银杏叶提取物对健康志愿者华法林抗凝及血药浓度的影响

[Effects of Ginkgo biloba extract on anticoagulation and blood drug level of warfarin in healthy wolunteers].

作者信息

Zhou Yulu, Zeng Rong

机构信息

The Third Xiangya Hospital of Central South University, Changsha 410013, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2011 Aug;36(16):2290-3.

PMID:22097347

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.

RESULT

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-infinity), t1/2, of warfarin significantly and decreased CL(F) of warfarin significantly (P < 0.05), and there were no singnificant difference of V(d) (F).

CONCLUSION

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.

摘要

目的

研究银杏叶提取物（GBE）对华法林药代动力学和药效学的影响，并观察GBE的抗凝活性。

方法

进行一项随机、双盲、安慰剂对照、双向交叉试验。12名健康志愿者（男女比例为1:1）被随机分为两组，分别接受GBE（每日3次，每次3片）或安慰剂（每日3次，每次3片），持续5周。在第29天，受试者接受单剂量华法林（5 mg）。采集用于药代动力学和药效学评估的血样。

结果

与安慰剂相比，GBE对华法林没有显著的药效学影响，对凝血酶原时间（PT）和活化部分凝血活酶时间（APTT）没有影响。GBE提取物显著增加了华法林的C(max)、AUC(0 - 144分钟)、AUC(0 - ∞)、t1/2，并显著降低了华法林的CL(F)（P < 0.05），而V(d)(F)没有显著差异。