舒肝解郁胶囊治疗慢性心力衰竭合并抑郁临床疗效观察

Curative efficacy of Shuganjieyu capsules on the patients with chronic heart failure plus depression

目的观察舒肝解郁胶囊治疗慢性心力衰竭(CHF)合并抑郁的临床疗效及安全性。方法 78例CHF合并抑郁患者随机分为对照组、舒肝解郁组和氟哌噻吨美利曲辛组,每组26例,疗程半年。评价患者治疗前后汉密尔顿抑郁量表(HAMD)评分、美国纽约心脏病协会(NYHA)心功能分级以及6分钟步行试验(6MWT),以明尼苏达心衰生活质量问卷(MLHFQ)评估生活质量,采用超声心动图测定左室射血分数(LVEF)和心输出量(CO),应用不良反应量表(TESS)评定不良反应。结果治疗后舒肝解郁组及氟哌噻吨美利曲辛组HAMD评分和MLHFQ均较治疗前明显降低(P<0.05),且低于对照组(P<0.05),但两组间差异无统计学意义(P>0.05);舒肝解郁组和氟哌噻吨美利曲辛组NYHA分级疗效有效率分别为73.1%和69.2%,与对照组比较差异有统计学意义(P<0.05),但两组间比较差异无统计学意义(P>0.05);对照组治疗前后6MWT和MLHFQ差异无统计学意义(P>0.05),但舒肝解郁组、氟哌噻吨美利曲辛组治疗后6MWT均增加(P<0.05),且显著高于对照组(P<0.05);治疗前各组LVEF、CO和E/A比较差异无统计学意义(P>0.05),治疗后舒肝解郁组、氟哌噻吨美利曲辛组LVEF、E/A均较对照组增加,舒肝解郁组CO高于对照组(P<0.05)。但舒肝解郁组、氟哌噻吨美利曲辛组两组间各指标差异无统计学意义(P>0.05)。各组不良反应,氟哌噻吨美利曲辛组出现11例(42.3%),舒肝解郁组共4例(15.4%),两组不良反应发生率相比差异具有统计学意义(P<0.05)。舒肝解郁组TESS评分显著低于氟哌噻吨美利曲辛组(P<0.05)。结论抗抑郁治疗可以改善合并抑郁的CHF患者的心功能及其生活质量,舒肝解郁胶囊安全性较好,值得临床推广应用。

Objective To observe the curative efficacy of Shuganjieyu capsules on the patients suffered from chronic heart failure （CHF） with depression. Methods A total of 78 patients accompanied with depression were divided into Shuganjieyu treatment group, Deanxit（flupentixol and melitracen tablets） group and control group （each group n=26）. The three group patients were respectively received the treatment with Shuganjieyu capsules, Deanxit and the placebo for half a year besides the CHF conventional therapy. After 6 months, the Hamilton depression scale （HAMD） score, the New York heart association （NYHA） cardiac heart grading and 6 minutes walk test （6MWT） were evaluated before and after treatment. Left ventricular ejection fraction （LVEF） and cardiac output （CO） were tested by echocardiography. The life quality was evaluated by Minnesota life quality of heart failure questionnaires （MLHFQ）. Adverse drug reactions （ADRs） were observed by treatment emergent symptom scale （TESS） before and after treatments. Results After 6 months treatment, the HAMD scores of the Shuganjieyu treatment group and the Deanxit group were reduced （P 〈0.05）. The total curative effect of NYHA of the Shuganjieyu group was 73.1% and 69.2% in the Deanxit group, which was superior to 38.5% in the control group （P 〈0.05）. After the treatment, the MLHFQ scores of the Shuganjieyu treatment group and the Deanxit group were decreased, which was lower than the control group （P 〈0.05）. The 6MWT, LVEF and E/A of both groups were increased significantly （P 〈0.05） after thetreatment, which were higher than the control group （P 〈0.05）. The incidence of ADRs in Shugenjieyu treatment group was less than that in the Deanxit group （P 〈0.05）. Conclusion Shuganjieyu capsule is effective to improve the life quality and cardiac function for the CHF patients accompanied with depression.