Qili Qiangxin capsule as adjunctive therapy for heart failure after acute myocardial infarction: a GRADE-assessed systematic review and meta-analysis of randomised controlled trials.
完整摘要 · 中文译文
背景:尽管传统治疗取得了进展,急性心肌梗死(AMI)后心力衰竭(HF)仍是发病和死亡的主要原因。芪苈强心胶囊(QLQX)在中国已广泛用于HF的辅助治疗,但其在AMI后HF患者中的疗效和安全性仍需进一步评估。 方法:检索了7个数据库,检索时间从建库至2026年1月。纳入比较QLQX联合常规西医(WM)与单用WM的随机对照试验(RCT)。主要结局为N末端B型利钠肽原(NT-proBNP)。次要结局包括左心室射血分数(LVEF)、B型利钠肽(BNP)、左心室舒张末期内径(LVEDD)、左心室收缩末期内径(LVESD)、左心室舒张末期容积(LVEDV)、临床有效率、高敏C反应蛋白(hs-CRP)、生活质量、全因死亡率、心力衰竭相关住院和不良事件。使用RevMan 5.4进行Meta分析。 结果:共纳入16项RCT,涉及1391名参与者。与单用WM相比,QLQX联合WM与NT-proBNP、BNP、LVEDD、LVESD和hs-CRP的更大幅度降低以及LVEF、生活质量和临床有效率的改善相关。在LVEDV、全因死亡率和不良事件方面未观察到统计学差异。任何纳入研究均未报告心力衰竭相关住院。根据G RADE 方法。 结论:QLQX 联合常规西药(WM)与急性心肌梗死(AMI)后心力衰竭(HF)患者若干替代终点和短期临床结局的改善相关。然而,证据确定性为低或极低,且关于死亡率和心力衰竭相关住院的数据不足。因此,当前证据不足以确定 QLQX 是否能改善长期临床预后。需要进一步开展随访时间更长、以临床重要终点为目标的高质量随机对照试验(RCT)。 系统评价注册:https://www.crd.york.ac.uk/PROSPERO/view/CRD420261277047,注册号 CRD420261277047。
完整摘要 · 英文原文
BACKGROUND: Heart failure (HF) after acute myocardial infarction (AMI) remains a major cause of morbidity and mortality despite advances in conventional therapy. Qili Qiangxin Capsule (QLQX) has been widely used as an adjunctive treatment for HF in China, but its efficacy and safety in patients with HF after AMI require further evaluation. METHODS: Seven databases were searched from their inception to January 2026. Randomised controlled trials (RCTs) comparing QLQX plus conventional Western medicine (WM) with WM alone were included. The primary outcome was N-terminal pro-B-type natriuretic peptide (NT-proBNP). Secondary outcomes included left ventricular ejection fraction (LVEF), B-type natriuretic peptide (BNP), left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic volume (LVEDV), clinical response rate, high-sensitivity C-reactive protein (hs-CRP), quality of life, all-cause mortality, heart failure-related hospitalisation, and adverse events. Meta-analysis was performed using RevMan 5.4. RESULTS: A total of 16 RCTs involving 1391 participants were included. Compared with WM alone, QLQX plus WM was associated with greater reductions in NT-proBNP, BNP, LVEDD, LVESD, and hs-CRP, and improving LVEF, quality of life and the clinical response rate. No statistical differences were observed in LVEDV, all-cause mortality, and adverse events. Heart failure-related hospitalisation was not reported in any included study. The certainty of evidence for all outcomes was rated as low or very low according to the GRADE approach. CONCLUSION: QLQX plus conventional WM was associated with improvements in several surrogate and short-term clinical outcomes in patients with HF after AMI. However, the certainty of evidence was low or very low, and data on mortality and heart failure-related hospitalisation were insufficient. The current evidence is therefore inadequate to determine whether QLQX improves long-term clinical prognosis. Further high-quality RCTs with longer follow-up and clinically important endpoints are needed. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261277047, identifier CRD420261277047.
摘要 待译
BACKGROUND: Heart failure (HF) after acute myocardial infarction (AMI) remains a major cause of morbidity and mortality despite advances in conventional therapy. Qili Qiangxin Capsule (QLQX) has been widely used as an adjunctive treatment for HF in China, but its efficacy and safety in patients with HF after AMI require further evaluation. METHODS: Seven databases were searched from their inception to January 2026. Randomised controlled trials (RCTs) comparing QLQX plus conventional Western medicine (WM) with WM alone were included.…