Eficácia e segurança do Felbamato comparado a medicamentos disponíveis no SUS para o tratamento da epilepsia refratária em crianças e adultos: revisão rápida de evidências / Effectiveness and safety of Felbamate compared to drugs available in SUS for the treatment of refractory epilepsy in children and adults: rapid evidence review

Tecnologia: Felbamato. Indicação: Tratamento de epilepsia refratária. Pergunta: O Felbamato é mais eficaz e seguro comparado a anticonvulsivantes disponíveis no Sistema Único de Saúde (SUS) em pacientes com epilepsia refratária? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas 2 revisões sistemáticas, que atendiam aos critérios de inclusão. Conclusão: O felbamato não demonstrou ser uma opção mais benéfica que os demais medicamentos disponíveis no SUS no tratamento de epilepsia refratária a medicamentos. Salienta-se que a maior parte das evidências eram de baixa certeza

Technology: Felbamate. Indication: Treatment of refractory epilepsy. Question: Is felbamate more effective and safer compared to anticonvulsants available in Brazilian Public Health System in patients with refractory epilepsy? Methods: A rapid review of evidence (overview) of systematic reviews, with bibliographic survey carried out in the PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed using AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Results: Two systematic reviews that met the inclusion criteria were selected. Conclusion: Felbamate did not prove to be a more beneficial option than the other drugs available in the Brazilian Public Health System in the treatment of drug-refractory epilepsy. It should be noted that most of the evidence was of low certainty

Eficácia e segurança da combinação Glicosamina e Condroitina comparada a medicamentos disponíveis no SUS para o tratamento de osteoartrite: revisão rápida / Effectiveness and safety of Glucosamine and Chondroitin combination compared to drugs available in Brazilian Public Health System for the treatment of Osteoarthritis: rapid review

Tecnologia: Combinação de glicosamina e condroitina. Indicação: Tratamento de osteoartrite em adultos. Pergunta: O tratamento com a combinação de glicosamina e condroitina é mais eficaz e seguro que os demais tratamentos para osteoartrite disponíveis no SUS? Métodos: Uma revisão rápida de evidências, uma revisão de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2. Resultados: Foi selecionada uma revisão sistemática, que atendiam aos critérios de inclusão. Conclusão: A combinação de glicosamina com condroitina, comparados ao placebo, mostrou ser mais eficaz para tratamento da dor e função e alcançou o segundo lugar nas alternativas terapêuticas para tratamento da dor e função

Technology: Combination of glucosamine and chondroitin. Indication: Treatment of osteoarthritis in adults. Question: Is the treatment with the combination of glucosamine and chondroitin more effective and safer than the other treatments for osteoarthritis available in the Brazilian Public Health System? Methods: A rapid review of evidence, a overview of systematic reviews, with bibliographic search done in PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed using AMSTAR-2. Results: A systematic review was selected, which met the inclusion criteria. Conclusion: The combination of glucosamine and chondroitin, compared to placebo, proved to be more effective for the treatment of pain and function and reached second place in therapeutic alternatives for the treatment of pain and function

Eficácia e segurança do Esomeprazol e Lansoprazol comparados ao Omeprazol para o tratamento de doença do refluxo gastroesofágico em adultos: revisão rápida / Effectiveness and safety of esomeprazole and lansoprazole compared to omeprazole for the treatment of gastroesophageal reflux disease in adults: rapid review

Tecnologia: Esomeprazol e lansoprazol. Indicação: Tratamento de doença do refluxo gastroesofágico em adultos. Pergunta: Esomeprazol e lansoprazol são mais eficazes e toleráveis que o omeprazol já incorporado ao SUS para o tratamento de Doença do Refluxo Gastroesofágico (DRGE) em adultos? Métodos: Uma revisão rápida de evidências, uma revisão de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas três revisões sistemáticas com meta-análise, que atendiam aos critérios de inclusão. Conclusão: O esomeprazol era mais eficaz para cicatrização da lesão nos casos de esofagite erosiva, prevenção da mucosa do esôfago, maior controle de ácido no tratamento de curto prazo (4 e 8 semanas) de esomeprazol 40mg e tratamento de longo prazo (6 meses) de esomeprazol 20mg. A taxa de resposta no alívio dos sintomas, o esomeprazol 20mg e 40mg apresentou ser mais eficaz, especialmente, na azia e dor epigástrica. Quanto ao perfil de segurança, não houve diferença significativa entre as taxas de eventos adversos, todos medicamentos eram parecidos entre si

Technology: Esomeprazole and Lansoprazole. Indication: Treatment of gastroesophageal reflux disease in adults. Question: Are Esomeprazole and Lansoprazole more effective and tolerable than omeprazole already incorporated into SUS for the treatment of Gastroesophageal Reflux Disease (GERD) in adults? Methods: A rapid review of evidence, an overview of systematic reviews, with bibliographic survey carried out in the PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed using AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Results: Three systematic reviews with meta-analysis were selected, which met the inclusion criteria. Conclusion: Esomeprazole was more effective in achieving wound healing in cases of erosive esophagitis, prevention of esophageal mucosa, greater acid control in short-term treatment (4 and 8 weeks) of esomeprazole 40mg and long-term treatment (6 months) of esomeprazole 20mg. the response rate in symptom relief, esomeprazole 20mg and 40mg proved to be more effective, especially in heartburn and epigastric pain. As for the safety profile, there was no significant difference between the rates of adverse events, all drugs were similar to each other

