苓桂术甘配方颗粒治疗慢性心力衰竭(心肾阳虚证)的临床观察

Clinical Effect of Linggui Zhugan Formula Granule on Chronic Heart Failure with Heart-Kidney Yang Deficiency Syndrome

目的观察苓桂术甘配方颗粒治疗慢性心力衰竭(心肾阳虚证)的临床疗效及治疗结束后3月内的复发率情况。方法将60例符合慢性心力衰竭Ⅱ-Ⅲ级(心肾阳虚证)诊断标准的患者随机分为中药配方颗粒治疗组、中药饮片治疗组与对照组,每组20例,中药配方颗粒组予西药常规治疗加苓桂术甘颗粒,中药饮片组予西药常规治疗加苓桂术甘饮片,对照组单予西药常规治疗,疗程均为两周。观察治疗前后患者临床症状、总有效率、左室射血分数(LVEF)、血浆脑尿钠肽(brain natriuretic peptide,BNP)的变化及治疗结束后3个月内复发率情况。结果治疗2周后,中药配方颗粒组患者心功能改善总有效率为95%,中医证候改善总有效率为85%,复发率为10%,与对照组比较,差异具有统计学意义(P<0.025);治疗后中药配方颗粒组左室射血分数(LVEF)显著提高、血液中BNP浓度明显降低(P<0.01);中药配方颗粒组与饮片治疗组差异无统计学意义(P>0.05),中药配方颗粒组与饮片组疗效相当。结论苓桂术甘配方颗粒可有效缓解慢性心力衰竭Ⅱ-Ⅲ级(心肾阳虚证)患者的中医证候,改善左室收缩功能,提高左室射血分数,明显降低血浆BNP含量,中西医结合治疗较单纯西药治疗副作用少,3个月内复发率低,服用方便,临床安全性及依从性更好。

Objective To observe the clinical effect and the recurrence rate in 3 months of Linggui Zhugan formu-la granule on chronic heart failure with heart-kidney Yang deficiency syndrome. Methods 60 patients were randomly divided into Chinese medicinal ganule group treated with Linggui Zhugan formula granule combined with Western medicine conven-tional therapy, Chinese medicinal decoction pieces group treated with Linggui Zhugan decoction pieces combined with West-ern medicine conventional therapy, control group treated with routine Western Medicine, the treatment course was for 2 weeks, 20 cases in each group. The clinical symptoms, total effective rate, left ventricular ejection fraction （LVEF）, plasma brain natriuetic peptide （BNP）, and the recurrence rate in 3 months were observed before and after treatment. Results After treatment for 2 weeks, compared with the control group, the total effective rate in Chinese medicine formula granule group was 95%, the effective rate of Chinese medicine syndrome was 85%, and the recurrence rate was 10% in formula granule group, there were significant differences between the two groups （P〈0.05）. The LVEF in Chinese medicine formula granule group sig-nificantly increased and BNP level decreased （P〈0.01）, there was no statistically significant differences between the Chi-nese medicine granule group and decoction pieces group （P〉0.05）. Conclusion Linggui Zhugan formula granule could effective-ly relieve chronic heart failure Ⅱ-Ⅲ with heart-kidney deficiency syndrome, improve left ventricular systolic function, increase left ventricular ejection fraction, reduce BNP content in plasma, and the recurrence rate in 3 months is low. Combination of TCM and Western medicine shows less side effects, good clinical safety and compliance.