Fadl Elmula Fadl Elmula M, Feng Ying-Mei, Jacobs Lotte, Larstorp Anne C, Kjeldsen Sverre E, Persu Alexandre, Staessen Jan A
a Department of Cardiology, Internal Medicine and Medical Biochemistry , Oslo University Hospital , Ullevaal , Norway.
b Faculty of Medicine , University of Oslo , Oslo , Norway.
Blood Press. 2017 Aug;26(4):195-203. doi: 10.1080/08037051.2017.1311769. Epub 2017 Apr 26.
Studies of renal denervation (RDN) in patients with apparent treatment resistant hypertension have been hampered by a number of patient and physician related confounders on blood pressure (BP) including poor drug adherence. It remains uncertain whether RDN lowers BP. We aimed to investigate whether the use of sham control is essential in RDN studies or whether systematic use of 24-hour ambulatory BP provides enough information thereby making an invasive sham control redundant.
We meta-analyzed randomized controlled trials of the BP response to RDN on top of continued or optimized antihypertensive drugs in patients with resistant hypertension. On top of the randomized trials reviewed earlier, we additionally included three studies, one conducted in Spain (24 patients, RDN vs. spironolactone), one conducted in Denmark (69 patients, sham controlled) and one conducted in Netherlands (139 patients, RDN vs. continued treatment). We analyzed 24-hour ambulatory BP in 3 sham controlled studies vs. 7 no sham controlled studies.
The updated meta-analysis of 10 studies showed 3.6 mmHg (p = .45) and 1.0 mmHg (p = .54) reductions in office and in 24-hour systolic BP, respectively. Meta-analysis of 24-hour systolic BP in the 3 sham-controlled studies showed a reduction of 2.18 mmHg (95% confidence intervals (CIs) -4.70 to 0.33 mmHg, n = 396 vs. 230, p = .07). For the 7 no sham controlled studies there was no difference in 24-hour systolic BP (+0.38 mmHg; 95% CIs -5.29 to 6.04 mmHg, n = 215 vs. 245, p = .90). The test for sub-group heterogeneity showed no significant interaction (p = .69). Removing one trial at a time produced confirmatory results.
The overall meta-analysis of 10 randomized and controlled studies showed no significant effect on BP of RDN in resistant hypertension. Moreover, our analysis does not support the use of sham control but rather suggests extensive use of 24-hour ambulatory BP in studies of RDN in resistant hypertension.
在明显治疗抵抗性高血压患者中进行肾去神经支配术（RDN）的研究受到了一些与患者和医生相关的血压（BP）混杂因素的阻碍，包括药物依从性差。RDN是否能降低血压仍不确定。我们旨在研究在RDN研究中使用假手术对照是否必不可少，或者系统使用24小时动态血压是否能提供足够信息，从而使侵入性假手术对照变得多余。
我们对在难治性高血压患者中，在持续或优化的抗高血压药物基础上，RDN对血压反应的随机对照试验进行了荟萃分析。在之前回顾的随机试验基础上，我们另外纳入了三项研究，一项在西班牙进行（24例患者，RDN与螺内酯对比），一项在丹麦进行（69例患者，假手术对照），一项在荷兰进行（139例患者，RDN与持续治疗对比）。我们分析了3项有假手术对照研究与7项无假手术对照研究中的24小时动态血压。
对10项研究的更新荟萃分析显示，诊室收缩压和24小时收缩压分别降低了3.6 mmHg（p = 0.45）和1.0 mmHg（p = 0.54）。对3项有假手术对照研究中的24小时收缩压进行的荟萃分析显示降低了2.18 mmHg（95%置信区间（CI）-4.70至0.33 mmHg，n = 396对230，p = 0.07）。对于7项无假手术对照研究，24小时收缩压无差异（+0.38 mmHg；95% CI -5.29至6.04 mmHg，n = 215对245，p = 0.90）。亚组异质性检验显示无显著交互作用（p = 0.69）。每次去除一项试验均产生了验证性结果。
对10项随机对照研究的总体荟萃分析显示，RDN对难治性高血压患者的血压无显著影响。此外，我们的分析不支持使用假手术对照，而是建议在难治性高血压患者的RDN研究中广泛使用24小时动态血压。
