中国药物警戒 ›› 2013, Vol. 10 ›› Issue (2): 65-67.

• 基础及临床研究 •    下一篇

复方丹参滴丸对华法林在人体内药动学和药效学的影响

易丹1,罗晓波1,陆向红1, 罗圣平1,周于禄2   

  1. 1.株洲市一医院药剂科,湖南株洲412000；
    2.中南大学湘雅三医院药剂科,湖南长沙410013
  • 收稿日期:2012-06-18 修回日期:2016-03-09 出版日期:2013-02-08 发布日期:2016-03-09
  • 通讯作者: 周于禄,男,硕士,副主任药师,临床药学与不良反应监测。E-mail:yulu0027@126.com
  • 作者简介:易丹,女,硕士,主管药师,临床药学与不良反应监测。

The Effects of Compound Danshen Dripping Pills on the Pharmacodynamics and Pharmacokinetics of Warfarin in Humans

YI Dan1, LUO Xiao -bo1 ,LU Xiang -hong1, LUO Sheng -ping1, ZHOU Yu -lu2   

  1. 1.Department of Pharmaly, the First Hospital of Zhuzhou, Hunan Zhuzhou 410013, China;
    2.Department of Pharmaly, the Third Xiangya Hospital of Central South University, Hunan Changsha 410013, China
  • Received:2012-06-18 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

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摘要： 目的 研究复方丹参滴丸对华法林在人体内药动学和药效学的影响,以及单独服用复方丹参滴丸4 周后对凝血酶原时间（PT）和活化部分凝血活酶时间（APTT）的影响。方法 采用随机、单盲、双周期交叉、安慰剂对照试验设计。12 名男性健康志愿者随机分为2 组（6 人/ 组）,连续5周每日分别服用复方丹参滴丸（10 片,每天3 次）或安慰剂（10 片,每天3 次）；d29 口服单剂量华法林5 mg；第2 周期2组交叉服用安慰剂或复方丹参滴丸,其余给药方案不变。按要求收集志愿者血样,分别以高效液相色谱法（HPLC）测定华法林的血药浓度以及半自动血凝仪测定常见凝血指标。结果 合用复方丹参滴丸后,华法林的药动学参数cmax、AUC0~144、AUC0~∞、t1/2显著增加（ P<0.05）,CL/F显著减小（ P<0.05）,tmax 和V/F 没有显著变化；华法林的药效学参数发生显著变化。单独服用复方丹参滴丸4 周后,PT和APTT 均发生显著变化。结论 复方丹参滴丸可影响华法林的药动学和药效学；单独服用复方丹参滴丸4 周对凝血功能有显著影响。

关键词: 复方丹参滴丸, 华法林, 药动学, 药效学, 药物相互作用

Abstract: Objective To study the effect of Danshen Dripping Pills on the pharmacokinetics and pharmacodynamics of warfarin, and to assess whether or not Danshen Dripping Pills alone has any anticoagulant activity. Methods A randomized, double-blind, placebo-controlled, two-way cross-over trial was designed.Twelve male healthy volunteers (6 person/group) were randomized to receive either Danshen Dripping Pills in the first treatment period and placebo in the second treatment period, or vice versa. In addition to their randomized trentment, all volunteers received a single dose of 5 mg warfarin ond 29 of each treatment period. Blood samples for assessment were taken at frequent intervals during each treatment period. Results Administration of Danshen Dripping Pills significantly increasedcmax、AUC0~144、AUC0~∞、t1/2 and significantly decreased CL/F of warfarin compared with placebo.In addition, Danshen Dripping Pills had clinically significant effect on the pharmacodynamic effects of warfarin, as assessed 144h after warfarin dosing by measurement of prothrombin time, activated partial thromboplastin time. Danshen Dripping Pills alone had significant effect on these indicators of the clotting process. Conclusion Usual doses of Danshen Dripping Pills seem to have significant effects on the pharmacokinetics and pharmacodynamics of single dose warfarin in healthy subjects.

Key words: Danshen Dripping Pills, Warfarin, pharmacokinetics, pharmacodynamics, drug interactions

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