Remifemin与替勃龙治疗围绝经期综合征的临床比较
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Clinical comparation of Remifemin in the treatment of climacteric symptoms with Tibolon
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    目的:与替勃龙比较观察Remifemin治疗我国妇女围绝经期综合征的有效性和安全性-方法:选取244例符合入选标准的受试者随机分成Remifemin组(试验组)和替勃龙组(对照组),通过随机-双盲-平行对照研究比较两组的Kupperman评分,Kupperman评分反应率和不良事件发生率-结果:Kupperman评分与不良事件频数复合变量的非劣效检验P < 0.0001,有统计学意义,Kupperman评分,Kupperman评分反应率两组组间比较P > 0.05,无统计学意义,不良反应事件两组组间比较P < 0.001,有极显著统计学意义,说明Remifemin的疗效非劣于替勃龙,安全性优于替勃龙-结论:Remifemin治疗我国妇女围绝经期综合征是安全有效的-

    Abstract:

    Objective:To compare the efficacy and the safety of Remifemin in the treatment of climacteric complaints with Tibolon. Methods:According to the standards,a total of 244 patients were randomly allocated to receive either two tablets of Remifemin or one tablet of Tibolon daily for 12 weeks. This double-blind parallel clinical trial was adopted to compare the Kupperman’s score,Kupperman’s reaction ratio and side effect between the two groups. Results:There was no significant difference between two groups in Kupperman’s scores and Kupperman’s reaction ratio(P > 0.05),but there was significant difference on compound frequency Kupperman’s score and side effect by non-inferiority trial(P < 0.0001). Remifemin showed less side effect compared with Tibolon.(P < 0.001). Conclusion:Remifemin should be effective and safe in relief of climacteric symptoms.

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钟华绣,王美莲,刘嘉茵. Remifemin与替勃龙治疗围绝经期综合征的临床比较[J].南京医科大学学报(自然科学版),2007,(9):992-995

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  • 收稿日期:2007-03-10
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