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JAK抑制剂治疗类风湿性关节炎的系统评价再评价

2021-07-20王海坤王婕吴娜李存明林紫薇吴炜

中国药房 2021年11期
关键词:类风湿性关节炎安全性有效性

王海坤 王婕 吴娜 李存明 林紫薇 吴炜

摘 要 目的:对Janus激酶(JAK)抑制剂治疗类风湿性关节炎(RA)的系统评价进行再评价,以期为该类药物治疗RA提供循证依据。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、万方数据库和维普网,搜集JAK抑制剂治疗RA的系统评价,检索时限为建库至2020年12月。对纳入的系统评价进行资料提取后,运用PRISMA声明、AMSTAR2量表及GRADE方法评价纳入文献的报告质量、方法学质量及结局指标证据等级。结果:最终纳入12篇系统评价,包含103个结局指标。其PRISMA评分介于17.5~22.5之间,报告质量缺陷主要表现在方案和注册等方面。AMSTAR2评价结果显示,纳入的系统评价中低质量和极低质量研究各6篇,无高质量和中等质量研究。GRADE评价结果显示,结局指标证据质量为中低等。证据总结表明,相较于安慰剂,JAK抑制剂可缓解RA的各项指标,而相较于阿达木单抗的优势则不明显;JAK抑制剂不增加严重不良事件的发生率,但对总不良事件和肝损伤发生率的影响各系统评价结论不一致。结论:JAK抑制剂治疗RA的有效性,相较于安慰剂具有一定的优势,相较于其他药物尚需更多的研究加以论证;而其在安全性方面的优势尚不确定。

关键词 Janus激酶抑制剂;类风湿性关节炎;系统评价再评价;有效性;安全性

ABSTRACT   OBJECTIVE: To overview the systematic reviews on JAK inhibitors in the treatment of rheumatoid arthritis (RA), and to provide evidence-based basis for the treatment of RA with these drugs. METHODS: The Cochrane Library, PubMed, Embase, CNKI, Wanfang database and VIP were electronically searched to collect systematic reviews of JAK inhibitors in the treatment of RA from inception to Dec. 2020. After data extraction of included systematic review, PRISMA statement, AMSTAR2 scale and GRADE were used to evaluate the report quality, methodological quality and the level of evidence for outcome indicators. RESULTS: A total of 12 systematic reviews involving 103 outcomes were included. PRISMA score of systematic reviews was between 17.5 and 22.5, and the reported quality defects were mainly reflected in scheme, registration and other aspects. AMSTAR2 evaluation results showed that there were 6 studies of low quality and 6 studies of very low quality, without high-quality study and medium-quality study. GRADE assessment results for outcome indicators showed low to medium quality of evidence. The summary of evidence showed that compared to placebo, JAK inhibitor could alleviate various indicators of RA; compared to adalimumab, the advantage was not obvious. JAK inhibitors did not increase the incidence of serious adverse events, but the systematic reviews were inconsistent in their effects on the incidence of total adverse events and liver injury. CONCLUSIONS: The efficacy of JAK inhibitors in the treatment of RA has certain advantages over placebo, but more studies are needed to demonstrate the efficacy of JAK inhibitors in the treatment of RA compared to other drugs; the advantage of safety is uncertain.

KEYWORDS   JAK inhibitors; Rheumatoid arthritis; Overview of systematic reviews; Efficacy; Safety

類风湿性关节炎(rheumatoid arthritis,RA)是一种慢性全身免疫系统疾病,其特征是持续的关节损伤,常常累及关节外的其他器官或系统[1]。RA在全球的发病率约为0.5%~1%,而在我国的发病率较低,约为0.2%~0.4%[2],但由于我国人口基数较大,故总体患病人数较多,严重影响了患者生活质量和预期寿命。……

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