作者：罗厚丽，冯健，张彦标，李先慧，薛刚，黄茜，游爽，董鸿斐，黄波

单位：

1.四川省成都市第一人民医院放射科2.西部战区总医院重症医学科3.西部战区总医院烧伤整形科

Units：

1.Department of Radiology, Chengdu First People's Hospital, Chengdu 610041, China 2.Department of Critical Care Medicine, the General Hospital of Western Theater Command, Chengdu 610083, China 3.Department of Burn and Plastic, the General Hospital of Western Theater Command, Chengdu 610083, China

关键词：

高血压; 肾交感神经消融术; 假手术; 随机对照试验; 治疗结果; Meta分析;

Keywords：

Hypertension; Renal denervation; Sham-operated; Randomized controlled trial; Treatment outcome; Meta-analysis

CLC：

　R 544.1

DOI：

10.12114/j.issn.1008-5971.2023.00.037

Funds：

1.610041四川省成都市第一人民医院放射科　2.610083四川省成都市，西部战区总医院重症医学科 3.610083四川省成都市，西部战区总医院烧伤整形科

摘要：

目的 系统评价肾交感神经消融术（RDN）治疗高血压的有效性及安全性。方法 计算机检索中国知网、万方数据知识服务平台、维普网、Cochrane Library、PubMed、Embase和Web of Science公开发表的RDN治疗高血压的随机、假手术对照试验，检索时间均从建库至2021年12月。结局指标为24 h动态血压、诊室血压、家庭血压、日间血压、夜间血压及不良事件发生率。采用Stata 14.0软件进行Meta分析；针对报道结局指标数量≥10篇的文献，根据试验期间抗高血压药物使用情况、高血压类型、消融设备、消融能量、消融方式进行亚组分析。结果 最终纳入10篇文献，均为英文文献，包括1 636例患者，其中RND组927例、假手术组709例。Meta分析结果显示，RDN组较假手术组24h动态收缩压降低3.04mmHg[95%CI (-4.27,-1.80)mmHg,P <0.001]、24h动态舒张压降低2.12mm Hg[95%CI(-2.88,-1.36)mm Hg,P<0.001]、诊室收缩压降低3.83 mm Hg[95%CI(-6.52,-1.15)mm Hg,P<0.001]、诊室舒张压降低1.10 mm Hg[95%CI(-1.94,-0.25)mm Hg,P<0.001]、家庭收缩压降低4.20mm Hg[95%CI(-6.14,-2.27)mm Hg,P<0.001]、家庭舒张压降低2.98 mm Hg[95%CI(-4.31,-1.64)mm Hg,P<0.001]、日间收缩压降低4.43 mm Hg[95%CI(-6.22,-2.63)mm Hg,P<0.001]、日间舒张压降低1.97mm Hg[95%CI(-3.10,-0.83)mm Hg,P<0.001]、夜间收缩压降低3.39 mm Hg[95%CI(-5.68,-1.11)mm Hg,P<0.001]、夜间舒张压降低1.82 mm Hg[95%CI(-3.33,-0.32)mm Hg,P=0.017]；RDN组与假手术组不良事件发生率比较，差异无统计学意义[危险度差（RD）=0.02,95%CI(-0.01,0.04),P=0.27]。亚组分析结果显示，在停药、非难治性高血压、使用第一代消融设备的患者中，RDN组与假手术组24 h动态收缩压比较，差异无统计学意义（P>0.05）。结论 与假手术相比，RDN能有效降低高血压患者24 h动态血压、诊室血压、家庭血压、日间血压及夜间血压，且未增加不良事件发生风险。但在试验期间停用抗高血压药物、非难治性高血压或使用第一代消融设备的高血压患者中，RDN对其24 h动态收缩压无明显降低作用。

Abstract：

Objective To evaluate the effect and safety of renal denervation (RDN) in the treatment of hypertension. CNKI, Wanfang Data, VIP, Cochrane Library, PubMed, Embase and Web of Science were searched for randomized sham-controlled trials of RDN in the treatment of hypertension from inception of the database to December 2021. The outcome indicators were 24 h ambulatory blood pressure, clinic blood pressure, home blood pressure, daytime blood pressure, nighttime blood pressure and incidence of adverse events. Meta-analysis was performed using Stata 14.0 software. For the outcome indicators with the number of literature ≥ 10, subgroup analysis was performed according to the use of antihypertensive drugs during the trial, type of hypertension, ablation equipment, ablation energy, and ablation method. Results Finally, 10 articles were included, all in English, including 1 636 patients, including 927 in the RND group and 709 in the sham-operated group. The results of meta analysis showed that, compared with the sham-operated group, the 24 h dynamic systolic blood pressure (SBP) of the RDN group decreased by 3.04 mm Hg [95%CI (-4.27, -1.80) mm Hg, P < 0.001] , the 24 h dynamic diastolic blood pressure (DBP) decreased by 2.12 mm Hg [95%CI (-2.88, -1.36) mm Hg, P < 0.001] , clinic SBP decreased by 3.83 mm Hg [95%CI (-6.52, -1.15) mm Hg , P < 0.001] , clinic DBP decreased by 1.10 mm Hg [95%CI (-1.94, -0.25) mm Hg, P < 0.001] , home SBP decreased by 4.20 mm Hg [95%CI (-6.14, -2.27) mm Hg, P < 0.001] , home DBP decreased by 2.98 mm Hg [95%CI (-4.31, -1.64) mm Hg, P < 0.001] , daytime SBP decreased by 4.43 mm Hg [95%CI (-6.22, -2.63) mm Hg, P < 0.001] , daytime DBP decreased by 1.97 mm Hg [95%CI (-3.10, -0.83) mm Hg, P < 0.001] , night SBP decreased by 3.39 mm Hg [95%CI (-5.68, -1.11) mm Hg, P < 0.001] , and night DBP decreased by 1.82 mm Hg [95%CI (-3.33, -0.32) mm Hg, P=0.017] ; there was no significant difference in the incidence of adverse events between RDN group and sham-operated group [risk difference (RD) =0.02, 95%CI (-0.01, 0.04) , P=0.27] . Subgroup analysis showed that there was no significant difference in 24 h SBP between RDN group and sham operated group in patients with drug withdrawal, non-refractory hypertension and using the first generation ablation equipment ( P > 0.05) . Conclusion Compared with sham-operated, RDN can effectively reduce 24 h ambulatory blood pressure, clinic blood pressure, home blood pressure, daytime blood pressure and nighttime blood pressure in patients with hypertension, and does not increase the risk of adverse events. However, in the hypertensive patients who discontinued antihypertensive drugs, non-refractory hypertension or used the first-generation ablation device during the trial, RDN did not significantly reduce 24-hour ambulatory SBP

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