丹参多酚酸盐临床药动学对临床试验的指导意义

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。

The Guiding Significance of Clinical Pharmacokinetics of Salvianolate for Clinical Trial

Objective To explore the guidance of clinical pharmacokinetic research of Salvianolate for its clinicaluse.Methods A randomized controlled trail was carried out in 41 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 12 h.The treatment group(n=20) was treated with salvianolate at the dose of 200 mg,intravenous drip,twice a day,and the control group(n=21) with salvianolate at the dose of 200 mg,intravenous drip,once a day.The curative effects of salvianolate on angina pectoris(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 reducing dosage of glonoine,but the difference was insignificant(P > 0.05).Conclusion The results of pharmacokinetic study on salvianolate can guide the clinical trial design and reasonableuse of medicaments in clinic.