与他类药物治疗相关的风险:随机临床试验的系统概述
Amir Kashani1, Christopher O Phillips, JoAnne M Foody
1Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn, USA.
Circulation
|December 13, 2006
概括
与安慰剂相比,他类药物通常是安全的,肌肉或肝脏损伤风险没有显著增加. 然而,他类药物治疗与转氨酶水平的小幅上升有关.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 类药物有效降低心血管事件风险.
- 对副作用的担忧可能会限制他类药物的处方.
- 这项研究系统地审查了他类药物试验,以评估并发症风险.
研究的目的:
- 量化来自于他类药物治疗的肌肉骨,脏和肝脏并发症风险.
- 在随机试验中评估他单一治疗与安慰剂的安全性概况.
主要方法:
- 随机化他类药物试验的系统概述 (MEDLINE搜索,1966-2005年).
- 包括患有高脂血症的成年人,双盲他与安慰剂,>=100名患者.
- 分析了有关肌痛,肌酸激酶,拉布多米解,转氨酶升高和不良事件中止的数据.
主要成果:
- 在35项试验中的74,102名受试者 (随访时间为1-65个月).
- 肌痛病,肌酸激酶升高,狂肌溶解或治疗中止没有显著增加.
- 观察到转氨酶水平的显著绝对升高 (RD,4.2;95% CI,1.5至6.9).
结论:
- 类固醇药物治疗显示了转氨酶升高的小额风险,但没有肌痛,肌酸激酶升高,狂犬病或戒断.
- 需要进一步的研究来证实这些发现在常规实践中,特别是对于高风险患者群体.
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