去肾神经术治疗高血压近期疗效及安全性的随机假手术对照研究的荟萃分析

Effectiveness and safety of renal denervation in hypertension:a meta-analysis of randomized,sham-controlled clinical trials

目的系统评价去肾神经术治疗高血压的近期疗效及安全性。方法计算机检索Pubmed、Embase、Cochrane图书馆等外文生物医学数据库,收集2009-01-01至2020-05-01关于去肾神经术治疗高血压疗效及安全性的临床随机对照试验(RCT)。按Cochrane系统评价方法,评价所纳入研究的文献质量,并提取有效数据,采用RevMan 5.3和Stata15.1软件进行荟萃分析。结果共纳入8个RCT,高血压患者1364例随机接受去肾神经术(n=789)或假手术(n=575)。荟萃分析结果显示,疗效方面,与假手术相比,肾交感神经去除可使24h动态收缩压降低3.81mm Hg(95%CI-5.06~-2.56;I^(2)=0%,Z=5.97,P<0.01);24h动态舒张压降低1.87 mm Hg(95%CI-2.70~-1.05;I^(2)=15%,Z=4.45,P<0.01);诊室收缩压降低5.82 mm Hg(95%CI-7.97~-3.68;I^(2)=0%,Z=5.33,P<0.01);诊室舒张压降低3.31mm Hg(95%CI-4.52~-2.10;I^(2)=31%,Z=5.37,P<0.01)。在安全性方面,与假手术相比,肾交感神经去除在肾小球滤过率和血清肌酐水平上差异无统计学意义,肾小球滤过率差异-0.23mL/(min·1.73m2)(95%CI-1.70~-1.23,I^(2)=0%,Z=0.31,P=0.76),血清肌酐水平差异0μmol/L(95%CI-0.02~0.02,I^(2)=0%,Z=0.28,P=0.78)。结论有效的肾交感神经消融可安全显著地达到临床意义的降压作用。

Objective To systematically evaluate the efficacy and safety of renal sympathetic nerve ablation in the treatment of hypertension.Methods The Pubmed,Embase,Cochrane Library and other foreign controlled trial biomedical databases were searched,and the clinical randomized trails(RCT)from January 1,2009 to May 1,2020 on the efficacy and safety of renal sympathetic nerve ablation in the treatment of hypertension were collected.According to the Cochrane systematic evaluation method,the quality of the literature included in the study was evaluated,valid data was extracted,and meta-analysis was performed with RevMan 5.3 and Stata 15.1 software.Results A total of 8 RCT were included,and a total of 1364 hypertensive patients were randomized to renal sympathectomy group(n=789)or sham group(n=575).Meta-analysis results showed that in terms of efficacy,compared with sham group,24-hour systolic ambulatory blood pressure in renal sympathectomy group decreased by 3.81 mm Hg(95%CI-5.06 to-2.56;I^(2)=0%,Z=5.97,P<0.001);24-hour diastolic ambulatory blood pressure decreased by 1.87 mm Hg(95%CI-2.70 to-1.05;I^(2)=15%,Z=4.45,P<0.01);systolic blood pressure in the office decreased by 5.82 mm Hg(95%CI-7.97 to-3.68;I^(2)=0%,Z=5.33,P<0.01);diastolic pressure in the office reduced by 3.31 mm Hg(95%CI-4.52 to-2.10;I^(2)=24%,Z=5.37,P<0.01).In terms of safety,there was no statistically significant difference in glomerular filtration rate and serum creatinine level between two groups.The difference in glomerular filtration rate was-0.23 mL/(min·1.73 m2)(95%CI-1.70 to1.23,I^(2)=0%,Z=0.31,P=0.76),the difference in serum creatinine level was 0μmol/L(95%CI-0.02 to0.02,I^(2)=0%,Z=0.28,P=0.78).Conclusion Effective renal denervation can safely and significantly achieve clinical significant blood pressure reduction.