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目的使用Ioannidis量表和CONSORT声明扩展版全面评价中文发表的乳腺癌随机对照试验不良反应报告情况。方法计算机检索中国知网数据库、中国生物医学文献数据库、中文科技期刊数据库及万方数据资源,并严格按照纳入排除标准筛选获得中文发表的乳腺癌随机对照试验。采用CONSORT声明扩展版及Ioannidis量表评价和分析所有纳入文献,各条目符合程度由高到低分别评为“1分”、“0.5分”、“0分”。将所获数据录入Excel软件,并使用Rev Man5.0软件进行统计分析。结果共纳入乳腺癌随机对照试验964篇,发表数量总体呈逐年上升之势。812篇(84.2%)研究提及了不良反应或不良事件,CONSORT总评分为(2.94±1.68)分,中位数为3分;Ioannidis总评分为(0.94±1.00)分,中位数为1分,且所有条目的完整报告率均低于50%。分层分析结果显示:仅Ioannidis评分在中国科学引文数据库期刊来源研究与非中国科学引文数据库期刊来源研究的差异具有统计学意义(P=0.03),其他方面的差异均无统计学意义。结论中文发表乳腺癌随机对照试验中不良反应的报告不够全面。作者和编辑需互相督促、学习,共同促进不良反应报告质量的提高。
Objective To evaluate the adverse reactions reported in Chinese published randomized controlled trials on breast cancer using the Ioannidis Scale and the CONSORT Statement Extended Edition. Methods The databases of CNKI, Chinese Biomedical Literature Database, Chinese Scientific and Technical Periodicals Database and Wanfang Data were searched by computer. The randomized controlled trials of breast cancer published in Chinese were screened strictly according to inclusion criteria. The CONSORT statement extended version and the Ioannidis scale were used to evaluate and analyze all the included articles. The scores of each item were rated as “1 score”, “0.5 score” and “0 score” from high to low respectively. The data obtained will be entered Excel software, and use Rev Man5.0 software for statistical analysis. Results A total of 964 randomized controlled trials of breast cancer were included in this study. A total of 812 articles (84.2%) referred to adverse events or adverse events. The overall CONSORT score was (2.94 ± 1.68) with a median of 3; the Ioannidis total score was (0.94 ± 1.00) with a median of 1 Points, and the full report rate for all entries is less than 50%. The results of stratification analysis showed that the Ioannidis score was statistically different from that of the sources from the Chinese citation database and non-Chinese citation databases (P = 0.03). There was no significant difference in other aspects. Conclusion The Chinese report of adverse reactions in randomized controlled trials of breast cancer is not comprehensive enough. Authors and editors need to urge each other, learn, and jointly promote the improvement of the quality of adverse reaction reports.