Saure A, Hirvonen E, Milsom I, Christensen A, Damber M G
Institute of Biomedicine, University of Helsinki, Finland.
Maturitas. 1996 May;24(1-2):111-8. doi: 10.1016/0378-5122(96)01029-8.
The aim of this study was to compare a new estradiol-desogestrel (E2-DG) regimen with an E2-norethisterone acetate (NETA) combination (Trisekvens) regarding the treatment of menopausal complaints, bleeding pattern, histology of the endometrium and the occurrence of adverse experiences.
A total of 310 peri-/postmenopausal women with climacteric symptoms were randomly allocated to oral sequential treatment with either the E2-DG combination (1.5 mg E2 for 24 days with 0.15 mg DG for the last 12 days followed by 1 placebo tablet for 4 days) or with the E2-NETA combination (Trisekvens, 2 mg E2 for 22 days with 1 mg NETA for the last 10 days followed by 1 mg E2 for 6 days). Treatments were administered double-blind for 12 cycles of 28 days.
One hundred and four women, 48 in the E2-DG group and 56 in the E2-NETA group, discontinued the study due to bleeding irregularities and various adverse effects. Both treatments reduced menopausal symptoms and complaints effectively and almost equally. The alleviation of perspirations and the improvement of general fitness were more apparent (P = 0.009) during cycle 1 with the E2-NETA treatment but were greater (P < 0.02) during the last 9/10-12 cycles of E2-DG treatment compared to E2-NETA. Regular withdrawal bleeding appeared in 93% and 90% of the women during treatment with E2-DG and E2-NETA, respectively. Intermenstrual bleeding occurred in 8% of women receiving E2-DG and in 13% of women treated with E2-NETA. The corresponding figures for intermenstrual bleeding-spotting were 21% and 22%. Secretory endometrium was detected in 65% and 54% of the samples taken at the end of treatment with E2-DG and E2-NETA, respectively. No hyperplasia or atypia was found. No serious adverse events related to treatment occurred.
Both regimens alleviated effectively menopausal complaints and did not induce hyperplasia of endometrium. The minor differences recorded between the two regimens were probably due to the differences in their composition concerning the amount of estradiol and its distribution along the cycle, the amount and type of progestin and the length of estradiol/progestin combination phase.
本研究旨在比较一种新的雌二醇 - 去氧孕烯（E2 - DG）方案与雌二醇 - 醋酸炔诺酮（NETA）组合（Trisekvens）在治疗更年期症状、出血模式、子宫内膜组织学以及不良事件发生情况方面的差异。
共有310名有更年期症状的围绝经期/绝经后妇女被随机分配接受口服序贯治疗，要么采用E2 - DG组合（1.5毫克E2服用24天，最后12天服用0.15毫克DG，随后4天服用1片安慰剂），要么采用E2 - NETA组合（Trisekvens，2毫克E2服用22天，最后10天服用1毫克NETA，随后6天服用1毫克E2）。治疗采用双盲方式，进行12个周期，每个周期28天。
104名妇女，E2 - DG组48名，E2 - NETA组56名，因出血不规律和各种不良反应而中断研究。两种治疗方法均有效且几乎同等程度地减轻了更年期症状和不适。在第1周期，E2 - NETA治疗时出汗缓解和总体健康状况改善更为明显（P = 0.009），但在E2 - DG治疗的最后9/10 - 12个周期中，与E2 - NETA相比改善程度更大（P < 0.02）。在接受E2 - DG和E2 - NETA治疗期间，分别有93%和90%的妇女出现规律的撤药性出血。接受E2 - DG治疗的妇女中有8%出现经间期出血，接受E2 - NETA治疗的妇女中有13%出现经间期出血。经间期点滴出血的相应比例分别为21%和22%。在E2 - DG和E2 - NETA治疗结束时采集的样本中，分别有65%和54%检测到分泌期子宫内膜。未发现增生或异型性。未发生与治疗相关的严重不良事件。
两种方案均有效减轻了更年期不适，且未诱发子宫内膜增生。两种方案之间记录的微小差异可能是由于它们在雌二醇含量及其在周期中的分布、孕激素的量和类型以及雌二醇/孕激素联合阶段的长度等成分方面的差异所致。
