针刺干预阿尔茨海默病临床研究的范围综述

Acupuncture for Alzheimer's disease:a scoping review of clinical studies

目的对针刺干预阿尔茨海默病(AD)的临床研究进行范围综述。方法计算机检索CNKI、WanFang Data、VIP、CBM、Web of Science、PubMed、EMbase、Cochrane Library数据库及ClinicalTrials.gov、ChiCTR临床试验注册平台,搜集针刺治疗AD的临床研究,检索时限均从建库至2022年5月14日。采用范围综述方法对纳入临床研究的发表年度趋势、研究类型、疾病程度、中医辨证分型、样本量、治疗方案、干预疗程、结局指标进行总结分析。结果共纳入226个临床研究。该研究领域兴起于1995年,目前研究发表数量呈增多趋势。临床研究类型主要为随机对照试验;56个研究关注AD的严重程度;54个研究对AD进行了不同标准的中医辨证分型;但样本量超过200例的研究只有4个。针刺治疗AD以普通针刺为主,共计129个研究;特殊方案针刺中以电针干预为多,共31个研究;超过70%的研究疗程在84~168天之间。12类结局指标中认知评价、临床有效率、活动功能评价、脑脊液和血液生物标记、不良反应是目前关注较多的结局指标,而对AD患者神经精神症状、生活质量等方面关注较少。大多数研究结果显示针刺可改善AD患者的认知功能。结论针刺干预AD临床研究已形成规模,但目前研究设计仍存在缺陷,针刺方案多样但尚未得到统一,同时缺乏相关权威的中医标准。

Objective To provide a scoping review of the clinical studies of acupuncture on Alzheimer's disease(AD).Methods The CNKI,Wan Fang Data,VIP,CBM,Web of Science,Pub Med,EMbase,Cochrane Library databases,and Clinical Trials.gov,Chi CTR clinical trial registration systems were searched to collect clinical studies on acupuncture treatment of AD from inception to May 14,2022.Scope review method was used to summarize and analyze the publication year trend,type,degree of disease,traditional Chinese medicine(TCM)syndrome differentiation,sample size,treatment plan,intervention time,and outcome.Results A total of 226 clinical original research were included.This field emerged in 1995 and has been increasing.The main type of clinical research was randomized controlled trials.56 studies paid attention to the severity of AD.Only 54 studies classified AD according to different criteria of TCM syndrome differentiation.There were only 4 studies with large sample size(200 cases).Conventional acupuncture was the main intervention method in clinical research,with a total of 129 articles.Electroacupuncture was the main special acupuncture method,a total of 31 articles.More than 70%of the studies had a course of intervention between 84 and 168 days.Among the 12 types of outcome indicators,cognitive function,clinical efficiency,activity function evaluation,cerebrospinal fluid and blood biomarkers,and adverse reactions were the most concerned outcomes.However,less attention was paid to neuropsychiatric symptoms and quality of life in AD patients.Acupuncture could improve the cognitive function of AD patients,but the current clinical related mechanism research was shallow,and the acupuncture point selection was also more diverse.Conclusion The clinical research of acupuncture in AD has formed a scale,but the current research type is single.The clinical research design schemes are various but not yet unified,and there is a lack of relevant authoritative TCM standards.