内皮素受体拮抗剂治疗肺动脉高压的有效性和安全性的系统评价  

Effectiveness and Safety of Endothelin Receptor Antagonists in the Treatment of Pulmonary Arterial Hypertension:A Systematic Evaluation

作　　者：郭思彤[1] 顾智淳 陈晓宇[1] 苏恒海 GUO Sitong;GU Zhichun;CHEN Xiaoyu;SU Henghai(Department of Pharmacy,the People's Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China;Department of Pharmacy,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200240,China)

机构地区：[1]广西壮族自治区人民医院药学部,南宁530021 [2]上海交通大学医学院附属仁济医院药剂科,上海200240

出　　处：《医药导报》2022年第2期206-212,共7页Herald of Medicine

基　　金：广西自然科学基金项目(2018GXNSFAA281159)。

摘　　要：目的系统评价单用内皮素受体拮抗剂(ERA)治疗肺动脉高压(PAH)的有效性和安全性。方法计算机检索Pubmed、Embase、Chochrane Library、美国临床试验数据库和世界卫生组织国际临床试验注册平台,收集单用ERA对比安慰药治疗PAH的临床随机对照试验(RCT),采用RevMan 5.3版软件进行文献质量评估和各结局指标Meta分析,采用STATA 14.0版软件进行敏感性分析、回归分析、序贯分析和发表偏倚分析。结果共纳入9项RCT研究,1919例PAH患者。Meta分析结果显示,单用安立生坦、波生坦和马昔腾坦组较安慰药组,病死率差异均无统计学意义[OR=0.81,95%CI(0.47,1.40),P=0.45],均能显著改善6 min步行距离[MD=23.06,95%CI(15.35,30.77),P<0.00001];ERA组头痛和贫血发生率显著高于安慰药组,而肝损伤、呼吸困难、外周水肿发生率与安慰药组差异无统计学意义。结论ERA能显著改善PAH患者运动能力,但对于减低病死率无明显优势,可能会增加PAH患者头痛和贫血风险。Objective To evaluate the effectiveness and safety of the monotherapy of endothelin receptor antagonists in the pulmonary arterial hypertension.Methods Retrieved from Pubmed,Embase,Chochrane Library,the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov,and the World Health Organization International Clinical Trials Registry Platform,randomized controlled trials(RCT) about monotherapy of endothelin receptor antagonists versus placebo in the treatment of pulmonary arterial hypertension were collected.The assessment of methodological bias risk and meta-analysis of each outcome were carried out by RevMan5.3 software.The sensitivity analysis,meta-regression analysis,trial sequential analysis,and publish bias analysis were carried out by STATA14.0 software.Results A total of 9 RCTs involving 1919 PAH patients were included in this meta-analysis.Compared with placebo,ambrisentan,bosentan,and macitentan had no significant difference in mortality rate [OR=0.81,95%CI(0.47,1.40),P=0.45],and they improved 6 minutes walking distance significantly [MD=23.06,95%CI(15.35,30.77),P<0.000 01]Compared with the placebo,ERA increased the risk of headache and anemia,and had no signifi cant difference in causing abnormal liver function,dyspnea,and peripheral edema.The evaluation results of the evidence ranged from moderate to low.Conclusion ERA can improve exercise capacity,but cannot reduce the incidence of mortality,and it may increase the risk of headache and anemia.

关 键 词：内皮素受体抑制剂 肺动脉高压 系统评价 

分 类 号：R969.4[医药卫生—药理学] R543.2[医药卫生—药学]