仙灵骨葆胶囊植物雌激素活性的临床观察

目的研究仙灵骨葆胶囊对药物性卵巢去势所带来的低雌激素状况的治疗效果。方法选取子宫内膜异位症患者120例,均经术后病理确诊,且应用促性腺激素释放激素激动剂（GnRHa）醋酸戈舍瑞林缓释植入剂治疗。患者于术后确诊后第一次月经来潮日给予醋酸戈舍瑞林缓释植入剂3.6 mg皮下注射,每28天1次,共4次。于注射第一针后28 d按下述分组给予口服药物进行反加治疗：对照组给予安慰剂,即维生素E 100 mg,每天1次;反加组给予妊马雌酮0.3 mg＋甲羟孕酮4 mg,每天1次;观察组予仙灵骨葆胶囊1.5 g,每天2次。3组均连用84 d。于注射第一针醋酸戈舍瑞林缓释植入剂后28 d及112 d分别检测Kupperman绝经指数、骨密度、子宫内膜厚度及血清雌二醇浓度,监测患者有无异常阴道出血状况,应用超声监测盆腔状况,了解有无复发。结果 GnRHa治疗28 d后,患者血清雌二醇水平显著降低,呈绝经状况,并一直持续。GnRHa治疗112 d后,对照组出现较明显的更年期症状;观察组无明显更年期症状,骨密度、子宫内膜厚度及血清雌二醇浓度均无明显改变;反加组血清雌二醇浓度升高,子宫内膜厚度轻度增加,且部分患者出现阴道不规则出血。结论仙灵骨葆胶囊可对药物性卵巢去势引起的雌激素水平低下所致的更年期症状及骨密度下降起到有效的预防和治疗作用,且不改变血清雌二醇浓度、不作用于子宫内膜。

Clinical Observation of Phytoestrogen Effect of Xianlinggubao Capsule

Objective To study the therapeutic effect of xianlinggubao（xlgb） capsules on hypoestrogenemia caused by drug induced menopause.Methods A total of 120 patients with endometriosis（EMT） were treated with GnRHa after EMT surgery and postoperative pathologic diagnosis.GnRHa was administered for 28 days from the first day of their first postoperative menses.The endometrial thickness was measured by B-ultrasonography,and bone mineral density（BMD）,serum E2 level,and Kupperman menopause index（KMI） were determined.Then the subjects were randomly divided into three groups and treated as follows： the control group receiving Vitamin E 100 mg qd;the Add-back group,premarin 0.3 mg＋provera 4 mg qd;the observation group,xlgb capsules 1.5 g bid.The above indexes were measured again 112 days after the GnRHa treatment.Results After the 28-day treatment of GnRHa,the patients＇ serum E2 level was significantly reduced to a menopausal state.The control group showed obvious climacteric symptoms 112 days after the GnRHa treatment.The observation group demonstrated no obvious climacteric symptoms and no noticeable changes in their BMD,endometrial thickness and serum E2 level.The Add-back group showed an obvious rise of serum E2 level and a slight increase in endometrial thicknesses and some patients reported irregular vaginal bleeding.Conclusion Xlgb capsules have preventive and therapeutic action on the climacteric symptom and decrease of BMD caused by hypoestrogenemia after drug induced menopause without adverse effect on serum E2 level and endometrium.