Lancet:肾去神经术降压治疗的长期效果和安全性

2022-04-06 MedSci原创 MedSci原创

肾去神经术具有持久且显著的降压效果,且无重大安全问题

在使用降压药的情况下,肾去神经已被证明可以降低血压;但是,目前缺乏关于肾去神经随机试验的长期安全性和疗效数据。

SPYRAL HTN-ON MED研究是一项在多个国家的25所临床中心开展的随机、单盲、假对照试验。本文汇报了该试验的预分析结果:肾去神经与假对照组随访长达36个月的血压、降压药使用和安全性对比。

招募了24小时动态收缩压在140 mmHg-170 mmHg、服用1-3种降压药且剂量稳定至少6周的患者。患者都进行了肾血管造影,并随机(1:1)分成两组,接受射频肾去神经术或假对照手术。随访12个月后,假对照组患者可以交叉至对组。主要终点是两组在 6 个月时平均 24 小时收缩压的治疗差异。

2015年7月22日至2017年6月14日,共筛查了467位患者,其中80位符合纳入标准,被随机分至肾去神经术组(n=38)或假对照手术组(n=42)。第24个月和第36个月时,肾去神经组的平均收缩压和舒张压均较基线显著降低,明显低于假对照组(两组的降血压药物强度相似)。第36个月时,肾去神经术组和假对照组的药物负荷分别是2.13种和2.55种药物(p=0.26);分别有24位(77%,24/31)和25位(93%,25/27)患者仍在服用降压药。


两组24小时收缩压和舒张压的变化趋势

36个月时,肾去神经术组和假对照组的收缩压分别平均降低了18.7 mmHg和8.6 mmHg(校正治疗差:-10.0 mmHg,p=0.0039)。第36个月时,肾去神经术组和假对照组的平均舒张压治疗差为-5.9 mmHg,晨起收缩压和夜间收缩压的治疗差分别是-11.0 mmHg(p=0.016)和-11.8 mmHg(p=0.0017)。

最后,无与肾去神经术相关的长期或短期安全性问题。


两组不同时间点的血压前后变化

与假手术对照组相比,射频肾去神经术具有持久的降低血压的效果,且无重大安全问题,也不受降压药物的影响。总之,肾去神经术可为高血压患者的管理提供一种安全有效的辅助治疗方式。

 

原始出处:

Felix Mahfoud, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 04, 2022. https://doi.org/10.1016/S0140-6736(22)00455-X.

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    2022-09-26 howi
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    2022-04-07 zhaojie88
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    2022-04-05 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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