在接受丸激素透皮疗法治疗的阴性腺症男性中, ambulatory 血压参数
Mitchell D Efros1, Jed C Kaminetsky2, Neil D Sherman3
1AccuMed Research Associates, Garden City, New York.
概括
激素透皮系统 (TTS) 治疗低血球症的治疗显示出对24小时缩血压 (SBP) 的潜在影响. 虽然非劣质标准并不能最终排除,但观察到的SBP变化可能没有临床意义.
科学领域:
- 内分泌学 在内分泌学.
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 替代疗法 (TRT) 对血压的影响需要进一步调查.
- 门诊血压监测提供了有关血压波动的详细见解.
- 阴性腺症与各种健康风险有关,需要进行TRT评估.
研究的目的:
- 评估丸激素透皮系统 (TTS) 对24小时门诊血压参数的影响.
- 为了确定是否可以确定TTS治疗的非劣势性,关于缩血压 (SBP) 变化.
主要方法:
- 一个单臂的非劣势性试验,涉及168名阴阴腺男性.
- 晚上TTS管理16周,剂量调整以达到目标水平.
- 主要终点:从基线到第16周的24小时SBP的平均变化.
主要成果:
- 在24小时SBP中观察到平均3.5mmHg的增加 (n=62).
- 95%置信区间的上限超过了3.0mmHg的非劣势率.
- 在白天和高血压亚组中观察到更大的血压变化;心血管不良事件很少发生.
结论:
- 根据非劣质标准,16周TTS治疗对24小时SBP的显著影响不能被排除在外.
- 观察到的平均SBP变化可能不会对心血管事件产生临床显著的影响.
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