参麦注射液治疗膝骨关节疗效及安全性的Meta分析

Efficacy and Safety of Shenmai Injection in Treating Knee Osteoarthritis: A Meta-Analysis

目的:应用Meta分析方法评价参麦注射液治疗膝骨关节炎的疗效及安全性。方法:检索中国知网(CNKI)、万方期刊数据库(WANFANG DATA)、维普期刊数据库(VIP)、中国生物医学文献数据库(CBM)以及PubMed、Cochrane Library、Embase等数据库中关于参麦注射液治疗膝骨关节炎的随机对照试验文献(RCT),采用Cochrane系统评价的方法,运用软件RevMan 5.3进行数据分析,并运用GRADE系统进行证据质量评价。结果:最终纳入15篇RCTs,共计1228例,其中参麦注射液治疗组619例,对照组609例,其中,Meta分析结果提示参麦注射液治疗组与对照组在治疗膝骨关节炎的总治疗率、VAS评分、Lequesne指数以及不良反应等方面无显著差异(P>0.05),但不良反应出现次数要高于对照组;与对照组相比,在改善WOMAC评分[MD=-9.55,95%CI(-13.17,-5.94),P<0.000 01]、AKS评分(P<0.000 01)、Lpsholms评分[MD=5.41,95%CI(3.52,7.30),P<0.000 01]以及优良率[OR=2.22,95%CI(1.11,4.43),P=0.02]等方面,参麦注射液治疗组疗效更好。GRADE证据质量评价系统提示本研究所得结果总体质量偏低。结论:参麦注射液治疗膝骨关节炎存在一定的临床疗效,与玻璃酸钠等常规治疗相比,在总治疗率、VAS评分和Lequesne指数等方面疗效相当,在改善WOMAC评分、AKS评分、Lpsholms评分以及优良率等方面,参麦注射液疗效更好,但存在一定的不良反应,临床应用时应注意。

Objective:To evaluate the efficacy and safety of Shenmai Injection in treating knee osteoarthritis by Meta-analysis.Methods:Databases including China National Knowledge Infrastructure(CNKI),WanFang Data,Weipu China Soience and Technology Journal Databases(VIP database),Chinese Biomedical Databases(CBM),PubMed,Embase and Cocbrane Library were searched to collect data of randomized controlled trials(RCTs)with respect to Shenmai Injection for knee osteoarthritis(KOA)according to Cochrane systematic review,and data analyses were performed by Revman 5.3 software and grading of evidence quality were assessed with the GRADE system.Results:A total of 15 RCTs involving 1228 cases were identified,with 619 patients in treatment group and 609 patients in control group.Meta-analysis indicated that no statistically significant differences were found in both treatment and control groups regarding to total effcacious rate,Lequesne index,Visual Analogue Scale(VAS)score and adverse reactions(P>0.05).However,the number of adverse reactions in treatment group was gerater than that in control group.There were statistical differences in WOMAC scale[MD=-9.55,95%CI(-13.17,-5.94),P<0.000 01],Lysholms score[MD=5.41,95%CI(3.52,7.30),P<0.000 01],AKS score(P<0.000 01)and good rate(OR=2.22,95%CI(1.11,4.43),P=0.02)The GRADE evaluation of the evidence quality showed the evidence of quality was low.Conclusion:Shenmai Injection is effective in treating KOA.Both groups show equivalent effects on total effcacious rate,Lequesne index and VAS score,whereas Shenmai Injection has better efficacies in WOMAC scale,Lysholms score,AKS score and good rate.However,certain adverse events may occur and more attentiom should be paid to in clinic.