复方18甲女用长效口服避孕药对恒河猴的远期安全性研究

选用40例成年健康雌性恒河猴(Macaca mulatta)为实验对象,随机将猴均分为两组。服药猴每月定日喂复方18甲1次,剂量按体重计算,约为妇女月用量的两倍。连续给药6年,停药观察4年。对照猴不给药,在相同条件下饲养观察10年。10年内先后进行了药物与肿瘤学、细胞遗传学和生殖内分泌学等方面的观察。结果表明:该药未能诱发猴的恶性肿瘤;没有造成猴子宫内膜超微结构的明显变化和损伤;不引起猴淋巴细胞染色体的畸变率和SCE 频率发生有统计学意义的改变;服药期间猴的排卵被抑制,停药一段时间后,排卵恢复,并能生育,说明恒河猴长期用该药是安全的。

A STUDY ON THE CHRONIC TOXICITY OF THE FEMALE ORAL LONG-ACTING CONTRACEPTIVE(NORGESTREL COMPOSITA)IN RHESUS MONKEY(MACACA MULATA)

40 healthy female rhesus monkeys were selected to be the object for experimentation.Theywere devided into two groups randomly.To the monkeys of the testing group two timesthe dose of Norgestrel Composita for adult woman was administered monthly to each animalfor six years,with 4 additional years of observation after termination of medication.Thecytogenetics and reproductive endocrinology of this drug were observed.Malignanttumor,significant ultramicrostructural change or damage of endometrium,statisticallysignificant change of SCE frequency and teratogenic incidence of chromosomes oflymphocytes were not found in this experiment.Ovulation of the female monkeyshad been inhibited but recovered after termination of medication for a period of timeand the females were able to bear newborn.The results indicate that NorgestrelCompositais safe in use.