新型镍钛记忆合金硅橡胶立式网状宫内节育器研制及大鼠避孕研究  

Study on the Contraceptive Effect of New Three-dimensional and Reticular Intrauterine Device with Nickel-titanium and Silicone Rubber in Rats

作　　者：邱毅 张美华 于玲 许观照 李欣迎 王磊光 

机构地区：[1]山东省计划生育科学技术研究所优生技术重点实验室,济南250002

出　　处：《国际生殖健康／计划生育杂志》2013年第2期80-83,共4页Journal of International Reproductive Health/Family Planning

基　　金：山东省计划生育科学技术研究项目(2009-1)

摘　　要：目的:研制新型镍钛记忆合金硅橡胶立式网状宫内节育器(new three-dimensional andreticular intrauterine device,NTDR-IUD),并观察其对大鼠的避孕效果。方法:NTDR-IUD所用材料为镍钛记忆合金丝,编织成网状支架,外包硅橡胶(弹性聚硅酮类)。成年Wistar大鼠90只随机分为3组各30只,实验组经腹暴露子宫后将NTDR-IUD放入大鼠子宫内,假手术组插入放置器后不放置NTDR-IUD,非手术组不做手术。术后半个月开始与雄鼠合笼(按雌鼠∶雄鼠=2∶1的比例),并观察避孕效果(分为术后1,2,3,4,5,6个月);术后3个月实验组未妊娠,10只雌鼠取出NTDR-IUD,术后半个月与雄鼠合笼,观察妊娠情况,其他2组各取10只进行相同实验观察。结果:研制出人用和实验动物用NTDR-IUD,人用NTDR-IUD为三维立体网状结构,心形或倒梨形;动物用NTDR-IUD为螺旋状结构。放置NTDR-IUD后与雄鼠合笼实验组30只雌鼠在术后1,2,3个月后均未妊娠,未取出NTDR-IUD的20只雌鼠继续观察到术后4,5,6个月时,也无妊娠发生,X线平片均可见子宫内的NTDR-IUD;术后1个月,假手术组有28只妊娠,平均每只产(9.6±1.0)只鼠仔,非手术组有29只妊娠,平均每只产(9.8±1.2)只鼠仔,实验组与假手术组和非手术组比较,妊娠数和出生鼠仔数差异均有统计学意义(P<0.01)。实验组10只鼠取出NTDR-IUD后1个月均生育鼠仔,平均每只产鼠仔(9.5±1.3)只,假手术组及非手术对照组10只雌鼠都生育鼠仔,2组平均每只产鼠仔均为(9.9±1.5)只,2组出生鼠仔数与实验组比较差异均无统计学意义(P>0.05)。结论:动物实验显示新型立体IUD具有很好的避孕效果,可能为育龄人群提供一种新的避孕节育器械。Objective: To develop a new three-dimensional and reticular intrauterine device(NTDRIUD) with nickel-titanium(Ni-Ti) and silicone rubber,and to observe its contraceptive effect in rats.Methods:The materials of NTDR-IUD were nitinol wire and silicone rubber.Frame surface was coated by a layer of silicone rubber.Ninety Wistar rats were equally divided into three groups,the test group(placing NTDR-IUD),the surgical control group(operation but no placing NTDR-IUD) and the non-surgical control group.NTDR-IUD was placed into uterus using inserter by lower abdominal incision.After 2 weeks,female rats of three groups were caged together with male rats(female∶male=2∶1).The contraceptive effects of NTDR-IUD were observed at post-operation 1,2,3,4,5 and 6 months.Ten female rats of the test group were removed the NTDR-IUD from bilateral uterine horns post-operation 3 months.After 2 weeks of removement,these 10 rats and 20 rats from two control groups were caged together with male rats.Results:NTDR-IUD was successfully developed for the three-dimensional and reticular structure.The shape of NTDR-IUD was heart-shaped or inverted pear-shaped.The shape of NTLDR-IUD for animals was spiral structure.After 1,2 and 3 months placing NTDR-IUD,there were not any pregnant,NTDR-IUD were detected by X-ray.There was no pregnancy in 20 female rats of the test group in following 4,5 and 6 months.In the sham operation group,28 of 30 rats were pregnant with average of 9.6±1.0 natal baby-rats per female rat.In the non-surgical control group,29 of 30 rats were pregnant with the average of 9.8±1.2 natal baby-rats.There were significant difference in the number of pregnant rats and natal baby-rats between the test group,the sham operation group and the non-surgical control group(P<0.01).In the test group,10 rats were pregnant with the average of 9.5 ±1.3 baby-rats after removed the NTDR-IUD,and 10 rats were pregnant with the average of 9.9±1.5 baby-rats in the sham operation group and the non-surgical control group.There were no significan

关 键 词：宫内避孕器 镍 钛 弹性聚硅酮类 大鼠 Wistar 避孕 动物实验 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]