原发性醛固酮增多症患者使用螺内酯或依普利酮有效性与安全性的meta分析  

Meta-analysis of the efficacy and safety of spironolactone or eplerenone in patients with primary aldosteronism

作　　者：万瑾瑾 李娟[1,2] 曾辉[3] 刘美 曾梅青 谢亚楠 敖检根 张卫芳[1] WAN Jinjin;LI Juan;ZENG Hui;LIU Mei;ZENG Meiqing;XIE Yanan;AO Jiangen;ZHANG Weifang(Department of Pharmacy,The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi 330006,China;Nanchang University Jiangxi Medical College,Nanchang,Jiangxi 330031,China;Department of Pharmacy,The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi 330006,China)

机构地区：[1]南昌大学第二附属医院药学部,南昌330006 [2]南昌大学江西医学院,南昌330031 [3]南昌大学第一附属医院药学部,南昌330006

出　　处：《重庆医学》2023年第4期552-557,共6页Chongqing medicine

基　　金：国家自然科学基金项目(82000062,81960015)。

摘　　要：目的比较两种醛固酮受体拮抗剂(ARA)螺内酯和依普利酮治疗原发性醛固酮增多症(PA)患者的临床效果和安全性。方法利用计算机在PubMed、Cochrane图书馆、Elsevier、中国知网、万方数据库中检索,时间为建库至2021年12月,内容为比较螺内酯及依普利酮治疗PA的临床研究。选取治疗前后收缩压、舒张压、血钾水平变化,以及治疗过程中不良事件发生率作为评价指标。获取数据资料后用R语言和STATA软件进行meta分析。结果通过筛选,最终纳入6项随机对照临床试验(RCTs),共计573例患者(433例螺内酯治疗,140例依普利酮治疗)。结果显示,在降压方面,螺内酯和依普利酮降低收缩压效果无差异[MD=4.5676,95%置信区间(95%CI)=-12.4467~21.5820,P=0.60],但螺内酯降低舒张压效果强于依普利酮(MD=4.4734,95%CI=0.6794~8.2674,P=0.02)。升高血钾方面,螺内酯相较于依普利酮,血钾升高效果更加显著(MD=-0.2440,95%CI=-0.4228~-0.0651,P=0.0075)。安全性方面,螺内酯和依普利酮的总不良反应发生率差异有统计学意义(RR=0.6382,95%CI=0.4929~0.8262,P=0.0007),但高钾血症发生率类似(RR=0.5307,95%CI=0.0553~5.0899,P=0.5829)。采用螺内酯治疗过程中,男性乳房女性化不良反应发生率显著高于依普利酮(RR=0.2191,95%CI=0.0793~0.6056,P=0.0034),螺内酯≤50 mg/d时的不良反应发生率显著低于>50 mg/d(RR=0.3413,95%CI=0.1872~0.6222,P=0.0005)。结论在PA药物治疗中,螺内酯降舒张压效果优于依普利酮,但出现男性乳房女性化不良反应高于依普利酮,不良反应发生率与剂量相关。Objective To compare the clinical efficacy and safety of two aldosterone receptor antagonists(ARA),spironolactone and eplerenone,in the treatment of patients with primary aldosteronism(PA).Methods The computer was used to search PubMed,Cochrane Library,Elsevier,China National Knowledge Internet(CNKI),and Wanfang electronic databases.The time was from the establishment of the database to December 2021.The content was the clinical study comparing spironolactone and eplerenone in the treatment of PA.The changes in systolic blood pressure,diastolic blood pressure,blood potassium level before and after treatment,and the incidence of adverse events during treatment were selected as the evaluation indicators.Meta-analysis was performed with R language and STATA software after data acquisition.Results After screening,six randomized controlled clinical trials(RCTs)were finally included,with a total of 573 patients(433 treated with spironolactone and 140 treated with eplerenone).The results showed that in terms of blood pressure reduction,there was no difference in the effect of spironolactone and eplerenone in reducing systolic blood pressure(MD=4.5676,95%CI=-12.4467-21.5820,P=0.60),but the effect of spironolactone in reducing diastolic blood pressure was stronger than that of eplerenone(MD=4.4734,95%CI=0.6794-8.2674,P=0.02).In terms of raising blood potassium,spironolactone had a more significant effect on raising blood potassium than that of eplerenone(MD=-0.2440,95%CI=-0.4228--0.0651,P=0.0075).In terms of safety,there was a statistically significant difference in the incidence of total adverse reactions between spironolactone and eplerenone(RR=0.6382,95%CI=0.4929-0.8262,P=0.0007),but the incidence of hyperkalemia was similar(RR=0.5307,95%CI=0.0553-5.0899,P=0.5829).During spironolactone treatment,the incidence of adverse reactions of gynecomastia feminization was significantly higher than that of the eplerenone(RR=0.2191,95%CI=0.0793-0.6056,P=0.0034),and the incidence of adverse reactions of the spironolactone≤50 mg/d

关 键 词：原发性醛固酮增多症 螺内酯 依普利酮 醛固酮受体拮抗剂 

分 类 号：R969.3[医药卫生—药理学]