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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 observe the safety, efficacy and refolding of NiTi silicone rubber tubal contraception (ITD-NTSR). Methods: Thirty-six subjects underwent one ITD-NTSR contraceptive procedure under bilateral hysteroscopy with qualified medical examination and signed informed consent. The contraception was performed at 1,3,6,9,12,15 , 18,21,24 months were followed up for abdominal pain, lumbago, duration of vaginal bleeding and bleeding, vaginal discharge, urine pregnancy test, B ultrasound, X-ray examination of the ITD-NTSR position. 16 subjects underwent hysterosalpingography (HSG) at 6 months. RESULTS: Twenty-six subjects successfully placed ITD-NTSR on both sides, and no waist, abdominal pain and vaginal irregular bleeding occurred after 1 to 24 months of placement. A total of 810 women were followed up during the follow-up period. Two patients underwent stent placement at the 9th month and one at 23 months after unilateral ITD-NTSR shedding. One case of pregnancy with ITD-NTSR shedding occurred, and no ectopic pregnancy occurred. Two cases of HSG with emboli shedding showed bilateral tubal patency. The rate of embolism was 4.2% (3/72), and the effective rate of contraception was 91.7% (33/36). CONCLUSION: ITD-NTSR has good contraceptive effect and no adverse reactions such as postoperative lumbar, abdominal pain, irregular vaginal bleeding and pregnancy with a device. It provides a new, safe, effective and reversible contraceptive method for women of childbearing age.