中医药治疗重症肌无力随机对照试验结局指标选用现状研究

Background Chinese herbal medicine and acupuncture are widely used in the treatment of myasthenia gravis, but there is a lack of high-quality evidence to verify its effectiveness and safety. One of the reasons is the lack of recognized and unified outcome indicators in the trial design, which leads to the inability to combine data in secondary studies such as meta-analysis. The construction of the core outcome set of traditional Chinese medicine for myasthenia gravis is conducive to the design of clinical research and the accumulation of high-quality evidence. Objective To describe the current situation of outcome selection in randomized controlled trials of traditional Chinese medicine in the treatment of myasthenia gravis, analyze the existing problems and put forward suggestions. Methods Comprehensively search the Chinese and English databases, screen the randomized controlled trials of traditional Chinese medicine in the treatment of myasthenia gravis, extract the outcome information, classify and count the frequency, divide the index domain, analyze the selection characteristics and existing problems, and put forward suggestions. Results Eight databases were searched and 186 literatures were included. The outcomes were used for 724 times in total, which were divided into seven categories: myasthenia gravis severity scale, myasthenia gravis quality of life scale, TCM syndrome score, safety index, blood biochemical index, muscle strength change and others. There are some problems in outcome selection, such as unclear primary and secondary distinction, lack of internationally recognized outcomes, insufficient attention to safety, large difference between quantity and evaluation time point, bias in evaluation, not included in health economics evaluation, non-standard evaluation standard of curative effect and so on. Conclusion According to the existing problems, specific suggestions were put forward as follow: promote the construction of the core outcome set of clinical research on the treatment of myasthenia gravis with traditional Chinese medicine, select internationally recognized primary and secondary outcomes, select appropriate treatment duration and evaluation time points, register clinical trials, use blind method, and standardized report writing.