中国循证医学杂志

中国循证医学杂志

塞妥珠单抗加甲氨蝶呤治疗活动性类风湿关节炎疗效和安全性的 Meta 分析

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目的 系统评价塞妥珠单抗(CZP)联合甲氨蝶呤(MTX)治疗活动性类风湿性关节炎的疗效和安全性。 方法 计算机检索 The Cochrane Library、PubMed、EMbase、CBM、CNKI、VIP 和 WanFang Data 数据库,搜集 CZP 联合 MTX 治疗活动性类风湿性关节炎的随机对照试验(RCT),检索时间从建库至 2017 年 5 月。由 2 位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采 Stata 11.0 软件进行统计分析。 结果 共纳入 7 个 RCT。Meta 分析结果显示:在 ACR20[CZP400 mg:RR=2.86,95%CI(1.70,4.79),P<0.001;CZP200 mg:RR=3.76,95%CI(2.59,5.46),P<0.001]、ACR50[CZP400 mg:RR=3.91,95%CI(2.10,7.27),P<0.001;CZP200 mg:RR=4.86,95%CI(3.20,7.39),P<0.001]和 ACR70[CZP400 mg:RR=5.65,95%CI(1.99,16.06),P=0.001;CZP200 mg:RR=10.08,95%CI(5.11,19.89),P<0.001]方面,CZP 联合 MTX 组均优于 MTX 联合安慰剂组。在肿胀关节评分[SMD=–12.72,95%CI(–15.39,–10.06),P<0.001]、疼痛关节评分[SMD=–11.54,95%CI(–13.97,–9.11),P<0.001]、医生对疾病活动性的综合评价[SMD=–11.78,95%CI(–13.81,–9.75),P<0.001]、患者对疾病活动性的综合评价[SMD=–9.62,95%CI(–11.09,–8.15),P<0.001]、患者对疼痛的评估[SMD=–9.10,95%CI(–10.91,–7.30),P<0.001]和健康评定问卷[SMD=–7.74,95%CI(–8.99,–6.49),P<0.001]方面,CZP 联合 MTX 组均优于 MTX 联合安慰剂组;但 CZP 联合 MTX 组不良反应发生情况明显高于 MTX 联合安慰剂组[RR=1.69,95%CI(1.30,2.19),P<0.001]。 结论 CZP 联合 MTX 治疗活动性类风湿性关节炎有一定的疗效,但不良反应发生率更高。受纳入研究数量和质量的限制,上述结论尚需大样本高质量临床研究予以证实。

Objectives To systematically review the efficacy and safety of certolizumab pegol (CZP) plus methotrexate (MTX) for active rheumatoid arthritis. Methods The Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP and WanFang Data were searched to collect randomized controlled trials (RCTs) on CZP plus MTX vs. MTX plus placebo for active rheumatoid arthritis from inception to May, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, data were analyzed by using Stata 11.0 software. Results Seven RCTs were included. The results of meta-analysis showed the CZP plus MTX group was superior to MTX plus placebo group in ACR20 (CZP400 mg: RR=2.86, 95%CI 1.70 to 4.79, P<0.001; CZP200 mg: RR=3.76, 95%CI 2.59, 5.46, P<0.001), ACR50 (CZP400 mg: RR=3.91, 95%CI 2.10 to 7.27, P<0.001; CZP200 mg: RR=4.86, 95%CI 3.20 to 7.39, P<0.001), and ACR70 (CZP400 mg: RR=5.65, 95%CI 1.99 to 16.06, P=0.001; CZP200 mg: RR=10.08, 95%CI 5.11 to 19.89, P<0.001). The CZP plus MTX group was also superior to MTX plus placebo group in swollen joint counts (SMD=–12.72, 95%CI –15.39 to –10.06,P<0.001), tender joint counts (SMD=–11.54, 95%CI –13.97 to –9.11,P<0.001), doctor's global assessment of disease activity (SMD=–11.78, 95%CI –13.81 to –9.75,P<0.001), patient's global assessment of disease activity (SMD=–9.62, 95%CI –11.09 to –8.15,P<0.001), and patient's assessment of pain (SMD=–9.10, 95%CI –10.91 to –7.30,P<0.001) and HAQ (SMD=–7.74, 95%CI –8.99, –6.49,P<0.001), respectively. However, the incidence of adverse events in CZP plus MTX group was higher than that in MTX plus placebo group. Conclusions CZP plus MTX is superior to MTX plus placebo for treatment of active rheumatoid arthritis but with higher adverse events. Due to limited quantity and quality of the included studies, the above conclusions are still needed to be verified by more high-quality studies.

关键词: 塞妥珠单抗; 甲氨蝶呤; 类风湿性关节炎; 随机对照试验; Meta 分析

Key words: Certolizumab pegol; Methotrxate; Rheumatoid arthritis; Randomized controlled trial; Meta-analysis

引用本文: 崔赛赛, 付凌雨, 闫雷, 张耀, 刘海娜. 塞妥珠单抗加甲氨蝶呤治疗活动性类风湿关节炎疗效和安全性的 Meta 分析. 中国循证医学杂志, 2018, 18(2): 172-177. doi: 10.7507/1672-2531.201707098 复制

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