Hornstein M D, Yuzpe A A, Burry K A, Heinrichs L R, Buttram V L, Orwoll E S
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Fertil Steril. 1995 May;63(5):955-62.
To determine the effectiveness of a 3-month course of nafarelin and, furthermore, to determine the long-term efficacy in patients treated for 3 and 6 months with nafarelin for symptoms associated with endometriosis.
Double-blind, prospective, multicenter, clinical trial.
Fifteen reproductive endocrine clinics throughout the United States.
One hundred seventy-nine women with pelvic pain and endometriosis.
Patients were assigned randomly to 3 months nafarelin followed by 3 months of placebo (n = 91) or to 6 months nafarelin (n = 88) in a prospective, randomized, double-blind multicenter trial. Patients were followed for 12 months after cessation of therapy.
Patient-reported pain scores and physician-reported physical exam findings.
Pain scores dropped significantly by the end of treatment in both groups. Symptoms recurred in both groups, and pain scores gradually increased during the follow-up period but always remained below baseline in both groups. No significant difference in efficacy was noted between the groups. A total of 26% of patients in each group underwent retreatment for recurrent symptoms.
A 3-month course of nafarelin provided effective symptom relief for endometriosis. One year follow-up demonstrated continued pain relief but with gradual return of symptoms.
确定那法瑞林3个月疗程的有效性，并进一步确定接受那法瑞林治疗3个月和6个月的患者针对子宫内膜异位症相关症状的长期疗效。
双盲、前瞻性、多中心临床试验。
美国各地的15家生殖内分泌诊所。
179名患有盆腔疼痛和子宫内膜异位症的女性。
在一项前瞻性、随机、双盲多中心试验中，患者被随机分配接受3个月那法瑞林治疗，随后3个月接受安慰剂治疗（n = 91），或接受6个月那法瑞林治疗（n = 88）。治疗停止后对患者进行12个月的随访。
患者报告的疼痛评分和医生报告的体格检查结果。
两组治疗结束时疼痛评分均显著下降。两组症状均复发，随访期间疼痛评分逐渐升高，但两组均始终低于基线水平。两组之间在疗效上未观察到显著差异。每组共有26%的患者因症状复发接受了再次治疗。
那法瑞林3个月疗程可为子宫内膜异位症提供有效的症状缓解。一年随访显示疼痛持续缓解，但症状逐渐复发。
