中文发表乳腺癌随机对照试验伦理学质量评价

Assessment of Ethical Quality of Randomized Controlled Clinical Trials in Breast Cancer Published in China

[目的]评价乳腺癌随机对照试验伦理学质量,分析其影响因素。[方法]计算机检索CBM、万方数据库、CNKI、维普数据库,查找乳腺癌随机对照试验,采用Berdeu量表评价伦理学质量。[结果]最终纳入965个乳腺癌RCT,作者数量平均为3.31±2.10,发表的杂志等级为CSCD期刊论文的占33.16%,合作机构数量平均为2.43±1.24;有方法学人员参与的仅占0.41%。伦理学质量评价显示：Berdeu量表平均得分为1.11±0.87,条目2、5、6、8、10能够充分报告的研究不足1%。文献发表期刊等级（MD=0.12,95%CI：0.02~0.22,P=0.02）和有方法学人员参与（MD=0.74,95%CI：0.13~1.35,P=0.02）可能会提高文献伦理学质量评分（P〈0.05）。[结论]乳腺癌随机对照试验伦理学质量报告还需进一步提高。

[Purpose] To evaluate the ethical quality of randomized controlled clinical trials（RCTs）in breast cancer published in China,and to analyze its influencing factors. [Methods] All RCTs of breast cancer indexed in CNKI,CBM and Wanfang database were retrieved. The ethical quality of RCTs was evaluated by using the Berdeu 10-item scale. [Results] All of 965 RCTs were included,33.16% of included RCTs were indexed in CSCD,the mean number of authors were 3.31 ±2.10,the average number of affiliations were 2.43 ±1.24,0.41% of RCTs were performed by methodologist. The results of ethical quality showed that the mean score of Berdeu scale was 1.11 ±0.87. Almost 1% of included RCTs completed reported item 2,5,6,8,10. The results of stratified analysis showed that,both statistician/ epidemiologist/evidence-based medicine involvement（MD=0.74,95%CI：0.13~1.35,P=0.02）,the type of publication（MD=0.12,95%CI：0.02~0.22,P=0.02）could improve the ethical quality,with a significant difference（P〈0.05）. [Conclusion] The overall ethical quality of randomized controlled clinical trials in breast cancer published in China must be improved in the future.