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本文为欧洲多中心平行的大样本研究,采用双盲双安慰剂设计,按2:1随机设置丹那唑(DA)对照组。受试者皆经腹腔镜(lap)或剖腹探查确诊为子宫内膜异位症(Em),月经规则无服药禁忌。每名同时鼻喷 nafarelin acetate(NA)200mg 每日2次(较北美剂量小1倍)及口服安慰剂,每日3次或口服丹那唑200mg 每日3次及鼻喷安慰剂每日2次。疗程6个月。按规定观察临床、腹腔镜及实验室指标。判断疗效指标为 lap 下 AFS 评分及分级、Em 症状(痛经、性交痛、盆腔痛)及体征(结节压痛)严重度评分,血清雌二醇(E_2) 水平及闭经。安全性指标为临床副反应及实验室指标。
In this multicenter multicenter European large sample study, a double-blind, double-placebo design was used and a 2: 1 randomized, controlled-dose ranitidine (DA) control was used. Subjects were diagnosed as endometriosis (lam) or laparotomy by lap or laparotomy, and the menstrual rule was not contraindicated. Each nafarelin acetate (NA) 200 mg twice daily (1-fold less than the North American dose) and oral placebo 3 times daily or oral danazol 200 mg 3 times daily and nasal spray placebo 2 times daily . Course of 6 months. According to the provisions of clinical observation, laparoscopy and laboratory indicators. The indexes of efficacy were evaluated as the AFS score and grading of lap, the severity of Em symptoms (dysmenorrhea, painful intercourse, pelvic pain) and signs (nodule tenderness), the level of serum estradiol (E2) and amenorrhea. Safety indicators for the clinical side effects and laboratory indicators.