摘要
目的了解中国病毒性肝炎临床治疗试验状况。方法手检1990～1997年8种中华系列医学杂志发表的治疗试验共84篇，进行分析评价。结果随机对照试验占27．4％，非随机对照试验占55．9％，自身前后对照试验占15．5％，序贯试验占1．2％。试验研究的病种主要是慢性肝炎，乙型肝炎和丙型肝炎占94％。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。38．1％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 quality of clinical therapeutic trials of viral hepatitis inChina. Methods Eighty-four clinical trials on viral hepatitis therapy were evaluated and they werepublished in series of the Chinese medical journals from 1990 to 1997, searching page after page byhand. Results The viral hepatitis studied were mainly chronic type,especially hepatitis B and C. Among designs of the therapeutic trials,randomized controlled trial(RCT) accounted for 27. 4%, nonRCT made up 55. 9%,self before-after control trial 15. 5 % and sequential trial 1. 2 %. The diagnosisof the patients was based on the criterion of the national conference on viral hepatitis. 34. 5 % of thepatients were verified by the hepatic tissue pathology. Twenty percent of the trials had excluding criteria and 10% had including criteria. The ratio of drug control versus placebo control was 100: 15.The articles with comparability of control group with treatment group constituted 54. 8%. Doubleblind RCT was used in two of 84 articles. The efficacy assessment of treatment was mostly based onthe criteria developed by the authors themselves,and only few based on the national one. The followup was achieved in 38. 1% of the trials after therapy regimens. The adverse effects of therapy wereobserved and documented in 47. 6% of the clinical trials. Conclusions The clinical trials of hepatitisin China were not strongly designed. The quality Of clinical trial needs to be improved. Multi-center,large-scale,and longer time trials on viral hepatitis therapy should be advocated.[
出处
《中华疾病控制杂志》
CAS
1998年第3期188-190,共3页
Chinese Journal of Disease Control & Prevention
关键词
病毒性肝炎
治疗试验
文献评价
viral hepatitis
therapeutic trial
literature evaluation