Insulinas análogas de ação prolongada comparadas à insulina NPH para tratamento de diabetes mellitus tipo 2 em adultos: revisão rápida / Long-acting basal insulin analogues compared to nph insulin for type 2 diabetes mellitus in adults: rapid review

Tecnologia: Insulinas análogas de liberação prolongada versus insulina NPH (protamina neutra de Hagedorn). Indicação: Tratamento de adultos com diabetes mellitus tipo 2. Pergunta: Há diferenças de efeito nos principais desfechos de eficácia e segurança entre insulinas análogas de liberação prolongada versus insulina NPH no tratamento de pacientes com DM2? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foi selecionada e incluída uma revisão sistemática. Conclusão: As insulinas análogas (glargina e detemir) não demonstraram superioridade nos desfechos de eficácia e segurança quando comparadas à insulina NPH, não demonstraram redução significativa em relação à mortalidade por todas as causas e complicações secundárias ao DM2. Quando comparadas à insulina NPH, foi observado redução na hipoglicemia confirmada e hipoglicemia noturna a favor das insulinas análogas e na hipoglicemia grave a favor da insulina detemir

Technology: Long-acting insulin analogues versus NPH insulin (human isophane insulin). Indication: Treatment of adults with type 2 diabetes mellitus. Question: Are there effect differences in key efficacy and safety outcomes between long-acting insulin analogues versus NPH insulin in the treatment of DM2 patients? Methods: Rapid review of evidence (overview) of systematic reviews, with a bibliographic survey carried out in the PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Results: A systematic review was selected and included. Conclusion: Analog insulins (glargine and detemir) did not demonstrate superiority in efficacy and safety outcomes when compared to NPH insulin, did not demonstrate a significant reduction in all-cause mortality and complications secondary to DM2. When compared to NPH insulin, a reduction in confirmed hypoglycemia and nocturnal hypoglycemia in favor of analogue insulins and in severe hypoglycemia in favor of insulin detemir was observed

Statistical methods of unmeasured confounder control based on negative control theory / 中华流行病学杂志

Controlling unmeasured confounders in non-randomized controlled studies is challenging. Negative control theory is based on the theoretical concept that the test result of negative controls must be negative. Setting appropriate negative control incorporates the specificity of association into population studies for the identification and control of unmeasured confounders. This paper explains the principles to control unmeasured confounders using negative control theory from a statistical perspective. A detailed introduction of derived methods based on negative control theory is also introduced, including adjusted standardized mortality ratio method, calibrating P-value method, generalized difference-in-difference model and double negative control method. The reasonable application of those derived methods is also comprehensively summarized based on representative case studies. Negative control is an important statistical design to identify, revise and control unmeasured confounders and a valuable method for comparative effectiveness research based on real-world data.

Utilidad del dispositivo de potenciación del esfínter esofágico distal (LINX®) para pacientes con reflujo gastroesofágico / Usefulness of the distal esophageal sphincter enhancement device (LINX®) for patients with gastroesophageal reflux

Resumen La fundoplicatura de Nissen laparoscópica (FNL) es el gold standard del tratamiento quirúrgico de pacientes con reflujo gastroesofágico patológico (RGE), con perfil de seguridad y resultados a largo plazo satisfactorios en un 80%. En la última década, se ha propuesto el uso de un dispositivo de potenciación del esfínter esofágico inferior (MSA) comercializado como LINX® (de Ethicon, Johnson & Johnson), como alternativa a la cirugía antirreflujo. El dispositivo consiste en una cadena expansible de cuentas de titanio con un núcleo magnético diseñadas para aumentar el tono del esfínter esofágico inferior (EEI) y evitar su relajación inadecuada. Los resultados preliminares han sido alentadores, sin embargo, no está exento de complicaciones. Las indicaciones más aceptadas son: RGE con motilidad esofágica normal y sin esofagitis erosiva, hernia hiatal < 3 cm, IMC <35 kg/m2 y pacientes sin cirugías gastroesofágicas previas. Se instala por vía laparoscópica. Los efectos adversos más importantes son: disfagia con necesidad de dilataciones endoscópicas, y, retiro del dispositivo, entre 1% y 7% a los 2,5 años. La mayoría de los estudios tienen limitaciones metodológicas, conflictos de interés, falta de resultados objetivos y seguimientos a largo plazo, impidiendo llegar a conclusiones extrapolables respecto a la eficacia del MSA.

