苏金单抗治疗风湿性关节炎有效性和安全性的Meta分析

发布时间：2018-06-05 19:22

本文选题：关节炎 + 类风湿　；参考：《中国全科医学》2017年29期

【摘要】：目的系统评价苏金单抗治疗风湿性关节炎(RA)的有效性和安全性。方法计算机检索Pub Med、Medline、EMBase、Web of Science、the Food and Drug Administration(FDA)Website、Clinical Trials Website、Cochrane Library、中国知网、万方数据知识服务平台、维普网等数据库中关于苏金单抗治疗RA有效性和安全性的随机对照试验(RCT),检索时间从建库至2016-08-31。进行资料提取及质量评价,采用Rev Man 5.2及Stata 12.0软件对数据进行Meta分析。结果共纳入6篇RCT,903例患者。Meta分析结果显示,苏金单抗组ACR20率[RR=1.56,95%CI(1.31,1.87),P0.000 01]、ACR50率[RR=2.11,95%CI(1.51,2.93),P0.000 01]、ACR70率[RR=2.75,95%CI(1.39,5.43),P=0.004]较对照组升高。苏金单抗组疾病活动性评分28(DAS28)-C反应蛋白(CRP)[加权均数差(WMD)=-0.48,95%CI(-0.67,-0.29),P0.000 01]、DAS28-红细胞沉降率(ESR)[WMD=-0.43,95%CI(-0.69,-0.16),P=0.001]、健康评估问卷残疾指数(HAQ-DI)[WMD=-0.16,95%CI(-0.24,-0.08),P=0.000 1]较对照组降低。苏金单抗组严重不良反应事件发生率[RR=1.97,95%CI(1.10,3.52),P=0.02]、消化道功能紊乱发生率[RR=1.81,95%CI(1.15,2.86),P=0.01]较对照组升高。Egger检验结果提示,苏金单抗组与对照组比较,纳入研究间不存在发表偏倚风险(P=0.205)。结论现有证据表明苏金单抗治疗RA安全有效。然而,由于纳入研究样本量较小,有必要进一步开展高质量、大样本RCT评价其疗效和安全性。
[Abstract]:Objective to evaluate the efficacy and safety of Sujin McAb in the treatment of rheumatoid arthritis (RA). Methods Pub Medline was used to search Pub Medline for randomized controlled trials on the efficacy and safety of Sujin McAb in the treatment of RA. The search time ranged from the construction of the database to 2016-08-31. Rev Man 5.2 and Stata 12.0 were used to analyze the data by Meta. Results the results of meta-analysis showed that the ACR20 rate of the Sujin McAb group [RRRN 1.5695 CIQ 1.31 1.87 P0.00001] ACR50 was higher than that of the control group [RRR2.11995 CI 1.51 + 2.93P0.00001] ACR70 [RRR2.75-95CIT 1.395.43Pn4] was higher than that of the control group (P < 0.05), but it was higher than that of the control group (P < 0.05), and the ACR50 rate was higher than that in the control group. The results showed that the ACR70 rate in the Sujin McAb group was higher than that in the control group (P < 0.05), and the ACR50 rate was higher than that in the control group. The disease activity score of 28(DAS28)-C reaction protein (28(DAS28)-C) in Su Jin McAb group was lower than that in the control group (WMD-0.169CI-0.249CI-0.248CI-0.248P0.0001) [WMD-0.43C95CI-0.69- 0.16P0.001] [WMD-0.1695CI-0.249CI-0.249CI-0.248P0.000000] and the health assessment disability index (HAQ-DI) was lower than that in the control group (WMD-0.1695CI-0.249CI-0.248P0.0001). The incidence of severe adverse events in the Sujin McAb group [RRN 1.97-95CII 1.101.103.52P0. 02], the incidence of gastrointestinal dysfunction [RRRN 1.81CIMA 1.152.86C P0.01] was higher than that in the control group. The results of Egger test showed that there was no risk of publishing bias between the two groups. The results of Egger test showed that there was no risk of publishing bias between the two groups. Conclusion the available evidence shows that Sujin McAb is safe and effective in the treatment of RA. However, due to the small sample size, it is necessary to further develop high quality and large sample RCT to evaluate its efficacy and safety.
【作者单位】：西南医科大学药学院;西南医科大学附属医院药剂科;西南医科大学临床医学院;成都外国语学校;
【分类号】：R593.22

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