针灸治疗溃疡性结肠炎结局指标的分析

Analysis of the outcomes in treatment of ulcerative colitis with acupuncture and moxibustion

目的:明确针灸治疗溃疡性结肠炎(UC)的关键结局指标。方法:检索中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普科技中文期刊数据库(VIP)、中国生物医学文献数据库(Sino Med)、Pub Med、EMbase、Cochrane Library、Web of Science(WOS)数据库收录的针灸治疗UC的随机对照试验(RCT),检索时限为建库至2023年3月20日。提取文献基本信息、干预措施、结局指标相关内容,分析主、次要结局指标的设置,各类指标的使用频次、组合使用情况,并归纳针灸治疗UC的RCT指标域。结果:共纳入215个RCT,涉及结局指标54个,包括中医病证、症状/体征、理化检测、生活质量、远期预后、安全性事件6类,使用频次排前3位的依次为临床疗效评价、针灸不良反应、主要症状评分。其中仅3篇文献明确报告了主、次要结局指标,180篇文献同时使用了两类结局指标,仅3篇文献描述了观察指标多个具体评价时点,明确报告疗效评定标准参考来源的126篇文献涉及的参考标准达57个。结论:目前针灸治疗UC的RCT,结局指标未形成统一标准,主、次要结局指标有待明确,临床疗效评价标准不一,对患者生活质量、随访、安全性事件关注较少,应注重构建以客观内镜评分为主,以症状/体征改善、生化检查等为辅的结局指标集。

Objective To clarify the key outcomes of acupuncture-moxibustion treatment of ulcerative colitis. Methods The clinical randomized controlled trials(RCTs) for ulcerative colitis treated with acupuncture and moxibustion were searched from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, from the inception of each database to March 20th, 2023. The basic information of literature, intervention measures and outcome indexes were collected. The selection of primary and secondary outcomes, the use frequency of each index and the combination of them in utility were analyzed;and index domains of acupuncture and moxibustion for ulcerative colitis were summarized. Results A total of 215 RCTs were included and 54 outcomes were involved, classified into 6 categories, i.e. TCM syndromes,symptoms/physical signs, physical and chemical tests, quality of life, long-term prognosis and safety events. The top 3outcomes with high use frequency were clinical effect evaluation, adverse reactions of acupuncture and moxibustion and the score of main symptoms. Only 3 articles clearly reported the primary outcome and the secondary ones, 180 articles used two types of outcomes simultaneously, 3 articles clearly described the time points of the observation indexes, and 126 articles determined the sources of the evaluation criteria of therapeutic effect, with 57 criteria involved. Conclusion At present, the outcomes have not been standardized in RCTs of acupuncture and moxibustion for ulcerative colitis. It needs to clarify the primary one and the secondary ones. The criteria have not been unified for the evaluation of therapeutic effects and there is less consideration on the quality of life in patients, the follow-up visit and safety events. The attention should be paid to develop the outcome set, in which, the endoscopic score is taken as the objective, and the improvements in the symptoms/physical signs and the biochemical examination as the supplementary.