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作 者 ：周于禄,曾嵘

期 刊 ：中国中药杂志 2011年 36卷 16期 页码：2290.

关键词：银杏叶提取物；华法林；药物相互作用；凝血；血药浓度；

Keywords:Ginkgo biloba extract(GBE), warfarin, anticoagulation, blood drug level, drug interaction,

摘 要 ：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9.6 mg,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C_max,AUC_0-144,AUC_0-∞,t_1/2显著增加(P<0.05);CL(F)显著减小(P<0.05),t_max和V_d(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。

Abstract:Objective: To study the effects of Ginkgo biloba extract (GBE) on the pharmacokinetics and pharmacodynamics of warfarin and observe the anticoagulant activity of GBE. Method: A randomized, double-blinded, placebo-controlled, two-way cross-over trial was conducted. Twelve healthy volunteers (sex ratio was 1∶1) were randomized into two groups and received GBE (three pill, tid) or placebo (three pill, tid) for 5 weeks respectively.the subjects received a single dose of warfarin (5 mg) on the day 29. Blood samples for pharmacokinetics and pharmacodynamics assessment were collectd. Ressult : Compared with placebo, BE had no significant pharmacodynamics effects on warfarin and had no effects on prothrombin time (PT) and activated partial thromboplastin time (APTT). GBE extract increased C_max,AUC_{0-144 min}, AUC_0-∞,t_1/2, of warfarin singnificantly and decreased CL(F) of warfarin significantly (P<0.05), and there were no singnificant difference of V_d (F)。 Conclution : GBE has limited effects on the pharmacokinetics but no effects on the pharmacodynamics of single dose warfain in health subjects. GBE has no effects on clotting process alone.

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