Laparoscopic Nissen Fundoplication (LNF) is the gold standard of surgical treatment for patients with Gastroesophageal Reflux Disease (GER), with safety profile and long term results satisfactory in 80%. In the last decade, the use of a Lower Esophageal Sphincter Enhancement Device (LESD), marketed as LINX® (from Ethicon, Johnson & Johnson), has been proposed as an alternative to Anti-Reflux Surgery. The device consists of an expandable chain of titanium beads with a magnetic core designed to increase the tone of the lower esophageal sphincter (LES) and prevent its improper relaxation. Preliminary results have been encouraging; however, it is not without complications. The most accepted indications are: GER with normal esophageal motility and without erosive esophagitis, hiatal hernia < 3 cm, BMI <35 kg/m2, and patients without previous gastroesophageal surgeries. It is installed by laparoscopy. The most important adverse effects are: dysphagia with the need for endoscopic dilations, and, removal of the device, between 1 and 7% at 2.5 years. Most of the studies have methodological limitations, conflicts of interest, lack of objective results and long-term follow-up, preventing the reaching of extrapolable conclusions regarding the efficacy of MSA.

Eficácia e segurança de Aripiprazol comparado aos antipsicóticos disponíveis no SUS para tratamento de Esquizofrenia em adultos: revisão rápida de evidências / Compared effectiveness and safety of Aripiprazol and antipsychotics available on Brazilian Public Health System for treatment of Schizophrenic adults: a rapid review of evidence

Tecnologia: Aripiprazol, antipsicóticos disponíveis no Sistema Único de Saúde (SUS). Indicação: Tratamento da esquizofrenia em adultos. Pergunta: O Aripiprazol é mais eficaz e seguro para promover controle sintomático, que os antipsicóticos disponíveis no SUS? Métodos: Levantamento bibliográfico foi realizado em bases de dados PUBMED, com estratégias estruturadas de busca, e a qualidade metodológica das revisões sistemáticas foi avaliada com a ferramenta AMSTAR II. Resultados: Foram identificados 109 resumos de revisões sistemáticas. Após leitura dos mesmos, foram selecionadas 2 revisões sistemáticas. Conclusão: Aripiprazol tem eficácia e segurança similar à Ziprasidona e Haloperidol, mas eficácia semelhante e maior segurança metabólica que a Quetiapina, Olanzapina, Clozapina e Risperidona. Ziprasidona apresenta vantagem sobre o Aripiprazol, pois tem menor risco de efeito colateral de mudanças na função sexual. Considerando que o perfil de eficácia e segurança do Aripiprazol é muito parecido com o dos outros antipsicóticos disponíveis no SUS, com mínimas diferenças, e seu custo de tratamento é inferior ao da Ziprasidona e Quetiapina, essa droga poderia estar disponível no SUS

Technology: Aripiprazole, antipsychotics available in the Brazilian Public Health System (BPHS). Indication: Treatment of schizophrenia in adults. Question: Is Aripiprazole more effective and safer to promote symptomatic control than antipsychotics available in BPHS? Methods: A bibliographic survey was carried out in PUBMED databases, with structured search strategies, and the methodological quality of systematic reviews was assessed using the AMSTAR II tool. Results: 109 abstracts of systematic reviews were identified. After reading them, 2 systematic reviews were selected. Conclusion: Aripiprazole has identical effectiveness and safety to Ziprasidone and Haloperidol, but similar efficacy and greater safety than Quetiapine, Olanzapine, Clozapine and Risperidone. Ziprasidone has an advantage over Aripiprazole as it has a lower risk of side effects of changes in sexual function. Since the Aripiprazole's effectiveness and safety profile is very similar to profile of others antipsychotics available in BPHS, with minimal differences, and it has cost lower than Ziprasidone and Quetiapine, this drug could be available in BPHS

Eficacia analgésica del EMLA en procedimientos transcutáneos. Revisión sistemática / Analgesic efficacy of EMLA in transcutaneous procedures. Systematic review

Los parches de EMLA son frecuentemente utilizados como anestésicos locales durante la realización en procedimientos invasivos. Con el fin de valorar su eficacia y compararla con la de otros analgésicos y anestésicos disponibles, se realizó una revisión sistemática de todos los estudios realizados que cumplieran criterios de inclusión entre los años 1990 y 2019. Población y métodos: la búsqueda bibliográfica de la evidencia disponible fue realizada en las bases de datos de Cochrane Medline y Lilacs. Se incluyeron todos los ECA y revisiones sistemáticas en pacientes menores de 16 años entre los años 1990 y 2019. Resultados: Fueron hallados 31 artículos de los cuales 21 cumplían con los criterios de inclusión. De dichos 21, solamente 8 estudios resultaron de muy buena y excelente calidad metodológica (JADAD). Conclusiones: El EMLA demostró mayor eficacia como analgésico en el 100% de los estudios donde se comparaba respecto del placebo. Sin embargo, no se encontraron diferencias significativas respecto de otros analgésicos farmacológicos y no farmacológicos.(AU)

