匹多莫德的生殖毒性实验研究

目的研究匹多莫德(pidotimod,PDM)对实验大鼠在致畸敏感期的生殖毒性。方法健康Wis-tar雌性受孕大鼠,于受孕后5~15d灌胃给予200、4008、00mg/kg的匹多莫德,至受孕后20d处死动物,检测各项指标,对匹多莫德的致畸敏感期生殖毒性进行评价。结果口服匹多莫德200、4008、00mg/kg后,匹多莫德对受孕大鼠的黄体数、着床率、胎儿数、胎儿体重及性别、胎儿内脏及骨骼检查等各项检测指标均无明显变化,同对照组比较差异无统计学意义。结论匹多莫德在本实验所用剂量时无致畸作用,这种用于大鼠的剂量,相当于该药的人用最大剂量的8倍、16倍、32倍,所以人用此药是安全的。

Experiment study on reproductive toxicity of pidotimod

ObjectiveTo study the reproductive toxicity of pidotimod on the malformations in rats.MethodsWistar female rats were treated with three dosages of pidotimod (200,400,800 mg/kg) from day 5 through day 15 of pregnancy.On the day 20 of pregnancy the animals were killed,and ovaries and uteri were removed to undergo the determination of the number of corpora lutea,number and distribution of intrauterine deaths,individual fetal weight and sexual abnormalities.Effects of pidotimod on the reproductive toxicity were evaluated.ResultsPidotimod had no toxic effects in a dosage up to 200800 mg/kg by oral route in the female rats on the day 20 of pregnancy.Compared with the control group,pidotimod did not change the number of corpora lutea,number of implantation,number of alive and dead fetuses,sex of fetuses,fetal weight,malformations and foetus anomalies.ConclusionPidotimod in its three dosages of 200,400 and 800 mg/kg does not induce malformation on the reproduction of rats.These dosages correspond to 8.0 times,16 times and 32 times of the maximum dosages for human,so pidotimod is safe in clinical use.