复方戊酸雌二醇片治疗妇女绝经综合征有效性及安全性临床观察.docVIP

复方戊酸雌二醇片治疗妇女绝经综合征有效性及安全性临床观察 　 作者：黄艳红　辛晓燕　陈亚琼　陈必良　王德堂　张红菊　魏莉　李桂云　石茹 【关键词】 复方戊酸雌二醇 　　Clinical study of safety and efficacy of compound estradiolvalerate in women with menopause syndrome 　　【Abstract】 AIM: To evaluate the efficacy and safety of compound Estradiolvalerate in the treatment of menopause syndrome. METHODS: Fortyfive women with menopause syndrome were followed up in a randomized, doubleblind and selfmatched trial for 3 mo, and were divided into control group (Kliogest group) and treated group (compound estradiolvalerate group). The clinical efficacy was determined by Kupperman score. Serum levels of FSH, E2 were evaluated at baseline and in the 3 mo and the vital signs and laboratory data were measured. RESULTS: After 3 mo, Kupperman scores of the control group and the treated group decreased significantly by 96% and 97% respectively （Plt;0.01）. The serum level of E2 increased (Plt;0.01) and reached the level of the late follicular phase ,while FSH decreased significantly （Plt;0.01）. The side effects in the two groups were only breast swollen pain and vaginal bleeding. CONCLUSION: Compound estradiolvalerate was effective and safe in the improvement of menopause syndromes such as flushing and psychological symptoms, and it could be used in clinical perimenopause women. 　　【Keywords】 compound estradiolvalerate; menopause syndrome 　　【摘要】 目的： 评价国产复方戊酸雌二醇治疗妇女绝经综合征的有效性及安全性. 方法： 对45例患绝经综合征的妇女进行了双盲随机、自身对照3 mo临床试验，分为对照组（服诺更宁片）及治疗组（服复方戊酸雌二醇片）；应用Kupperman症状评分标准判定临床疗效，检测患者生命体征、实验室指标及放免测定性激素，并进行安全性评价. 结果： 对照组和治疗组在3 mo治疗后，患者的绝经综合征症状均有明显改善，Kupperman评分总分显著下降，对照组服药后较服药前总分下降97% （Plt;0.01），治疗组服药后较服药前总分下降96% （Plt;0.01）,组间比较无差异（Pgt;0.05）；对照组和治疗组药物治疗后卵泡刺激素下降(Plt;0.01)，雌二醇上升，（Plt;0.01）. 其他生化检查治疗前后无变化. 两组治疗的主要不良反应为乳房胀痛7例、阴道出血7例. 结论： 复方戊酸雌二醇能有效的改善绝经综合征临床症状，升高体内雌激素水平，提高妇女生活质量，安全性好. 　　【关键词】 复方戊酸雌二醇；绝经综合征 　　0引言 　　据国内外文献报道［1］，在绝经前后的一段时间，90%的妇女都有轻重不等的绝经综合征表现，约10%-15%的妇女症状较严重，影响正常的生活及学习. 应用雌激素替代治疗能缓解临床症状，且长期应用可以预防冠心病、骨质疏松、中风及阿尔茨海默病（Alzheimer disease, AD）［2］. 但目前激素替代治疗所用的复方制剂多数为国外公司生产，费用