EMLA patches are commonly used as local anesthetics in minor invasive procedures. To assess efficacy and compare the patches with other available analgesics and anesthetics, a systematic review was conducted evaluated all studies that met the inclusion criteria published between 1990 and 2019. Population and methods: A literature search of the available evidence was conducted in the Cochrane, Medline, and Lilacs databases. All RCTs and systematic reviews in patients younger than 16 years published between 1990 and 2019 were included. Results: 31 articles were identified of which 21 met the inclusion criteria. Of these 21, of only 8 studies the methodology was of very good and excellent quality (JADAD). Conclusions: EMLA better efficacy as an analgesic in 100% of the studies comparing EMLA patches with placebo. However, no significant differences were found when comparing the patches with other pharmacological and non-pharmacological analgesics.(AU)

Cirugía laparoscópica con imagen 3D: indicaciones, resultados y evaluación subjetiva y objetiva de cirujanos participantes / Laparoscopic surgery with 3D image: indications, results and subjective and objective evaluation of participating surgeons

Resumen Introducción El uso del sistema de visión 3D en cirugía laparoscópica puede significar una mejor performance de los procedimientos quirúrgicos de mayor complejidad. Objetivo Reportar las indicaciones, los resultados y la valoración de un grupo de cirujanos de diferentes especialidades en el uso de visión 3D. Materiales y Método: Se analizan las indicaciones quirúrgicas y los resultados subjetivos y objetivos del uso del sistema óptico 3D (n = 155 pacientes) en cirugía laparoscópica compleja. Para evaluación subjetiva se aplicó a una encuesta de percepción cualitativa a los cirujanos participantes tipo Likert. Para la evaluación objetiva, se registran los tiempos quirúrgicos empleados en los diferentes procedimientos efectuados y las complicaciones postoperatorias y se comparan con los pacientes operados con sistema 2D (n = 783 pacientes) en el mismo periodo. Resultados el 70,6% concuerda tener mejor imagen con la técnica 3D, el 64,7% de los cirujanos refieren que se puede reducir el tiempo operatorio, el 58,8% considera que se puede reducir el error quirúrgico, el 92% y 100% respectivamente afirman que el confort del cirujano es mejor con el uso de óptica 3D y que esta técnica es recomendable para los procedimientos complejos. El tiempo operatorio se redujo en algunos procedimientos, especialmente urológicos. No se encontró diferencias sustanciales al comparar los resultados con el uso de sistema 3D versus 2D en cuanto a complicaciones postoperatorias. En la 3D no se encontró mortalidad postoperatoria, probablemente por el menor número de pacientes de ese grupo. Conclusión La laparoscopia 3D posee una buena valoración por los cirujanos que la emplearon, principalmente en calidad de imagen, reducción del tiempo operatorio y confort del cirujano en comparación con la laparoscopía 2D convencional. No se encontró diferencias sustanciales al comparar los resultados con el uso de sistema 3D versus 2D en cuanto a tiempo operatorio ni complicaciones postoperatorias.

Introduction The use of the 3D vision system in laparoscopic surgery can mean better performance in more complex surgical procedures. Aim Report the indications, results and assessment of a group of surgeons of different specialties in the use of 3D vision. Materials and Method Surgical indications and subjective and objective results of the use of 3D optical system in patients (n = 155) submitted to complex laparoscopic surgery are analyzed. Subjective evaluation based on a survey of qualitative perception (Likert) was applied to the participating surgeons. For objective evaluation, the operatory times and postoperative complications were recorded and compared with the results observed with the use of the 2D system (783 patients) in the same period. Results 70.6% agree to have a better image with the 3D technique, 64.7% of surgeons report that the operative time can be reduced, 58.8% consider that it can be reduced the surgical error, 92% and 100% respectively considered that the comfort of the surgeon is better with the use of 3D optics and that this technique is recommended for complex procedures. No substantial differences were found when comparing the results with the use of 3D versus 2D system by the same surgical teams in terms of operative times and postoperative complications. In 3D, postoperative mortality was probably not found due to the lower number of patients in this group. Conclusion 3D laparoscopy has a good evaluation by the surgeons who used it, mainly in image quality, reduction of operative time and comfort of the surgeon compared to conventional 2D laparoscopy. No substantial differences were found when comparing the results with the use of 3D versus 2D system in terms of operative times or postoperative complications.

Comparative effectiveness research in observational studies

No abstract available.

Evaluación de la eficacia de los laboratorios de embriología y anatomía patológica en el análisis de las biopsias testiculares de pacientes azoospérmicos / Evaluation of the Efficacy of the Laboratories of Embryology and Pathological Anatomy in the Analysis of Testicular Biopsies of Patients with Azoospermia

