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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。
Forty adult healthy female Macaca mulatta adults were randomly divided into two groups. Drug monkeys every day of the day feeding compound 18 A 1 dose by weight, about twice the amount of women on the month. Continuous administration of 6 years, withdrawal observed for 4 years. Control monkeys were given no drug and kept under the same conditions for 10 years. 10 years has conducted a drug and oncology, cytogenetics and reproductive endocrinology and other aspects of the observation. The results showed that: the drug failed to induce malignant tumors in monkey; did not cause significant changes and damage in the endometrial ultrastructure of monkey; did not cause a statistically significant change in the frequency of chromosome aberration and SCE frequency; Monkeys ovulation was inhibited, withdrawal for a period of time, ovulation recovery, and fertility, indicating that long-term use of the drug is safe for rhesus monkeys.