張平 高存州 鄒婧 吳愛(ài)萍

中圖分類(lèi)號(hào) R543;R972 文獻(xiàn)標(biāo)志碼 A 文章編號(hào) 1001-0408（2021）20-2530-08

DOI 10.6039/j.issn.1001-0408.2021.20.16

摘 要 目的：對(duì)依普利酮治療原發(fā)性高血壓療效和安全性的系統(tǒng)評(píng)價(jià)/Meta分析進(jìn)行再評(píng)價(jià)。方法：計(jì)算機(jī)檢索PubMed、Embase、Cochrane圖書(shū)館、Web of Science、萬(wàn)方數(shù)據(jù)、中國(guó)知網(wǎng)、維普網(wǎng)等，收集依普利酮治療原發(fā)性高血壓的系統(tǒng)評(píng)價(jià)/Meta分析，檢索時(shí)限均為建庫(kù)起至2021年6月24日。篩選文獻(xiàn)并進(jìn)行資料提取后，采用PRISMA聲明評(píng)價(jià)納入文獻(xiàn)的報(bào)告質(zhì)量，采用AMSTAR 2量表評(píng)價(jià)納入文獻(xiàn)的方法學(xué)質(zhì)量，采用GRADE方法評(píng)價(jià)納入文獻(xiàn)結(jié)局指標(biāo)的證據(jù)質(zhì)量，并對(duì)納入文獻(xiàn)的療效和安全性指標(biāo)評(píng)價(jià)進(jìn)行匯總。結(jié)果：共納入8篇系統(tǒng)評(píng)價(jià)/Meta分析，其中5篇為系統(tǒng)評(píng)價(jià)、3篇為Meta分析，共包含73個(gè)結(jié)局指標(biāo)。PRISMA評(píng)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(píng)價(jià)結(jié)果顯示，2項(xiàng)研究的方法學(xué)質(zhì)量等級(jí)為低級(jí)，6項(xiàng)研究為極低級(jí)。GRADE證據(jù)質(zhì)量評(píng)價(jià)結(jié)果顯示，高質(zhì)量指標(biāo)有3個(gè)，中質(zhì)量指標(biāo)有24個(gè)，低或極低質(zhì)量指標(biāo)有46個(gè);導(dǎo)致降級(jí)的因素主要為局限性、不一致性、不精確性及發(fā)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(dòng)態(tài)血壓;其在降低診室血壓方面的效果顯著優(yōu)于其他降壓藥物或與其他降壓藥物相當(dāng)。依普利酮降低診室收縮壓的效果不及螺內(nèi)酯和依那普利，或優(yōu)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(dāng);依普利酮降低診室舒張壓的效果不及螺內(nèi)酯、鈣通道阻滯劑和依那普利，或與依那普利相當(dāng)，而優(yōu)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(yīng)、嚴(yán)重不良反應(yīng)和高鉀血癥發(fā)生率與安慰劑比較差異均無(wú)統(tǒng)計(jì)學(xué)意義，或其不良反應(yīng)發(fā)生率顯著高于安慰劑;該藥的不良反應(yīng)、嚴(yán)重不良反應(yīng)發(fā)生率與其他降壓藥物比較差異均無(wú)統(tǒng)計(jì)學(xué)意義。結(jié)論：依普利酮治療原發(fā)性高血壓的療效和安全性均較好，但目前相關(guān)系統(tǒng)評(píng)價(jià)/Meta分析的方法學(xué)質(zhì)量整體較低，且證據(jù)水平普遍為中、低或極低，可能會(huì)降低該結(jié)論的真實(shí)性與有效性，應(yīng)謹(jǐn)慎解讀。

關(guān)鍵詞 依普利酮;原發(fā)性高血壓;療效;安全性;系統(tǒng)評(píng)價(jià);Meta分析;再評(píng)價(jià)

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.