摘要
目的：观察新式立体宫腔形网状宫内节育器（3D UR-IUD）的避孕效果及不良反应。方法志愿受试者按数字表法随机分为两组，接受3D UR-IUD组和放置元宫药铜宫内节育器（2D-IUD）组，各66例。分别于术后1、3、6和12个月进行随访，了解两组放置IUD后的不良反应、带器妊娠率、IUD脱落率、因症取出率、续用率及避孕效果，B超、X光腹部平片检查3D UR-IUD位置。结果两组66例均成功放置IUD，术中均无明显疼痛。3D UR-IUD组、2D-IUD组不良反应发生率分别为6.1％、40.9％，差异有统计学意义。3D UR-IUD组无脱落，无带器妊娠者，续用率为100.0％，2D-IUD组终止率为13.6％，续用率86.4％，差异均有统计学意义。结论3D UR-IUD具有很好的避孕效果，术后不良反应轻微，可为育龄妇女提供新的、安全、高效的IUD。
Objective To explore the efficacy and safety of a new uterine cavity-shaped 3-dimensional,reticular intrauterine device （3-DUR-IUD）. Methods The 3-DUR-IUD was made from nitinol and silicone rubber.One hundred and thirty-two women were randomly divided into the 3-DUR-IUD group （n =66 ） （3-DUR-IUD group ） or the 2-dimensional IUD （2-D-IUD）group （n=66）（2-D-IUD control group）.Patient follow-ups were performed at 1st,3rd, 6th,and 12th of month post-operation.Side effects such as abnormal leucorrhea,menstrual flow changes in uterine bleeding profusely and pain were recorded.Pregnancy rate,expulsion rate,removal rate of IUD for medical reasons and the continuation rate were evaluated.Ultrasound and pelvic X-ray were used to examine IUDs. Results IUDs were successfully placed in all women in both groups and there were no severe pain during the operation.The rate of the lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DUR-IUD group （6.1%） was significantly lower than that of the 2-D-IUD group （40.9%）during the first 12 months of IUD use.The pregnancy rate,expulsion rate and take-off rate due to symptom were 0,0 and 0 in the 3-DUR-IUD group,respectively.The continuation rate was 100.0% in the 3-DUR-IUD group as opposed to 86.4% in the 2-D-IUD group. Conclusion The 3-DUR-IUD demonstrates long-term patient tolerability,satisfaction and efficacy as a contraceptive device.
出处
《中国生育健康杂志》
2014年第4期305-310,共6页
Chinese Journal of Reproductive Health
基金
山东省人口和计划生育科研计划项目（2009-1）
关键词
新式立体宫腔形宫内节育器
元宫药铜宫内节育器
不良反应
避孕
Cavity-shaped 3-dimensional reticular intrauterine device （3-DUR-IUD）
Clinical trial
Sideeffects
Contraceptive efficacy
