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首页> 外文期刊>Journal of Traditional Chinese Medical Sciences >Chinese herbal medicine for chronic heart failure: a multicenter, randomized, double-blind, placebo-controlled trial
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Chinese herbal medicine for chronic heart failure: a multicenter, randomized, double-blind, placebo-controlled trial

机译:慢性心力衰竭的中草药:一项多中心,随机,双盲,安慰剂对照试验

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Objective The purpose of this study was to assess the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of chronic heart failure (CHF) patients according to syndrome differentiation. Methods In this multicenter, randomized, double-blind, placebo-controlled clinical trial, a total of 220 CHF patients were assigned to receive CHM or placebo granules without decoction according to syndrome differentiation in addition to their standard western treatment for 4 weeks. The change in the left ventricular ejection fraction (LVEF) was the primary outcome, and the changes in the TCM syndrome scores (TCM-SS) and New York Heart Association functional classification (NYHA-FC) were the secondary outcomes. Results After 4 weeks of treatment, the mean changes in the LVEF (13.1?±?9.78 vs. 7.34?±?7.40, P ?
机译:目的本研究旨在根据中医辨证论治,评估中草药(CHM)在治疗慢性心力衰竭(CHF)患者中的疗效和安全性。方法在这项多中心,随机,双盲,安慰剂对照的临床试验中,除标准的西药治疗外,根据证候的不同,共有220名CHF患者根据症状的不同被分配接受CHM或安慰剂颗粒的治疗。主要结果是左室射血分数(LVEF)的变化,次要结果是TCM综合征评分(TCM-SS)和纽约心脏协会功能分类(NYHA-FC)的变化。结果治疗4周后,LVEF的平均变化(13.1?±?9.78 vs. 7.34?±?7.40,P?<?0.001)和中医证候评分(?34.2?±?24.6 vs.?23.5?)。与安慰剂组相比,CHM组的±±25.2,P≥0.002)更好。经过两周的治疗,LVEF的平均变化(9.26±±7.83对4.72±±5.60,P 0.001)和中医综合症评分(±23.5±±18.6对±14.0±±)。 CHM组比安慰剂组好(<15.9,P 0.001)。此外,重复测量方差分析(ANOVA)表明CHM与安慰剂在LVEF和TCM证候核心中具有显着的时程效应(所有P均<0.001)。 CHM组的颈静脉扩张(P = 0.021),排痰(P = 0.044),腹胀(P = 0.004)和肋骨疼痛(P = 0.005)明显减少。治疗两周后,与安慰剂组相比。疲劳(P = 0.001),少气和懒惰词(P = 0.001),头晕(P = 0.003),喘气(P = 0.027),腹胀(P = 0.011)治疗4周后,CHM组的恶心(P = 0.001)和呕吐(P = 0.012)显着低于安慰剂组。治疗四周后,CHM组的NYHA功能分类改变优于安慰剂组(P≤0.001)。安慰剂组有1例死亡,CHM组有1例患者发生房颤。结论根据辨证论治的CHM治疗可有效改善CHF患者的LVEF,TCM-SS和NYHA-FC,并且似乎是安全的。因此,CHM治疗可以用作CHF治疗的辅助治疗(临床试验注册:NCT01939236)。

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