激素替代加抗抑郁剂对更年期综合征患者焦虑、抑郁症状的干预效应(英文)

Efficacy of hormone replacement plus antidepressant for anxiety and depression in patients with menopause syndrome

背景:运用雌激素治疗更年期综合征临床有很多不足之处,除了激素水平紊乱外,5-羟色胺、去甲肾上腺素也偏低,从而引起相应症状。盐酸氟西汀是选择性5-羟色胺再摄取抑制剂的代表药物,对焦虑近、抑郁件神经症等非常有效。目的:评估抗抑郁药物合并雌激素对围绝经期更年期综合征治疗效果,并与单独使用雌激素进行开放性对照。设计:随机分组设计,对比观察。单位:重庆医科大学附属第一医院妇产科。对象:选择2003-11/2004-01在重庆医科大学附属第一医院妇科门诊诊断为更年期综合征患者60例,年龄42～52岁,平均(46±3)岁,病程3～12个月。随机分为两组,联合用药组30例,激素替代组30例。方法:联合用药组:口服盐酸氟西汀胶囊,每天晨服1次,20mg/次,连服2个月,同时口服雌二醇,每2周1片,连服2个月。激素替代组:单服雌二醇,每2周1片,连服2个月。期间停用其他药物。治疗2个月后进行功能测评:①女性更年期评分项目:症状消失为完全缓解,明显改善为显效,症状减轻为有效,治疗前后无变化者为无效。总体疗效以50%临床症状改善为准。②汉密顿抑郁量表:代表患者精力和内心动力的第一因子(睡眠因子和焦虑因子)评分。③绝经指数:进行临床评估以及不良事件的描述性分析,评估盐酸氟西汀胶囊合用雌二醇治疗围绝经期更年期综合征的安全性。主要观察指标:女性更年期评分;汉密顿抑郁量表评分;绝经指数评估。结果:①联合用药组在女性更年期评分项目中完全缓解和显效评分明显优于激素替代组。②联合用药组汉密顿抑郁量表第一因子评分优于激素替代组(联合用药组治疗1～8周评分分别为25,18,15,10,8,5,5,4分,激素替代组治疗1～8周评分分别为25,17,15,14,13,12,13,13分)。③联合用药组绝经指数总分评分优于激素替代组(联合用药组治疗1～8周绝经指数分别为32,22.5,15,15,14,15,15,14,激素替代组治疗1～8周绝经指数分别为33,21,16,14,13,12,13,13),且对睡眠障碍、抑郁、焦虑的缓解率大大提高,而不良事件的发生率与激素替代组差异无显著性。结论:使用盐酸氟西汀联合雌激素治疗女性更年期综合征确实有比较明显的疗效,能缩短疗程,症状改善明显。

BACKGROUND： There are many drawbacks with hormone replacement therapy for menopausal syndrome. The blood levels of 5-HT and norepinephrine are lower. Fluoxetine hydrochlorde（ProzacR） is a selective serotonin reuptake inhibitor which is widely used in treating anxiety and depression. OBJECTIVE： To evaluate the effect of combined antidepressant and estrogen therapy compared to estrogen alone in the treatment of perimenopausal syndrome in this prospective open study. DESIGN： Randomized comparative study. SETTING： Department of Obstetrics and Gynecology of the First Affiliated Hospital of Chongqing Medical University PARTICIPANTS： From November 2003 to December 2004, 60 female patients with diagnosed menopausal syndrome of 3-12 month duration, aged （46±3） years, from Department of Obstetrics and Gynecology of the First Affiliated Hospital of Chongqing Medical University were enrolled into the study after giving their informed consents. The patients were randomly divided into two equal groups with Group 1 （n=30） receiving a combination of antidepressant ＋ estrogen and Group 2 （n=30） receiving estrogen only. METHODS： Patients in Group 1 received fluoxetine hydrochloride （ProzacR） 20 mg orally every morning plus oral estradiol 1 mg once every two weeks for 2 months. Patients in Group 2 received only oral estradiol 1 mg once every two weeks for two months. Patients were not taking any other drug during the treatment period. At the end of two month treatment all patients were evaluated with the following 3 assessment tools： ①female menopausal symptom evaluation with the following 4 categories： Complete symptom relief, markedly improved, improved and no effect. Overall efficacy was defined as 50% symptom improvement. ② Hamilton Depression Scale which reflects energy level and psychosomatic factor of sleep and anxiety. ③Menopause index： Which are description of clinical evaluation and adverse effects; this would help to assess the safety of using both drugs in treating the menopausal syndrome. MAIN OUTCOME MEASURES： female menopausal symptom assessment, hamilton depression scale, and menopause index. RESULTS：① In female menopausal symptom assessment group 1 showed better results in the complete relief and markedly improved scores.② Hamilton Depression Scale group 1 also showed better scores than Group 2（In Groupl, the scores at week 1 to 8 were 25,18,15,10,8,5,5,4 respectively ,in Group 2, the scores at week 1 to 8 were 25,17,15,14,13, 12,13,13 respectively）. ③ Group 3 showed a significant better score in the menopausal index with improvement in sleep disorder, anxiety and depression than Group 2 （In Group 1 the scores at week 1-8 were 32,22.5, 15,15,14,15,15,14 respectively,In group 2, the scores at week 1 to 8 were 33,21,16,14,13,12,13,13 respectively） .there was no significant difference of incidence of adverse events as compared with Group 3 . CONCLUSION： Combined therapy of fluoxetine hydrochlorde（PROZAC） plus estrogen showed better efficacy in the treatment of menopausal syndrome than estrogen alone.