缓慢释放孕酮宫内节育器的体内释药研究及对垂体—卵巢轴影响的探讨

本文依据雌性家兔及人体内使用9%乙烯醋酸乙烯(9%Ethylene Vinyl Acetate,简称EVA)共聚物作为释药系统,含一定量孕酮的宫内节育器,经过使用不同时间后分别取出测定剩余的孕酮量,观察本释药系统在体内的药物释放情况。测定结果证明家兔体内释放符合零级动力学,即恒速释放,释放速度为46.6μg/cm~2/天。在人体内也达到恒速释放,释药速度为29μg/cm~2/天。此外对四名育龄妇女进行上环前一个周期及上环后九个月至一年的基础体温、宫颈粘液、阴道脱落细胞成熟指数及血清促黄体生成激素、促卵泡激素、雌二醇和孕酮的放射免疫测定的系统纵向观察,结果证明受试者上环后每个周期均有排卵,释放孕酮量为29μg/cm~2/天的宫内节育器对机体垂体-卵巢轴无显著影响。

IN VIVO STUDY OF THE RELEASE RATE OF INTRAUTERINE DEVICE WITH PROGESTERONE DELIVERY SYSTEM AND ITS EFFECTS ON PITUITARY-OVARIAN AXIS

IUDs incorporated with an intrauterine progesterone delivery system were insertedseparately in rabbits and fertile women.The rods and IUDs were removed after differentperiods of insertion.From the residual amounts of progesterone in rods or IUDs,the releaserates of progesterone determined were 46.6ug/cm~2/day in rabbits and 29ug/cm~2/day inwomen.It was also proved that this system had a constant release rate.In addition,4 fertile women using this delivery system for 9 to 12 months were studiedto sce if there had occurred changes in basal body temperature,cervical mucus,vaginal cell maturation index and serum levels of LH,FSH,estradiol and progesterone byradio immuno assay.The results suggested that there was no effect on pituitary-ovarianaxis.Ovulation was observed in each cycle after insertion of this device.