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目的评价雌激素替代治疗妇女更年期综合征的近期疗效和安全性。方法根据本研究的纳入与排除标准,选取妇女更年期综合征患者70例,按1∶1随机分为治疗组35例和对照组35例,进行随机对照试验。两组病例疗程均为3个月。结果对总体疗效而言,意向性分析(intention-to-treat,ITT)结果显示两组总有效率分别为94.28%、77.15%,方案数据分析(per-protocol populatipn,PP)结果显示两组总有效率分别为100%、83.33%,疗效差异均具有统计学意义(P<0.01)。PP分析显示治疗组经3个月治疗后在改善Kuppermen积分方面优于对照组(P<0.01)。ITT分析与PP分析结果一致。临床观察中未发现雌激素替代疗法有何不良反应。结论雌激素替代疗法治疗妇女更年期综合征安全有效。
Objective To evaluate the short-term efficacy and safety of estrogen replacement therapy for menopausal syndrome in women. Methods According to the inclusion and exclusion criteria of this study, 70 women with menopause syndrome were selected and randomly divided into treatment group (35 cases) and control group (35 cases) according to randomized controlled trials. Two groups of patients were treated for 3 months. Results In terms of overall efficacy, the results of intention-to-treat (ITT) analysis showed that the total effective rates of the two groups were 94.28% and 77.15% respectively. The results of per-protocol populatipn (PP) The effective rates were 100% and 83.33%, respectively, with statistically significant differences (P <0.01). PP analysis showed that the treatment group was better than the control group (P <0.01) in improving the Kuppermen score after 3 months of treatment. ITT analysis and PP analysis results. Clinical observations did not find any adverse reactions to estrogen replacement therapy. Conclusion Estrogen replacement therapy is safe and effective in the treatment of menopausal syndrome in women.