中草药辅助治疗晚期非小细胞肺癌随机对照临床试验报告质量评估  

Quality assessment of reporting items in randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer

作　　者：张宏博[1] 翟静波 单丽珠[1] Zhang Hongbo;Zhai Jingbo;Shan Lizhu(Department of Oncology, Tianjin Nankai Hospital, Tianjin 300100, China;Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China)

机构地区：[1]天津市南开医院肿瘤科,300100 [2]天津中医药大学循证医学中心,300193

出　　处：《国际生物医学工程杂志》2018年第2期182-186,共5页International Journal of Biomedical Engineering

基　　金：国家自然科学基金（81303093）

摘　　要：目的评估中草药辅助治疗晚期非小细胞肺癌随机对照临床试验的报告条目.方法以中医药、中草药、随机对照、试验、非小细胞肺癌等为检索词,采用计算机系统检索中英文数据库中的相关文献,基于CONSORT2010声明评估合格文献中摘要和正文报告条目情况.结果共检索95篇合格文献,其中0篇文献按照CONSORT声明完整地报道摘要和正文条目,4.12％的文献题目指明为随机试验,超过40％的文献仅在摘要中报道了研究目的或假设,3.16％的文献报道了主要和次要疗效指标条目,0篇文献报道了受试者从入组到纳入数据分析集的完整信息.结论中草药辅助治疗晚期非小细胞肺癌随机对照临床试验文献中,存在报告条目严重不足的情况.研究者应基于CONSORT声明,对中草药辅助治疗肿瘤随机对照临床试验进行报告,从而提高试验质量.Objective To evaluate the reporting item quality of randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. Methods The terms including Chinese medicine, Chinese herbal medicine, randomized controlled trials, and non-small cell lung cancer were searched in Chinese and English databases by computer systems to collect relevant literatures. Based on the CONSORT 2010 （consolidated standards of reporting trials 2010）, the reporting item quality of the abstracts and main text in eligible papers was evaluated. Results Ninety-five eligible studies were identified from 692 potential eligible articles. None reported all of abstract and main text items in CONSORT 2010. Only 4.12％could be identified as the randomized trial in the title. More than 40％of reports showed the scientific background or rationale in the abstract but not in the main text. Three （3.16％） eligible reports defined the primary or secondary outcome measures. None reported complete information of subjects throughout the clinical trial process. Results A total of 95 eligible papers were collected, of which 0 papers reported complete abstracts and text entries according to the CONSORT. The titles of 4.12％papers were identified as randomized trials. More than 40％of the papers only reported the study purpose or hypothesis in the abstract. 3.16％of the papers reported primary and secondary efficacy index entries, and 0 papers reported complete information of subjects from enrollment to included data analysis sets. Conclusion There is a serious problem of items shortage in the literatures of randomized controlled clinical trials on Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. The randomized controlled clinical trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer should be reported based on the CONSORT to improve the quality of trials.

关 键 词：中草药 非小细胞肺癌 随机对照临床试验 报告质量 

分 类 号：R734.2[医药卫生—肿瘤]