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目的 :了解国内病毒性肝炎临床治疗试验状况。方法 :手检 1990～ 1998年八种中华系列医学杂志发表的治疗试验共 10 6篇 ,进行分析评价。结果 :随机对照试验占 3 1 1% ,非随机的对照试验占 47 2 % ,序贯试验占 0 9% ,无对照的治疗试验占 2 0 8%。试验研究的病种主要为慢性肝炎 ,乙肝和丙肝占 92 %。使用安慰剂或空白对照的占 13 1% ;疗效评价标准多为自定标准。 3 8 1%的试验有随访观察 ;47 6 %报告了药物不良反应或副作用。结论 :病毒性肝炎治疗试验的质量有待进一步提高 ,对存在问题进行分析。
Objective: To understand the status of clinical trials of viral hepatitis in China. Methods: Manuscripts from 1986 to 1998, eight Chinese series of medical journals published a total of 106 trials for analysis and evaluation. Results: Randomized controlled trials accounted for 31.1%, non-randomized controlled trials 47 2%, sequential tests 0.9%, and uncontrolled therapeutic trials 28.0%. The main types of diseases studied are chronic hepatitis, with hepatitis B and hepatitis C accounting for 92%. The use of placebo or blank control accounted for 13 1%; efficacy evaluation criteria are mostly self-defined standards. 381% of the trials were followed up; 47.6% reported adverse drug reactions or side effects. Conclusion: The quality of viral hepatitis treatment trials needs to be further improved, and the existing problems analyzed.