替代疗法的心血管安全性
A Michael Lincoff1, Shalender Bhasin1, Panagiotis Flevaris1
1From the Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland (A.M.L., L.M.M., Q.W., K.W., D.D., V.K., S.E.N.); the Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School (S. Bhasin, S. Basaria, K.M.P.), Veterans Affairs Boston Healthcare System and Massachusetts Veterans Epidemiology, Research, and Information Center, Boston University School of Medicine (W.E.B.), and Marcus Institute for Aging Research, Beth Israel Deaconess Medical Center, Harvard Medical School (T.G.T.) - all in Boston; AbbVie, North Chicago, IL (P.F., N.K., M.G.M., M.C.S., A.C., E.D., X.L., T.Y., B.H.); Baylor College of Medicine, Houston (G.R.C., M.K.), and CHRISTUS Santa Rosa Health System and the University of Texas Health Science Center, San Antonio (I.M.T.) - all in Texas; and Duke Clinical Research Institute, Durham, NC (C.B.G.).
替代疗法对患有阴道腺和心血管疾病的男性是安全的. 这项研究发现,与安慰剂相比,在接受丸激素的男性中,主要心脏不良事件的风险没有增加.
科学领域:
- 内分泌学 在内分泌学.
- 心血管医学 心血管医学
- 临床试验 临床试验
背景情况:
- 替代疗法 (TRT) 对低腺男性的心血管安全性尚未得到充分证实.
- 阴性腺缺陷症影响中年和老年男性,通常具有先前存在的心血管疾病.
研究的目的:
- 为了确定TRT在45-80岁男性的心血管安全性,这些男性患有阴性腺体缺陷症和心血管疾病或风险.
- 评估TRT在预防主要心脏不良事件方面是否与安慰剂无差.
主要方法:
- 多中心,随机,双盲,安慰剂控制,非劣势性试验 (TRAVERSE).
- 5246名患有阴性腺体缺陷症和心血管疾病/风险的男性每天接受透皮丸激素凝或安慰剂.
- 主要终点:心血管死亡,非致命的心肌梗塞或非致命中风的组合.
主要成果:
- 丸激素治疗与安慰剂 (HR 0.96;95% CI 0.78-1.17) 相比没有劣势.
- 组之间主要复合心血管事件没有显著差异 (7.0%对7.3%).
- 在丸激素组中,心房动,急性损伤和肺栓塞的发病率更高.
结论:
- 替代疗法对心血管疾病的阴阴腺男性主要心脏不良事件的治疗效果不低于安慰剂.
- 虽然满足了主要安全终点,但其他不良事件的风险增加需要考虑.
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