鹿瓜多肽注射液治疗类风湿性关节炎疗效及安全性的Meta分析

目的:系统评价鹿瓜多肽注射液治疗类风湿性关节炎的有效性和安全性。方法:采用循证医学的文献分析评价方法,计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、Medline、EMbase、Cochrane图书馆临床对照试验资料库等数据库,收集鹿瓜多肽注射液治疗类风湿性关节炎的临床研究证据。评价纳入研究的方法学质量,提取有效数据,采用RevMan5.0软件对数据进行Meta分析。结果:共纳入7篇随机对照试验文献。Meta分析结果显示,鹿瓜多肽治疗类风湿性关节炎的有效率明显高于对照组OR=3.31,95%C(I1.79,6.13)],但在改善红细胞沉降率WMD=10.41,95%CI(-1.28,22.11)]、C反应蛋白WMD=9.19,95%CI(-1.91,20.29)]、类风湿因子水平WMD=4.16,95%CI(-10.77,19.10)]及不良反应发生率OR=0.29,95%CI(0.06,1.35)]方面,与对照组比较差异无统计学意义(P>0.05)。结论:鹿瓜多肽注射液治疗类风湿性关节炎疗效较好,且未见明显不良反应。然而,由于纳入研究样本量较少,期待将来多中心、大样本双盲随机对照试验提供更高级别的证据。

Meta-analysis of Therapeutic Efficacy and Safety of Cervus and Cucumis Polypeptide Injection in the Treatment of Rheumatoid Arthritis

OBJECTIVE： To evaluate the efficacy and safety of Cervus and cucumis polypeptide injection in the treatment of rheumatoid arthritis （RA）. METHODS： By literature analysis based on evidence-based medicine, clinical trials about Cervus and cucumis polypeptide injection in the treatment of RA were retrieved from CBM, CNKI, Medline, EMbase and Cochrane library. The quality of included studies was evaluated. Data were extracted into a specially designed extraction form. The Cochrane collabo- ration＇ s Rev Man 5.0 software was used for data analysis. RESULTS： A total of 7 RCTs were included. Results of Meta-analysis showed that the effective rate OR= 3.31, 95 % CI （ 1.79, 6.13） ] of Cervus and cucumis polypeptide injection group was better than control group, there was statistical difference. There was no statistical difference in improving erythrocyte sedimentation rate WMD=10.41, 95%CI （--1.28, 22.11）], C-reactive protein WMD=9.19, 95%CI （--1.91, 20.29）], rheumatoid factor WMD= 4.16, 95%CI （--10.77, 19.10）] and the incidence of adverse reactions OR=0.29, 95%CI （0.06, 1.35）] between 2 groups. CON- CLUSIONS： Compared with control group, Cervus and cucumis polypeptide injection can significantly improve clinical efficacy in the treatment of RA. And no significant adverse drug reactions are observed. However, well-designed larger double blind RCT is necessary because of small scale samples and absence of double blind.