中西医结合治疗肝炎后肝硬化腹水随机对照试验的质量评价
Randomized controlled trial of integrated traditional Chinese and western medicine treatment for posthepatitic cirrhotic ascites: a systematic review
摘要目的 探索国内肝炎后肝硬化腹水中西医结合临床治疗性研究的概况及质量.方法选用中国知识资源总库、维普中文期刊数据库、万方学术期刊全文数据库、中国生物医学文献服务系统等作为资料源,检索出1980年1月-2010年1月正式刊载的"中西医结合治疗肝硬化腹水"文献,并对其进行Jadad量表评分,对其中记2分以上文献进行系统评价,包括受试对象描述、研究设计与方法、疗效判定、统计学方法等.结果 共检索出符合要求的文献136篇,其中Jadad记分2分以上的58篇纳入本研究.30年来,国内肝炎后肝硬化腹水中西医结合临床治疗性研究存在的主要问题包括:临床随机对照试验设计不严密,缺乏盲法的使用,缺乏统一规范的研究标准,样本含量低且无具体的估算方法,缺乏依从性、病例脱落及失访情况的分析,忽视不良反应的报告和生命质量的研究.结论 肝炎后肝硬化腹水的中西医结合临床治疗具有"个性化"和"多样化"的特点,但其临床科研方法的质量及水平亟待提高.
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abstractsObjective To research domestic general situation and quality of the clinical treatment of posthepatitic cirrhotic ascites in Integrated Traditional Chinese and Western Medicine. Methods Chose CNKI, VIP, Wang fang and CBM as data source and searched the literature of the clinical treatment of posthepatitic cirrhotic ascites in Integrated Traditional Chinese and Western Medicine which published officially from January 1980 to January 2010 and which received a Jaded score of 2 or greater to do a systematic evaluation, including the description of subjects, study design and methods, therapeutic efficacy and statistical methods. Results 136 articles in all met inclusion criteria and 58 articles which received a Jaded score of 2 or greater did this research. The main problems of domestic posthepatitic cirrhotic ascites in Integrated Traditional Chinese and Western Medicine in 30 years included: randomized controlled trial design was unreasonable, lack of blinding, lack of standardized criteria, the sample size was small and lack of specific estimation methods, lack of compliance, case off and withdraw, ignoring adverse reaction and the research of life quality. Conclusion The clinical treatment of posthepatitic cirrhotic ascites in Integrated Traditional Chinese and Western Medicine have a "personalized" and "diversity" character and the methods and standards of clinical research need to be improved.
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