巨刺法治疗中风病的随机对照试验系统评价与Meta分析

Efficacy of Juci therapy for Treatment of Ischemic Stroke:A Systematic Review and Meta-analysis of Randomized Controlled Trials

背景目前国内已有许多关于巨刺法治疗中风病的随机对照试验,但每项研究样本含量有限且部分研究质量评价不高,尚无研究对巨刺法治疗中风病进行系统评价。目的评价巨刺法治疗中风病病人的临床疗效。方法检索中文文献检索万方数据库、中国知网数据库(CNKI)、重庆维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM),外文文献检索Pubmed和Cochrane图书馆。从建库到2016年12月5日,语种为中英文。纳入巨刺法加常规治疗与常规治疗比较或巨刺法与患侧针刺法比较的随机对照试验文献。使用Cochrane系统评价手册进行偏倚风险评估,运用RevMan 5.3软件进行Meta分析。研究个数在10个及以上的Meta分析,采用倒漏斗图对检验是否有发表偏倚存在,比较结局指标随机效应模型及固定效应模型结果进行敏感性分析。结果共纳入27项研究1 795例中风病病人,试验的方法学质量部分较低。巨刺法治疗中风病,巨刺法与常规针刺法比较,修订的Ashworth痉挛量表(MAS)评定MD(95%CI)为-0.24[-0.46,-0.01];MAS评定有效率RR(95%CI)为1.26[1.02,1.55];Barthel指数(MBI)MD(95%CI)为6.00[3.71,8.28];视觉模拟评分法(VAS)评分MD(95%CI)为-1.29[-1.65,-0.93];脑卒中病人临床神经功能缺损程度评分(NDS)MD(95%CI)为-2.52[-3.80,-1.25];NDS评分有效率RR(95%CI)为1.11[0.99,1.24];有9项研究试验组Fugl-meyer(FMA)评分疗效优于对照组。巨刺法加常规治疗与常规治疗组比较,MAS评定有效率RR(95%CI)为1.07[0.99,1.16];FMA评分MD(95%CI)为8.40[6.45,10.36];Barthel指数MD(95%CI)为14.59[12.49,16.70];VAS评分MD(95%CI)为-1.31[-1.71,-0.91]。描述不良反应的2项研究中,且均表明未发现病人在治疗前后出现不良反应。结论巨刺法对中风病病人的恢复具有一定疗效,可能缓解肌痉挛病人肌张力,改善病人患肢运动功能,提高病人日常生活能力,缓解病人患肢疼痛,使病人神经功能缺损状况得到改善。但由于纳入研究的方法学质量偏低,证据质量等级为中至低不等,因而未来研究可能改变该评价结果的可信度。未来需更多严格设计实施的能够提供更多明确痉挛部位、多个测量时点的高质量证据的RCT研究,进一步论证巨刺法治疗本病的临床疗效。

Objective There are many domestic randomized controlled trials （ RCTs）on the treatment of ischemic stroke with Jucimethod （ opposing needling technique） ,but most of the quality evaluation is not high. There is no research on Juci method systemat -ic review on the treatment of ischemic stroke.performed a meta-analysis to systematically evaluate the effect of Juci method fortreatment of ischemic stroke.Methods China National Knowledge Infrastructure Database （ CNKI） ,Wangfang Database,ChongqingVIP Database （ VIP） ,China Biology Medicine Database （ CBM） ,MEDLINE （ Pubmed） ,and Cochrane Library were retrieved withthe deadline on December 5, 2016. The inclusion trials of ischemic stroke were Juci method together with conventional treatment toconventional treatment or Juci method together with normal acupuncture. The risk of bias of Cochrane handbook and RevMan 5.3were conducted by authors. A funnel plot was created to analyze potential publication bias. Besides,sensitivity analysis was con -structed using two different effect models. Results One thousand, seven hundreds and ninety-five patients from twenty-sevenstudies were included,and the quality of methodology was low. As for Juci method for treatment of ischemic stroke,and Juci methodtogether with normal acupuncture,the mean deviation （ MD）and 95% confidence interval （ CI ）of MAS, MBI, VAS and NDS were -0.24 [ -0.46, -0.01] , 6.00 [ 3.71, 8.28] , -1.29 [ -1.65, -0.93]and -2.52 [ -3.80, -1.25] .The relative risk （ RR）and 95% CI ofMAS and NDS were 1.26 [ 1.02, 1.55]and 1.11 [ 0.99, 1.24] .Nine studies of FMA showed that the experimental group was obviouslysuperior to the control group.As for Juci method together with conventional treatment to conventional treatment,the mean deviation（ MD）and 95% CI of FMA, MBI and VAS were 8.40 [ 6.45, , 10.36] , 14.59 [ 12.49, 16.70] , -1.31 [ -1.71, -0.91] .The relative risk（ RR）and 95% CI of MAS was 1.07 [ 0.99, 1.16] . Experimental group and control group without adverse reaction in 2 studies that de -scribed it. Conclusion Juci method may improve the scores of modified ashworth scale, Fugl Meyer assessment scale, modifiedBarthel index, visual analogue scale and nervous functional deficiency in patiehts with ischemic stroke.However,due to the low quali-ty of the methodology included in the study,the quality level of the evidence is middle and low,so future research may change thecredibility of the evaluation results. In the future,more stringent design,and implementation of the RCT study of high quality evidencefor more explicit spasm and multiple measurement points should be carried out to further demonstrate the clinical efficacy of the treat -ment of this disease.