用生物治疗治疗的类风湿性关节炎患者的恶性瘤风险:一个元分析
Maria A Lopez-Olivo1, Jean H Tayar, Juan A Martinez-Lopez
1University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.
JAMA
|September 6, 2012
概括
对类风湿性关节炎 (RA) 的生物响应修饰剂 (BRM) 在随机对照试验中没有显示恶性瘤风险增加. 这项研究发现BRM使用与RA患者癌症发展之间没有显著的关联.
科学领域:
- 类风湿病学 类风湿病学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 人们对用生物反应修饰剂 (BRM) 治疗的类风湿性关节炎 (RA) 患者的潜在恶性瘤存在担忧.
- 评估与RA中的BRMs相关的癌症风险对于患者安全和治疗决策至关重要.
研究的目的:
- 评估参与生物响应修饰剂 (BRM) 随机对照试验 (RCT) 的类风湿性关节炎 (RA) 患者恶性瘤风险.
主要方法:
- 对RCT进行了电子数据库,会议记录和监管机构网站的系统搜索.
- 包括的RCT比较了RA的BRM与安慰剂或传统疾病修饰性抗风湿药物 (DMARD) 进行至少24周的随访.
- 数据提取和质量评估是独立进行的,对每个BRM计算了聚合估计和置信区间.
主要成果:
- 分析了涉及29423名RA患者的63个RCT.
- 在使用BRM时,没有观察到恶性瘤总体风险的统计显著增加.
- 在治疗的第一年内,恶性瘤的发病率在BRM组和对照组中很低,在阿纳金拉加上甲索特酸的一例中,与单独使用甲索特酸相比,患病率降低了.
结论:
- 在至少六个月的RCT中,在RA患者中使用BRM与恶性瘤的风险增加没有显著关联.
- 研究结果表明,在RA患者中,与安慰剂或传统DMARD相比,BRM可以安全地用于癌症风险.
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