两种结合雌激素软膏治疗萎缩性阴道炎的疗效及安全性分析  

Analysis of the efficacy and safety of two kinds of conjugated equien estrogens cream in the treatment of atrophic vaginitis

作　　者：左宏玲 林守清[1] 郑淑荣[3] 李诗兰 卞美璐[5] 刘建立[6] 胡丽娜[7] 高晓黎[8] 孙爱军[1] ZUO Hong-ling;LIN Shou-qing;ZHENG Shu-rong;LI Shi-lan;BIAN Mei-lu;LIU Jian-li;HU Li-na;GAO Xiao-li;SUN Ai-jun(Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China)

机构地区：[1]中国医学科学院北京协和医科大学北京协和医院妇产科,北京100730 [2]河北医科大学第二医院妇产科,河北石家庄050000 [3]北京大学第一医院妇产科,北京100034 [4]北京大学第三医院妇产科,北京100191 [5]中日友好医院妇产科,北京100029 [6]解放军总医院妇产科,北京100853 [7]重庆医科大学附属第二医院妇产科,重庆400010 [8]新疆医科大学药学院,新疆乌鲁木齐830001

出　　处：《中国实用妇科与产科杂志》2018年第5期550-554,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：国家自然科学基金(11471024)

摘　　要：目的探讨国产与进口结合雌激素软膏治疗绝经后妇女萎缩性阴道炎的疗效及安全性。方法 2003年9月至2004年6月就诊于北京协和医院等6家医院的萎缩性阴道炎患者被随机分为试验组(国产结合雌激素软膏)122例,对照组(进口雌激素软膏)118例。疗程为21d。记录用药前后受试者的阴道脱落细胞成熟指数、萎缩性阴道炎症状评分及阴道健康评分;测定用药前后受试者血清卵泡刺激素(FSH)、雌二醇(E2)水平及子宫内膜厚度。结果主要疗效指标:阴道脱落细胞成熟指数治疗前试验组为25.15±23.3,对照组为29.84±25.29;治疗后试验组为77.15±21.25,对照组为78.09±20.56。两组治疗后较治疗前均显著升高(P<0.01);两组间较基线上升值的差异无统计学意义(P>0.05)。次要疗效指标:萎缩性阴道炎症状总评分比较:治疗前试验组(4.99±2.13)分,对照组(4.96±2.22)分;治疗后试验组(0.79±1.20)分,对照组(0.42±0.83)分,治疗前后比较均P<0.01;两组间较基线下降值的差异有统计学意义(P<0.05)。阴道健康总评分比较:治疗前试验组为(7.34±2.15)分,对照组为(7.51±2.16)分;治疗后试验组为(15.72±2.53)分,对照组为(16.02±2.21)分。两组治疗后较治疗前均显著升高(P<0.01);两组间较基线上升值的差异无统计学意义(P>0.05)。安全性方面:血清FSH、E2水平及子宫内膜厚度:治疗后较基线的变化均有统计学意义(P<0.01),两组间上升及下降值的差异均无统计学意义(P>0.05)。结论国产结合雌激素软膏与进口结合雌激素软膏临床疗治疗疗效相似,可安全有效地治疗绝经后妇女萎缩性阴道炎,提高其生活质量。Objective To compare the efficacy and safety of domestic and imported conjugated estrogens cream in the treatment of postmenopausal women with atrophic vaginitis.Methods The trial was conducted between September 2003 and June 2004.The subjects were randomly divided into the test group（domestic conjugated estrogens cream,122 cases）and the control group（imported estrogen cream,118 cases）.The treatment course was 21 days.The vaginal mature index（VMI）,the atrophic vaginitis evaluation score and vaginal health evaluation score were recorded before and after treatment.The level of follicle stimulation hormone（FSH）and estradiol（E2）in serum and thickness of endometrium were detected before and after treatment.Results Main efficacy indexes：before treatment：the VMI of the test group was 25.15±23.3 and that of the control group was 29.84±25.29;after treatment：the VMI of the test group was 77.15±21.25 and that of the control group was 78.09±20.56.The VMI was significantly elevated both in test group and control group after treatment（P0.01）.The difference between the two groups was not statistically significant（P0.05）.Secondary efficacy indexes：comparison of the total score of atrophic vaginitis showed that before the test group was 4.99±2.13 and the control group was 4.96 ± 2.22,while aftertreatment,the test group was 0.79±1.20 and the control group was 0.42±0.83.The total score was significantly reduced both in test group and control group after treatment（P0.01）;the difference between the two groups was statistically significant（P0.05）.Comparison of total vaginal health scores showed that before treatment,the test group was 7.34±2.15 and the control group was 7.51±2.16;after treatment,the test group was 15.72±2.53 and the control group was 16.02±2.21.The scores were significantly elevated both in test group and control group after treatment（P0.01）.The difference between the two groups was not statistically significant（P0.05）.Safety aspects：serum levels of FSH

关 键 词：结合雌激素软膏 萎缩性阴道炎 阴道炎症状评分 阴道健康评分 

分 类 号：R711.31[医药卫生—妇产科学]