中医药治疗异位妊娠随机对照试验文献的质量评价  

Quality Evaluation on the Claimed "Randomized Controlled Trials" of Traditional Chinese Medicine for Treatment of Ectopic Pregnancy

作　　者：王登凤[1] 方芳[1] 吴泰相[2] 贾海军[1] 张静[1] 孙莹[1] 谢灵遐[1] 胡丽娜[1] 

机构地区：[1]四川大学华西第二附属医院,四川成都610041 [2]四川大学华西医院中国循证医学中心,四川成都610041

出　　处：《实用妇产科杂志》2007年第9期541-544,共4页Journal of Practical Obstetrics and Gynecology

摘　　要：目的:评价中医药治疗异位妊娠的临床随机对照试验(randomized controlled trials,RCT)文献的质量。方法:在多个数据库中检索相关文献,并电话访问纳入研究的原作者,以了解试验的随机方法和一些质量相关特征,根据CONSORT进一步评价合格RCT的质量。结果:共纳入166篇文献,3篇为重复发表文献,在回答了问题的97篇中,2篇是(2.1%)符合标准RCT,均来自医学院校附属医院。在不完全符合标准的RCT中,绝大部分采用了非随机分配方法进行分组,最常见的是按患者就诊先后顺序、病情轻重等分组,还有部分是对既往异位妊娠病例的回顾性总结。结论:中医药治疗异位妊娠的RCT文献与严格的RCT标准存在一定差距。Objective：To evaluate the quality of claimed randomized controlled trials （RCTs） of traditional Chinese medicine for treatment of ectopic pregnancy. Methods：A comprehensive and exhaustive search strategy had been formulated in an attempt to identify all relevant studies regardless of language or publication status. Several electronic data-bases were searched. We contacted the authors selected for the evaluation through telephone to find out how on earth the trials be carried out. Then further evaluation was made for qualified RCT according to CONSORT statemerit.Results;166 claimed RCTs were included for telephone interview, 97 responsed. Finally, 2 studies which be conducted by medical university affiliated hospitals were identified as qualified RCTs （2.1%）, and scored 12 （35.3%） and 14 （41.2%） respectively. Most of the claimed RCTs didn＇t adopt the proper method for generation of the allocation sequence, frequent methods used had allocated according to the sequence of administration, or to de- grea of the pathogenetic condition, and even some of were retrospective summary to ectepic pregnancy cases. Conclusions;The claimed RCTs about traditional Chinese medicine for treatment of ectepic pregnancy are different from strict standards RCT. Strictly clinical trial registration and approval system will be an important measure to ensure the producing of high quality trials.

关 键 词：异位妊娠 中医药治疗 随机对照试验 

分 类 号：R714[医药卫生—妇产科学]