绝经早期妇女长期周期联合应用经皮雌二醇与口服孕激素的阴道出血情况

The vaginal bleeding pattern in early postmenopausal women with long-term combined cyclic regimen of percutaneous estradiol and oral progestin

目的探讨中国绝经早期妇女长期周期联合应用经皮雌二醇与口服孕激素的出血情况。方法开放性随机前瞻性研究7年。周期联合应用雌孕激素,雌激素为经皮雌二醇(E_2)凝胶,口服孕激素为微粉化天然黄体酮(MP)与甲羟孕酮(MPA)。60例绝经早期(1～5年)妇女随机分为4组:G1(E_2 1.5 mg/d+MP100 mg/d);G2(E_2 1.5 mg/d+MPA 2 mg/d);G3(E_2 0.75 mg/d+MP100 mg/d);G4(E_2 0.75 mg/d+MPA 2 mg/d)。每周期连用25 d,停药5 d。记录出血日记,包括出血日、出血天数和出血量;分别将出血天数≤7 d且血量≤1.0、出血天数≤7 d且血量>1.0、出血天数>7 d且血量≤1.0、出血天数>7 d且血量>1.0定义为可接受性优、良、中、差;出血次数/记录周期数定义为出血率。分别于用药1～7年时进行子宫内膜细胞吸片检查。结果(1)95.60%的出血集中于第10～32 d之间,88.83%的出血天数在7 d之内,96.75%的出血量少于2.0。(2)4组间不同可接受程度出血的构成比有显著差别。G1、G3、G4接受性优的比例高于G2,G4接受性差的比例显著低于G1、G2、G3。(3)各组总体出血率分别为1 6.05%、59.03%、9.77%、30.66%,组间差异显著(P<0.05);出血率随用药时间延长而降低。(4)子宫内膜细胞吸片均未见恶性改变。结论低剂量雌激素加用天然黄体酮的出血率明显低于其他组;高剂量雌激素加用甲羟孕酮的出血率明显高于其他组;出血率随用药时间延长而降低;低剂量雌激素加用甲羟孕酮可能在控制出血天数和出血量方面效果较好;4种方案的内膜安全性均好。

Objective： To observe the influence of percutaneous estradiol and oral progestin on vaginal bleeding pattern in early postmenopausal Chinese women. Methods： A 7-year open, randomized, prospective study was designed. The cyclic-combined estrogen and progestin were used. The percutaneous estradiol （E2） was regarded as estrogen, while the micronized progesterone （MP） and medroxyprogesterone （MPA） served as progestin. 60 healthy women （naturally menopaused for 1 to 5 years） were recruited and divided into four groups. The regimen was as follows： （1） G1, percutaneous E2 1.5 mg/d plus oral MP 100mg/d. （2） G2, percutaneous E2 1.5 mg/d plus oral MPA 2 mg/d. （3）G3, percutaneous E2 0.75 mg/d plus oral MP 100 mg/d. （4） percutaneous E2 0.75 mg/d plus oral MPA 2 mg/d. Drugs were given for successive 25 days per cycle, and discontinued for 5 days. The beginning day, duration （days） and the amount of bleeding were recorded. The admissibility of vaginal bleeding was defined as follows： （1） superior admissibility： bleeding duration≤ 7 d and amount≤ 1.0. （2） reasonable admissibility： bleeding duration≤7 d and amount〉1.0. （3） moderate admissibility： bleeding duration〉 7 d and amount≤l. 0. （4） inferior admissibility： bleeding duration〉 7 d and amount〉 1.0. The bleeding rate was defined as the ratio of the frequency of bleeding to the number of recorded cycles. The endometrium biopsying by Pipella tube was conducted during 1-7 year. Results： 95.60% of vaginal bleeding happened on day 10 to day 32 of the cycle, while the bleeding lasting for less than 7 days accounted for 88. 83%. As regards the amount of bleeding, 96. 75% of bleedings were below 2. 0 and 55. 32% were below 1. 0. Significant difference was found in the admissibility between the 4 groups. than in G2, while the percentage of bleeding rate was 16.05%, 59.03% The percentage of superior admiss inferior admissibility in G4 was , 9.77% and 30.66%, in G1, ibility in G1, G3 and G4 was higher ower than in G1, G2 and G3. The G2, G3 and G4, respectively. There was a significant difference between the groups, with the highest rate in G2 and lowest in G3. The bleeding rate showed a descending tendency in course of therapy. The endometrium biopsy by Pipella tube showed no malignancy. Conclusions. The vaginal bleeding rate was lower in low-dose estradiol plus MP regimen than in other regimens while that of high-dose estradiol plus medroxyprogesterone was higher than others. The bleeding rate showed a descending tendency during the 7 years of treatment. The bleeding admissibility of G2 was inferior. The endometrium showed no malignancy in all 4 groups.