修改释放吗啡或安慰剂治疗慢性呼吸困难:MABEL试验协议
Kathryn Date1, Bronwen Williams1, Judith Cohen1
1Hull Health Trials Unit, Hull York Medical School, University of Hull, Hull, UK.
ERJ open research
|August 16, 2023
概括
这项研究研究了低剂量口服修饰释放吗啡治疗慢性呼吸不良,这是一种致残症状. 结果将澄清它对心脏或肺部疾病,癌症或COVID-19后患者的有效性和安全性.
科学领域:
- 抚慰性护理是一种缓解性护理.
- 临床药理学 临床药理学
- 呼吸系统医学 呼吸系统医学
背景情况:
- 慢性喘息严重影响患者和护理人员,尽管最佳治疗.
- 临床指南建议在慢性喘息时使用吗啡,但有效性和安全性数据有限.
- 需要对这种衰弱症状进行低剂量口服改性释放吗啡的评估.
研究的目的:
- 评估低剂量口服改性释放吗啡在缓解慢性呼吸困难方面的有效性.
- 评估修改释放吗啡对慢性呼吸困难的安全性和耐受性.
- 探索在临床实践中采用吗啡作为一线治疗的可能性.
主要方法:
- 一个多中心,双盲,随机,安慰剂控制的试验,涉及158名未使用过阿片类药物的参与者.
- 参与者每天两次接受修改释放吗啡 (5mg或10mg) 或安慰剂,持续56天.
- 主要终点是28日最严重的喘息严重程度;次要结果包括咳,焦虑,疼痛和生活质量.
主要成果:
- 该研究的动力是检测呼吸困难严重程度的显著差异.
- 二次结果包括咳,痛苦,疼痛,功能状态,体力活动和生活质量.
- 将监测与吗啡相关的副作用,以便及早识别和管理.
结论:
- 该试验将提供关于低剂量修改释放吗啡治疗慢性呼吸困难的临床有效性和安全性的关键数据.
- 这些发现可能会支持将吗啡纳入治疗这种症状的临床指南.
- 一项定性副研究将探索在临床实践中实施吗啡的障碍和促进因素.
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