依普利酮治療原發性高血壓療效和安全性的系統評價/Meta分析再評價

張平 高存州 鄒婧 吳愛萍

中圖分類號 R543;R972 文獻標志碼 A 文章編號 1001-0408（2021）20-2530-08

DOI 10.6039/j.issn.1001-0408.2021.20.16

摘 要 目的：對依普利酮治療原發性高血壓療效和安全性的系統評價/Meta分析進行再評價。方法：計算機檢索PubMed、Embase、Cochrane圖書館、Web of Science、萬方數據、中國知網、維普網等，收集依普利酮治療原發性高血壓的系統評價/Meta分析，檢索時限均為建庫起至2021年6月24日。篩選文獻并進行資料提取后，采用PRISMA聲明評價納入文獻的報告質量，采用AMSTAR 2量表評價納入文獻的方法學質量，采用GRADE方法評價納入文獻結局指標的證據質量，并對納入文獻的療效和安全性指標評價進行匯總。結果：共納入8篇系統評價/Meta分析，其中5篇為系統評價、3篇為Meta分析，共包含73個結局指標。PRISMA評分為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評價結果顯示，2項研究的方法學質量等級為低級，6項研究為極低級。GRADE證據質量評價結果顯示，高質量指標有3個，中質量指標有24個，低或極低質量指標有46個;導致降級的因素主要為局限性、不一致性、不精確性及發表偏倚。在治療有效性方面，與安慰劑比較，依普利酮可顯著降低患者的診室血壓和24 h動態血壓;其在降低診室血壓方面的效果顯著優于其他降壓藥物或與其他降壓藥物相當。依普利酮降低診室收縮壓的效果不及螺內酯和依那普利，或優于鈣通道阻滯劑、依那普利和血管緊張素受體拮抗劑，或與鈣通道阻滯劑和依那普利相當;依普利酮降低診室舒張壓的效果不及螺內酯、鈣通道阻滯劑和依那普利，或與依那普利相當，而優于血管緊張素受體拮抗劑。在安全性方面，依普利酮的不良反應、嚴重不良反應和高鉀血癥發生率與安慰劑比較差異均無統計學意義，或其不良反應發生率顯著高于安慰劑;該藥的不良反應、嚴重不良反應發生率與其他降壓藥物比較差異均無統計學意義。結論：依普利酮治療原發性高血壓的療效和安全性均較好，但目前相關系統評價/Meta分析的方法學質量整體較低，且證據水平普遍為中、低或極低，可能會降低該結論的真實性與有效性，應謹慎解讀。

關鍵詞 依普利酮;原發性高血壓;療效;安全性;系統評價;Meta分析;再評價

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 on reducing clinical diastolic blood pressure was not as good as spironolactone， calcium channel blocker and enalapril， or as good as enalapril， but better than angiotensin receptor antagonist. In terms of safety， there was no significant difference in the incidence of ADR， serious ADR or hyperkalemia caused by eplerenone， compared with placebo， or the incidence of ADR was higher than that of placebo. There was no statistical significance in the incidence of ADR or serious ADR， compared with other antihypertensive drugs. CONCLUSIONS： Efficacy and safety of eplerenone in the treatment of essential hypertension was good，but in view of the poor methodological quality of systematic reviews or Meta-analysis and the low or very low level of outcome indicator evidence， the authenticity and effectiveness of the conclusion will be reduced， so that those indcaters should be interpreted carefully.