Wang Xi, Hu Dan, Dang Song, Huang He, Huang Cong-Xin, Yuan Ming-Jie, Tang Yan-Hong, Zheng Qing-Shan, Yin Fang, Zhang Shu, Zhang Bo-Li, Gao Run-Lin
Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China; Department of Experimental Cardiology, Masonic Medical Research Laboratory, Utica, NY 13501, USA.
Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.
Pharmacological therapy for congestive heart failure (CHF) with ventricular arrhythmia is limited. In the study, our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules (SSYX) on heart rhythm and function in CHF patients with frequent ventricular premature complexes (VPCs).
This double-blind, placebo-controlled, multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX (n = 232) and placebo groups (n = 233) for 12 weeks of treatment. The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram. The secondary endpoints included the left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter, N-terminal pro-brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) classification, 6-min walking distance (6MWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores, and composite cardiac events (CCEs).
The clinical characteristics were similar at baseline. SSYX caused a significantly greater decline in the total number of VPCs than the placebo did (-2145 ± 2848 vs. -841 ± 3411, P < 0.05). The secondary endpoints of the LVEF, NYHA classification, NT-proBNP, 6MWD, and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group (ΔLVEF at 12th week: 4.75 ± 7.13 vs. 3.30 ± 6.53; NYHA improvement rate at the 8th and 12th week: 32.6% vs. 21.8%, 40.5% vs. 25.7%; mean level of NT-proBNP in patients with NT-proBNP ≥125 pg/ml at 12th week: -122 [Q1, Q3: -524, 0] vs. -75 [Q1, Q3: -245, 0]; Δ6MWD at 12th week: 35.1 ± 38.6 vs. 17.2 ± 45.6; ΔMLHFQ at the 4th, 8th, and 12th week: -4.24 ± 6.15 vs. -2.31 ± 6.96, -8.19 ± 8.41 vs. -3.25 ± 9.40, -10.60 ± 9.41 vs. -4.83 ± 11.23, all P < 0.05). CCEs were not different between the groups during the study period.
In this 12-week pilot study, SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a background of standard treatment for CHF.
www.chictr.org.cn, ChiCTR-TRC-12002061 (http://www.chictr.org.cn/showproj.aspx?proj=7487) and Clinicaltrials.gov, NCT01612260 (https://clinicaltrials.gov/ct2/show/NCT01612260).
用于伴有室性心律失常的充血性心力衰竭（CHF）的药物治疗有限。在本研究中，我们的目的是评估中药参松养心胶囊（SSYX）对伴有频发室性早搏（VPC）的CHF患者心律和心功能的影响。
这项双盲、安慰剂对照、多中心研究将465例伴有频发VPC的CHF患者随机分为SSYX组（n = 232）和安慰剂组（n = 233），进行为期12周的治疗。主要终点是通过24小时动态心电图监测的VPC。次要终点包括左心室射血分数（LVEF）、左心室舒张末期直径、N末端脑钠肽前体（NT-proBNP）、纽约心脏协会（NYHA）分级、6分钟步行距离（6MWD）、明尼苏达心力衰竭生活问卷（MLHFQ）评分以及复合心脏事件（CCE）。
基线时临床特征相似。SSYX导致VPC总数下降幅度显著大于安慰剂组（-2145±2848对-841±3411，P<0.05）。LVEF、NYHA分级、NT-proBNP、6MWD和MLHFQ评分等次要终点在SSYX组中的改善程度大于安慰剂组（第12周时LVEF的变化：4.75±7.13对3.30±6.53；第8周和第12周时NYHA改善率：32.6%对21.8%，40.5%对25.7%；NT-proBNP≥125 pg/ml的患者在第12周时NT-proBNP的平均水平：-122[四分位数间距：-524, 0]对-75[四分位数间距：-245, 0]；第12周时6MWD的变化：35.1±38.6对17.2±45.6；第4周、第8周和第12周时MLHFQ的变化：-4.24±6.15对-2.31±6.96，-8.19±8.41对-3.25±9.40，-10.60±9.41对-4.83±11.23，均P<0.05）。研究期间两组间CCE无差异。
在这项为期12周的初步研究中，在CHF标准治疗的背景下，SSYX被证明具有抑制VPC和改善心功能的益处，且依从性良好。
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