摘要
目的:研究低剂量结合雌激素(CEE)与标准剂量CEE联合天然孕酮或地屈孕酮治疗围绝经期综合征的疗效比较。方法:本试验为单中心、前瞻性随机对照试验,2014年2月至2015年12月招募绝经早期有子宫、有绝经相关症状的妇女(共107例完成试验),随机分为3组:A组35例(低剂量CEE+天然孕酮)、B组37例(标准剂量CEE+天然孕酮)、C组35例(标准剂量CEE+地屈孕酮),采用连续序贯方案治疗12个周期,在第3、6、9、12周期结束后记录改良Kupperman评分,计算有效率,用药前与用药后抽血测定卵泡刺激素(FSH)、雌二醇(E2)。结果:在治疗3个周期后,改良Kupperman评分值均显著性下降(P均<0.01),3组间的完全缓解率、显效率差异均无统计学意义,但B组有效率(89.2%)显著高于A组(60%,P=0.024)和C组(61.9%,P=0.035)。治疗结束后,3组的完全缓解率、显效率、有效率差异均无统计学意义(P>0.05)。治疗结束后与治疗前比,3组的FSH值均有显著性降低(P<0.001),E2值均显著性升高(P<0.001)。治疗结束后,3组FSH值比较差异无统计学意义(P=0.26);E2值A组显著低于B组(P=0.002)及C组(P=0.004),B组与C组比较差异无统计学意义(P=0.832)。不良反应主要为阴道不规则流血和乳房胀痛,A、B、C组阴道不规则流血的发生率分别为20.91%、39.51%、19.99%,B组显著高于A与C组(PAB=0.034,PBC=0.015),A组与C组比较差异无统计学意义;乳房胀痛的发生率A、B、C组分别为30.22%、37.46%、68.06%,A、B两组差异无统计学意义,C组显著高于A、B组(PAC=0.008,PBC=0.002)。结论:低剂量雌激素补充已可满足大部分患者缓解围绝经期综合征的需求,加用天然孕酮比加用地屈孕酮对围绝经期症状的缓解作用更显著。
Objective：To explore the effect of low-dose conjugated combined estrogen（CEE） or standard-dose CEE combined with natural progesterone （P） or dydrogesterone （D） on menopausal syndrome. Methods： This was a single center,prospective, randomized controlled trial. Early menopausal women who complained of menopausal symptoms were recruited and randomized into 3 groups：group A（ low-dose CEE ＋ P）,group B（ standard dose CEE ＋ P） ,group C（ standard dose CEE ＋ D）. Using continuous sequential regimen,the duration of interven- tion was 12 cycles. Modified Kupperman index score was recorded after cycle 3,6,9,12. Effective rates were calculated and the changes of FSH, E2 were determined. The statistics analysis methods were t test, ANOVA and Chi-square test. Results.107 cases completed the trial. After 3 cycles of treatment, Kupperman index decreased significantly in all the 3 groups（P 〈0.01 ）. The complete remission rate, marked remission rate were comparable among the 3 groups. The effective rate in group B was significantly higher than group A（89.2% vs 60%, P = 0.024） and group C（89.2% vs 61.9% ,P=0. 035）. After 12 cycles of treatment,the complete remission rate, marked remission rate and effective rate were comparable among 3 groups（ P 〉 0.05）. The FSH levels were significantly decreased in all of the 3 groups after treatment and with no significance was observed. The E2 levels were significantly increased after treatment in all of the 3 groups. The level in group A was significantly lower than group B（ P=0. 002） and group C（ P=0. 004）. There was no significant difference between group B and group C （P = 0. 832）. The most common adverse reactions were irregular vaginal bleeding and breast tenderness. The incidence of irregular vaginal bleeding was 20.91% ,39.51% and 19, 99% in group A,group B and group C,group B was higher than group A and group B（ PAB =0. 034, PBC =0. 015）. The incidence of breast tenderness in the 3 group was 30.22% ,37.46% and 68.06% ,group C was higher than group A and B（ PAC =0. 008, Pec =0. 002）. Conclusions： Low-dose CEE can meet the need of most patients with menopausal syndrome. The effect is more obviously that adding natural progesterone ratio dydrogesterone.
出处
《实用妇产科杂志》
CAS
CSCD
北大核心
2017年第5期388-391,共4页
Journal of Practical Obstetrics and Gynecology
关键词
围绝经期综合征
绝经激素治疗
低剂量雌激素
天然孕酮
地屈孕酮
Menopausal syndrome
Menopausal hormone therapy
Low-dose estrogen
Natural progesterone
Dydrogesterone