Objetivos: El propósito de este estudio es evaluar la eficacia de los laboratorios de embriología y de anatomía patológica para hallar espermatozoides en las muestras de tejido testicular obtenido por biopsia testicular (testicular sperm extraction, TESE) en pacientes con azoospermia no obstructiva. Materiales y métodos: Se realizó un análisis retrospectivo y prospectivo de todos los pacientes con azoospermia no obstructiva atendidos en CRECER y en la Clínica Privada Pueyrredón, entre enero de 2006 y diciembre de 2016. En este estudio solo se incluyeron aquellos pacientes en los que la muestra obtenida con TESE fue enviada simultáneamente al anatomopatólogo y al laboratorio de embriología. Para el análisis de los resultados de las biopsias el estudio se detuvo a fines de 2016, pero el seguimiento de los pacientes continuó hasta el mes de octubre de 2017, registrándose todos aquellos casos que realizaron procedimientos de inyección intracitoplasmática de espermatozoides (intracytoplasmic sperm injection, ICSI) con muestras obtenidas de TESE y se anotó la obtención de embriones, embarazos y nacimientos. Resultados: El laboratorio de embriología halló espermatozoides en 36 de los 68 pacientes (52,9%), mientras que el laboratorio de patología solo informó presencia en 21 pacientes (30,88%). Hubo acuerdo en el hallazgo de espermatozoides entre ambos laboratorios en 20 de los 68 casos (29,41%), mientras que en 16 pacientes el laboratorio de embriología encontró espermatozoides donde el de patología no pudo hacerlo (23,53%). Al mismo tiempo, el laboratorio de patología halló espermatozoides solo en un caso en el que el de embriología informó su ausencia para la misma muestra analizada (1,47%) (p=0,0003). Conclusiones: El laboratorio de embriología es significativamente más eficaz para determinar la presencia de espermatozoides en las muestras de TESE, teniendo mejor rendimiento que el de patología, por lo que consideramos que, si las muestras fueran analizadas solo por el patólogo, se perdería la posibilidad de lograr muchos embarazos realizando ICSI más TESE.(AU)

Objectives: The purpose of this study is to evaluate the efficacy of embryology and pathological anatomy laboratories to find spermatozoa in testicular tissue samples obtained by testicular sperm extraction (TESE) in patients with non-obstructive azoospermia. Materials and methods: It was carried out a retrospective and prospective analysis of all the patients with non-obstructive azoospermia treated at CRECER and at Clínica Privada Pueyrredón, between January 2006 and December 2016. This study only includes patients in whom the sample obtained with TESE was sent at the same time to the pathology and embryology laboratory. For the analysis of the results of the biopsies, the study was stopped at the end of 2016, but the follow-up of the patients continued until October 2017, registering all those cases that performed intracytoplasmic sperm injection (ICSI) with samples obtained from TESE and wrote down the patients who´ve got embryos, pregnancies, and births. Results: The embryology laboratory found sperm in 36 of the 68 patients (52.9%), while the pathology laboratory only reported presence in 21 patients (30.88%). There was agreement in the finding of sperm between both laboratories in 20 of the 68 cases (29.41%), while in 16 patients the embryology laboratory found sperm where the pathology department could not do so (23.53%). At the same time, the pathology laboratory found sperm only in one case in which the embryology department reported its absence for the same sample analyzed (1.47%) (p=0.0003). Conclusions: The embryology laboratory is significantly more efficient to determine the presence of sperm in the samples of TESE, having better performance than the pathology one. Taking into account that, we believe that if the samples are only analyzed by the pathologist, the possibility of getting many pregnancies performing ICSI plus TESE would be lost. (AU)

Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids

PURPOSE: Extrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone). METHODS: This historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change. RESULTS: Each cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide. CONCLUSIONS: In this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.

Application of three-stitch preventive transverse colostomy in anterior resection of low rectal cancer / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To explore the application of three-stitch preventive transverse colostomy in anterior resection of low rectal cancer.</p><p><b>METHOD</b>From May 2015 to March 2016, 70 consecutive low rectal cancer patients undergoing anterior resection and preventive transverse colostomy in our department were recruited in this prospective study. According to the random number table method, 70 patients were divided into three-stitch transverse colostomy group(observation group, n=35) and traditional transverse colostomy group(control group, n=35). Procedure of three-stitch preventive transverse colostomy was as follows: firstly, at the upper 1/3 incision 0.5-1.0 cm distance from the skin, 7# silk was used to suture from outside to inside, then the needle belt line went through the transverse edge of the mesangial avascular zone. At the lower 1/3 incision 0.5-1.0 cm distance from the skin, 7# silk was used to suture from inside to outside, then silk went through the transverse edge of the mesangial avascular zone again and was ligatured. Finally, in the upper and lower ends of the stoma, 7# silk was used to suture and fix transverse seromuscular layer and the skin. The operation time and morbidity of postoperative complications associated with colostomy were compared between two groups.</p><p><b>RESULTS</b>There were no significant differences in baseline data between the two groups(all P>0.05). The operative time of observation group was shorter than that of control group [(3.2±1.3) min vs. (15.5±3.4) min, P<0.05]. Incidences of colostomy skin-mucous separation, dermatitis, stoma rebound were significantly lower in observation group [5.7%(2/35) vs. 34.3%(12/35), P=0.007; 8.6%(3/35) vs. 31.4%(11/35), P=0.036; 0 vs. 17.1%(6/35), P=0.025, respectively], while incidences of parastomal hernia and stoma prolapse in two groups were similar (both P>0.05).</p><p><b>CONCLUSION</b>Compared with traditional transverse colostomy method, the three-stitch preventive transverse colostomy has more operating advantages and can reduce postoperative complications associated with colostomy.</p>

