在慢性病多种疗法时代,对未来的保护试验进行设计考虑
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Doreen Zhu1,2, Parminder K Judge1,2, Natalie Staplin1
1Renal Studies Group, Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
概括
新的治疗方法减缓慢性病 (CKD) 的进展,但不能阻止它. 未来的CKD临床试验需要更大,更具包容性,更简单,以改善患者护理.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 临床试验 临床试验
- 药物治疗 药物治疗
背景情况:
- 最近的高质量试验已经推进了病学,特别是在糖尿病和慢性病 (CKD) 患者中.
- 多种药物治疗,包括-葡萄糖辅运输体2抑制剂 (SGLT2i),现在为某些CKD患者提供脏和心血管保护.
- 关键的SGLT2i试验在各种CKD原因中显示出广泛的疗效和安全性,支持常见CKD进展途径的概念.
研究的目的:
- 评估用于减缓CKD进展的新药疗法的有效性和安全性.
- 探索新疗法对未来临床试验的设计和进行的影响.
- 确定挑战,并提出解决方案,以便进行大规模,包容性和高效的CKD试验.
主要方法:
- 分析来自大型高质量研究试验的数据,比较CKD患者的新疗法与安慰剂.
- 在关键试验中包括各种病患者群体的多样化.
- 考虑新的试验设计策略,以应对诸如事件率下降和研究不足的人群等挑战.
主要成果:
- 包括SGLT2i在内的新药疗法显著减缓CKD进展,降低心血管风险.
- 这些治疗方法并不能完全阻止功能下降,也不能完全缓解过度心血管疾病.
- 试验结果表明,无论最初的原因如何,CKD的进展都类似,这支持了广泛的资格标准.
结论:
- 已确立的CKD似乎通过共同的途径进展,不管是什么初始条件.
- 目前的治疗方法缓慢但不能阻止CKD的进展,需要对新疗法进行持续的研究.
- 未来的CKD试验需要简化,更大的样本大小,更广泛的包容性和创新的设计,以克服当前的挑战并推进患者护理.
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