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

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

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中文关键词: 生脉注射液地戈辛血药浓度药代动力学充血性心力衰竭

英文关键词:Shengmai Injection digoxin serum concentration of drug pharmacokinetics congestive heart failure

基金项目:天津市教委科技发展基金资助项目 (No .2 0 0 1 0 90 9)

作者	单位
毛静远	天津中医学院第一附属医院心内科
徐为人	天津药物研究院药物评价中心药动学室
王恒和	天津中医学院第一附属医院心内科
王强	天津中医学院第一附属医院心内科
张运	天津中医学院第一附属医院心内科
常延平	天津中医学院第一附属医院心内科
李红	天津中医学院第一附属医院心内科
郑颖	天津中医学院第一附属医院心内科
吴慧轩	天津中医学院第一附属医院心内科
张宇	天津中医学院第一附属医院心内科

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中文摘要:

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 4 0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 2 0ml、4 0ml、6 0ml 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 0 1) ,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 0 5或P <0 0 1) ;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 0 5 )。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。

英文摘要:

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 (T 1/2 ), 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.

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