生物陶瓷宫内节育器的应用与安全性

Contraceptive effect and safety of a biological ceramic intrauterine device

背景:宫内放置节育器是一种应用十分广泛的避孕方法,可通过一定的机械刺激或者化学物质干扰等方式达到避孕的效果。目前,关于生物陶瓷的优良性能及其生物相容性等方面的研究较多,但关于其应用于宫内节育器的效果少见报道。目的:探讨应用生物陶瓷宫内节育器的避孕效果。方法:90只雌性大鼠,随机分为3组,每组30只,分别设为空白对照组、金属裸铜组、生物陶瓷组。将生物陶瓷宫内节育器与金属裸铜宫内节育器置入大鼠子宫中段,空白对照组不做任何处理。置器30 d后,按照雌雄比3∶1的方式,对30只雄性大鼠与3组雌性大鼠进行交配。孕14 d。每组随机取10只大鼠,记录3组置器侧子宫胚胎数和受孕动物数,并计算避孕率。余下大鼠中每组随机取10只大鼠,取出金属裸铜组、生物陶瓷组节育器,再次进行交配实验。交配后14 d记录3组置器侧子宫胚胎数和受孕动物数,计算怀孕率。置器60 d后,处死3组剩余的大鼠,进行肝、肾组织与子宫内膜组织学观察。结果与结论:(1)避孕情况:金属裸铜组和生物陶瓷组的置器侧子宫胚胎数和受孕动物数均显著低于空白对照组(P均<0.05),避孕率均达到100%;(2)生育能力恢复情况:空白对照组和生物陶瓷组的置器侧子宫胚胎数、受孕动物数以及生育能力恢复率均显著优于金属裸铜组(P均<0.05),空白对照组和生物陶瓷组之间差异均无显著性意义(P均>0.05);(3)子宫内膜组织形态学检查:生物陶瓷组可观察到腺体存在轻度扩张现象,腔内外均可观察到一定的中性粒细胞浸润,但程度较金属裸铜组相对较轻。各组大鼠肾、肝组织形态学检查均未出现异常;(4)结果表明,生物陶瓷宫内节育器与金属裸铜宫内节育器均可以获得理想的避孕效果,不会对大鼠的肾、肝组织产生异常影响。但生物陶瓷宫内节育器具有更好的生育力可逆性恢复能力,且对子宫内膜产生的刺激作用较轻。

BACKGROUND： Intrauterine device （IUD）, widely used for contraception, achieves contraceptive effect by mechanical stimulation or chemical interference. Biological ceramics have been reported to have good performance and biocompatibility, but its effect used for IUD is rarely reported. OBJECTIVE： To explore the contraceptive effect of biological ceramic IUDS. METHODS： Totally 90 female rats were randomly divided into three groups （n=30 per group）. The biological ceramic IUD and the bare copper IUD were respectively implanted into the middle of rat uterus and blank control group received no intervention. One month later, according to the male and female ratio of 3：1, 30 male rats were selected to mate with female rats in the three groups. At 14 days after mating, 10 female rats were randomly selected from each group to detect the number of embryos in the implanted side and the number of pregnant rats, and the contraceptive rate was calculated. Ten rats among the remaining rats in each group underwent removal surgery of IUD, and mated with male rats again. After 60 days, the remaining rats were sacrificed to observe the morphology of liver, kidney and uterus. RESULTS AND CONCLUSION： The number of uterine embryos and pregnant rats in the groups of biological ceramic and bare copper IUD was significantly lower than that in the blank control group （P 〈 0.05）, and the contraceptive rate reached 100% in the former two groups. The number of uterine embryos of implanted side and pregnant rats, and fertility recovery rate in the blank control and biological ceramic IUD groups were significantly higher than those in the bare copper IUD group （P 〈 0.05）, but no significant differences were found between blank control and biological ceramic groups （P 〈 0.05）. In the biological ceramic IUD group, there existed mild gland expansion, and visible some neutrophils both inside and outside the uterine cavity, but these phenomena were milder compared with the bare copper IUD group. No abnormal changes occurred in the rat kidney and liver. These results show that the biological ceramic IUD and bare copper IUD both can obtain the ideal contraceptive effect but make no damage to the rat kidney and liver. Especially, biological ceramic IUD holds better reversible recovery of fertility ability with less endometrial stimulation.