mate分析：芪参益气滴丸治疗射血分数保留心力衰竭患者安全有效

心力衰竭（HF）是心脏结构或功能异常的临床综合征，是许多心血管疾病的终末期。欧洲心脏学会(ESC)将HF分为射血分数保留HF(HFpEF，LVEF[左心室射血分数]>50%)、射血分数轻度降低HF(HFmrEF，LVEF 40–49%)和射血分数降低HF(HFrEF，LVEF<40%)¹。HFpEF患者生活质量差，再住院率和死亡率高，给社会带来了巨大的负担^2,3。

虽然ACEI/ARB^4,5、β-肾上腺素能受体阻断剂⁶、醛固酮受体拮抗剂⁷、ARNI⁸和SGLT-2⁹等药物已被证明可提高HFrEF患者的生活质量，降低住院率和死亡率，但上述药物未能改善HFpEF患者的预后^10-14。

芪参益气滴丸(QSYQ)是经国家医药产品管理局批准的具有益气活血作用的中成药。大量临床研究已证实了QSYQ治疗HF¹⁵的有效性。本研究将采用系统综述和meta分析的方法对QSYQ治疗HFpEF的疗效和安全性进行评价，以期为中医药治疗HF提供更多证据。

研究方法

数据库检索：中国国家知识基础设施(CNKI)、中国科技期刊数据库(VIP)、万方数据库、中国生物医学文献数据库(CBM)、PubMed、Embase、Web of Science和The Cochrane Library。

研究纳入标准：1)随机对照试验(RCTs)；2)患者诊断为HFpEF；3)对照组给予利尿剂、醛固酮受体等常规治疗拮抗剂、β-阻断剂、ACEI、ARB、伊伐布雷定以及改善心肌代谢；4)干预组采用常规治疗联合QSYQ治疗。

研究排除标准：1数据不完整；2)病例报告、综述、会议文献、理论讨论和经验总结；3)患者基线特征不一致。

主要终点：舒张早期二尖瓣血流速度与舒张晚期二尖瓣血流速度比值(E/A)和舒张早期二尖瓣血流速度与二尖瓣环运动速度比值(E/e′)；次要终点：脑钠肽(BNP)，心功能改善率和6分钟步行距离(6-MWD)。

结果

最终纳入8项研究^16-23，共895例患者(干预组452例，对照组443例)。对照组接受常规治疗，包括利尿剂、醛固酮受体拮抗剂、β-受体阻滞剂、ACEI和ARB。干预组在常规治疗的基础上加用芪参益气滴丸(口服，一次0.5 g，一日3次)。治疗时间为56-180天。（表1）

主要终点

E/A

8项研究^16-23报告E/A：与单用西药相比，西药联合QSYQ可显著增加E/A(MD=0.20，95%CI[0.14，0.26]，P<0.00001)(图1)。

E/e′

3项研究^17,20,23报告E/e′：与单用西药相比，西药与QSYQ联用可显著降低E/e′(MD=-2.50，95%CI[-3.18，-1.82]，P<0.00001)(图2)。

次要终点

BNP

5项研究^16-20报告BNP：与单用西药相比，西药联合QSYQ可显著降低BNP(MD=-151.83，95% CI[-245.78，-57.89]，P=0.002)(图3)。

心功能改善率

5项研究^16-20报告心功能改善率：与单用西药治疗相比，西药联合QSYQ治疗可显著提高心功能改善率(RR 1.30，95%CI[1.11，1.52]，P=0.001)(图4)。

6-MWD

4项研究^16,17,20,22报告6-MWD：与单用西药相比，西药联合QSYQ可显著增加6-MWD(MD=64.75，95%CI[22.65，106.85]，P=0.003) (图5)。

安全性

4项研究^16,18,19,22报告不良事件。其中3项^16,18,19在随访期间未发现不良事件发生，1项研究²²中干预组有3例患者出现轻度恶心，并自发缓解。

亚组分析

根据治疗持续时间(超过4个月或小于4个月)和平均年龄(超过65岁或小于65岁)对E/A、BNP、心功能改善率和6-MWD进行亚组分析。

大多数亚组与总体研究结果一致。在平均年龄＞65岁患者中，西药联合QSYQ与单用西药后BNP下降无显著差异；但是BNP仍有下降趋势。此外，根据治疗持续时间进行亚组分析时，E/A、BNP和6MWD的异质性显著降低，治疗持续时间可能是E/A、BNP和6-MWD异质性的来源之一。根据平均年龄进行亚组分析时，心功能改善率的异质性显著降低，平均年龄可能是心功能改善率异质性的来源之一。（表2，表3）

结论

通过对895例患者的系统评价发现，与单纯西药治疗相比，QSYQ联合西药治疗可显著降低E/e′和BNP，增加E/A，提高心功能改善率和6MWD。只有3例患者出现轻度恶心，没有发现严重的不良事件，安全性良好。

目前的证据表明，QSYQ治疗HFpEF安全且有效。

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