Xian Shao-xiang, Yang Zhong-qi, Ren Pei-hua, Ye Xiao-han, Ye Sui-lin, Wang Qing-hai, Wang Zhao-hui, Shen Shu-jing, Huang Xi-wen
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510407, China.
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510120, China.
Chin J Integr Med. 2015 Oct;21(10):733-42. doi: 10.1007/s11655-015-2170-x. Epub 2015 May 6.
To investigate the safety and efficacy of yangxinkang tablets in patients with chronic heart failure (CHF) and syndrome of qi and yin deficiency, blood stasis, and water retention.
In a double-blinded, randomized, placebo-controlled, multicenter clinical trail, 228 patients with CHF New York Heart Association (NYHA) class II or III in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus yangxinkang tablets for 4 weeks. The outcome measure were effect of cardiac function, Chinese medicine (CM) syndromes, scores of symptoms, signs, and quality of life measured by Minnesota Living with heart failure questionnaire (MLHFQ) before and after the treatment.
Totally 112 patients were analyzed in the treatment group and 109 in the control group. They were comparable in NYHA functional class, basic parameters and primary diseases before treatment. Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment. Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group (P<0.05). Total symptom score and sign score in the treatment group decreased significantly after treatment (P<0.01), which were significantly lower than those in the control group (P<0.05). There were statistically significant differences in post-treatment scores of gasp, cough with phlegm, pulmonary rales and jugular vein engorgement between the two groups (P<0.05 or P<0.01). Three MLHFQ scores decreased significantly in both groups after treatment (P<0.01). Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences (P<0.05) as compared with the control group. There was no significant difference between the two groups in emotional subscale score and the reduction after treatment (P>0.05). There was no obvious adverse reaction in either group noted during the study.
Yangxinkang tablets were safe and efficacious in improving cardiac function, CM syndromes, symptoms, signs, and quality of life in patients with CHF class II or III in stage C on the base of conventional treatment.
探讨养心康片治疗慢性心力衰竭（CHF）气阴两虚兼血瘀水停证患者的安全性和有效性。
采用双盲、随机、安慰剂对照、多中心临床试验，将228例纽约心脏病协会（NYHA）心功能Ⅱ级或Ⅲ级的C期CHF患者按随机区组法1:1分为两组，分别接受单纯西医常规治疗或西医常规治疗加养心康片治疗4周。观察指标为治疗前后的心功能疗效、中医证候、症状体征积分及明尼苏达心力衰竭生活质量问卷（MLHFQ）评分。
治疗组共纳入112例患者，对照组纳入109例患者。两组患者治疗前NYHA心功能分级、基础指标及原发疾病等方面具有可比性。两组治疗后心功能及中医证候均有明显改善。治疗组心功能疗效及中医证候总有效率均显著高于对照组（P<0.05）。治疗组治疗后总症状积分和总体征积分显著降低（P<0.01），且显著低于对照组（P<0.05）。两组治疗后气喘、咳痰、肺部啰音及颈静脉怒张积分比较，差异有统计学意义（P<0.05或P<0.01）。两组治疗后MLHFQ三个维度评分均显著降低（P<0.01）。治疗组治疗后总量表积分及生理维度积分与对照组比较，差异有统计学意义（P<0.05）。两组治疗后情感维度积分及降低幅度比较，差异无统计学意义（P>0.05）。研究期间两组均未观察到明显不良反应。
在常规治疗基础上，养心康片治疗C期Ⅱ～Ⅲ级CHF患者，在改善心功能、中医证候、症状体征及生活质量方面安全有效。
