METHODS: Eight electronic databases, including PubMed, EMBASE, Clinicaltrials.gov, Cochrane Library, Wanfang, CNKI, CQVIP, and CBM were searched for literature from inception to June 2023. All randomized controlled trials (RCTs) using pueraria in the treatment of HFrEF were included. The Cochrane Risk of Bias tool was utilized for RCTs\' methodological evaluation, while Review Manager 5.4.1 was used to analyze the data.
RESULTS: Nineteen RCTs with a total of 1,911 patients (1,077 males and 834 females) were identified. Meta-analysis indicated that combination medication of pueraria and conventional medicine (CM) was superior to the CM alone in raising left ventricular ejection fraction (LVEF; MD = 6.46, 95% CI, 4.88 to 8.04, P < 0.00001), and decreasing left ventricular end-diastolic diameter (LVEDD; MD = -4.78, 95% CI, -6.55 to -3.01, P < 0.00001), left ventricular end-Systolic diameter (LVESD; MD = -3.98, 95% CI, -5.98 to -1.99, P < 0.00001) and N-terminal pro-brain natriuretic peptide (NT-proBNP; MD = -126.16, 95% CI, -185.30 to -67.03, P < 0.0001). Besides, combination medication improved clinical efficacy rate (RR = 3.42, 95% CI, 2.54 to 4.59, P < 0.00001), 6-min walk test (6-MWT; MD = 65.54, 95% CI, 41.77 to 89.31, P < 0.00001), and TCM syndrome score efficacy (RR = 3.03, 95% CI, 1.57 to 5.83, P = 0.0009). Regarding safety, no difference was observed for adverse events (RR = 0.59, 95% CI, 0.22 to 1.54, P = 0.28).
CONCLUSIONS: The use of pueraria combined with conventional medicine in HFrEF patients has superiority over conventional medicine alone in ameliorating cardiac function and reversing left ventricular remodeling. Moreover, combination medication has no increase in adverse drug events. Given some limitations, more prudence and high-quality clinical trials are needed in the future to verify the conclusions.
方法:八个电子数据库,包括PubMed,EMBASE,Clinicaltrials.gov,科克伦图书馆,万方,CNKI,CQVIP,从开始到2023年6月,对CBM进行了文献搜索。包括所有使用葛根治疗HFrEF的随机对照试验(RCT)。Cochrane偏差风险工具用于RCT方法学评估,而ReviewManager5.4.1用于分析数据。
结果:确定了19个RCT,共有1,911名患者(男性1,077名,女性834名)。Meta分析表明,葛根与常规药物(CM)联合用药在提高左心室射血分数方面优于单纯CM(LVEF;MD=6.46,95%CI,4.88至8.04,P<0.00001)。左心室舒张末期内径减小(LVEDD;MD=-4.78,95%CI,-6.55至-3.01,P<0.00001),左心室收缩末期直径(LVESD;MD=-3.98,95%CI,-5.98至-1.99,P<0.00001)和N末端脑钠肽前体(NT-proBNP;MD=-126.16,95%CI,-185.30至-67.03,P<0.0001)。此外,联合用药提高临床有效率(RR=3.42,95%CI,2.54~4.59,P<0.00001),6分钟步行试验(6-MWT;MD=65.54,95%CI,41.77~89.31,P<0.00001),中医证候积分疗效(RR=3.03,95%CI,1.57~5.83,P=0.0009)。关于安全,不良事件无差异(RR=0.59,95%CI,0.22~1.54,P=0.28).
结论:在HFrEF患者中使用葛根联合常规药物在改善心功能和逆转左心室重构方面优于单纯常规药物。此外,联合用药没有增加药物不良事件.鉴于某些限制,未来需要更多的审慎和高质量的临床试验来验证结论。