[关键词]
[摘要]
目的 通过证据图可视化技术,直观且多角度地展现、描述和评价中医药治疗干燥综合征相关研究证据。方法 检索中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、、中国生物医学文献服务系统、PubMed、EMbase、Webof Science、Cochrane Library数据库,搜集中医药治疗干燥综合征的随机对照试验(RCT)、系统评价/Meta分析,检索时限均从建库至2025年6月1日。通过证据图系统梳理相关文献,全面分析中医药治疗干燥综合征的临床分布特征。结果 (1)共纳入319篇文献,中医药治疗干燥综合征的研究热点较高,发文整体呈上升趋势,研究样本量集中在51~100例;(2)干预措施集中于中药汤药及中成药,占比达93%,核心证型以阴虚津亏证(75篇)、气阴两虚证(69篇)为主;(3)研究以单中心、小样本、短疗程为主,对干预疗程、中医证候、随访情况关注度不足;结局指标主次不分,种类繁杂,缺乏突出中医药特色疗效、辨证观的指标;(4)方法学质量亟待提升,随机序列产生、分配方案隐藏及盲法实施等方面存在问题,偏倚风险较高,Meta分析/系统评价主要在研究方案注册、文献排除清单等方面存在问题。结论 中医药治疗干燥综合征具有一定优势,但也存在问题,后续应着力开展高质量循证研究,优化治疗方案,设计多中心、大样本、长期随访的临床研究,制定突出中医药整体观、辨证观的特色,构建具有普适性和公认度的中医临床研究核心指标集,为相关研究开展提供方法学支持。
[Key word]
[Abstract]
Objective To intuitively, multi-dimensionally demonstrate, describe and evaluate the research evidence of traditional Chinese medicine (TCM) in the treatment of Sjögren’s syndrome (SS) by means of evidence mapping visualization technology. Methods Databases including CNKI (China National Knowledge Infrastructure), Wanfang Data, VIP Chinese Journal Database, SinoMed, PubMed, EMbase, Web of Science and the Cochrane Library were retrieved to collect randomized controlled trials (RCTs) as well as systematic reviews/Meta-analyses regarding TCM for SS. The retrieval time was from the establishment of each database to June 1st, 2025. Relevant literatures were systematically sorted out via evidence mapping, and the clinical distribution characteristics of TCM in the treatment of SS were comprehensively analyzed. Results A total of 319 literatures were included. The research on TCM treatment for SS has attracted considerable attention, with the number of published papers showing an overall upward trend; the sample size of most studies ranged from 51 to 100 cases. Interventions were mainly concentrated on TCM decoctions and Chinese patent medicines, accounting for 93% of all included studies. The core TCM syndrome types were Yin deficiency and fluid depletion syndrome (75 papers) and Qi-Yin deficiency syndrome (69 papers). Most studies featured single-center design, small sample size and short treatment course, with insufficient attention paid to intervention duration, TCM syndrome manifestations and follow-up outcomes. The primary and secondary outcome indicators were not clearly distinguished, with a great variety of indicators used; there was a lack of indicators that highlight the characteristic efficacy and syndrome differentiation concept of TCM. The methodological quality needs to be improved urgently. Problems existed in the generation of random sequences, allocation concealment, and implementation of blinding, leading to a relatively high risk of bias. For systematic reviews/meta-analyses, main deficiencies were found in study protocol registration and provision of literature exclusion lists. Conclusion TCM has certain advantages in the treatment of SS, but there are still some problems to be solved. In future research, efforts should be made to carry out high-quality evidence-based studies and optimize treatment regimens. It is necessary to design clinical studies with multi-center, large-sample and long-term follow-up, formulate core outcome sets for TCM clinical research that highlight the holistic view and syndrome differentiation concept of TCM and possess universality and recognition, so as to provide methodological support for relevant research practice.
[中图分类号]
R285.5
[基金项目]
国家自然科学基金面上项目(81874465);河南省自然基金项目(262300422247);河南省中医药科学专项局省共建课题;博士科研启动基金项目(CZ0377-14);河南省国家中医药传承创新中心联合共建科研专项(2024ZXZX1091)