机构地区:[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]黑龙江中医药大学附属第二医院,黑龙江哈尔滨150001
出 处:《康复学报》2021年第6期514-522,共9页Rehabilitation Medicine
基 金:国家重点研发计划项目(2019YFC1710304);黑龙江省脑功能与神经康复重点实验开放课题(2020-NSKF-01);黑龙江省重点研发计划指导类项目(GZ20210141)。
摘 要:目的:采用Meta分析评价补阳还五汤治疗急性期缺血性中风患者的疗效及安全性,为补阳还五汤的临床应用提供循证依据。方法:运用计算机检索PubMed、Embase、CochraneLibrary、中国知网数据库(CNKI)、万方数据库(WanfangData)、维普数据库(VIP)、中国生物医学文献数据库(CBMdisc),以急性期气虚血瘀型缺血性中风患者为研究对象,检索补阳还五汤治疗急性期缺血性中风的临床随机对照试验(RCTs)文献。检索时间设定为2015年1月1日—2020年1月31日,主要结局指标为临床总有效率、肢体运动功能评分(FMA);次要结局指标为D-二聚体含量、血浆纤维蛋白原含量、同型半胱氨酸(Hcy)含量及不良反应。由2名研究人员独立筛选文献、提取数据、评价文献质量,采用RevMan 5.3软件进行数据分析,根据Cochrane协作网提供的系统评价手册,连续型变量以均数差(MD)及95%置信区间(CI)为效应指标,计数资料采用相对危险度(RR)和95%CI为效应指标。通过I2值或P值综合判断是否存在异质性,当P>0.1且I2<50%时,采用固定效应模型;当P≤0.1或I2≥50%时,采用随机效应模型。结果:纳入22项RCTs,共有2078例患者,其中对照组1040例,试验组1038例。Meta分析结果显示:与对照组比较,试验组临床总有效率更高[RR=1.21,95%CI(1.17,1.26),Z=9.73,P<0.00001]、FMA评分更高[MD=6.88,95%CI(5.48,8.27),Z=9.67,P<0.00001]、D-二聚体含量更低[MD=-0.42,95%CI(-0.53,-0.32),Z=7.96,P<0.00001]、血浆纤维蛋白原含量更低[MD=-0.50,95%CI(-0.61,-0.40),Z=9.40,P<0.00001]、Hcy水平更低[MD=-2.78,95%CI(-3.60,-1.96),Z=6.64,P<0.00001]。2组治疗安全性无明显区别,差异无统计学意义[RR=1.00,95%CI(0.45,2.24),Z=0.00,P=1.00]。结论:补阳还五汤治疗急性期缺血性中风能有效提高临床疗效,改善患者的神经功能缺损程度、肢体运动功能,治疗安全性较好。下一步研究中仍需进一步开展大样本和高质量的临床随机对照试验加以验�Objective:Meta analysis was used to evaluate the efficacy and safety of Buyang Huanwu decoction in the treat‐ment of patients with acute ischemic stroke,so as to provide evidence-based basis for the clinical application of Buyang Huanwu de‐coction.Methods:Data were searched from the databases of PubMed,Embase,Cochrane Library,CNKI,Wanfang Data,VIP and CBMdisc.Patients with acute ischemic stroke with Qi deficiency and blood stasis syndrome differentiation in traditional Chinese medicine were included in the randomized controlled trials(RCTs),who were treated with Buyang Huanwu decoction.The retrieval time for each database was from January 1,2015 to January 31,2020.The main outcome indicators were clinical total effective rate,Fugl-Meyer assement(FMA);and the secondary outcome indicators were D-dimer content,plasma fibrinogen content,homocyste‐ine(Hcy)content and adverse reaction.Two researchers independently screened literature,extracted data and evaluated the quality of literature.Revman 5.3 software was used to analyze the data.According to the system review manual provided by the Cochrane Collaboration Network,mean difference(MD)and 95%confidence interval(CI)were used as indicators for continuous variables,and risk ratio(RR)and 95%CI were used as indicators for enumeration data.The statistical heterogeneity was judged comprehen‐sively by the Heterogeneity value(I 2 value)and probability value(P value).If P>0.1 and I 2<50%,a fixed effect model would be used.In contrast,if P≤0.1 or I 2≥50%,a random effect model would be used.Results:A total of 22 RCTs(2078 cases)were includ‐ed,with 1040,1038 cases in the control group and the experimental group respectively.The results of meta-analysis showed that,compared with the control group,the total clinical effective rate of the experimental group was higher[RR=1.21,95%CI(1.17,1.26),Z=9.73,P<0.00001],the FMA score was higher[MD=6.88,95%CI(5.48,8.27),Z=9.67,P<0.00001],the content of D-di‐mer was lower[MD=-0.42,95%CI(-0.53,-0.32),Z=7.96,P<0.00001],and the co
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