Comparative study of 3D and 2D laparoscopic surgery for gastrointestinal tumors / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the technical advantages of 3D laparoscopic and 2D laparoscopic surgery for gastrointestinal tumors.</p><p><b>METHODS</b>Clinical data of gastrointestinal cancer patients undergoing 3D laparoscopic or 2D laparoscopic surgery from January 2015 to January 2017 in our department were retrospectively analyzed These patients included 93 gastric cancer cases undergoing laparoscopic radical resection (total gastrectomy, 48 cases in 3D group, 45 cases in 2D group), 45 rectal cancer cases undergoing radical resection combined with lateral lymph node dissection (27 cases in 3D group, 18 cases in 2D group) and 76 right colon cancer cases undergoing radical resection (37 cases in 3D group, 39 cases in 2D group). The enrolled criteria of cases were 18-80 years old and diagnosed as advanced gastric or colorectal cancer by pathological examination. Patients with preoperative distant metastasis, severe heart or lung diseases who were not suitable for laparoscopic surgery, combined organ resection and conversion to open surgery were excluded. The choice of surgical procedure was determined by the discussion between patients and surgeon. Operations were performed by the same surgical team. Total operation time, complex operation time (deep lymph node dissection time, endoscopic intestinal anastomosis time), number of harvested lymph node, number of times in wrong grasp (accurate grasp for the same site needs to position for two times or more) and intraoperative bleeding were compared between 3D group and 2D group.</p><p><b>RESULTS</b>There were no significant differences in baseline data between 3D group and 2D group. All the patients completed laparoscopic radical operation successfully without conversion to open surgery. In patients with gastric cancer, compared with 2D group, the total operation time was shorter [(185±25) min vs. (190±27) min, P<0.05]; dissection time of No.10 and 11d lymph node [(40±8) min vs. (55±12)min, P<0.05], and No.7, 8, 9 and 12 lymph node [(30±6) min vs. (41±9) min, P<0.05] was shorter; the number of times in wrong grasp (5±2 vs. 11±2, P<0.05) was less in 3D group. In patients with rectal cancer, compared with group 2D, 3D group had shorter time of lateral lymph node dissection [(27±6) min vs. (35±9) min, P<0.05] and laparoscopic anastomosis [(45±7) min vs. (58±11) min, P<0.05]; less number of times in wrong grasp (4±2 vs. 13±2, P<0.05]. In patients with right colon cancer, 3D group had shorter laparoscopic anastomosis time [(38±7) min vs. (44±5) min, P<0.05] and less number of times in wrong grasp (5±1 vs. 13±3, P<0.05] as compared to 2D group.</p><p><b>CONCLUSION</b>3D laparoscopic surgery for gastrointestinal tumors, compared with 2D laparoscopic technology has significant advantages, which can improve the spatial location and depth of operation, decrease the difficulty of fine operation, and shorten the operation time.</p>

Application of bowel plication combined with early enteral nutrition in the enhanced recovery after surgery for neonates with jejunal atresia / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy of bowel plication combined with early enteral nutrition (EEN) in the enhanced recovery after surgery(ERAS) of jejunal atresia (JA) neonates.</p><p><b>METHODS</b>Between January 2005 and January 2014, 58 neonates with JA underwent surgical treatment in Children's Hospital of Nanjing Medical University. Their clinical data, including operation procedures, ages, birth weight, concomitant diseases, age at surgery, hospital stay, total parenteral nutrition (TPN), postoperative intestinal function recovery (the time to the first oral feeding and the time to oral feeding volume reaching 150 ml·kg·d), complications and reoperation, were retrospectively analyzed.</p><p><b>RESULTS</b>According to the surgical procedures, the 58 neonates were divided into three groups: control group(18 cases, undergoing atretic segments resection and primary anastomosis), bowel plication group(19 cases, undergoing bowel plication after atretic segments resection and primary anastomosis) and bowel plication combined with EEN group (21 cases, undergoing bowel plication combined with EEN). No significant differences of ages, birth weight, age at operation, and concomitant diseases were found among 3 groups (all P>0.05). The time of hospital stay, the time to the first oral feeding, the time to oral feeding volume reaching 150 ml·kg·d, and the time of TPN in bowel plication group were significantly shorter than those of control group [(19.3±4.4) d vs. (22.7±3.1) d, t=2.696, P=0.011; (9.8±3.3) d vs. (12.5±3.0) d, t=2.630, P=0.013; (18.5±4.1) d vs. (21.5±2.5) d, t=2.726, P=0.011; (13.1±2.9) d vs. (15.0±2.3) d, t=2.219, P=0.033]. However, above parameters of bowel plication combined with EEN group were significantly shorter than those of bowel plication group [(15.3±3.5) d vs. (19.3±4.4), t=4.120, P=0.003; (7.7±2.2) d vs. (9.8±3.3) d, t=2.428, P=0.020; (14.8±2.5) d vs. (18.5±4.1) d, t=3.752, P=0.001; (9.5±3.0) vs. (13.1±2.9) d, t=4.370, P=0.000].</p><p><b>CONCLUSION</b>The bowel plication combined with EEN contributes to the early use of intestinal function, shorten the time to the first oral feeding, and reduces the use of TPN, which can improve the recovery of jejunal atresia neonates.</p>

