PROSPECTIVE RANDOMIZED DOUBLE-BLIND TRIAL OF 3 VERSUS 6 MONTHS OF NAFARELIN THERAPY FOR ENDOMETRIOSIS-ASSOCIATED PELVIC PAIN
PROSPECTIVE RANDOMIZED DOUBLE-BLIND TRIAL OF 3 VERSUS 6 MONTHS OF NAFARELIN THERAPY FOR ENDOMETRIOSIS-ASSOCIATED PELVIC PAIN
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DOI：
10.1016/s0015-0282(16)57530-x
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发表时间：
1995-05-01
影响因子：
6.7
通讯作者：
ORWOLL, ES
中科院分区：
文献类型：
--
作者：
HORNSTEIN, MD;YUZPE, AA;ORWOLL, ES
目的：为了确定3个月疗程的那法瑞林的有效性，并进一步确定用那法瑞林治疗3个月和6个月的患者对子宫内膜异位症相关症状的长期疗效。设计：双盲，前瞻性，多中心，临床试验。设置：美国15个生殖内分泌诊所。患者：179名盆腔疼痛和子宫内膜异位症妇女。干预措施：在一项前瞻性、随机、双盲、多中心试验中，患者被随机分配到3个月的那法瑞林组，随后是3个月的安慰剂组（n = 98）或6个月的那法瑞林组（n = 88）。患者被随访12个月后停止therapy.Main结果Measures：患者报告的疼痛评分和医生报告的体检findings.Results：疼痛评分显着下降，在两组治疗结束。两组的症状均复发，随访期间疼痛评分逐渐增加，但始终低于基线水平。两组间疗效无显著差异。每组中共有26%的患者进行了再治疗复发symptoms.Conclusions：为期3个月的那法瑞林提供了有效的症状缓解子宫内膜异位症。一年的随访显示疼痛持续缓解，但症状逐渐恢复。
Objectives: 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.Design: Double-blind, prospective, multicenter, clinical trial.Setting: Fifteen reproductive endocrine clinics throughout the United States.Patients: One hundred seventy-nine women with pelvic pain and endometriosis.Interventions: Patients were assigned randomly to 3 months nafarelin followed by 3 months of placebo (n = 98) 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.Main Outcome Measures: Patient-reported pain scores and physician-reported physical exam findings.Results: 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.Conclusions: 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.