内鼻17β-雌激醇治疗更年期症状的有效性和可接受性:随机剂量反应研究. 航空醇研究小组研究小组
1Chelsea and Westminster Hospital, London, UK. JStudd@harleyjs.prestel.co.uk
Lancet (London, England)
|May 20, 1999
概括
鼻内17β-雌醇喷雾有效地治疗更年期症状,为口服雌激素提供了具有类似功效和更好的耐受性的替代品. 这种新的输送方法绕过了第一通代谢,为激素替代疗法提供可重复的剂量.
科学领域:
- 内分泌学 在内分泌学.
- 药理学 药理学 是一个学科.
- 妇女健康 妇女健康
背景情况:
- 雌激素治疗对更年期症状有好处,但目前的输送方法有缺点.
- 鼻内17β-雌醇喷雾剂 (S21400) 是为了克服这些局限性而开发的.
- 这项研究评估了S21400的疗效和耐受性,以缓解绝经后症状.
研究的目的:
- 评估S21400在治疗绝经后症状中的有效性.
- 为了比较S21400与口服雌激素valerate和安慰剂.
- 评估鼻内S21400的耐受性和安全性.
主要方法:
- 这是一项双盲研究,涉及420名绝经后妇女.
- 在12周内随机分配给鼻内安慰剂,S21400 (100-400毫克),或口服雌激醇氨酸 (1-2毫克).
- 主要结局包括库珀曼指数 (KI) 和热发病率;通过鼻镜和状功能测试评估耐受性.
主要成果:
- S21400剂量取决于降低KI和热,有效剂量确定在200-300微克/天.
- 鼻内用S21400达到与口服雌激素相比的血清雌激素水平,变异性较低.
- 耳鼻功能没有显著差异;在S21400使用时,观察到轻微的应用部位反应 (打喷),但患者的服从性和方便性很高.
结论:
- 内17β-雌醇是一种耐受性良好,有效的治疗更年期症状的方法,与口服雌激素相当.
- 这种输送方法绕过了第一通代谢,提供可重复和可调节的剂量.
- 内鼻式S21400为激素替代疗法提供了一个可行的新选择.
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