手术后口服小剂量米非司酮治疗子宫内膜异位症的近期疗效和副作用的初步观察

Mifepristone following conservative surgery in the treatment of endometriosis

目的 探讨保留生育功能或保留卵巢功能手术后服用小剂量米非司酮治疗子宫内膜异位症 (内异症 )的临床疗效、副反应及对生殖激素水平和骨代谢的影响。方法 米非司酮组 31例 ,予米非司酮 10mg口服 ,每日 1次 ;达那唑组 30例 ,予达那唑 2 0 0mg口服 ,每日 2～ 3次 ,均连续用药 3个月。观察两组症状、体征改善情况 ,用药后的副反应及用药 3个月时血清生殖激素水平和骨代谢生化指标的变化。结果 两组症状、体征缓解率相似。米非司酮组潮热、阴道出血、腰背疼痛、体重增加、痤疮等副反应发生率显著低于达那唑组 (P <0 0 5 )。用药 3个月时 ,米非司酮组血清促卵泡激素和黄体生成激素与达那唑组比较 ,差异无显著性 (P >0 0 5 ) ;米非司酮组雌二醇 (E2 )为 (2 0 4 9± 4 5 3)pmol/L ,保持在卵泡期水平 ,达那唑组为 (94 3± 33 0 )pmol/L ,为绝经后水平 ,两组比较 ,差异有极显著性 (P <0 0 1)。停药 13～ 15d ,米非司酮组E2 水平为 (12 2 1 6± 384 2 )pmol/L ,较用药前排卵期下降 ,但差异无显著性 (P >0 0 5 ) ,达那唑组为 (815 1± 376 0 )pmol/L ,明显下降 (P <0 0 5 )。停药当月黄体高峰期孕酮水平 ,米非司酮组为 (33 1± 5 6 )nmol/L ,与治疗前相似 ,而达那唑组为 (2 7 4± 4 9)nmol/L 。

Objective To compare the efficacy and safety of mifepristone and danazol after conservative surgery in the treatment of patients with endometriosis Methods Sixty one patients with endometriosis (RAFS stage Ⅰ～Ⅳ) after conservative surgery were treated orally either with mifepristone 10 mg/d (group M, n =31) or danazol 200 mg 2～3 times/d (group D, n =30) for 3 months Changes of symptoms and signs, serum reproductive hormone levels as well as side effects were assessed before and at the end of therapy Moreover, biochemical parameters of bone metabolism: urinary deoxypyridine /creatinine (UDpd/Cr),serum alkaline phosphatase (AKP) and bone gala protein (BGP) were also measured before and after treatments Results During treatment symptoms and signs were remarkbly relieved in both groups Side effects including hot flushes, irregular vaginal bleeding, back pain, weight gain and acne, were less commnly seen in group M as compared with group D Serum luteal hormone (LH), follicular stimulating homone (FSH) levels remained in the range of follicular phase in both groups So was serum estradiol (E 2) levels in group M[(204 9±45 3 ) pmol/L], but declined to postmenopausal level in group D [(94 3±33 0) pmol/L] About two weeks after discontinuation of the thrapy, serum E 2 levels [(1 221 6± 384 2) pmol/L] was not significantly different from the normal ovulatory range in group M, but significantly lower in group D [(815 1±376 0) pmo/L, P <0 05] So were the serum progesterone levels at mid luteal phase [(33 1±5 6) nmol/L Vs (27 4±4 9) nmol/L] There were no significant changes of biochemical parameters of bone metabolism before and at the end of treatment except significant increases of serum AKP and BGP in group D Conclusions Mifepristone is equally effective to danazol when combined with conservative surgery in the management of endometriosis with fewer side effects Serum E 2 levels remained in the range of follicular phase No impact on the bone turnover after 3 months of therapy was found