在急性辐射肠炎中Racecadotril与loperamide相比:一个随机的,双面罩的,第三阶段的非劣势性试验
Abhijith P B1, Shyama Prem Sudha2, Pazhanivel Mohan3
1Department of Radiation Oncology, MVR Cancer Centre and Research Institute, Kozhikode, Kerala.
International journal of radiation oncology, biology, physics
|September 24, 2023
概括
拉赛卡多特里尔在急性辐射肠炎中并没有被证明不低于洛佩拉米德,但它提供了有利的安全性. 由于效果相似,副作用较少,racecadotril是一种潜在的替代品.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
背景情况:
- 治疗急性辐射肠炎 (ARE) 缺乏一个黄金标准.
- ARE显著影响正在接受盆腔放射治疗的患者.
研究的目的:
- 为了比较Racecadotril (抗高分泌) 与Loperamide (抗运动) 在治疗ARE的疗效和安全性.
- 为了确定Racecadotril是否在解决腹方面不劣于洛佩拉米德.
主要方法:
- 进行了一项随机的,双面罩的,非劣等性试验.
- 纳入了162名患有2级或3级腹的患者.
- 主要结局:腹在48小时内消失.
主要成果:
- 拉塞卡多特里尔 (84%) 和洛佩拉米德 (86.4%) 的腹解决率相似 (P=.66).
- 没有证明Racecadotril的非劣势性 (95% CI: -8.5%至13.4%).
- 洛佩拉胺显著增加了反弹便秘 (17.3%与6.2%,P=.028).
结论:
- 在ARE中,Racecadotril与洛佩拉米德的非劣势性没有被证明.
- 由于类似的疗效和更好的安全性,Racecadotril是一种可行的替代品.
- 拉塞卡多特里尔对肠道运动缺乏影响可能会带来好处.
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