我国口服降糖药临床试验研究论文的伦理情况研究

Ethical Issues in Clinical Trials of Oral Hypoglycemic Drugs

目的:对口服降糖药相关临床试验研究论文中的伦理情况进行分析,以便了解我国药物临床试验中研究者遵循伦理道德的情况。方法:在中国知网(CNKI)数据库中检索2005年和2015年以口服降糖药为主要研究药物的涉及人的论文,记录论文发表的年代、是否为核心期刊、研究药物属于西药或中药、试验方案是否获得相关伦理委员会的审批以及受试者是否签署了知情同意书等并进行比较分析。结果:论文中2005年和2015年试验方案通过伦理委员会审查的比例分别为1.56%和18.50%,受试者签署知情同意书的比例分别为10.16%和33.92%,差异均有统计学意义。2015年口服降糖药相关核心期刊研究论文和非核心期刊论文中提及通过伦理委员会审查比例分别是43.68%和2.86%,签署知情同意书的比例分别是67.82%和12.86%,差异明显并具有统计学意义。结论:2015年我国口服降糖药临床研究论文的伦理情况比2005年有明显进步,但与国外研究论文仍有一定的差距,需要我国科研人员不断提高科学研究的伦理道德水平。

Objective:To explore whether the researchers have followed the ethics requirements in clinical trials of oral hypoglycemic drugs.Methods:We searched CNKI database for articles of clinical trials of oral hypoglycemic drugs in2005and2015.We summarized and analyzed the ratesof ethics committee approval and signing the informed consents.Results:In2005and2015studies,the rates of ethics committee approval were1.56%and18.50%respectively,the rates of signing informed consents were10.16%and33.92%.In the papers published in the core journals andthe ordinary journals in2015,the rates of ethics committee approval were43.68%and2.86%respectively,the rates of signing informed consentswere67.82%and12.86%.These differences have statistical significance.Conclusion:Compared with2005,ethical issues in clinical trials of oralhypoglycemic drugs in2015have improved obviously;however,its overall level has a certain gap while being compared with other countries.Thereis an urgent need to enhance the ethical level of our science researchers.