摘要
盲法质量评价是对实施盲法的临床试验所获得的临床盲化数据进行评估,通过调查分析不同设盲对象的致盲效果来判断盲法实施的有效性。成功的盲法能够在一定程度上避免受试对象和研究者由于主观因素对试验结果造成的影响,而通过盲法质量评价不仅可以反映盲法实施的有效性,更能体现临床试验结果的准确性和可信度。近年来随机对照试验广泛应用于中医药临床疗效评价,但其盲法的实施质量参差不齐,尚未形成评价标准。该文对两种定量盲法质量评价方法——James盲法指数(JBI)和Bang盲法指数(BBI)的数据收集方式、计算原理和优缺点进行介绍,并在一项针灸缓解口腔术后疼痛的随机对照试验中进行2种指数的实例分析,应用R软件演示结果计算过程并通过森林图进行可视化展示,同时设计了便于在试验不同阶段进行中医药临床试验盲法评价资料收集的工具表,最后对盲法质量评价在中医药研究中的必要性和可行性进行探讨,以期为评价和提高中医药临床试验中盲法实施质量提供依据。
The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects.A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent.The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results.In recent years,randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine(TCM),but the quality of the implementation of blind methods is uneven,and the evaluation criteria have not yet been formed.In this paper,the data collection methods,calculation principles,advantages,and disadvantages of two quantitative quality evaluation methods of blind methods,namely James Blinding Index(JBI)and Bang Blinding Index(BBI),were introduced.The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain.The calculation process of the results was demonstrated by R software and visualized by forest map.At the same time,a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages.Finally,the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
作者
施泽阳
孙源
马文欣
王禹毅
卜志军
王雪惠
郑酉友
刘建平
刘兆兰
SHI Zeyang;SUN Yuan;MA Wenxin;WANG Yuyi;BU Zhijun;WANG Xuehui;ZHENG Youyou;LIU Jianping;LIU Zhaolan(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Yantai Centre for Disease Control and Prevention,Yantai 264003,China;Chongqing Hospital of Traditional Chinese Medicine(TCM),Chongqing 400017,China;Institute of Information on TCM,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2024年第3期75-80,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(82374298)
北京中医药大学学科后备带头人支持计划项目(90010960920033)
国家中医药管理局高水平中医药重点学科建设项目——中医药循证医学(zyyzdxk-2023249)。
关键词
盲法
质量评价
临床试验
中医
方法学
blind method
quality evaluation
clinical trials
traditional Chinese Medicine
methodology
