降浊通络颗粒联合西药治疗痰瘀互结型射血分数保留性心力衰竭36例临床观察

Clinical Observation on Jiangzhuo Tongluo Granules(降浊通络颗粒) Combined with Western Medicine in the Treatment of 36 Cases of Heart Failure with Preserved Ejection Fraction of Intermingled Phlegm and Blood Stasis Type

目的观察降浊通络颗粒联合西药治疗痰瘀互结型射血分数保留性心力衰竭患者的临床疗效及安全性。方法72例痰瘀互结型射血分数保留性心力衰竭患者随机分为治疗组和对照组各36例,两组均予以常规标准化西药抗心力衰竭治疗,治疗组加用降浊通络颗粒,对照组加用降浊通络颗粒安慰剂,均每日3袋(约含生药量25.2 g)口服。8周后评价心功能疗效及中医证候疗效,比较两组患者治疗前后中医症状评分、平板运动试验、6分钟步行距离、生存质量评分、血浆N-末端B型利钠肽原(NT-proBNP)水平以及超声心动图指标。结果治疗组心功能疗效总有效率为83.33%,中医证候疗效为88.89%,对照组分别为66.67%、72.22%,治疗组心功能疗效、中医证候疗效总有效率均高于对照组(P<0.05)。与本组治疗前比较,两组患者治疗后中医症状评分、血浆NT-proBNP水平均明显下降,平板运动各项指标均明显改善,6分钟步行距离及生存质量评分均显著增加(P<0.05);治疗后治疗组气喘、倦怠乏力、肢体困重、心悸、纳呆恶心等症状评分及平板运动各项指标、6分钟步行距离、生存质量评分、血浆NT-proBNP水平改善均优于对照组(P<0.05)。与治疗前比较,两组治疗后左室舒张末期内径、室间隔厚度、左室后壁厚度、左室射血分数(LVEF)及治疗组左房内径明显降低,两组二尖瓣口舒张早期及舒张晚期流速峰值比值、LVEF明显升高(P<0.05),且治疗组左房内径降低较对照组明显(P<0.05)。两组均不良反应轻。结论降浊通络颗粒联合常规标准化西药治疗能显著改善射血分数保留性心力衰竭患者的临床症状、心脏舒张功能及生活质量,疗效优于单用常规标准化西药治疗。

Objective To observe the clinical efficacy and safety of Jiangzhuo Tongluo Granules(降浊通络颗粒)combined with western medicine in the treatment of patients with heart failure with preserved ejection fraction of intermingled phlegm and blood stasis type.Methods A total of 72 patients with heart failure with preserved ejection fraction of intermingled phlegm and blood stasis type were randomly divided into a treatment group and a control group,with 36 cases in each group.Both groups were treated with conventional standardized western medicine for against heart failure.The treatment group was treated with Jiangzhuo Tongluo Granules.The control group was treated with placebo of Jiangzhuo Tongluo Granules,3 times a day,1 bag(about 25.2 g of crude drug),and both groups were treated for 8 weeks.Then,the effects of cardiac function and traditional Chinese medicine(TCM)syndromes were evaluated.TCM symptom scores,treadmill exercise test,6 min walking distance,quality of life score,N-terminal B-type natriuretic peptide(NT-proBNP)level and echocardiographic index were compared between the 2 groups.Results The total effective rate of cardiac function in the treatment group was 83.33%,and the efficacy of TCM syndrome was 88.89%,and those of the control group was 66.67% and 72.22%r espectively.The total effective rate of cardiac function and TCM syndrome in the treatment group was higher than that of the control group(P<0.05).After treatment,the TCM symptom scores and NT-proBNP levels were significantly decreased,and the indexes of treadmill exercise were significantly improved,the 6-minute walking distance and quality of life scores were significantly increased(P<0.05).In the treatment group,asthma,fatigue,heavy limbs and body,palpitations,poor appetite,nausea,index of treadmill exercise,6-minute walking distance,quality of life score and NT-proBNP were better than the control group(P<0.05).After treatment,left ventricular end-diastolic diameter,ventricular septal thickness,left ventricular posterior wall thickness,left ventricular ejection fraction of both groups,and left atrial diameter of the treatment group were significantly decreased;the mitral valve diastolic early and late diastolic phase peak flow rate ratio and left ventricular ejection fraction(LVEF)were significantly increased(P<0.05),and the left atrial diameter of the treatment group was significantly decreased than that of the control group(P<0.05).The adverse reactions in both groups were mild.Conclusion Jiangzhuo Tongluo Granules combined with conventional standardized western medicine can significantly improve the clinical symptoms,diastolic function and quality of life of patients with heart failure with preserved ejection fraction of intermingled phlegm and blood stasis type.The curative effect is superior to that of conventional standardized western medicine alone.