自我报告的慢性治疗使用在24周的随访后,参与者完成了简化随机对照试验
Alex H Gifford1, Katherine Odem-Davis2, Margaret Kloster2
1University Hospitals Cleveland Medical Center, Cleveland, OH, USA; University Hospitals Rainbow Babies and Children's Hospital, Cleveland, OH, USA.
概括
参与一项囊性纤维化试验,鼓励停止多尔纳斯阿尔法 (DA) 或高盐水 (HS) 治疗,导致患者在试验后不使用这些药物的几率更高.
科学领域:
- 肺部医学 肺部医学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 高效的CFTR调制剂疗法 (HEMT) 已经推进了囊性纤维化 (CF) 护理,使其他疗法的潜在中止成为可能.
- 在SIMPLIFY试验中,评估了停止dornase alfa (DA) 或高血压盐水 (HS) 与在HEMT上继续治疗CF (pwCF) 患者6周的非劣势性.
- 这项研究调查了SIMPLIFY试验后的试验后药物使用情况.
研究的目的:
- 为了确定在SIMPLIFY试验期间随机选择停止DA或HS是否影响了试验后不使用这些药物的可能性.
- 评估参与终止治疗试验对随后患者治疗决定的影响.
主要方法:
- 在试验结束后的24周内,每4周对SIMPLIFY参与者进行电子调查,然后在公开结果之前进行调查.
- 参与者报告在前一周使用药物 (DA或HS).
- 对不使用药物的共变量调整的几率比率 (ORs) 估计使用逻辑回归与概括估计方程.
主要成果:
- 472名参与者 (181名来自HS试验,291名来自DA试验) 被纳入分析.
- 在所有随访点上,随机选择停止DA或HS的参与者中,与随机选择继续使用者相比,报告的非使用者比例更高.
- 调整后的分析显示,随机选择停止DA的参与者比随机选择停止HS的参与者高8.7倍 (95% CI: 4.3-17.7),随机选择停止HS的参与者比随机选择停止HS的参与者高5.2倍 (95% CI: 2.1-12.8),在试验后不使用各自的药物.
结论:
- 在SIMPLIFY试验中随机选择停止DA或HS与试验结束后不使用这些药物的可能性增加有关.
- 参与治疗中止试验可能会影响患者的长期治疗选择.
- 这些发现对于有关CF护理研究参与和临床管理的讨论是有意义的.
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