CAJ | 학술논문

目的：评价2000~2014年中国中医药干预化疗致消化道毒性反应临床试验的方法学质量。方法计算机检索知网、万方、维普、中国生物医学文献数据库及中国中医药数据库(2000年1月至2014年12月)，并辅以手工检索。采用 Cochrane偏倚风险评估表对纳入的随机对照试验、半随机对照试验进行方法学质量评价。结果最终筛选研究291篇，符合 Cochrane 偏倚风险评估表“低风险”标准至少一条的随机对照试验及半随机对照试验仅76个，总体方法学质量欠佳。结论近14年来，中医药疗法干预化疗致消化道毒性反应的临床试验发表呈逐年上升趋势，但总体研究设计存在缺陷。
목적：평개2000~2014년중국중의약간예화료치소화도독성반응림상시험적방법학질량。방법계산궤검색지망、만방、유보、중국생물의학문헌수거고급중국중의약수거고(2000년1월지2014년12월)，병보이수공검색。채용 Cochrane편의풍험평고표대납입적수궤대조시험、반수궤대조시험진행방법학질량평개。결과최종사선연구291편，부합 Cochrane 편의풍험평고표“저풍험”표준지소일조적수궤대조시험급반수궤대조시험부76개，총체방법학질량흠가。결론근14년래，중의약요법간예화료치소화도독성반응적림상시험발표정축년상승추세，단총체연구설계존재결함。
Objective To evaluate the methodological quality of clinical trials on Chinese medicine interventional chemothera-py induced gastrointestinal toxic reactions from 2000 to 2014.Methods The randomized controlled trials(RCT)and semi-RCT on Chinese medicine interventional chemotherapy induced gastrointestinal toxic reactions were retrieved from the China National Knowledge Infrastructure (CNKI),Wanfang databases,VIP,China Biology Medicine Database (CBM)and Traditional Chinese Medicine (TCM)database by computer and supplemented by the manual retrieval (January 2000 to December 2014).The methodo-logical quality assessment on the included RCT and semi-RCT was conducted by using the Cochrane risk assessment table of bias. Results 291 articles were finally screened out,only 76 of RCT and semi-RCT were conformed to the at least one of low risk stand-ards of Cochrane risk assessment table of bias.Therefore the total methodological quality was not good enough.Conclusion The publishing of clinical trials on Chinese medicine interventional chemotherapy induced gastrointestinal toxic reactions shows the in-creasing trend year by year during the past 14 years.However,the different defects exist in the overall trial design.