丹参多酚酸盐临床药动学对临床试验的指导意义.pdfVIP

Research Clinical Pharmacol 2006 Mav。Vo1．17 No．3 · 226· · 临 床 研 究 · 丹参多酚酸盐临床药动学对临床试验的指导意义 高 蕊1，王书臣-，张 颖t，张 琼，，陈志杨z(1．中国中医科学院西苑医院，北京 100091；2．安徽省药物评 价中心，安徽 芜湖 241001) 摘要：目的 探讨丹参多酚酸盐药物动力学研究对临床用药的指导作用。方法 根据丹参酚酸B在体内半衰期小于2h， 12h内药物基本从体内消除的研究结果设计给药方案，采用随机对照的方法，试验组 (20例)丹参多酚酸盐200mg，静 脉滴注，每日2次，对照组 (21例)丹参多酚酸盐200mg，每天1次，比较两种给药方法对冠心病心绞痛(心血瘀阻证) 的疗效差别。结果 试验组对心绞痛、心电图疗效及速效扩冠药物停减情况均有优于对照组的趋势，但无统计学差 (P 0．05)。结论 药物动力学的研究结果对指导中药临床试验的设计和临床合理用药有指导的作用。 关键词：丹参多酚酸盐；临床试验；药物动力学 中图分类号：R285．6 文献标识码：A 文章编号：1003—9783(2006)03—0226～o3 The Guiding Significance of Clinical Pharmacokinetics of Salvianolate for Clinical Trial GAO Lei ．WANG Shuncheng‘，ZHANG Ying‘，ZHANG Qiong‘，CHEN Zhiyang (1．Xiyuan Hospital，China Academy ofTraditional Chinese Medicine．Beijing 100091；2．Drug Evaluation Center of Anhui Province，Wuhu 241001 Anhui) Abstract：Objective To explore the guidance of clinical pharmacokinetic research of Salvianolate for its clinicaluse． Methods A randomized controlled trail was carried out in 4 1 patients．The medication design was based on the findings that the half life time of salvianolate was less than 2 h and its time of clearance uas 1 2 h．The treatment group(凡=20) was treated with salvianolate at the dose of 200 mg，intravenous drip，twice a day，and the control group (凡=2 1)with salvianolate at the dose of 200 mg，intravenous drip，once a day．The curative effects of salvianolate on angina peetoris (with syndrome of heart—blood obstruction)in the two groups was compared．Results The effect of the treatment group trended to be more superior to the control group in relieving angina pectoris．improving electrocardiogram(ECG)and re- ducing dosage of glonoine，but the difference was insignificant(P0．05)．Conclusion The results of pharmacokinetic study on salvianolate can guide the clinical trial design and reasonableuse of medicaments in clinic． Keywords：Salvianolate；Clinical trial；Pharmacokineti