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

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,E2 and endometrial thickness：the changes after treatment were statistically significant compared with baseline（P0.01）.There were no significant differences in the rise and decline levels between the two groups（P0.05）.Conclusion Comparing domestic conjugated equine estrogen cream with imported conjugated equine estrogen cream,the therapeutic effect is similar,both of which can safely and effectively treat the atrophic vaginitis of postmenopausal women and improve their quality of life.