Chen Guoming, Huang Chuyao, Lu Jiaxin, Huang Ruilan, Zhang Jie, Chen Ziyin, Xu Hua
Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of paediatrics, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Medicine (Baltimore). 2019 Jan;98(2):e13935. doi: 10.1097/MD.0000000000013935.
Biliary atresia (BA) is a neonatal obstructive biliary tract disease in which the intrahepatic and extrahepatic bile ducts are obstructed and can lead to congenital biliary atresia of cholestatic cirrhosis and eventually liver failure. It has been confirmed that the Kasai portoenterostomy is an effective treatment for BA. But most patients still face complications, such as cholangitis and liver fibrosis. Yinchen Sini decoction (YCSND), a traditional herbal formula, is used as a treatment for BA after Kasai portoenterostomy. And it is supported that YCSND can improve jaundice and liver fibrosis through multiple targets and pathways. Based on the published literature, this study aims to evaluate the current situation in the treatment of BA in children with YCSND.
The following databases will be searched until October 2018: PubMed, The Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese biomedical literature database (CBM), Wan Fang Database, Chinese Scientific Journals Database (VIP) and other sources such as Hand searching, Conference proceeding, International Clinical Trials Registry Platform and Chinese Clinical Trials Registry. All randomized controlled trials (RCTs) of YCSND or related formula as a treatment for postoperative patients of Kasai portoenterostomy for BA will be collected. Data extraction and risk of bias assessments will be carried out by 2 verifiers independently. The risk of bias will be evaluated through the Cochrane risk of bias tool. Review Manager software (RevMan V.5.3.0) and STATA 15 will be used for statistical analyses.
This study will provide a high-quality synthesis of current evidence of YCSND in treating children undergoing Kasai portoenterostomy for BA from several aspects.
The conclusion of the meta-analysis will offer evidence for deciding whether YCSND is an effective measure for children undergoing Kasai portoenterostomy for BA.
Not only will this systematic review be published in a peer-reviewed journal, but it will also be propagated electronically and in print. The review will bring patients benefit and provide practitioners reference in the fields of conventional medicine.
PROSPERO CRD 42018111321.
胆道闭锁（BA）是一种新生儿梗阻性胆道疾病，其中肝内和肝外胆管受阻，可导致先天性胆汁淤积性肝硬化胆道闭锁并最终导致肝功能衰竭。已证实肝门空肠吻合术是治疗BA的有效方法。但大多数患者仍面临并发症，如胆管炎和肝纤维化。茵陈四逆汤（YCSND）是一种传统中药配方，用于肝门空肠吻合术后BA的治疗。并且有证据支持茵陈四逆汤可通过多种靶点和途径改善黄疸和肝纤维化。基于已发表的文献，本研究旨在评估茵陈四逆汤治疗儿童BA的现状。
检索以下数据库至2018年10月：PubMed、Cochrane图书馆、Embase、科学网、中国知网（CNKI）、中国生物医学文献数据库（CBM）、万方数据库、中文科技期刊数据库（VIP）以及其他来源，如手工检索、会议论文集、国际临床试验注册平台和中国临床试验注册中心。将收集所有以茵陈四逆汤或相关配方作为肝门空肠吻合术后BA患者治疗方法的随机对照试验（RCT）。数据提取和偏倚风险评估将由2名验证者独立进行。偏倚风险将通过Cochrane偏倚风险工具进行评估。将使用Review Manager软件（RevMan V.5.3.0）和STATA 15进行统计分析。
本研究将从多个方面对茵陈四逆汤治疗接受肝门空肠吻合术的儿童BA的现有证据进行高质量的综合分析。
荟萃分析的结论将为判定茵陈四逆汤是否是接受肝门空肠吻合术的儿童BA的有效治疗措施提供证据。
本系统评价不仅将发表在同行评审期刊上，还将以电子和印刷形式传播。该评价将使患者受益，并为传统医学领域的从业者提供参考。
PROSPERO注册号：PROSPERO CRD 42018111321。
