国际生殖健康/计划生育杂志

国际生殖健康/计划生育 ›› 2013, Vol. 32 ›› Issue (2): 80-83.

• 论著 • 上一篇    下一篇

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

邱 毅, 张美华, 于 玲, 许观照, 李欣迎, 王磊光   

  1. 250002 济南，山东省计划生育科学技术研究所优生技术重点实验室
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2013-03-15 发布日期:2013-03-15
  • 通讯作者: 王磊光

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

QIU Yi，ZHANG Mei-hua，YU Ling，XU Guan-zhao，LI Xin-ying，WANG Lei-guang   

  1. Key Laboratory for Improving Birth Outcome Technique，Shandong Provincial Institute of Science and Technology for Family Planning，Jinan 250002，China
  • Received:1900-01-01 Revised:1900-01-01 Published:2013-03-15 Online:2013-03-15
  • Contact: WANG Lei-guang

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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 and reticular 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。

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

Abstract: Objective： To develop a new three-dimensional and reticular intrauterine device （NTDR-IUD） 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 significant difference in the number of natal baby-rats between the sham operation group，the non-surgical control group and the test group（P>0.05）. Conclusions：This three-dimensional and reticular IUD has a good contraceptive effect for female rats，and it may be used as a new contraceptive device for women in future.

Key words: Intrauterine devices, Nickel, Titanium, Silicone elastomers, Rats, wistar, Contraception, Animal experimentation