可复性镍钛记忆合金硅橡胶输卵管避孕栓的临床观察

摘要

目的:观察镍钛记忆合金硅橡胶输卵管避孕栓(ITD - NTSR)的安全性、有效性及可复性.方法:36名受试者在体检合格及签署知情同意书的情况下,宫腔镜下双侧输卵管各放置1个ITD - NTSR避孕,分别于术后1、3、6、9、12、15、18、21、24个月进行随访,了解腹痛、腰痛、阴道出血持续时间及出血量、白带情况,尿妊娠试验,B超、X光腹部平片检查ITD - NTSR位置.6个月时有16例受试者进行子宫输卵管造影(HSG)检查.结果:36例受试者双侧均成功放置了ITD - NTSR,放置1～24个月后未出现腰、腹痛及阴道不规则出血等.共观察随访810个妇女月,2例于置器第9个月和1例于第23个月单侧ITD - NTSR脱落.1例ITD - NTSR脱落后妊娠,无异位妊娠发生；2例栓子脱落者HSG提示双侧输卵管通畅.栓子脱落率为4.2％ (3/72),避孕有效率为91.7％ (33/36).结论:ITD - NTSR具有较好的避孕效果,无术后腰、腹痛、阴道不规则出血、带器妊娠等不良反应,为育龄妇女提供了新的、安全、有效及可逆的避孕节育方法.%Objective: To explore the safety, the contraceptive effectiveness and reversibility of intra - tubal device with nickel- titanium and silicone - rubber (ITD - NTSR). Methods: Thirty - six women were recruited into this study after physical examination and informed consent. A ITD - NTSR was inserted into the fallopian tube under hysteroscopy. The follow - up was carried out for abdominal and back pain, vaginal bleeding, urine pregnancy test, ultrasound and X - ray examinations 1 month and 3, 6, 9, 12, 15, 18, 21, 24 months after ITD - NTSR insertion. At the sixth month after ITD - NTSR insertion, hystero-salpingography (HSG) was performed in 16 women. Results; The ITD -NTSR was placed successfully into bilateral tubes of 36 women. Severe abdominal and back pain as well as abnormal vaginal bleeding were not found within 24 months after ITD - NTSR insertion. The expulsion of ITD - NTSR from the unilateral tube was found in 3 women at the 6th and 23rd month after ITD - NTSR insertion, respectively, and one of them became pregnant. No ectopic pregnancy was found. The expulsive rate of the ITD - NTSR was 4. 2% (3/72) , and the continuation rate was 91.7% (33/36). In 2 women with expulsion of the ITD- NTSR, bilateral tubal patency was confirmed by HSG. Conclusion; The ITD - NTSR could be a new, safe, effective and reversible contraceptive tool.