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采用多中心随机化临床试验,共接纳1705例合格受术对象,其中871例使用复方苯酚糊剂(PAP),834例使用显影苯酚胶浆(PM)。观察结果表明,术后发热率两组分别为8.0％和4.4％,组间差别有统计学意义。发热主要因药物反应所致。两组附件感染率分别为2.3‰和1.2‰。盆腔化学性腹膜炎发生率分别为1.1‰和2.4‰。未见子宫穿孔、盆腔脓肿和宫外孕。术后伴有轻度腹痛者分别占33.6％和30.8％,偶见重度者。腹痛与药物在卵管内充盈的长度和引起的组织反应范围明显有关。腰痛情况与腹痛相似。术后有症状者,多数在短时间内缓解,少数需对症治疗。术后,轻度子宫出血者两组分别为23.2％和18.0％。出血与术时取出节育器明显有关。本术对受术妇女月经无明显影响。五年随访做妇科检查和宫颈细胞学检查无阳性发现,也未查见与绝育药物主要成份有关的潜在疾患。研究表明,本术安全可靠。为进一步降低副反应和并发症的发生,研究机构应着重于现有药物配方的改进,并在保证效果的基础上,尽量减少阿的平含量。主管部门应重新估价这一技术,并加强施术管理和施术者培训,制定全国统一的操作规范,确保服务质量。本术现已得到广泛使用,有很大的发展前景,各界应予更大的关注。
In a multicenter randomized clinical trial, a total of 1,705 eligible recipients were enrolled. Of these, 871 received compound phenol paste (PAP) and 834 received developmental phenol glue (PM). Observations showed that postoperative fever rate was 8.0% and 4.4% in both groups, the difference between the two groups was statistically significant. Fever due to drug reactions. Infection rates of the two groups were 2.3 ‰ and 1.2 ‰, respectively. The incidence of pelvic chemical peritonitis was 1.1 ‰ and 2.4 ‰. No uterine perforation, pelvic abscess and ectopic pregnancy. Postoperative patients with mild abdominal pain were 33.6% and 30.8%, occasionally severe. Abdominal pain and drug filling in the length of the ovule and the tissue reaction caused by the apparent range. Low back pain and abdominal pain similar. Postoperative symptoms, the majority of relief in a short time, a few need symptomatic treatment. After surgery, mild uterine bleeding in both groups were 23.2% and 18.0%. Bleeding was significantly associated with the removal of the IUD. The operation of women with menstrual no significant effect. Five-year follow-up gynecological examination and cervical cytology no positive findings, nor the potential problems associated with the main components of sterilized drugs. Research shows that this technique is safe and reliable. To further reduce the incidence of side effects and complications, research institutes should focus on improving existing drug formulations and, on the basis of the assured effect, minimize the level of alpha. Authorities should re-evaluate this technology, and strengthen the surgical management and training of practitioners to develop a unified national practices to ensure quality of service. This technique has now been widely used, with great development prospects, all sectors should pay more attention.