in improving clinical symptoms of mild to moderate diaper dermatitis: a multicenter, open-labeled, randomized controlled clinical study / 中华皮肤科杂志

Objective:To evaluate clinical efficacy and safety of topical compound oleum lithospermi in the treatment of mild to moderate diaper dermatitis.Methods:A multicenter, randomized, positive-drug parallel-controlled clinical trial was conducted in 19 hospitals from July 2019 to August 2020. Children aged 0 - 12 months with mild to moderate diaper dermatitis were enrolled and randomly divided into 2 groups using a random number table: test group topically treated with compound oleum lithospermi, and control group topically treated with zinc oxide cream. The treatment was carried out 6 - 8 times a day for 7 days. Visits were scheduled on days 0 and 7, and total response rate and clinical healing time were evaluated. Changes in the dermatitis family impact (DFI) score were compared between the test group and control group, and adverse events were recorded. Statistical analysis was carried out by using independent-sample t test for normally distributed continuous data, Wilcoxon rank sum test for non-normally distributed continuous data, and chi-square test or Fisher′s exact test for unordered categorical data; survival curves were drawn, and log-rank test was used for comparisons between two groups. Results:A total of 343 children with diaper dermatitis were enrolled in this study. Among them, 31 children violated the protocol, so 312 were included in the per protocol set, including 157 in the test group and 155 in the control group, and all completed the visits on days 0 and 7. The total response rate was significantly higher in the test group (87.26%, 137/157) than in the control group (78.71%, 122/155; χ2 = 4.04, P = 0.044) . The clinical healing time was significantly shorter in the test group (5.33 days) than in the control group (6.13 days; χ2 = 4.67, P = 0.025) . After 7-day treatment, the DFI score significantly decreased in both the 2 groups compared with that before the treatment, but there was no significant difference in the DFI score between the 2 groups (test group: 4.02 ± 6.96, control group: 3.58 ± 5.90, Z = -0.39, P = 0.686) . The incidence of adverse events was 2.92% (5/171) and 5.45% (9/165) in the test group and control group respectively, and there was no significant difference between the 2 groups ( χ2 = 0.03, P = 0.865) . Conclusion:Compound oleum lithospermi can markedly reduce the clinical severity of diaper dermatitis, improve the total response rate, shorten the clinical treatment period, and improve the quality of life of children′s families with a favorable safety profile.

Clinical Treatment of Insomnia with Syndrome of Qi Stagnation and Blood Stasis by Uyghur Medicine Yangxin Dawayimicol Honey Ointment / 中国实验方剂学杂志

ObjectiveTo evaluate the clinical efficacy and safety of Yangxin Dawayimicol honey ointment （YDHO） in the treatment of insomnia with the syndrome of Qi stagnation and blood stasis. MethodEighty insomnia patients who met the inclusion criteria in the Department of Encephalopathy of the Third Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to October 2020 were randomly divided into an experimental group （48 cases） and a control group （32 cases）. The experimental group was treated with YDHO + Xuefu Zhuyu capsule simulators，and the control group was treated with Xuefu Zhuyu capsules + YDHO simulators for eight weeks. The changes in Pittsburgh sleep quality index（PSQI）score，traditional Chinese medicine （TCM） syndrome score，insomnia severity index （ISI），neurotransmitter indexes ［γ-aminobutyric acid（GABA），glutamic acid（Glu），and 5-hydroxy tryptamine（5-HT）］，serum inflammatory indexes ［interleukin-6（IL-6）and interleukin-10（IL-10）］， and safety index of the two groups were compared. ResultThe total effective rate was 97.83%（45/46） in the experimental group， higher than 68.75%（22/32） in the control group（Z=-4.292，P<0.01）. The experimental group was superior to the control group in PSQI score，ISI score，TCM syndrome score， and sleep duration（P<0.05）. The curative effects were equivalent between the two groups in shortening the time to fall asleep. The experimental group showed increased serum content of GABA，5-HT， and IL-10 and reduced content of Glu and IL-6，with few adverse reactions （P<0.05）. ConclusionYDHO is effective，safe， and reliable in the treatment of insomnia with Qi stagnation and blood stasis syndrome.

Research Trends and Future Issues Related to Pre-analysis Data Preprocessing in Large-scale Real-World Data ―With the Goal of Using it in Clinical Research― / 薬剤疫学

In recent years, the utilization of health care databases has been increasing worldwide. It is expected that Real World Data (RWD) will soon be effectively used for clinical research in Japan. On the other hand, database studies that use accumulated existing data such as electronic medical records, Diagnosis Procedure Combinations (DPCs), and health insurance claims, require extremely high loads of data preprocessing before statistical analysis is possible. So far, there is insufficient literature that describes the challenges of RWD preprocessing from an academic point of view. In this review paper, the challenges of database study are classified into three categories：（1）data content,（2）data structure, and（3）large-volume data handling. We then investigated existing preprocessing research and systematically introduced them. Most data preprocessing research targeted the improvement and reliability of the database itself through supplementing data contents required for each clinical research. There is very little research with the primary purpose of solving problems related to data structures and large-volume data processing. As the use of RWD for clinical research increases, the importance of the data preprocessing field will be recognized. In the future, we expect to see more research focused on RWD, which can enable the growth of clinical researches using RWD.

How to master the clinical study on digestive tract reconstruction in gastric cancer surgery / 中华胃肠外科杂志

Digestive tract reconstruction is extremely important during gastric cancer surgery, which is related to long-tern quality of life of patients. The selection of reconstruction methods and the application of reconstruction techniques are major topics in the field of reconstruction-related study of gastric cancer surgery. The clinical research on digestive tract reconstruction needs to be designed and implemented scientifically to comprehensively evaluate the impact of reconstruction methods on surgical safety, long-term survival outcomes, short- and long-term changes in quality of life, endoscopic mucosal changes and postoperative nutritional status. In addition, health economic analysis is also important and should be considered in reconstruction-related studies. In brief, selection of appropriate gastrointestinal reconstruction methods based on individual characteristics of each gastric cancer patients may be an important direction of clinical trials in the future.