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目的:研究银杏叶提取物对华法林在人体内药动学和药效学的影响。方法:采用随机、单盲、双周期交叉、安慰荆对照试验设计。12名健康志愿者(男女各半)随机分为2组,连续5周每日分别服用银杏叶片(EGB,每片含总黄酮醇苷9.6mg,萜类内酯2.4 mg)或安慰剂2粒,1日3次;29 d口服单剂量华法林5 mg;第2周期2组交叉服用安慰剂或银杏叶片,其余给药方案不变。按要求收集志愿者血样,分别以半自动血凝仪测定常见凝血指标,以HPLC测定华法林的血药浓度。结果:单独服用银杏叶提取物4周后,华法林凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)无显著变化。华法林药动学参数Cmax,AUC0-144,AUC0-∞,t1/2显著增加(P<0.05);CL(F)显著减小(P<0.05),tmax和Vd(F)没有显著变化。结论:银杏叶提取物可影响华法林的药动学指标,但不影响华法林的药效学;单独服用银杏叶提取物4周对凝血功能无明显影响。
Objective: To study the effects of Ginkgo biloba extract on pharmacokinetics and pharmacodynamics of warfarin in human. Methods: Randomized, single-blind, double-cycle crossover, comfort control design. Twelve healthy volunteers (half male and half female) were randomly divided into two groups. Five consecutive days of taking ginkgo leaf tablets (EGB, each containing 9.6 mg of total flavonol glycosides, 2.4 mg of terpene lactones) or 2 placebo tablets , Three times a day; 29 d oral warfarin single-dose 5 mg; the second cycle of two groups crossed placebo or ginkgo leaves, the rest of the dosing schedule unchanged. Volunteers were collected according to the requirements of blood samples were measured by semi-automatic coagulation analyzer common coagulation index, determination of warfarin plasma concentration by HPLC. RESULTS: There was no significant change in warfarin prothrombin time (PT) and activated partial thromboplastin time (APTT) after taking Ginkgo biloba extract for 4 weeks alone. The pharmacokinetic parameters Cmax, AUC0-144, AUC0-∞, t1 / 2 of warfarin increased significantly (P <0.05), but CL (F) decreased significantly . Conclusion: Ginkgo biloba extract can influence warfarin pharmacokinetics, but does not affect the warfarin pharmacodynamics; taking Ginkgo biloba extract alone for 4 weeks on coagulation has no significant effect.