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阿那白滞素治疗类风湿关节炎的疗效和不良反应:系统评价。

Effectiveness and adverse effects of anakinra in treatment of rheumatoid arthritis: a systematic review.

机构信息

Department of Medicine, College of Medicine, Rheumatology Unit, King Saud University, Riyadh, Saudi Arabia.

出版信息

Eur Rev Med Pharmacol Sci. 2021 Dec;25(24):7833-7839. doi: 10.26355/eurrev_202112_27630.

Abstract

OBJECTIVE

Rheumatoid arthritis (RA) can be described as a chronic, inflammatory, progressive, autoimmune disorder characterized by generalized inflammation of the synovial joints, which hereby triggers the progressive erosion of both cartilage and bone. Anakinra is a recombinant form of human IL-1 receptor antagonist which targets the type I IL-1 receptor. In the present systematic review, we intend to evaluate the effectiveness and adverse effects of interleukin-1 antagonists in the treatment of rheumatoid arthritis.

MATERIALS AND METHODS

The database search was carried out using PubMed (Medline), Web of Science (Clarivate), Embase, Scopus, and Cochrane Library for the existing studies. A total of 3912 relevant articles were identified as per the search strategy. Out of them, 854 duplicate records and further 3024 records were excluded after going through their titles and abstracts. Further, out of 42 articles left, we excluded 32 more articles matching our inclusion criteria and excluding the reviews and case studies. Finally, we included 10 relevant studies that focused on both the effectiveness and adverse effects of interleukin-1 antagonists during the treatment of adult patients with rheumatoid arthritis in the present analysis. Nine out of 10 included studies are randomized trials (RCT) except for 1 study, which was an extension study.

RESULTS

The results showed an ACR20 response at week 12 and were the most common primary outcome measure in the present review. Various secondary outcome measures studied were changed from baseline at week 24 in individual ACR components. ACR50 and ACR70 responses at subsequent weeks (12 and 24), ESR components, HAQ score, CRP levels, and ESR. Notably, more improvement was observed with anakinra in comparison to placebo for achieving ACR50 and ACR70 responses at 24 weeks. Premature withdrawal of participants was observed in almost all the studies. Adverse drug reactions were attributed to be the most common reason followed by loss of efficacy for withdrawal of patients from the treatment. The infectious episode was another common adverse effect observed in both anakinra and placebo groups. Some malignancies were also documented in the included researches of this systematic analysis. We observed a lower overall incidence of malignancies for the studies screened compared with that of the general population.

CONCLUSIONS

This review demonstrated that anakinra is safe, effective, and well-tolerated, with no significant difference in adverse effects compared to placebo in rheumatoid arthritis patients.

摘要

目的

类风湿关节炎(RA)可被描述为一种慢性、炎症性、进行性、自身免疫性疾病,其特征为滑膜关节的广泛性炎症,由此引发软骨和骨的进行性侵蚀。阿那白滞素是一种人白细胞介素-1 受体拮抗剂的重组形式,针对 I 型白细胞介素-1 受体。在本系统评价中,我们旨在评估白细胞介素-1 拮抗剂在治疗类风湿关节炎中的疗效和不良反应。

材料和方法

使用 PubMed(医学在线)、Web of Science(科睿唯安)、Embase、Scopus 和 Cochrane Library 对现有研究进行数据库检索。根据搜索策略,共确定了 3912 篇相关文章。其中,854 篇重复记录,进一步阅读标题和摘要后排除了 3024 篇记录。进一步,在剩下的 42 篇文章中,我们排除了 32 篇与我们的纳入标准匹配的文章,并排除了综述和病例研究。最后,我们纳入了 10 项研究,这些研究均侧重于白细胞介素-1 拮抗剂在治疗成人类风湿关节炎患者中的疗效和不良反应。10 项研究中,除了 1 项是扩展研究外,其余 9 项均为随机对照试验(RCT)。

结果

结果显示,在第 12 周时 ACR20 应答是最常见的主要结局指标。在本综述中,各种次要结局指标是在个体 ACR 成分的第 24 周时从基线开始变化。第 12 和 24 周时的 ACR50 和 ACR70 应答、ESR 成分、HAQ 评分、CRP 水平和 ESR。值得注意的是,与安慰剂相比,阿那白滞素在第 24 周时更能改善 ACR50 和 ACR70 的应答。几乎所有研究都观察到参与者提前退出。不良药物反应被认为是最常见的原因,其次是因疗效丧失而导致患者退出治疗。感染事件也是阿那白滞素和安慰剂组中观察到的另一种常见不良影响。纳入本系统分析的研究还记录了一些恶性肿瘤。与一般人群相比,我们观察到筛选出的研究中恶性肿瘤的总体发生率较低。

结论

本综述表明,阿那白滞素在类风湿关节炎患者中安全、有效且耐受性良好,与安慰剂相比,不良反应无显著差异。

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