摘要
目的系统评价Janus激酶(JAK)抑制剂托法替布治疗类风湿性关节炎的有效性、安全性。方法计算机检索Pub Med、EMbase、The Cochrane Library(2017年8期)、Web of Science、CBM、万方数据库和CNKI数据库,搜集托法替布相关临床研究,检索时限均从建库至2017年6月1日。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,采用Rev Man 5.3软件对疗效指标、安全性指标进行疗效和安全性的Meta分析。结果共纳入9个研究、3 742例患者。Meta分析结果显示:与安慰剂相比,托法替布剂量为5 mg或者10 mg,疗程为3个月或者6个月,在疗效指标美国风湿病学会改善标准ACR20、ACR50、ACR70反应率方面均优于安慰剂组,差异有统计学意义(P<0.05);在ACR20、ACR70反应率方面托法替布剂量为10 mg优于5 mg(P<0.05),在ACR50反应率方面两组之间差异无统计学意义(P>0.05)。安全性方面,托法替布增加除严重不良反应外的不良事件发生率和腹泻发生率(P<0.05)。结论托法替布治疗类风湿性关节炎疗效较好,但轻微不良反应增多。
Objective To systematically evaluate the efficacy and safety of Janus kinase （JAK） inhibitor, tofacitinib, in the treatment of rheumatoid arthritis. Methods Randomized controlled trials （RCTs） about tofacitinib versus placebo in the treatment of rheumatoid arthritis were searched in PubMed, EMbase, the Coehrane Library （Issue 8, 2017） , Web of Science, CBM, CNKI, and VIP databases from inception to June 1, 2017. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of eligible studies. Then meta-analysis of effective indexes such as the American College of Rheumatology 20% improvement criteria response rate （ACR20） and safety indexes such as serious adverse events were conducted by using RevMan 5.3 software. Results A total of 9 RCTs involving 3 742 patients were included. The results of meta-analysis showed that ： the ACR20, ACR50, ACR70 response rates of 5 mg or 10 mg tofacitinib group were higher than those of the placebo group no matter the treatment duration was 3or 6 months （P 〈0.05）. Tofacitinib 10 mg group was better than tofacitinib 5 mg group in the indexes of ACR20 and ACR70 （P 〈 0.05 ）, but there was no statistically difference between the 2 groups in the ACR50 reaction rate （ P 〉 0.05 ）. On the safety, tofacitinib increased the incidence rate of adverse events and diarrhea than placebo （ P 〈 0.05 ） , Conclusion Evidence shows that treatment of rheumatoid arthritis. but had no difference in the rate of serious adverse events （P 〉 0.05 ） tofacitinib have considerable effect but with more mild adverse events in the
出处
《第三军医大学学报》
CAS
CSCD
北大核心
2018年第6期543-550,共8页
Journal of Third Military Medical University
基金
重庆市社会事业与民生保障科技创新专项(CSTC2015shmszx120073
CSTC2017shmsA130105)
重庆市万州区科技计划基金(201403055)~~
