Association study between clinical pharmacokinetic of paclitaxel and chinical effect in patients with gynecological malignant tumor / 中国生化药物杂志

ABSTRACT

Objective To observe the association between clinical pharmacokinetic of paclitaxel and adverse reactions in patients with gynecological malignant tumor.Methods 78 patients with female malignant tumor selected from Jan.2009 to Dec.2013 in Kailuan General Hospital were treated with paclitaxel (intravenous drip 175 mg/m2 3 h).The blood drug level of paclitaxel was measured at different time after treating.The DAS software was used to calculate the parameter of pharmacokinetic of paclitaxel,and the SPSS software was used to analyze the association between clinical pharmacokinetic of paclitaxel and adverse reaction in patients with female malignant tumor.Results The peak plasma concentrations (Cmax)was (3.99 ± 1.07)mg/L,the areas under the plasma concentration-time curve (AUC)was (9.74 ±2.45)mg/(h·L),the plasma elimination half-life (t1/2z)was (13.7 ±3.2)h,the apparent volumes of distribution (Vd)was (162.9 ±49.5)L/m2,the plasma clearance rates (CL)was (8.2 ±1.0)L/(h·kg).The kinetics of paclitaxel was fitted to two-compartment model.The time of drug concentration >0.1 μmol/L (t>0.1 )in responder patients (16.8 ± 4.8)h was higher than that in nonresponder patients (13.5 ±2.9)h,and the difference was significant (P<0.05).The Cmax in patients with severity adverse reactions (4.61 ±0.86)mg/L were higher than those in patients without severity adverse reaction (3.65 ±1.13)mg/L,and the difference was significant (P<0.01).Conclusion The Cmax of paclitaxel is associated with efficacy after treatment and severity adverse reactions.