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目的:比较Syst-China和Syst-Eur的一线药物中国资寿尼群地平和德国拜尔尼群地平的药代动力学、药效学、副作用的异同.方法:用随机、交叉比较方法,分别给8个男性健康志愿者口服40mg资寿尼群地平或拜尔尼群地平,采用高效液相紫外荧光检测法测定服药前及服药后不同时点血清中尼群地平的浓度.结果:8个健康志愿者服用上述药物后,各时点测定的平均血药浓度在两种药物之间无明显差别;其药代动力学参数AUC、Cmax、Tmax均无明显差别,两药的AUC之比为0.996;两药对收缩压影响不大,对舒张压降低明显,降压幅度及反射性心率增快作用相似,最大降压幅度分别为37、3%和47.6%.结论:中国资寿尼群地平和德国拜尔尼群地平是“生物等效”的,因此分别用上述两种药物作为一线药物的大规模临床试验Syst-China和Syst-Eur得出的结果是可比的.
OBJECTIVE: To compare the pharmacokinetics, pharmacodynamics and side effects of Zirgrenitapentine in the first-line drugs of Syst-China and Syst-Eur with those of the Germanic Byrne group.Methods: By using randomized and cross-comparison methods, Eight healthy male volunteers were orally administered with 40 mg of Zinniotecan or bernididipine and the concentrations of nitrendipine in serum before and after administration were determined by HPLC.Results: After taking the above drugs in healthy volunteers, the average plasma concentration measured at each time point was no significant difference between the two drugs; the pharmacokinetic parameters AUC, Cmax, Tmax were no significant difference between the two drugs AUC ratio 0.996; the two drugs have little effect on systolic blood pressure, and have obvious effect on reducing diastolic blood pressure, decreasing blood pressure amplitude and reflex heart rate, with the maximum depressing rate being 37.3% and 47.6% respectively.Conclusion: Therefore, the results obtained from Syst-China and Syst-Eur, a large-scale clinical trial using the above two drugs as first-line drugs respectively, are comparable.