CAJ | 학술논문

目的：利用 Meta 分析方法可合并同质研究提高检验效能的特点，对肾去交感神经术治疗顽固性高血压的临床试验结果进行再评价。方法对纳入的 Symplicity HNT-1、Symplicity HNT-1补充、Symplicity HNT-2、Catheter-based RSD临床随机对照试验，依据GRADE系统推荐分级方法，进行质量评价，运用Review Manager对选定的随机试验进Meta分析。结果 Meta分析的两个终点的结果显示：肾去交感神经术治疗优于单纯药物治疗，其差异具有统计学意义，OR（95%CI）分别为14.83（6.63，32.20）、3.45（1.18，10.08）。GRADE系统推荐分级显示：以术后降压药物剂量和（或）种类减少为事件终点，四项试验证据等级均为低级；以术后6个月患者收缩压血压值为终点，Symplicity HNT-1试验、Catheter-based RSD试验证据等级为中级，Symplicity HNT-1补充试验、Symplicity HNT-2试验证据等级为低级。结论以收缩压降低10 mm Hg为疗效标准，肾去交感神经术治疗顽固性高血压优于单纯药物治疗，且无严重并发症及后遗症。鉴于纳入研究少、样本含量低，仍需开展大样本、多中心、科学规范的临床随机对照试验，以全面评价肾去交感神经术的安全性与有效性。
목적：이용 Meta 분석방법가합병동질연구제고검험효능적특점，대신거교감신경술치료완고성고혈압적림상시험결과진행재평개。방법대납입적 Symplicity HNT-1、Symplicity HNT-1보충、Symplicity HNT-2、Catheter-based RSD림상수궤대조시험，의거GRADE계통추천분급방법，진행질량평개，운용Review Manager대선정적수궤시험진Meta분석。결과 Meta분석적량개종점적결과현시：신거교감신경술치료우우단순약물치료，기차이구유통계학의의，OR（95%CI）분별위14.83（6.63，32.20）、3.45（1.18，10.08）。GRADE계통추천분급현시：이술후강압약물제량화（혹）충류감소위사건종점，사항시험증거등급균위저급；이술후6개월환자수축압혈압치위종점，Symplicity HNT-1시험、Catheter-based RSD시험증거등급위중급，Symplicity HNT-1보충시험、Symplicity HNT-2시험증거등급위저급。결론이수축압강저10 mm Hg위료효표준，신거교감신경술치료완고성고혈압우우단순약물치료，차무엄중병발증급후유증。감우납입연구소、양본함량저，잉수개전대양본、다중심、과학규범적림상수궤대조시험，이전면평개신거교감신경술적안전성여유효성。
Objective The results of RSD as a treatment of resistant hypertension in clinical trials is revaluated by using Meta-analysis to combine homogeneous studies and improve the power of test. Methods The included clinical randomized controlled trails-Symplicity HNT-1, Symplicity HNT-1 Complement, Symplicity HNT-2, Catheter-based RSD-are evaluated by GRADE system and Review Manager system. Results The two endpoints of meta-analysis show: the therapy of RSD is much better than medication (Odds Ratio:14.83, 95%confidence interval:6.63-32.20, P<0.000 01/Odds Ratio: 3.45, 95% confidence interval: 1.18-10.08, P=0.02, respectively). The results of the GRADE system show:defined the reduction of dose and/or type of antihypertensive drugs after surgery as the endpoint, the four tests are low level of evidence. Defined the SBP of hypertensive after 6 months of surgery as another endpoint, the evidence of Symplicity HNT-1 and Catheter-based RSD are moderate level and the evidence of Symplicity HNT-1 Complement and Symplicity HNT-2 are low level. Conclusion Defined the systolic blood-pressure reduction of 10 mm Hg as the therapy criteria, the therapy of RSD is much better than medication, and it is less of severe complication and sequel. Because of lack of sample, randomized controlled trials of large sample, multi-center, scientific standard are still needed to evaluate the safety and effectiveness of RSD.