中国工程科学
中國工程科學
중국공정과학
ENGINEERING SCIENCE
2014年
5期
39-46
,共8页
3-DR-IUD%临床实验%副反应%避孕效果
3-DR-IUD%臨床實驗%副反應%避孕效果
3-DR-IUD%림상실험%부반응%피잉효과
3-DR-IUD%clinical trials%side effects%contraceptive efficacy
为了观察新型立体式网状宫内节育器（3-DR-IUD）的避孕效果及副反应，将152例志愿受试者随机分为两组，即接受3-DR-IUD组和放置元宫药铜宫内节育器(2-D-IUD)组，每组各76例，常规放置3-DR-IUD和2-D-IUD。分别于术后1个月、3个月、6个月和12个月进行随访，了解放置宫内节育器（IUD）后副反应（如腹痛、腰痛、阴道出血持续时间及出血量、白带等）的发生率、带器妊娠率、IUD脱落率、因症取出率、续用率及避孕效果，并利用B超、X光腹部平片检查3-DR-IUD位置等。两组各76例均成功放置了IUD，术中均无明显疼痛。3-DR-IUD组术后出现白带增多、月经期延长、不规则出血、月经量增多及腰腹部疼痛等副反应6例(7.9%)，而2-D-IUD组出现31例（40.8%），两组比较差异有统计学意义(P<0.0001)。3-DR-IUD组无脱落，无带器妊娠者，3个月时因对硅橡胶过敏取出1例，12个月时终止率为1.3%，续用率为98.7%（75/76）；2-D-IUD组终止率为13.2%，续用率为86.8%（66/76），两组比较差异有统计学意义(P=0.009)。实验结果表明，3-DR-IUD具有很好的避孕效果，术后副反应轻微，可为育龄妇女提供新的、安全、高效的IUD。
為瞭觀察新型立體式網狀宮內節育器（3-DR-IUD）的避孕效果及副反應，將152例誌願受試者隨機分為兩組，即接受3-DR-IUD組和放置元宮藥銅宮內節育器(2-D-IUD)組，每組各76例，常規放置3-DR-IUD和2-D-IUD。分彆于術後1箇月、3箇月、6箇月和12箇月進行隨訪，瞭解放置宮內節育器（IUD）後副反應（如腹痛、腰痛、陰道齣血持續時間及齣血量、白帶等）的髮生率、帶器妊娠率、IUD脫落率、因癥取齣率、續用率及避孕效果，併利用B超、X光腹部平片檢查3-DR-IUD位置等。兩組各76例均成功放置瞭IUD，術中均無明顯疼痛。3-DR-IUD組術後齣現白帶增多、月經期延長、不規則齣血、月經量增多及腰腹部疼痛等副反應6例(7.9%)，而2-D-IUD組齣現31例（40.8%），兩組比較差異有統計學意義(P<0.0001)。3-DR-IUD組無脫落，無帶器妊娠者，3箇月時因對硅橡膠過敏取齣1例，12箇月時終止率為1.3%，續用率為98.7%（75/76）；2-D-IUD組終止率為13.2%，續用率為86.8%（66/76），兩組比較差異有統計學意義(P=0.009)。實驗結果錶明，3-DR-IUD具有很好的避孕效果，術後副反應輕微，可為育齡婦女提供新的、安全、高效的IUD。
위료관찰신형입체식망상궁내절육기（3-DR-IUD）적피잉효과급부반응，장152례지원수시자수궤분위량조，즉접수3-DR-IUD조화방치원궁약동궁내절육기(2-D-IUD)조，매조각76례，상규방치3-DR-IUD화2-D-IUD。분별우술후1개월、3개월、6개월화12개월진행수방，료해방치궁내절육기（IUD）후부반응（여복통、요통、음도출혈지속시간급출혈량、백대등）적발생솔、대기임신솔、IUD탈락솔、인증취출솔、속용솔급피잉효과，병이용B초、X광복부평편검사3-DR-IUD위치등。량조각76례균성공방치료IUD，술중균무명현동통。3-DR-IUD조술후출현백대증다、월경기연장、불규칙출혈、월경량증다급요복부동통등부반응6례(7.9%)，이2-D-IUD조출현31례（40.8%），량조비교차이유통계학의의(P<0.0001)。3-DR-IUD조무탈락，무대기임신자，3개월시인대규상효과민취출1례，12개월시종지솔위1.3%，속용솔위98.7%（75/76）；2-D-IUD조종지솔위13.2%，속용솔위86.8%（66/76），량조비교차이유통계학의의(P=0.009)。실험결과표명，3-DR-IUD구유흔호적피잉효과，술후부반응경미，가위육령부녀제공신적、안전、고효적IUD。
This study aimed at exploring a new 3-dimensional reticular intrauterine device (3-DR-IUD) composed of nitinol and silicone rubber and observing the contraceptive efficacy and side effects of the device in reproductive women. The frame of the 3-DR-IUD was con-structed with silicone rubber and nitinol wire. The 3-DR-IUD was placed into uterus in an outpa-tient procedure. One hundred and fifty-two women were divided equally into the 3-DR-IUD group (n=76) and the 2-dimensional intrauterine device (2-D-IUD) group (n=76,control group). Patient follow-ups were performed in 1~12 months post-operation. The side effects of intrauterine device (IUD),such as abnormal leucorrhea,menstrual flow changes in uterine bleeding profusely and pain,etc,were investigated. The pregnancy rate,expulsion rate,re-moval rate of IUD for medical reasons and the continuation rate were evaluated. The ultrasound and pelvic X-ray were carried out to examine IUDs. The results showed that two groups with 76 cases of each successfully placed IUD and there were no severe pain during the operation. The incidence of lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DR-IUD group (7.9 %,6/76) were significantly lower than that of the 2-D-IUD group (40.8 %,31/76) during the first 12 months for use of IUD (P<0.000 1). The preg-nancy rate,expulsion rate and take-off rate due to symptom were 0%,0%and 1.3%in 3-DR-IUD group,respectively,and 1 of 76 woman take-off 3-DR-IUD was due to allergy for silicon rubber. The continuation rate was 98.7%(75/76) in the 3-DR-IUD group,comparing with the 2-D-IUD group (86.8 %, 66/76) , the difference was significantly (P=0.009). Therefore , the 3-DR-IUD demonstrates long-term patient tolerability,satisfaction and efficacy as a contra-ceptive. The 3-DR-IUD appears to be a new,safe and effective devise of contraception.
