CAJ | 학술논문

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。
목적：관찰신식입체궁강형망상궁내절육기（3D UR-IUD）적피잉효과급불량반응。방법지원수시자안수자표법수궤분위량조，접수3D UR-IUD조화방치원궁약동궁내절육기（2D-IUD）조，각66례。분별우술후1、3、6화12개월진행수방，료해량조방치IUD후적불량반응、대기임신솔、IUD탈락솔、인증취출솔、속용솔급피잉효과，B초、X광복부평편검사3D UR-IUD위치。결과량조66례균성공방치IUD，술중균무명현동통。3D UR-IUD조、2D-IUD조불량반응발생솔분별위6.1％、40.9％，차이유통계학의의。3D UR-IUD조무탈락，무대기임신자，속용솔위100.0％，2D-IUD조종지솔위13.6％，속용솔86.4％，차이균유통계학의의。결론3D UR-IUD구유흔호적피잉효과，술후불량반응경미，가위육령부녀제공신적、안전、고효적IUD。
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.