生物制剂和托法替布对风湿性疾病患者心血管危险因素和结局的影响：系统文献评价。
The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review.
机构信息
Department of Rheumatology, Reade, VU University Medical Center, 3A50, Amsterdam Rheumatology and Immunology Center, Dr. Jan van Breemenstraat 2, 1056 AB, Amsterdam, The Netherlands.
Cardiff University School of Medicine, Cardiff, Wales, UK.
出版信息
Drug Saf. 2018 May;41(5):473-488. doi: 10.1007/s40264-017-0628-9.
INTRODUCTION
Rheumatic diseases are autoimmune, inflammatory diseases often associated with cardiovascular (CV) disease, a major cause of mortality in these patients. In recent years, treatment with biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), either as monotherapy or in combination with other drugs, have become the standard of treatment. In this systematic literature review, we evaluated the effect of treatment with biologic or tofacitinib on the CV risk and outcomes in these patients.
METHODS
A systematic search was performed in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews for articles reporting on CV risk and events in patients with rheumatic disease treated with a biologic agent or tofacitinib. Articles identified were subjected to two levels of screening. Articles that passed the first level based on title and abstract were assessed on full-text evaluation. The quality of randomized clinical trials was assessed by Jadad scoring system and the quality of the other studies and abstracts was assessed using the Downs and Black instrument. The data extracted included study design, baseline patient characteristics, and measurements of CV risk and events.
RESULTS
Of the 5722 articles identified in the initial search, screening yielded 105 unique publications from 90 unique studies (33 clinical trials, 39 prospective cohort studies, and an additional 18 retrospective studies) that reported CV risk outcomes. A risk of bias analysis for each type of report indicated that they were of good or excellent quality. Importantly, despite some limitations in data reported, there were no indications of significant increase in adverse CV events or risk in response to treatment with the agents evaluated.
CONCLUSIONS
Treatment with biologic or tofacitinib appears to be well-tolerated with respect to CV outcomes in these patients.
简介
风湿性疾病是自身免疫性、炎症性疾病，常与心血管（CV）疾病相关，这是此类患者的主要死亡原因。近年来，生物制剂和靶向合成的疾病修饰抗风湿药物（DMARDs）的治疗，无论是单药治疗还是与其他药物联合治疗，已成为治疗标准。在本次系统文献综述中，我们评估了生物制剂或托法替尼治疗对这些患者的心血管风险和结局的影响。
方法
我们在 MEDLINE、Embase、Cochrane 对照试验中心注册库和 Cochrane 系统评价数据库中进行了系统检索，以查找报告风湿性疾病患者使用生物制剂或托法替尼治疗后心血管风险和事件的文章。对识别出的文章进行了两级筛选。根据标题和摘要通过第一级筛选的文章，将进行全文评估。随机临床试验的质量采用 Jadad 评分系统评估，其他研究和摘要的质量采用 Downs 和 Black 工具评估。提取的数据包括研究设计、基线患者特征以及心血管风险和事件的测量。
结果
在最初的搜索中，共确定了 5722 篇文章，筛选出了 90 项独特研究（33 项临床试验、39 项前瞻性队列研究和另外 18 项回顾性研究）中的 105 篇独特出版物，这些研究报告了心血管风险结局。对每种报告类型的风险偏倚分析表明，它们的质量为良好或优秀。重要的是，尽管报告的数据存在一些局限性，但没有迹象表明这些患者在接受评估的药物治疗后，心血管不良事件或风险显著增加。
结论
生物制剂或托法替尼治疗在这些患者的心血管结局方面似乎具有良好的耐受性。
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