生脉注射液对充血性心力衰竭患者地戈辛血药浓度和药动学参数的影响

目的：探讨生脉注射液对充血性心力衰竭(心衰)患者地戈辛血药浓度和药动学参数的影响。方法：选择符合充血性心衰诊断标准的住院患者40例，随机分为治疗1组、治疗2组、治疗3组(地戈辛加生脉注射液20ml、40ml、60ml 3个剂量组)和对照组(地戈辛组)，每组10例，采用放射免疫分析法(RIA)测定不同时点地戈辛血药浓度，以3P97药动学软件拟合地戈辛药动学参数。结果：治疗1组地戈辛血药浓度显著低于对照组(P<0．01)，消除半衰期(T1／2)、消除速率常数(Ke)、表观分布容积(Vd)、血浆清除率(CL)、药时曲线下面积(AUC)等药动学参数与对照组比较，差异有显著性(P<0．05或P<0．01)；治疗2组和治疗3组地戈辛血药浓度和上述药动学参数与对照组比较，则无明显变化(P>0．05)。结论：生脉注射液对充血性心衰患者体内地戈辛代谢存在影响，从而为两者的安全、合理配伍应用提供了重要的临床参考。

Clinical Study on Effect of Shengmai Injection on Serum Concentration and Pharmacokinetic Parameters of Digoxin in Patients with Congestive Heart Failure

OBJECTIVE: To investigate the effect of Shengmai Injection (SMI) on serum concentration and pharmacokinetic parameters of digoxin in patients with congestive heart failure. METHODS: Forty in-patients with congestive heart failure were selected and randomly divided into 4 groups, the three treated groups I, II and III treated with digoxin combined with 20 ml, 40 ml and 60 ml of SMI respectively, and the control group, 10 patients in each group. The serum concentration of digoxin at different time points was determined with radioimmunoassay and the pharmacokinetical parameters were calculated with 3P97 pharmacokinetic software. RESULTS: The serum concentration of digoxin in the treated group I was significantly lower than that in the control group (P < 0.05), with the pharmacokinetical parameters, including the elimination half-life time (T1/2), elimination rate constant (Ke), apparent volume of distribution (Vd), plasma clearance (CL) and area under curve (AUC), significantly different to those in the control group (P < 0.05 or P < 0.01). But the serum concentration of digoxin with its pharmacokinetical parameters in the other two treated groups were not different significantly to those in the control group respectively (P > 0.05). CONCLUSION: SMI could influence the metabolism of digoxin in patients with congestive heart failure. This study has provided an important reference for safe and rational combined use of digoxin and SMI in clinical practice.