›› 2011, Vol. 23 ›› Issue (5): 388-391.doi: 10.3969/j.issn.1004-616x.2011.05.016

• 检测研究 • 上一篇    下一篇

含铜宫内节育器的致畸作用评价

叶向锋,刘芷含,张淑敏,王灵芝,王爱平,魏金锋*   

  1. 中国医学科学院北京协和医学院新药安全评价研究中心,北京 100050
  • 收稿日期:2011-01-13 修回日期:2011-04-28 出版日期:2011-09-30 发布日期:2011-09-30
  • 通讯作者: 魏金锋

Evaluation of the teratogenicity of copper-bearing intrauterine device

YE Xiang-feng,LIU Zhi-han,ZHANG Shu-min,WANG Ling-zhi,WANG Ai-ping,WEI Jin-feng*   

  1. New Drug Safety Evaluation Center in Chinese Academy of Medical Sciences & Pelcing Union Medical College, Beijing 100050, China
  • Received:2011-01-13 Revised:2011-04-28 Online:2011-09-30 Published:2011-09-30
  • Contact: WEI Jin-feng

摘要: 目的: 评价含铜宫内节育器对SD大鼠的致畸作用。方法:试验设4组,分别为溶剂对照组(生理盐水)、给药组含铜宫内节育器浸提液,浸提比例分别为0.1、0.3和0.9 g/ml),每组24只孕鼠。各组于妊娠期第6~15天静脉注射给予受试物,于孕第20天时处死孕鼠,观察孕鼠一般状况、体质量、活胎数、胎鼠外观、骨骼及内脏等。结果:受试组孕鼠孕期的体质量增长、窝质量、黄体数、着床数、活胎数、胎鼠的身长、尾长等指标与溶剂对照组相比,差异均无统计学意义(P>0.05)。但0.9 g/ml组的吸收胎率(7.3%)较对照组(3.4%)明显升高(P<0.05)。胎鼠外观、内脏及骨骼检查均未见畸形。结论:在本实验条件下,SD大鼠静脉注射含铜宫内节育器样品浸提液(0.1~0.9 g/ml),仅0.9 g/ml时有早期胚胎发育毒性,各浓度均未见母体毒性与致畸性。

关键词: 宫内节育器, 发育毒性, 致畸性

Abstract: OBJECTIVE: To study the teratogenicity of copper-bearing intrauterine device(Cu-IUD) using Sprague-Dawley rats. METHODS: Timed-pregnant rats were divided into 4 groups (24 for each group),including three treatment groups (0.1,0.3,and 0.9 g/ml,IV) and vehicle control group (NS,IV.). Rats received extract solution of Cu-IUD or vehicle on gestational days (GD) 6 through 15. Body weight and clinical signs of maternal rats were monitored at regular intervals throughout gestation. At termination (GD 20),pregnant females were evaluated for clinical status and gestational outcome;live fetuses were examined for external appearance,visceral,and skeletal malformation and variations. RESULTS:There were no maternal deaths and no dose-related clinical signs. Maternal weight gain,liver weight,number of corpora lutea,implantation and live fetuses,body length and tail length of fetuses were not affected. IUD did not affect prenatal viability or incidences of fetal malformations or variations. Percent of resorbed embryos in high dose group was significantly higher than that in control group. CONCLUSION:No maternal toxicity and teratogenicity,but toxic effects in early embryo development were found when rats were treated with extract solution of Cu- IUD at a dose of 0.9 g/ml.

Key words: copper-bearing intrauterine device, toxicity on development, teratogenicity