中成药治疗男性不育症随机对照试验报告的研究特征及质量评价

Research characteristics and quality evaluation of randomized controlled trial report of Chinese patent drug in the treatment of male infertility

目的 梳理中成药治疗男性不育症随机对照试验(RCT)的临床特征并评价其报告质量,讨论研究现状及存在问题。方法 检索中国知网、万方数据知识服务平台、维普等数据库建库至2021年12月31日发表的关于单纯使用中成药治疗男性不育症的RCT研究,以临床试验报告统一标准(CONSORT)-中药复方和改良Jadad量表为依据,对纳入的RCT报告质量进行评价。结果 共纳入54篇RCT,涉及23种中成药,出现最多的是复方玄驹胶囊;26篇研究样本量大于101例,最大样本量为405例;对照组药物共使用11种,频率最高的是五子衍宗丸;结局评价指标除精液分析外,包括妊娠率、性激素等;涉及5种中医证型,其中最多的是肾精不足。以CONSORT-中药复方评价:32篇提供诊断标准以及纳排标准,但中医诊断标准出处不统一;13篇报告中成药具体的厂家、批号等信息;22篇阐述了具体随机方法;2篇提及“盲法”;18篇记录了研究过程中的不良事件;所有研究均无适当的关键词、无完整的干预措施、无合理的分配隐藏实施方式、无受试者流程图、无临床试验注册、无研究方案和资助说明。以改良Jadad量表评价:0~3分的低质量文献53篇,4分1篇,无5分以上文献。结论 目前国内有关单独使用中成药治疗男性不育症的RCT报告质量普遍偏低,结论可信度存疑,在采纳和运用其结果时应谨慎;研究者应遵循CONSORT-中药复方、改良Jadad量表进行方案设计、注册、实施及报告,充分考虑中成药治疗男性不育症的临床特点,合理设计和报告结局评价指标和结果。

Objective To sort out the clinical characteristics of randomized controlled trial(RCT) of Chinese patent medicine in the treatment of male infertility and evaluate the quality of its RCT reports, and discuss the research status and existing problems. Methods The RCT studies on the treatment of male infertility with Chinese patent drug alone published in CNKI, WF and VIP database were searched, from the establishment of them to December 31, 2021. The quality of the included RCT reports was evaluated based on consolidated standards of reporting of trials(CONSORT)-CHM formulas and modified Jadad scale. Results 54 RCTs were included, involving 23 kinds of Chinese patent drugs, the most used was Fufang Xuanju capsule;26 study samples were larger than 101 cases, and the maximum sample size was 405 cases;a total of 11 kinds of control drugs were used, and the highest frequency was Wuzi Yanzong pill;in addition to semen analysis, outcome indexes included pregnancy rate, sex hormone and so on;there were 5 types of TCM syndrome, the most of which was deficiency of kidney essence. Evaluated by CONSORT-CHM formulas: 32 studies provided diagnostic criteria, inclusion and exclusion criteria, but the diagnostic criteria of traditional Chinese medicine are not uniform;13 studies reported specific manufacturers, batch numbers and other information of Chinese patent drugs;22 studies described specific randomized methods;2 studies mentioned "blind method";18 studies reported adverse events in the research process. All studies had no appropriate keywords, no complete intervention measures, no reasonable allocation and hidden implementation methods, no subject flow chart, no clinical trial registration, no research scheme and funding description. According to the modified Jadad score scale: there were 53 low-quality literatures with 0-3 points, only 1 literature with 4 points, and no literature with more than 5 points. Conclusions At present, the quality of the reports on the use of Chinese patent medicine in the treatment of male infertility is generally low in China, and the credibility of the conclusions is doubtful. Therefore, caution should be exercised when adopting and applying the results. Researchers should design, register, implement and report the scheme according to CONSORT-traditional Chinese medicine compound and improved Jadad scale, fully consider the clinical characteristics of Chinese patent medicine in the treatment of male infertility, and reasonably design and report outcome evaluation indicators and results.