心衰Ⅰ号对慢性收缩性心力衰竭的临床研究
Clinical Research on XinshuaiⅠfor Chronic Systolic Heart Failure
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摘要: 目的 评价具有益气养阴、活血化痰作用的心衰Ⅰ号配方颗粒（心衰Ⅰ号）对慢性收缩性心力衰竭（CHF）的治疗效果。方法 将120例CHF患者随机分为治疗组与对照组，每组60例，2组在西医治疗的基础上治疗组口服心衰Ⅰ号，每日1袋，分2次服，对照组口服心衰Ⅰ号安慰剂，每日1袋，分2次服。4周为1个疗程，观察时间为6个疗程。比较2组治疗后症状、体征、生活质量评分、脑钠肽（BNP）、左室射血分数（LVEF）、6 min步行试验（6MWT）的变化和综合疗效。结果 2组治疗前后对比在症状、体征、综合疗效、BNP、LVEF、6MWT等方面有显著性差异(P<0.05)；治疗组总有效率为67.24%，对照组总有效率为45.61%，组间对比治疗组优于对照组(P<0.05)；治疗期间2组均无不良反应发生。结论 心衰Ⅰ号长期治疗CHF患者安全有效。Abstract: OBECTIVE To observe and evaluate the curative effects of XinshuaiⅠwith the function of replenishing qi and nourishing yin， activating blood circulation and resolving phlegm on chronic systolic heart failure (CHF). METHODS 120 cases with CHF were randomized into treatment group (60 cases) and control group (60 cases). The treatment group were given XinshuaiⅠadministration on the basis of western medicine treatment， 1 package per day for twice use; the control group given XinshuaiⅠplacebo， 1 package per day for twice use， 4 weeks as 1 treatment course， 6 treatment courses as the observation period. The changes of symptoms， life quality score， brain natriuretic peptide (BNP)， left ventricular ejection fraction (LVEF)， 6min walking test (6MWT) and comprehensive effects of 2 groups were compared. RESULTS Significant difference of the symptoms， comprehensive effects， BNP， LVEF， 6MWT appeared before and after the treatment (P<0.05). The overall response rate of the treatment group is 67.24% while that of the control group is 45.61% and the treatment group was better than the control group(P<0.05). During the treatment period， no adverse reaction appeared in both 2 groups. CONCLUSION XinshuaiⅠis safe and effective for the long-term treatment of CHF.
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