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肾去神经支配——射频与超声:来自随机假手术对照试验混合治疗比较荟萃分析的见解

Renal denervation - radiofrequency vs. ultrasound: insights from a mixed treatment comparison meta-analysis of randomized sham controlled trials.

作者信息

Bangalore Sripal, Maqsood M Haisum, Bakris George L, Rao Sunil V, Messerli Franz H

机构信息

Department of Medicine, Leon H. Charney Division of Cardiology, NYU Grossman School of Medicine, New York, New York.

Department of Cardiology, DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas.

出版信息

J Hypertens. 2025 Feb 1;43(2):325-335. doi: 10.1097/HJH.0000000000003909. Epub 2024 Oct 17.

DOI:10.1097/HJH.0000000000003909
PMID:39466083
Abstract

BACKGROUND AND AIMS

Multiple randomized trials have shown that renal denervation (RDN) reduces blood pressure (BP) when compared with sham control but the antihypertensive efficacy of radiofrequency vs. ultrasound-based RDN is uncertain. We aimed to compare the outcomes of radiofrequency RDN (rRDN) and ultrasound RDN (uRDN), when compared with sham in patients with hypertension.

METHODS

PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized sham-controlled trials (RCTs) of rRDN or uRDN or for trials of rRDN vs. uRDN. Primary efficacy outcome was 24-h ambulatory SBP. A mixed treatment comparison meta-analysis was performed comparing the efficacy and safety against sham and against each other.

RESULTS

Among 13 RCTs that enrolled 2285 hypertensive patients, rRDN reduced 24-h ambulatory SBP [(MD = 2.34 mmHg; 95% confidence interval (95% CI): 0.72-3.95], office SBP (MD = 5.04 mmHg; 95% CI: 2.68-7.40)], and office DBP (MD = 2.95 mmHg; 95% CI: 1.68-4.22) when compared with sham. Similarly, uRDN reduced 24-h ambulatory SBP (MD = 4.74 mmHg; 95% CI: 2.80-6.67), day-time ambulatory SBP (MD = 5.40 mmHg; 95% CI: 3.68-7.13), night-time ambulatory SBP (MD = 3.84 mmHg; 95% CI: 0.02-7.67), and office SBP (3.98 mmHg; 95% CI: 0.78-7.19) when compared with sham. There was significantly greater reduction in 24-h ambulatory SBP (MD = 2.40 mmHg; 95% CI: 0.09-4.71), day-time ambulatory SBP (MD = 4.09 mmHg; 95% CI: 1.61-6.56), and night-time ambulatory SBP (MD = 5.76 mmHg; 95% CI: 0.48-11.0) with uRDN when compared with rRDN. For primary efficacy outcome, uRDN ranked #1, followed by rRDN (#2), and sham (#3).

CONCLUSION

In hypertensive patients, rRDN and uRDN significantly reduced 24-h ambulatory and office SBP when compared with sham control with significantly greater reduction in ambulatory BP with uRDN than with rRDN at 4 months (mean) of follow-up. A large-scale randomized head-to-head trial of rRDN or uRDN is warranted to evaluate if there are differences in efficacy.

摘要

背景与目的

多项随机试验表明,与假手术对照相比,肾去神经支配术(RDN)可降低血压(BP),但射频与超声介导的肾去神经支配术的降压效果尚不确定。我们旨在比较高血压患者中射频肾去神经支配术(rRDN)和超声肾去神经支配术(uRDN)与假手术对照的疗效。

方法

检索PubMed、EMBASE和clinicaltrials.gov数据库,查找rRDN或uRDN的随机假手术对照试验(RCT),或rRDN与uRDN对比的试验。主要疗效指标为24小时动态收缩压。进行混合治疗比较荟萃分析,比较与假手术对照及两者之间的疗效和安全性。

结果

在纳入2285例高血压患者的13项RCT中,与假手术对照相比,rRDN降低了24小时动态收缩压[平均差(MD)=2.34mmHg;95%置信区间(95%CI):0.72 - 3.95]、诊室收缩压(MD = 5.04mmHg;95%CI:2.68 - 7.40)和诊室舒张压(MD = 2.95mmHg;95%CI:1.68 - 4.22)。同样,与假手术对照相比,uRDN降低了24小时动态收缩压(MD = 4.74mmHg;95%CI:2.80 - 6.67)、日间动态收缩压(MD = 5.40mmHg;95%CI:3.68 - 7.13)、夜间动态收缩压(MD = 3.84mmHg;95%CI:0.02 - 7.67)和诊室收缩压(3.98mmHg;95%CI:0.78 - 7.19)。与rRDN相比,uRDN在24小时动态收缩压(MD = 2.40mmHg;95%CI:0.09 - 4.71)、日间动态收缩压(MD = 4.09mmHg;95%CI:1.61 - 6.56)和夜间动态收缩压(MD = 5.76mmHg;95%CI:0.48 - 11.0)方面的降低幅度显著更大。对于主要疗效指标,uRDN排名第一,其次是rRDN(第二),假手术对照(第三)。

结论

在高血压患者中,与假手术对照相比,rRDN和uRDN均显著降低了24小时动态血压和诊室收缩压,在随访4个月(平均)时,uRDN降低动态血压的幅度显著大于rRDN。有必要进行一项rRDN或uRDN的大规模随机头对头试验,以评估疗效是否存在差异。

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