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茵栀黄注射液治疗黄疸型病毒性肝炎临床研究的方法学质量评价
引用本文:陈辉扬,陈军,吴泰相,刘志承,温平康.茵栀黄注射液治疗黄疸型病毒性肝炎临床研究的方法学质量评价[J].中国药房,2005,16(13):1031-1033.
作者姓名:陈辉扬  陈军  吴泰相  刘志承  温平康
作者单位:1. 深圳市中医院药剂科,深圳市,518033
2. 四川大学华西医院中国循证医学中心,成都市,610041
摘    要:目的:评价茵栀黄注射液治疗黄疸型病毒性肝炎临床研究论文的方法学质量。方法:对相关文献77篇,按照CochraneReviewer'sHandbook4.2.2评价指南的质量评价标准进行质量评价、分析。结果:仅有4篇随机对照试验符合纳入标准,其中随机对照研究(RCT)2篇,半随机对照研究(CCT)2篇;4篇研究均为低质量的研究(C级),存在选择性偏倚、实施偏倚、测量偏倚及损耗性偏倚的高度可能性。结论:要获得临床茵栀黄注射液治疗黄疸型病毒性肝炎的可靠证据,尚需进行更多高质量的随机对照研究。

关 键 词:茵栀黄注射液  病毒性肝炎  黄疸  高胆红素血症  质量评价
文章编号:1001-0408(2005)13-1031-03
修稿时间:2005年5月27日

Quality Evaluation on Methodology of Clinical Research of Yinzhihuang Injection in the Treatment of Icteric Virus Hepatitis
CHEN Huiyang,CHEN Jun,Liu Zhicheng,WEN Pingkang,WU Taixiang.Quality Evaluation on Methodology of Clinical Research of Yinzhihuang Injection in the Treatment of Icteric Virus Hepatitis[J].China Pharmacy,2005,16(13):1031-1033.
Authors:CHEN Huiyang  CHEN Jun  Liu Zhicheng  WEN Pingkang  WU Taixiang
Abstract:OBJECTIVE:To evaluate the quality of the methodology of clinical research on Yinzhihuang injection in the treatment of icteruc virus hepatitis.METHODS:The methodology quality of77pertinent literatures was evaluated and analyzed according to the quality assessment criteria in the evaluation manual of Cochrane Reviewer's Handbook 4.2.2.RESULTS:Only 4 literatures were up to the related standards,2 of which were randomized controlled trials(RCT)and other 2 were semi-randomized controlled trials(CCT).All of the 4 studies were low quality(Grade C)researches,in which the biases on selectivity,practice,measurement and wastage were highly possible.CONCLUSION:More randomized controlled trials of high quality are needed to obtain reliable evidences on Yinzhihuang injection in the treatment of icteric virus hepatitis.
Keywords:Yinzhihuang injection  Virus hepatitis  Icterus  Hyperbilirubinemia  Quality evaluation
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