摘要
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。
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.
出处
《南京医科大学学报（自然科学版）》
CAS
CSCD
北大核心
2007年第9期992-995,共4页
Journal of Nanjing Medical University(Natural Sciences)
