对良性前列腺阻塞的新治疗方法的评估:ICI-RS 2023
Hashim Hashim1, Tufan Tarcan2,3, Omer Acar4
1Bristol Urological Institute, Bristol, UK.
Neurourology and urodynamics
|December 11, 2023
概括
对良性前列腺阻塞 (BPO) 的新型侵入性疗法在广泛采用之前需要严格的长期临床试验. 目前的评估往往缺乏与黄金标准的比较,以及关于疗效和不良事件的足够数据.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 医疗器械评估 医疗器械评估
背景情况:
- 良性前列腺阻塞 (BPO) 是老年男性常见的疾病.
- 侵袭性疗法经常用于管理BPO,但它们的评估方法不一致.
研究的目的:
- 评估用于评估BPO的侵入性治疗方法的方法.
- 为了确定当前的BPO治疗是否可以预防疾病的进展.
- 在临床实施之前建立评估新型BPO疗法的标准.
主要方法:
- 关于主要泌尿病学协会 (AUA,EAU,ICUD) 的指导方针的文献综述.
- 评估BPO程序的试验设计,包括与黄金标准的比较.
- 评估尿动力学和术语在BPO临床试验中的作用.
主要成果:
- 在指南中,BPO的术语不一致 (例如,良性前列腺增生症).
- 许多BPO程序,如TUNA,已经过时了,但仍然在指南中.
- 大多数程序缺乏对黄金标准和长期结果数据的比较试验.
- 在BPO治疗的成功率和不良事件机制方面存在重大未知因素.
结论:
- 强大的,长期的临床试验对于新的BPO疗法至关重要.
- 试验应包括患有下尿路症状和尿的患者.
- 在实践中引入新的BPO治疗之前,需要更严格的评估协议.
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