Wenzel K W, Mehrländer U
Klinikum Charlottenburg, Freie Universität, Berlin.
Dtsch Med Wochenschr. 1987 Jan 15;113(2):53-8.
Three proprietary preparations of L-thyroxine were tested for their bioequivalence in a cross-over trial. Comparing the two most commonly prescribed preparations, during administration of preparation B (Euthyrox) serum concentrations of basal thyrotropin (TSH) was significantly higher than with preparation A (L-Thyroxin Henning) in both subgroups and in the cross-over calculation, as well as after stimulation with thyrotropin-releasing hormone (TRH) in one of the subgroups. During administration of a third preparation, C (Levothyroxine, enos), serum concentrations of total thyroxine (T4) and free thyroxine (fT4) were significantly lower than with preparation A, while basal and TRH-stimulated TSH levels were in all measurements highly significantly higher. Although there was the tendency for preparation B to be inferior, a greater effectiveness of preparation A could not be statistically proven for all data. But a markedly reduced bio-availability or effectiveness was demonstrated with respect to preparation C.
在一项交叉试验中对三种左旋甲状腺素专利制剂进行了生物等效性测试。比较两种最常用的制剂,在服用制剂B(优甲乐)期间,两个亚组以及交叉计算中,基础促甲状腺激素(TSH)的血清浓度均显著高于制剂A(左甲状腺素亨宁),在其中一个亚组中促甲状腺激素释放激素(TRH)刺激后也是如此。在服用第三种制剂C(左甲状腺素,伊诺斯)期间,总甲状腺素(T4)和游离甲状腺素(fT4)的血清浓度显著低于制剂A,而基础和TRH刺激后的TSH水平在所有测量中均显著更高。尽管制剂B有劣势倾向,但对于所有数据,制剂A的更大有效性无法得到统计学证明。但制剂C的生物利用度或有效性明显降低。