穴位贴敷治疗颈椎病的疗效系统评价与试验序贯分析  

Systematic Evaluation and Trial Sequential Analysis on Therapeutic Effect of Acupoint Application on Cervical Spondylosis

作　　者：马唯 高蕊[1,2,3] 李庆娜 赵阳[1,2,3] 王一名 栗蕊[4] 李辰飞 郭曼萍 MA Wei;GAO Rui;LI Qingna;ZHAO Yang;WANG Yiming;LI Rui;LI Chenfei;GUO Manping(Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;NMPA for Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine,Beijing 100091,China;National Clinical Research Center for Chinese Medicine Cardiology,Beijing 100091,China;The First Affiliated Hospital of He'nan University of Traditional Chinese Medicine,Zhenzhou Henan 450099,China;Postdoctoral Work Station of Yabao Pharmaceutical Group Co.,Ltd.,Yuncheng Shanxi 044000,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中药临床研究与评价重点实验室,北京100091 [3]国家中医心血管病临床医学研究中心,北京100091 [4]河南中医药大学第一附属医院,河南郑州450099 [5]亚宝药业集团股份有限公司博士后工作站,山西运城044000

出　　处：《中医药导报》2023年第9期158-164,共7页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中国中医科学院科技创新工程“三结合审评证据体系下的中药新药临床评价关键技术研究”(CI2021A04701)。

摘　　要：目的:系统评价穴位贴敷治疗颈椎病的有效性与安全性。方法:检索中国知网(CNKI)、维普(VIP)、万方(Wanfang Data)、PubMed、Web of science等数据库有关穴位贴敷治疗颈椎病的随机对照试验(RCT),检索时间从建库至2022年9月,结局指标选用总有效率、痊愈率,以及治疗后疼痛视觉模拟评分(VAS)、Northwick Park颈痛量表(NPQ)评分。采用RevMan 5.4软件对数据进行Meta分析,再使用TSA V0.9软件对研究结果进行试验序贯分析。结果:共纳入7篇RCT,1121例患者,Meta分析结果显示,试验组总有效率[OR=3.04,95%CI(2.13,4.34),P<0.00001]、痊愈率[OR=3.10,95%CI(1.73,5.53),P=0.0001]均高于对照组,VAS评分低于对照组[MD=-0.61,95%CI(-0.94,-0.29),P=0.0002];试验组NPQ评分与对照组比较,差异无统计学意义(P>0.05);试验组的不良反应发生率低于对照组(P<0.05)。试验序贯分析结果显示,总有效率的累计Z曲线穿过传统界值和试验序贯分析界值,但样本量未达到期望信息值量。结论:与传统中西药治疗比较,联合或单用穴位贴敷治疗颈椎病的疗效确切,安全性更高,值得进一步推广应用。但鉴于纳入文献数量较少,质量偏低,仍需开展高质量的RCT,以进一步验证其临床疗效。Objective:To systematically evaluate the efficacy and safety of acupoint application in the treatment of cervical spondylosis.Methods:We searched for randomized controlled trials of acupoint application for the treatment of cervical spondylosis in CNKI,VIP,Wanfang,PubMed,Web of seience databases,from the establishment of the database to September 2022,and the outcomes were selected as total effective rate,recovery rate,and VAS and NPQ scores after treatment.RevMan 5.4 software was used for Meta-analysis,and TSA V0.9 software was used for trial sequential analysis.Results:A total of 7 RCTs with 1121 patients were included.According to the results of Meta-analysis,the experimental group showed higher total effective rate[OR=3.04,95%CI(2.13,4.34),P<0.00001]and recovery rate[OR=3.10,95%CI(1.73,5.53),P=0.0001]than control group,while lower VAS score than control group[MD=-0.61,95%CI(-0.94,-0.29),P=0.0002].There was no significant difference in NPQ score between experimental group and control group(P>0.05).The experimental group showed lower incidence of adverse reactions than control group(P<0.05).The results of the trial sequential analysis showed that the cumulative Z-curve of total effective passed through the traditional and experimental sequential analysis bounds,but the sample size did not reach the desired amount of information.Conclusion:Compared with the traditional Chinese and Western medicine treatment,the combination or single use of acupoint application in the treatment of cervical spondylosis shows a definite efficacy and higher safety,which is worthy of further promotion and application.However,given the small number of included studies and low quality,high-quality RCTs of acupressure for cervical spondylosis still needed to further verify their clinical efficacy.

关 键 词：颈椎病 穴位贴敷 系统评价 试验序贯分析 

分 类 号：R274.33[医药卫生—中医骨伤科学]