慢性斑块牛皮和心血管事件的生物疗法之间的关联:随机对照试验的元分析
Caitriona Ryan1, Craig L Leonardi, James G Krueger
1Department of Dermatology, Baylor Research Institute, 3900 Junius St, Ste 125, Dallas, TX 75246, USA. caitriona.ryan@baylorhealth.edu
JAMA
|August 25, 2011
概括
这项元分析发现,与安慰剂相比,在治疗慢性斑块牛皮的患者中,使用抗干白素-12/23或抗瘤坏死因子-α疗法治疗的患者中,主要心血管不良事件 (MACE) 没有显著增加.
科学领域:
- 皮肤病学 皮肤病学
- 心脏病学 心脏病学
- 免疫学 免疫学 免疫学
背景情况:
- 生物疗法,包括针对IL-12/23的ustekinumab和briakinumab,对慢性斑块牛皮 (CPP) 有效.
- 关于与抗IL-12/23药物相关的重大心血管不良事件 (MACE) 在牛皮患者中存在担忧.
研究的目的:
- 进行一项元分析,评估CPP和MACE的生物疗法之间的关联.
- 为了比较抗IL-12/23和抗瘤坏死因子-α (TNF-α) 药物的心血管安全概况.
主要方法:
- 对CPP的抗IL-12/23和抗TNF-α药物的随机对照试验 (RCT) 的系统综述和元分析.
- 包括单疗法研究与MACE结局数据,不包括牛皮关节炎试验.
- 使用Mantle-Haenszel固定效应方法对绝对风险差异进行数据提取和分析.
主要成果:
- 分析了22个带有10,183名患者的RCT.
- 在抗IL-12/23疗法和安慰剂之间没有观察到MACE率的统计学上显著差异 (风险差异:0.012事件/人-年;P=.12).
- 同样,与安慰剂相比,抗TNF-α疗法在MACE率上没有显著差异 (风险差异: -0.0005事件/人-年;P=.94).
结论:
- 在CPP患者中,抗IL-12/23或抗TNF-α治疗与安慰剂之间没有发现MACE率的显著差异.
- 这项研究可能不足以检测MACE的统计学上显著差异.
- 这些生物药物的心血管安全性需要持续监测.
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