补肾启枢强心颗粒治疗慢性心力衰竭心肾阳虚证的临床研究以及对免疫功能、微炎症的影响

Clinical Study of Bushen Qishu Qiangxin Granule( 补肾启枢强心颗粒) in Treatment ofChronic Heart Failure and Its Effect on Immune Function

目的通过观察慢性心力衰竭(chronic heart failure,CHF)患者免疫功能、与心功能的关系及其运用补肾启枢强心颗粒治疗CHF患者临床研究以及对免疫功能的影响,为中医药治疗CHF提供可靠的依据。方法病例来自于本院心血管科内科住院和门诊CHF(心肾阳虚型)患者96例,分析免疫功能与心功能的关系,按拆信封方式将96例患者随机分为观察组和对照组,每组各48例。对照组给予CHF常规治疗,观察组在常规治疗上加服补肾启枢强心颗粒,实验周期为12周。评估两组患者干预前、后心衰疗效计分(Lee氏心衰计分)、明尼苏达心衰量表积分(Minnesota heart failure quality of life,MLHFQ)、6 min步行试验(6 minute walk test,6MWT);检测两组患者服药前、后免疫功能、心脏彩超,同时观察两组治疗前后安全性指标及再入院率。结果(1)CHF时患者CD+4、CD+4/CD+8下降,CD+8升高,与心功能Ⅱ级比较,心功能Ⅲ级时患者CD+4、CD+4/CD+8下降及CD+8升高更显著(P<0.05);(2)对照组脱落和剔除6例,最终纳入有效病例为42例,观察组脱落和提出4例,最终纳入有效病例为44例;(3)中医证候疗效比较:观察组总体有效率为88.63%(39/44),对照组总体有效率69.05%(29/42),观察组总有效率高于对照组(P<0.05);(4)两组治疗后均可降低Lee氏心衰计分、MLHFQ及提高6MWT(P<0.05),与对照组相比,观察组降低Lee氏心衰计分、MLHFQ及提高6MWT更明显(P<0.05);(5)两组治疗后均可提高CD+4、CD+4/CD+8及降低CD+8(P<0.05),与对照组比较,观察组提高CD+4、CD+4/CD+8及降低CD+8更明显(P<0.05);(6)两组治疗后均可以提高左心室射血分数(left ventricular ejection fraction,LVEF)及降低左室舒张末内径(left ventricular end diastolic dimension,LVDd)、左室舒张末内径(left ventricular end-systolic dimension,LVDs)、左室后壁厚度(left ventricu-lar posterior wall thickness,LVPWT)(P<0.05),与对照组比较,观察组提高LVEF及降低LVDd、LVDs、LVPWT更明显(P<0.05);(7)两组干预前后ALT、AST、Scr、BUN、Na+、Cl-、K+、PT、APTT、血小板比较无统计学差异(P>0.05),说明服用补肾启枢强心颗粒期间未出现明显不良反应;(8)与对照组相比,观察组干预后可以降低3个月、6个月再入院率。结论补肾启枢强心颗粒可能是通过调节CHF(心肾阳虚型)患者免疫功能从而改善CHF患者心脏功能、结构及临床症状,提高患者生活质量,进而降低再入院率,临床上使用安全,值得推广。

Objective To observe the immune function of chronic heart failure(CHF)patients and its relationship with cardiac function and its clinical research in the treatment of CHF patients with Bushen Qishu Qiangxin Granule(补肾启枢强心颗粒)and the effect on immune function.Methods A total of 96 patients with CHF(heart-kidney Yang deficiency)from inpatient and outpatient in the hospital were selected.The relationship between immune function and cardiac function was analyzed.The patients were randomly divided into observation group and control group by the method of unpacking,48 cases in each group.The control group was given conventional CHF treatment,and the observation group was supplemented with Bushen Qishu Qiangxin Granule,and the experimental period was 12 weeks.The heart failure efficacy score(Lee′s heart failure score),Minnesota heart failure quality of life(MLHFQ),and 6 minute walk test(6 MWT)before and after intervention in the two groups were evaluated.The immune function and cardiac ultrasound were measured before and after taking the drugs in the two groups,and the safety indicators and readmission rates before and after treatment were observed in both groups.Results(1)CD+4 and CD+4/CD+8 were decreased and CD+8 was increased in patients with CHF.Compared with cardiac functionⅡ,CD+4 and CD+4/CD+8 were decreased and CD+8 was increased in patients with cardiac functionⅢ(P<0.05);(2)6 cases were dropped out and removed in the control group,42 cases were eventually included effectively.4 cases were dropped out in the observation group,and 44 cases were finally included effectively;(3)Comparison of the efficacy of TCM symptoms:The overall effective rate in the observation group was 88.63%(39/44)and that in the control group was 69.05%(29/42).The total effective rate in the observation group was higher than that in the control group(P<0.05);(4)Heart failure score,MLHFQ and 6 MWT were increased(P<0.05).Compared with the control group,the observation group reduced Lee′s heart failure score,MLHFQ and 6 MWT more significantly(P<0.05);(5)After treatment in both groups,it can increase CD+4 and CD+4/CD+8 and decrease CD+8(P<0.05).Compared with the control group,the observation group increased CD+4 and CD+4/CD8+and decreased CD+8 more significantly(P<0.05);(6)Left ventricular ejection fraction(LVEF)was increased and reduction of left ventricular end diastolic dimension(LVDd),left ventricular end-diastolic diameter(LVDs),left ventricular posterior wall thickness(left ventricu-lar posterior wall thickness,LVPWT)was more significant(P<0.05).Compared with the control group,the observation group increased LVEF and decreased LVDd,LVDs and LVPWT more significantly(P<0.05);(7)Before and after intervention between the two groups,ALT,AST,Scr,BUN,Na+,Cl-,K+,PT,APTT and platelets had no statistically significant difference(P>0.05),indicating that there were no significant adverse reactions during taking Bushen Qishu Qiangxin Granule;(8)Compared with the control group,the observation group could reduce the readmission rate 3 and 6 months after intervention.Conclusion Bushen Qishu Qiangxin Granule may improve the heart function,structure and clinical symptoms by regulating the immune function of patients with CHF(heart-kidney Yang deficiency type),improve the quality of life of patients,and then reduce the readmission rate.It is safe and worthy of promoting.