Haenggi W, Birkhaeuser M H
Department of Obstetrics and Gynaecology, University of Berne, Switzerland.
Maturitas. 1993 Mar;16(2):111-22. doi: 10.1016/0378-5122(93)90055-m.
An open prospective multicentric trial has been conducted over 6 months in 241 postmenopausal volunteers. One-hundred forty-one women had an intact uterus. All patients received a fixed peroral combination of conjugated estrogens CE (1.25 mg per day from day 1 to day 21) and medrogestone (5 mg per day from day 12 to day 21) followed by 7 days without substitution (day 22 to day 28). After 3 months of treatment, the managing physician could, according to the patient's clinical response, reduce the dosage of CE to 0.625 mg daily. This dose reduction took place in 79 patients (38.9%). The trial was designed to study efficacy, compliance and side-effects of this combination. Of the patients 68.9% showed a very good, 27.7% a good and 1.9% a satisfactory improvement of their preexisting subjective complaints. Of the patients 28.6% suffered from minor side-effects leading to drop-outs in 7.8% of the cases. Of the women participating in the study 92.2% completed the trial without from the treatment scheme. No serious complications have been noted. After 6 months of treatment, a regular bleeding pattern has been observed in 71.5% of the 144 non-hysterectomized women, an irregular pattern in 9.7% and amenorrhoea in 18.8%. Total cholesterol showed no change, whereas HDL rose significantly from 1.58 to 1.72 mmol/l (P < 0.01) resulting in a drop of Total-Cholesterol-HDL-Ratio of -8.8% (P < 0.01). LDL decreased from 3.71 +/- 1.56 to 3.45 +/- 1.39 (P < 0.05). Considering the two patient groups with and without estrogen reduction after 3 months, HDL increase was significant in both groups but was dose dependent. The HDL increase compared to the initial value was 5.7% with 0.625 mg CE and +10.8% with 1.25 mg CE, respectively. The fixed peroral combination of CE and medrogestone tested was effective, easy to administer and safe. The bleeding pattern observed was mostly regular. The pattern of serum lipids changed favorably in a significant way. Therefore, the use of this new peroral estrogen/progestin combination can be recommended for routine substitution in postmenopausal women.
一项开放性前瞻性多中心试验在241名绝经后志愿者中进行了6个月。141名女性子宫完整。所有患者口服固定剂量的结合雌激素（CE，第1天至第21天每天1.25毫克）和甲地孕酮（第12天至第21天每天5毫克），随后7天不进行替代治疗（第22天至第28天）。治疗3个月后，主治医生可根据患者的临床反应将CE剂量减至每日0.625毫克。79名患者（38.9%）进行了剂量减少。该试验旨在研究这种联合用药的疗效、依从性和副作用。68.9%的患者原有主观症状有非常好的改善，27.7%有良好改善，1.9%有满意改善。28.6%的患者出现轻微副作用，导致7.8%的病例退出治疗。参与研究的女性中有92.2%完成了试验，未偏离治疗方案。未发现严重并发症。治疗6个月后，144名未行子宫切除术的女性中，71.5%出现规律出血模式，9.7%出现不规律模式，18.8%出现闭经。总胆固醇无变化，而高密度脂蛋白（HDL）从1.58显著升至1.72毫摩尔/升（P<0.01），导致总胆固醇与HDL比值下降8.8%（P<0.01）。低密度脂蛋白（LDL）从3.71±1.56降至3.45±1.39（P<0.05）。考虑3个月后有雌激素减量和无雌激素减量的两组患者，两组HDL均显著升高，但呈剂量依赖性。与初始值相比，0.625毫克CE组HDL升高5.7%，1.25毫克CE组升高10.8%。所测试的CE与甲地孕酮口服固定联合用药有效、易于给药且安全。观察到的出血模式大多规律。血脂模式有显著的有利变化。因此，这种新型口服雌激素/孕激素联合用药可推荐用于绝经后女性的常规替代治疗。
