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目的评价中国发表的中西医结合治疗肝炎后肝硬化随机对照研究的概况及质量。方法计算机检索CNKI、万方学术期刊全文数据库、CBM等数据库,对1980年1月～2010年1月正式刊载的121篇入选文献进行Jadad量表评分,对其中记2分以上的39篇肝炎后肝硬化中西医结合随机对照试验(RCT)文献进行综合分析。结果 30年来国内肝炎后肝硬化中西医结合临床治疗性研究主要存在以下几个方面的问题: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活质量的研究。结论肝炎后肝硬化的中西医结合临床治疗具有“个性化”“多样化”的特点,临床疗效均优于单纯西医药,但因其临床科研方法的质量及水平存在偏倚,在临床应用上应注意结合医师经验。
Objective To evaluate the status and quality of randomized controlled clinical trials of integrated traditional Chinese and western medicine in treating posthepatitic cirrhosis in China. Methods The databases of CNKI, Wanfang Academic Journals Full Text Database and CBM were searched by computer, and Jadad scale was applied to 121 selected articles published from January 1980 to January 2010, Integrated Cirrhosis of Chinese and Western Randomized Controlled Trials (RCT) literature. Results The clinical treatment of hepatitis C cirrhosis in the past 30 years mainly includes the following aspects: The clinical randomized controlled trials are not well-designed, lack of blind use, lack of standardized research standards, low sample content and no Specific assessment methods, lack of compliance, case shedding and loss of follow-up analysis, neglect of adverse reaction reports and quality of life research. Conclusion The clinical treatment of posthepatitic cirrhosis with integrated traditional Chinese and western medicine has the characteristics of “personalized ” “diversification ”, and the clinical curative effect is superior to that of pure western medicine. However, due to the bias of the quality and level of clinical research methods, Clinical application should pay attention to the experience of physicians.