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

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10 mg口服,每日1次;达那唑组30例,予达那唑200 mg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<0.05).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>0.05);米非司酮组雌二醇(E2)为(204.9±45.3) 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<0.01).停药13～15 d,米非司酮组E2水平为(1 221.6±384.2) pmol/L,较用药前排卵期下降,但差异无显著性(P>0.05),达那唑组为(815.1±376.0) pmol/L,明显下降(P<0.05).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(27.4±4.9) nmol/L,显著降低(P<0.01),两组间差异有显著性(P<0.05).用药3个月时,米非司酮组尿脱氧吡啶啉/尿肌酐(UDpd/Cr)、血碱性磷酸酶(AKP)和骨钙素(BGP)与用药前比较,差异均无显著性(P>0.05);达那唑组血AKP为(54.0±10.7) U/L,BGP为(7.7±1.9) μg/L,较用药前明显升高(P<0.01),而UDpd/Cr水平无显著变化(P>0.05).米非司酮组停药后基础体温上升和月经复潮时间较达那唑组为短.结论手术后加用米非司酮可明显改善患者症状和体征,疗效与达那唑类似,但副反应明显减少.10 mg/d米非司酮3个月治疗可使血清E2保持在卵泡期水平,且对骨代谢无明显影响.

Mifepristone following conservative surgery in the treatment of endometriosis

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 (E2) 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 E2 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 E2 levels remained in the range of follicular phase. No impact on the bone turnover after 3 months of therapy was found.