基于中医药循证文献大数据平台的慢性萎缩性胃炎临床证据图研究

Clinical Researches Evidence Mapping of Traditional Chinese Medicine for Chronic Atrophic Gastritis based on Big Data Platform of Evidence-based Literature of Traditional Chinese Medicine

目的系统了解中医药防治慢性萎缩性胃炎(CAG)领域的临床研究证据分布,总结疗效,为未来的研究提供指引。方法借助涵盖消化领域多个优势病种的中医药循证文献大数据平台,检索其收录的2000—2020年发表的中医药防治CAG的临床研究、系统评价/Meta分析、指南与专家共识文献;对符合纳入标准文献的发表时间、研究类型,临床研究样本量及干预疗程,中医证候及体质相关观察性研究内容及分布,中医防治方案类别及作用(预防、治疗、康复/二级预防、不确定),临床评价指标等信息进行统计分析,并以图文结合形式呈现该领域证据分布。结果共纳入文献796篇,包括775篇临床研究,19篇系统评价,2篇专家共识。年度文献发表量总体呈缓慢上升趋势,2015年及2019年文献发表量最高,均为51篇。临床研究类型以干预性研究为主,共714篇,包括随机对照临床试验518篇、非随机对照试验196篇;观察性研究61篇。有46.50%(332/714)的干预性研究的样本量为60~100例,47.48%(339/714)的干预性研究疗程为3~6个月,干预措施以中药治疗为主,结局指标多关注总有效率、内镜下表现、病理组织学、中医证候积分、临床症状改善、Hp转阴率等,而对生活质量、心理评价等方面疗效关注较少。系统评价文献方法学质量普遍不高,AMSTAR量表评分集中在4~8分,16篇(84.21%)系统评价结论提示“证据显示有潜在疗效”。结论中医药在治疗CAG方面有一定优势,但多数研究在研究设计合理性、诊断标准统一性、疗效评价科学性等方面存在不足,未来有待加强该领域临床诊疗规范性,开展严谨的大样本、多中心、随机对照试验以提高中医药防治CAG的循证证据。

Objective To systematically analyze the clinical research evidence on traditional Chinese medicine(TCM)in the prevention and treatment of chronic atrophic gastritis(CAG),summarize the efficacy,and provide guidance for future research.Methods With the help of the big data platform of evidence-based literature of traditional Chinese medicine which covers multiple dominant digestive diseases of TCM,the clinical researches,systematic reviews,guidelines and consensuses on the prevention and treatment of CAG by TCM published between the year 2000 and 2020 were searched for.The publication time,research type,sample size and intervention duration,the distribution of TCM syndromes and constitution in the observational studies,the category and role of prevention and treatment TCM programs(prevention,treatment,rehabilitation/secondary prevention,uncertainty),clinical evaluation indicators and other information of the included articles were statistically analyzed,and the distribution of evidence was presented in the form of both graphics and text.Results A total of 796 articles were included,involving 775 clinical studies,19 systematic reviews and 2 expert consensus.Total number of annual publications was slowly moving upward,with highest volume published in 2015 and 2019,both of which were 51.The clinical researches were mainly interventional studies(714 articles),including 518 randomized controlled trials and 196 non-randomized controlled trials;besides,there were 61 observational studies.The sample size in 46.50%(332/714)of the interventional studies was 60~100 cases,and the duration of the intervention in 47.48%(339/714)of the intervention studies was 3~6 months.The intervention explored in the included studies was mainly Chinese herbal medicine.The focused outcome indicators were the total effective rate,endoscopic appearance,histopathology,TCM syndrome scores,clinical symptom improvement,and Hp negative conversion rate,while less attention was paid to the quality of life and psychological evaluation.The methodological quality of systematic reviews was generally low,with the AMSTAR scale scores mainly at 4 to 8 points,and 16 systematic reviews(84.21%)concluded that"evidence shows potential efficacy".Conclusion TCM has certain advantages in the treatment of CAG,but most evidence have deficiencies in the rationality of research design,the uniformity of diagnostic criteria,and the scientificity of efficacy evaluation.In the future,it is necessary to strengthen the standardization of clinical diagnosis and treatment,and carry out rigorous large sample size,multi-center,randomized controlled trials to improve the evidence of TCM in the prevention and treatment of CAG.