盐酸替扎尼定联合康复训练治疗脑卒中后肌痉挛疗效的Meta分析

Meta-analysis of the Efficacy of Tizanidine Hydrochloride Combined with Rehabilitation Training in the Treatment of Muscle Spasm after Sroke

目的:系统性评价盐酸替扎尼定联合康复训练治疗脑卒中后肌痉挛的临床疗效。方法:在中国知网数据库、万方数据库、维普数据库、Pubmed、Web of Science、Embase和Cochrane Library数据库中检索盐酸替扎尼定治疗卒中后肌痉挛的随机对照试验(RCTs),检索时间从建库至2022年9月。对符合纳入标准的研究采用RevMan 5.4软件进行Meta分析。结果:共纳入9项随机对照试验(n=683)。Meta分析结果显示,替扎尼定联合康复训练组MAS评分[WMD=-0.22,95%CI-0.29~-0.14,P<0.00001]和MBI评分[WMD=2.68,95%CI 0.10~5.27,P=0.04]明显优于对照组,但FMA评分[WMD=2.14,95%CI-0.33~4.61,P=0.09]与对照组无差异。在不同对照干预措施的亚组分析中,相比于单纯康复训练,替扎尼定可有效缓解脑卒中后患者肌痉挛[MAS评分:WMD=-0.38,95%CI-0.48~-0.27,P<0.00001;CSI评分:WMD=-2.61,95%CI-3.30~-1.92,P<0.00001],提高ADL能力[MBI评分:WMD=10.48,95%CI 8.20~12.75,P<0.00001],但在运动障碍的改善上无明显优势[FMA评分:WMD=4.55,95%CI-1.03~10.13,P=0.11]。相比对照药物巴氯芬、乙哌立松,替扎尼定组MAS评分[WMD=-0.06,95%CI-0.16~0.05,P=0.31]、FMA评分[WMD=0.82,95%CI-0.31~1.96,P=0.16]、MBI评分[WMD=0.27,95%CI-0.77~1.32,P=0.61]和临床有效率[WMD=2.07,95%CI 0.97~4.43,P=0.06]均与对照组无差异。替扎尼定的不良反应的发生率低于巴氯芬[WMD=0.51,95%CI 0.30~0.88,P=0.02],但与乙哌立松没有差异[WMD=1.37,95%CI 0.52~3.57,P=0.53]。结论:盐酸替扎尼定联合康复训练较单纯康复训练能有效改善脑卒中后患者肌肉痉挛,提高患者日常生活能力,与其他口服抗痉挛药物疗效相当,安全性较好。

Objective:To systematically evaluate the effect of tizanidine hydrochloride combined with rehabilitation training in the treatment of muscle spasm after stroke.Methods:Randomized controlled trials of tizanidine hydrochloride in the treatment of muscle spasm after stroke were searched from China National Knowledge Intemet(CNKI),Wanfang Data medicalinformation system(WF),VIP database,Pubmed,Web of Science,Embase and Cochrane Library databases from the establishment to September 2022.Meta-analysis of the studies that met the inclusion criteria was performed using RevMan 5.4.Results:Nine studies involving 683 patients were included.The results of Meta-analysis showed that the modified Ashworth Scale(MAS)score(WMD=-0.22,95%CI-0.29~-0.14,P<0.00001)and modified Barthel Index(MBI)score(WMD=2.68,95%CI 0.10~5.27,P=0.04)in the treatment group were better than those in the control group,but there was no difference in the Fugl-Meyer assessment(FMA)score[WMD=2.14,95%CI-0.33~4.61,P=0.09].In subgroup analysis of different control interventions,compared with rehabilitation training alone,tizanidine can effectively relieve muscle spasm(MAS score:WMD=-0.38,95%CI-0.48~-0.27,P<0.00001;CSI score:WMD=-2.61,95%CI-3.30~-1.92,P<0.00001)after stroke and improve the activies of daily living(ADL)(MBI score:WMD=10.48,95%CI 8.20~12.75,P<0.00001),but has no obvious advantage in improving movement disorders(FMA score:WMD=4.55,95%CI-1.03~10.13,P=0.11).There was no difference in MAS score[WMD=-0.06,95%CI-0.16~0.05,P=0.31],FMA score[WMD=0.82,95%CI(-0.31,1.96),P=0.16],MBI score[WMD=0.27,95%CI-0.77~1.32,P=0.61]and clinical effective rate[WMD=2.07,95%CI 0.97~4.43,P=0.06]between the treatment group(Tizanidine)and the control drug group(Baclofen and Eperisone).The incidence of adverse reactions of tizanidine was lower than that of Baclofen(WMD=0.51,95%CI 0.30~0.88,P=0.02),but not different from eperisone(WMD=1.37,95%CI 0.52~3.57,P=0.53).Conclusion:Compared with rehabilitation training alone,tizanidine combined with rehabilitation training can effectively reduce muscle tone and improve daily living ability of patients after stroke,while the efficacy is comparable to other oral antispasticity drugs,and the safety is better.