Efficacy comparison of robotic and laparoscopic radical surgery in the treatment of middle-low rectal cancer / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To compare the clinical efficacy of robotic and laparoscopic radical surgery in the treatment of middle-low rectal cancers.</p><p><b>METHODS</b>From January 2015 to March 2016, intra-operative and postoperative follow-up data of 30 patients with middle-low rectal cancers who underwent robotic radical resection(robot group) and 32 patients with middle-low rectal cancers who underwent laparoscopic radical resection (laparoscopy group)n in our department were retrospectively collected. The distance from cancer to anal margin was less than 10 cm in both two groups and advanced rectal cancers were confirmed by preoperative colonoscopy biopsy. Associated data were compared between two groups.</p><p><b>RESULTS</b>There were 13 males and 17 females in robot group with age of 27 to 85 (mean 59.7) years, disease course of 3 to 12 (mean 6.2) months and clinical stage T2-3N0-1. There were 16 males and 16 females in laparoscopic group with age of 32 to 79 (mean 60.3) years, disease course of 2 to 10(mean 5.9) months and clinical stage T2-3N0-1. The baseline data of two groups were not significantly different (all P>0.05). All the patients in two groups completed operations successfully without conversion to open operation. Compared with laparoscopic group, the blood loss was less [(100.3±43.7) ml vs. (150.3±68.2) ml, t=3.413, P=0.001], the first flatus time [(49.3±12.4) h vs. (58.6±12.5) h, t=2.838, P=0.006] and urinary catheter removal time [(3.0±0.7) d vs. (4.8±0.9) d, t=5.491, P=0.000] were shorter, while the operation time [(217.3±57.8) min vs. (187.9±23.1) min, t=2.772, P=0.009] was longer in robot group. No cancer tissue was observed in resection margin of two groups. Number of harvested lymph node per case (15.2±7.4 vs. 13.9±4.9, t=-0.764, P=0.448), distance from anal margin to tumor distal edge [(7±3) cm vs. (6.5±3) cm, t=-1.952, P=0.056] and postoperative hospital stay [(13.6±1.3) d vs. (13.8±1.8) d, t=0.925, P=0.359] were not significantly different between two groups. No serious complications occurred in two groups during intra-operative and postoperative period. During following up of 3 to 12 (average 8.7) months, 1 case of anastomotic fistula occurred in each group and was cured by conservative treatment without significant difference [3.3%(1/30) vs. 3.1%(1/32), P=1.000]. No sexual dysfunction was found in either groups. Two cases in laparoscopic group presented relapse and metastasis, but no recurrence and metastasis was observed in robot group. There was no death in two groups.</p><p><b>CONCLUSION</b>Robotic radical surgery in the treatment of middle-low rectal cancers is safe and effective with the advantages of less trauma, less bleeding, rapid recovery of intestinal function and urinary function.</p>

Efficacy evaluation of laparoscopic complete mesocolic excision for transverse colon cancer / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate the safety, feasibility and long-term outcomes of laparoscopic complete mesocolic excision for the transverse colon cancer.</p><p><b>METHODS</b>Clinical data of 61 patients who underwent laparoscopic complete mesocolic excision for transverse colon cancer (transverse group) in our department from January 2011 to January 2014 were retrospectively analyzed, which were compared with those of 155 patients undergoing laparoscopic complete mesocolic excision for ascending colon cancer (ascending group) and 230 patients undergoing laparoscopic complete mesocolic excision for sigmoid colon cancer (sigmoid group). Differences in operative details, postoperative recovery, postoperative complications and long-term survival among 3 groups were evaluated.</p><p><b>RESULTS</b>No significant differences in the baseline information were found among 3 groups(all P>0.05). The average operative time was significantly longer in transverse group as compared to ascending group and sigmoid group [(192.1±58.7) min vs. (172.2±54.7) min and (169.1±53.6) min]( P<0.05), while the blood loss [(89.7±63.6) ml, (86.3±66.3) ml, (82.6±61.5) ml], conversion rate [3.3%(2/61), 2.6%(4/155), 2.2%(5/230)], number of harvested lymph node (13.0±4.7, 14.4±6.5, 13.4±5.6), time to flatus [(2.7±1.1) d, (2.6±1.1) d, (2.5±1.0) d], time to liquid diet [(3.0±1.7) d, (2.8±1.5) d, (2.7±1.4) d], incidence of postoperative complication(6.6%, 9.0%, 11.7%), and hospital stay [(11.6±5.8) d, (10.7±5.8) d, (10.6±5.7) d] among 3 groups were not significantly different (all P>0.05). A total of 436 patients received postoperative follow-up of median 36 (5 to 67) months. The overall 5-year survival rate was 73.1%, 73.7% and 74.8%, and the 5-year disease-free survival rate was 71.5%, 71.1% and 72.7% in transverse, ascending and sigmoid colon cancer groups respectively, whose differences were not significant among 3 groups (all P>0.05).</p><p><b>CONCLUSION</b>Laparoscopic complete mesocolic excision for transverse colon cancer is safe and feasible with slightly longer operation time, and has quite good long-term oncologic efficacy.</p>

