Parazzini F, Fedele L, Busacca M, Falsetti L, Pellegrini S, Venturini P L, Stella M
Istituto di Ricerche Farmacologiche Mario Negri, Università di Milano, Italy.
Am J Obstet Gynecol. 1994 Nov;171(5):1205-7. doi: 10.1016/0002-9378(94)90133-3.
Our purpose was to investigate the efficacy of postsurgical treatment with nafarelin in women with advanced endometriosis.
Eligible for trial were women < or = 38 years old with unexplained infertility with or without chronic pelvic pain and stage III or IV endometriosis according to the American Fertility Society, revised, classification who underwent laparotomy as first surgical treatment for debulking or radical surgery of endometriotic lesions. Patients were assigned according to a randomization list to nasal nafarelin, 400 micrograms/day (36 subjects) or placebo nasal spray (39 subjects) for 3 months. Pelvic pain was assessed before first surgery and at the 12-month follow-up visit in women with pelvic pain by means of a multidimensional score system and a 10-point linear pain scale.
No marked differences in pain scores emerged among women allocated to different treatments. The mean reduction of the multidimensional score was 3.6 and 4.0, respectively, in women allocated to nafarelin and placebo and of the 10-point linear scale scores was 7.0 and 6.9. These differences were not statistically significant. Within 1 year from randomization, of the 36 women allocated to nafarelin and the 39 allocated to placebo, seven (19%) and seven (18%), respectively, became pregnant.
This study suggests that medical treatment with nafarelin does not markedly improve pelvic pain and short-term reproductive prognosis in women with stages III and IV endometriosis.
我们的目的是研究那法瑞林对晚期子宫内膜异位症女性患者术后治疗的疗效。
年龄小于或等于38岁、患有不明原因不孕症（伴有或不伴有慢性盆腔疼痛）且根据美国生育协会修订分类为III期或IV期子宫内膜异位症的女性符合试验条件，她们接受剖腹手术作为对子宫内膜异位病变进行减瘤或根治手术的首次手术治疗。患者根据随机列表被分配接受鼻用那法瑞林，400微克/天（36名受试者）或安慰剂鼻喷雾剂（39名受试者），为期3个月。对于有盆腔疼痛的女性，在首次手术前以及12个月随访时通过多维评分系统和10分线性疼痛量表评估盆腔疼痛情况。
分配到不同治疗组的女性疼痛评分没有显著差异。分配到那法瑞林组和安慰剂组的女性多维评分平均降低分别为3.6和4.0，10分线性量表评分分别为7.0和6.9。这些差异无统计学意义。随机分组后1年内，分配到那法瑞林组的36名女性和分配到安慰剂组的39名女性中，分别有7名（19%）和7名（18%）怀孕。
本研究表明，那法瑞林药物治疗对III期和IV期子宫内膜异位症女性的盆腔疼痛和短期生殖预后没有明显改善。
