基于CONSORT声明评价消痔灵注射液治疗直肠脱垂随机对照试验的报告质量

Reporting quality of randomized controlled trials of Xiaozhiling Injection for rectal prolapse based on CONSORT statement

目的评价消痔灵注射液治疗直肠脱垂随机对照试验(RCT)的报告质量。方法计算机检索PubMed、Cochrane图书馆、CNKI、VIP、万方数据库、CBM,收集各文献库自建库至2021年7月发表的消痔灵注射液治疗直肠脱垂RCT的中英文文献,并基于CONSORT声明(2010版)对所纳入文献进行报告质量评价。结果共纳入18篇文献,其中8篇(44%)阐述了研究的目的或假设,5篇(28%)报道了随机序列产生的方法,1篇(6%)给出了随机方法的类型,1篇(6%)提及了分配隐藏机制,8篇(44%)报道了不良事件,2篇(11%)阐述了研究的局限性。题目的撰写均不符合规范,所有文献均未实施盲法,而且整体缺乏对试验设计、样本量估算、辅助分析、可推广性、试验注册、资助等方面的描述。结论消痔灵注射液治疗直肠脱垂RCT的报告质量存在些许不足,建议研究者在今后的研究中参照CONSORT声明进行RCT的设计、实施和撰写,提高研究质量。

Objective To evaluate the reporting quality of randomized controlled trials(RCT)on the treatment of rectal prolapse by Xiaozhiling Injection.Methods The RCTs of Xiaozhiling Injection in the treatment of rectal prolapse were systematically searched by PubMed,Cochrane Library,CNKI,VIP,Wanfang dara and CBM from the database establishment to July 2021,and the included literature was evaluated by CONSORT statement(2010 edition).Results A total of 18 articles were included.Among them,8 articles(44%)described the purpose or hypothesis of the study,5 articles(28%)reported the method of generating random sequence,1 articles(6%)gave the type of random method,1 articles(6%)mentioned the allocation hidden mechanism,8 articles(44%)referred to adverse events,and 2 articles(11%)described the limitations of the study.The writing of the topic was not in accordance with the standard,and blind method was not applied in all the literature,and there was a lack of description of the trial design,sample size estimation,auxiliary analysis,extensibility,trial registration,funding,and other aspects.Conclusion There are some deficiencies in the report quality of Xiaozhiling Injection in the treatment of rectal prolapse RCTs.It is suggested that the researchers refer to CONSORT statement to design,implement and write RCT,so as to improve the research quality.