Clinical investigation on transarterial chemoembolization with indigenous drug-eluting beads in treatment of unresectable hepatocellular carcinoma / 浙江大学学报·医学版

To evaluate the efficacy and safety of drug-eluding beads transarterial chemoembolization (DEB-TACE) in treatment of unrecectable hepatocellular carcinoma (HCC).The clinical data of 42 consecutive HCC patients undergoing TACE were retrospectively analyzed, including 20 cases received conventional TACE (cTACE group) and 22 cases received TACE with epirubicine-loaded microspheres (CalliSpheres) (DEB-TACE group). MRI scans were performed 1 week before and 1, 3 and 6 months after initial therapy. The response to treatment, disease recurrence, complications and adverse effects were documented and compared between two groups.There were no significant differences in 1-month, 3-month and 6-month objective response rate (CR+PR) and disease control rate (CR+PR+SD), disease recurrence, complications and adverse effects of interventional therapy between cTACE group and DEB-TACE group. Additionally, there were no significant differences about locoregional biliary injuries, intrahepatic biloma, and newly detected intra- or extrahepatic HCC on MRI between cTACE group and DEB-TACE group.There were no statistically significant differences between cTACE group and DEB-TACE group with regard to the short-term response, disease recurrence, complications and side effects. Hepatic-locoregional complications may be more frequent in DEB-TACE group than those in cTACE group.

Clinical research of delta-shaped anastomosis technology in laparoscopic distal gastrectomy and digestive tract reconstruction / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the feasibility and safety of the delta-shaped anastomosis in laparoscopic distal gastrectomy and digestive tract reconstruction.</p><p><b>METHODS</b>Clinical data of 34 gastric cancer patients undergoing laparoscopic distal gastrectomy with the delta-shaped anastomosis for digestive tract reconstruction (delta-shaped group) and 83 gastric cancer patients undergoing laparoscopic distal gastrectomy with Billroth I( for digestive tract reconstruction (Billroth group) by same surgeon team from July 2013 to July 2015 at the Department of Digestive Surgery, Affiliated Tumor Hospital of Shanxi Medical University were retrospectively analyzed. Data of two groups were compared.</p><p><b>RESULT</b>Age, gender, tumor stage were not significantly different between the two groups(all P>0.05). Operation time of the first 15 cases in delta-shaped group was longer than that in Billroth group [(254.7±35.4) min vs. (177.8±33.0) min, t=11.190, P=0.000], while after above 15 cases, the operation time of delta-shaped group was significantly shorter than that of Billroth group [(142.1±14.6) min vs. (177.8±33.0) min, t=-4.109, P=0.001]. Delta-shaped group had less blood loss during operation [(87.1±36.7) ml vs. (194.0±55.1) ml, t=-10.268, P=0.000], and shorter length of incision [(4.1±0.4) cm vs. (6.1±1.0) cm, t=-10.331, P=0.000] than Billroth group. Compared with Billroth group, delta-shaped group presented faster postoperative bowel function return [(2.8±0.6) d vs. (3.3±0.5) d, t=-3.755, P=0.000], earlier liquid food intake [(7.4±1.5) d vs. (8.1±1.7) d, t=-4.135, P=0.000], earlier ambulation [(4.0±1.6) d vs. (6.8±1.4) d, t=-7.197, P=0.000] and shorter postoperative hospital stay [(12.6±1.9) d vs.(13.6±2.0) d, t=-20.149, P=0.000]. Morbidity of postoperative complication was 5.9%(2/34) in delta-shaped group, including anastomotic fistula in 1 case and incision infection in 1 case, and 6.0%(5/83) in Billroth group, including anastomotic fistula, incision infection, anastomotic stricture and dumping syndrome, without significant difference(P>0.05). Difference value of total protein and albumin between pre-operation and post-operation, and average decreased value of total protein, albumin, body weight between pre-operation and postoperative 6-month were not significantly different between two groups(all P>0.05). As for patients with BMI > 25 kg/m, compared to Billroth group, delta-shaped group presented less blood loss during operation [(94.1±36.7) ml vs. (203.0±55.1) ml, t=-10.268, P=0.000], lower injective dosage of postoperative analgesics [(1.9±1.1) ampule vs.(3.3±2.0) ampule, t=-2.188, P=0.032], faster intestinal recovery [(2.9±0.7) d vs. (3.2±0.9) d, t=-3.755, P=0.009], shorter hospital stay [(10.5±1.2) d vs. (11.7±1.5) d, t=-2.026, P=0.004], and lower morbidity of postoperative complication [7.1%(1/14) vs. 13.6%(3/22), χ=4.066, P=0.031].</p><p><b>CONCLUSION</b>In laparoscopic distal gastrectomy and digestive tract reconstruction, the delta-shaped anastomosis is safe and feasible, especially suitable for obese patients.</p>