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Effect of Yugengtongyu Granules in Patients with Stable Coronary Artery Disease on Reducing Adverse Cardiovascular Events: A Double-Blind Controlled Trial.

育根通瘀颗粒在稳定性冠心病患者中降低不良心血管事件的作用: 一项双盲对照试验。

  • 影响因子:0
  • DOI:10.1089/acm.2020.0361
  • 作者列表:"Wang D","Li C","Xu X","Xu H","Guo C","Wang J","Guo J","Huang L
  • 发表时间:2021-02-01
Abstract

: Objectives: To evaluate the effect of Yugengtongyu granules on reducing the incidence of adverse cardiovascular events and improving quality of life (QOL) in patients with stable coronary artery disease (SCAD). Methods: A double-blind randomized controlled trial was conducted among SCAD population. One hundred fourteen patients were randomly assigned to experimental group (n = 57) and control group (n = 57) following randomized block design. Combined with the basis of standard treatment of SCAD, the experimental group and control group received Yugengtongyu granules or placebo, respectively, twice daily for 6 months and were followed for another 1 year (18 months in total from enrollment). Major outcomes (any occurrence of cardiovascular death, nonfatal myocardial infarction, or coronary revascularization), minor outcomes (any occurrence of all-cause death, ischemic stroke, readmission due to unstable angina, heart failure, or malignant arrhythmia), and composite outcomes (union of major and minor outcomes) were used to evaluate prognosis; Seattle Angina Questionnaire (SAQ) was applied to evaluate QOL, and levels of low density lipoprotein-cholesterol (LDL-C) and high sensitive C reacting protein (HS-CRP) in serum were tested. Results: The incidence of composite outcomes in the experimental group was significantly lower than that in the control group (3 [5.2%] vs. 11 [19.2%], hazard ratio: 0.273, 95% confidence interval: 0.080-0.926, p = 0.022); major outcomes, minor outcomes, and independent events such as nonfatal myocardial infarction showed lowering trend in experimental group. Experimental group scored significantly higher than control group in four dimensions of SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception at the third- and sixth-month follow-up; there was no significant difference in serum level of LDL or HS-CRP at all scheduled timepoints. Conclusion: The addition of Yugengtongyu granules based on current standard treatment reduced the incidence of composite outcomes and improved QOL in patients with SCAD. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13004370).

摘要

: 目标: 评价育更通瘀颗粒降低稳定性冠心病 (SCAD) 患者不良心血管事件发生率及改善生活质量 (QOL) 的作用。 方法: 在SCAD人群中进行双盲随机对照试验。采用随机区组设计,将114例患者随机分为实验组 (n = 57) 和对照组 (n = 57)。结合SCAD标准治疗的基础上,实验组和对照组分别给予愈更通郁颗粒或安慰剂,每日2次,共6个月,随访1年 (自入组起共18个月)。主要结局 (任何心血管死亡、非致死性心肌梗死或冠状动脉血运重建的发生) 、次要结局 (任何全因死亡、缺血性卒中、因不稳定型心绞痛、心力衰竭或恶性心律失常再入院的发生) 和复合结局 (主要和次要结局的合并) 用于评估预后;采用西雅图心绞痛问卷 (SAQ) 评定QOL,检测血清低密度脂蛋白胆固醇 (ldl-c) 和高敏C反应蛋白 (HS-CRP) 水平。 结果: 实验组复合结局的发生率显著低于对照组 (3 [5.2%] 对11 [19.2%],风险比: 0.273,95% 置信区间: 0.080-0.926,p   =   0.022); 主要结局,次要结局,非致死性心肌梗死等独立事件在实验组呈下降趋势。在第3个月和第6个月随访时,实验组在SAQ的4个维度: 身体受限、心绞痛频率、治疗满意度和疾病感知评分显著高于对照组; 在所有预定时间点,血清LDL和HS-CRP水平无显著差异。 结论: 在目前标准治疗的基础上加用愈庚通瘀颗粒降低了SCAD患者复合结局的发生率,改善了QOL。该试验在中国临床试验注册中心 (ChiCTR-TRC-13004370) 注册。

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