Page 108 - 《中国药房》2021年20期

·循证药学·

依普利酮治疗原发性高血压疗效和安全性的系统评价/Meta分析

再评价 Δ

张 平 ，高存州，邹 婧，吴爱萍（贵州健康职业学院基础医学部，贵州 铜仁 554300）
＊

中图分类号 R543；R972 文献标志码 A 文章编号 1001-0408（2021）20-2530-08
DOI 10.6039/j.issn.1001-0408.2021.20.16

摘 要 目的：对依普利酮治疗原发性高血压疗效和安全性的系统评价/Meta 分析进行再评价。方法：计算机检索 PubMed、
Embase、Cochrane 图书馆、Web of Science、万方数据、中国知网、维普网等，收集依普利酮治疗原发性高血压的系统评价/Meta 分
析，检索时限均为建库起至 2021 年 6 月 24 日。筛选文献并进行资料提取后，采用 PRISMA 声明评价纳入文献的报告质量，采用
AMSTAR 2量表评价纳入文献的方法学质量，采用GRADE方法评价纳入文献结局指标的证据质量，并对纳入文献的疗效和安全
性指标评价进行汇总。结果：共纳入 8 篇系统评价/Meta 分析，其中 5 篇为系统评价、3 篇为 Meta 分析，共包含 73 个结局指标。
PRISMA评分为7.5～23.5分，其中≤15分的有6篇（75.0％），＞15～＜21分的有1篇（12.5％），≥21分的有1篇（12.5％）。AMSTAR 2
评价结果显示，2项研究的方法学质量等级为低级，6项研究为极低级。GRADE证据质量评价结果显示，高质量指标有3个，中质
量指标有24个，低或极低质量指标有46个；导致降级的因素主要为局限性、不一致性、不精确性及发表偏倚。在治疗有效性方面，
与安慰剂比较，依普利酮可显著降低患者的诊室血压和24 h动态血压；其在降低诊室血压方面的效果显著优于其他降压药物或与
其他降压药物相当。依普利酮降低诊室收缩压的效果不及螺内酯和依那普利，或优于钙通道阻滞剂、依那普利和血管紧张素受体
拮抗剂，或与钙通道阻滞剂和依那普利相当；依普利酮降低诊室舒张压的效果不及螺内酯、钙通道阻滞剂和依那普利，或与依那普
利相当，而优于血管紧张素受体拮抗剂。在安全性方面，依普利酮的不良反应、严重不良反应和高钾血症发生率与安慰剂比较差
异均无统计学意义，或其不良反应发生率显著高于安慰剂；该药的不良反应、严重不良反应发生率与其他降压药物比较差异均无
统计学意义。结论：依普利酮治疗原发性高血压的疗效和安全性均较好，但目前相关系统评价/Meta分析的方法学质量整体较低，
且证据水平普遍为中、低或极低，可能会降低该结论的真实性与有效性，应谨慎解读。
关键词 依普利酮；原发性高血压；疗效；安全性；系统评价；Meta分析；再评价

Efficacy and Safety of Eplerenone in the Treatment of Essential Hypertension：Reevaluation of Systematic
Review/Meta-analysis
ZHANG Ping，GAO Cunzhou，ZOU Jing，WU Aiping（Dept. of Basic Medicine，Guizhou College of Health
Professions，Guizhou Tongren 554300，China）

ABSTRACT OBJECTIVE：To reevaluate the systematic review/Meta-analysis of efficacy and safety of eplerenone in the
treatment of essential hypertension. METHODS：Retrieved from PubMed，Embase，Cochrane Library，Web of Science，Wanfang
database，CNKI，VIP，systematic review/Meta-analysis about eplerenone in the treatment of essential hypertension were collected
from the inception to June 24th，2021. After literature screening and data extraction，the quality of included literatures were
evaluated with PRISMA statement；methodology quality of included literatures were evaluated with AMSTAR 2 scale；GRADE
method was adopted to evaluate the evidence quality of outcome measures. Efficacy and safety index evaluation of included
literatures were summeried. RESULTS：A total of 8 systematic reviews/Meta-analyses were included，involving 5 systematic
reviews and 3 Meta-analysis，including 73 outcome indicators. PRISMA scores ranged from 7.5 to 23.5，including 6 literatures
（75.0％） with≤15 points，1 （12.5％） with ＞15-＜21 points and 1 （12.5％） with ≥21 points. The results of AMSTAR 2
evaluation indicated that the methodological quality of 2 studies was low，and that of 6 studies was very low. GRADE quality
evaluation results showed that there were 3 high quality indicators，24 medium quality indicators and 46 low or very low quality
indicators；the factors contributed to downgrading evidence quality were limitation，inconsistency，imprecision and publication
bias. In terms of efficacy，compared with placebo，eplerenone could significantly reduce clinical blood pressure（CBP）and 24-hour
ambulatory blood pressure （ABP）. Its effect in reducing CBP was significantly better than other antihypertensive drugs or
equivalent to other antihypertensive drugs. The effects of eplerenone on reducing clinical systolic blood pressure was not as good as
spironolactone and enalapril，or better than calcium channel blocker，enalapril and angiotensin receptor antagonist，or equivalent to
calcium channel blocker and enalapril；the effect of eplerenone
Δ 基金项目：铜仁市科技计划项目（No.铜市科研〔2020〕90号）
＊讲师，硕士。研究方向：心血管疾病。E-mail：545077638@qq. on reducing clinical diastolic blood pressure was not as good
com as spironolactone，calcium channel blocker and enalapril，or

·2530 · China Pharmacy 2021 Vol. 32 No. 20 中国药房 2021年第32卷第20期