[Clinical study on effect of shengmai injection on serum concentration and pharmacokinetic parameters of digoxin in patients with congestive heart failure]

Author(s): Mao JY, Xu WR, Wang HH

Affiliation(s): First Teaching Hospital of Tianjin TCM University, Tianjin 300193. jymao@263.net

Publication date & source: 2003-05, Zhongguo Zhong Xi Yi Jie He Za Zhi., 23(5):347-50.

Publication type: Clinical Trial; Randomized Controlled Trial

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.