Bolaji I I, Mortimer G, Grimes H, Tallon D F, O'Dwyer E, Fottrell P F
Department of Obstetrics and Gynaecology, University College Hospital, Galway, Ireland.
Gynecol Endocrinol. 1996 Feb;10(1):41-7. doi: 10.3109/09513599609041269.
In an open non-comparative prospective trial of 12 months' duration, we investigated the role of a novel hormone replacement therapy regimen in 40 post-menopausal women who sought hormone replacement therapy. The regimen consisted of continuous administration of 0.625 mg of conjugated equine estrogen coupled with a fixed low-dose of micronized oral progesterone administered for 23 days every calendar month. The regimen was well-tolerated, producing no major side-effects and was effective in relieving menopausal symptoms. The study showed that 40% of the women experienced side-effects and 20% withdrew from the study. Half of the 20% of the women who dropped out did so for reasons not related to treatment. All symptomatic women experienced improvement after the 1st month, and virtually all were asymptomatic by the 3rd month of treatment, persisting until the end of the trial with the average number of hot flushes per day declining from the pretreatment levels by 96%. Amenorrhea was observed in 47% of patients, amenorrhea and minimal vaginal bleeding in 78% but acyclic bleeding was present in 28% of those in whom bleeding was re-established. Endometrial atrophy was induced in the majority of patients and no atypical endometrial hyperplasia was encountered. No significant changes were observed in blood glucose or liver enzymes. The mean percentage changes from baseline for serum cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoproteins (LDL) and LDL/HDL ratio were -6%, +32% (p < 0.001), -16% (p < 0.05), +15% (p < 0.05) and -23% (p < 0.05), respectively. The regimen was clinically effective and its apparent lack of major side-effects, the protective effect on the endometrium, the added advantage of minimal vaginal bleeding and the beneficial effect on lipid/lipoprotein levels, offer an attractive therapy and improved compliance with postmenopausal hormone replacement therapy.
在一项为期12个月的开放性非对照前瞻性试验中，我们对40名寻求激素替代疗法的绝经后女性，研究了一种新型激素替代疗法方案的作用。该方案包括持续服用0.625毫克结合马雌激素，并每月固定低剂量口服微粒化孕酮23天。该方案耐受性良好，未产生重大副作用，且在缓解绝经症状方面有效。研究表明，40%的女性出现了副作用，20%退出了研究。退出的20%女性中有一半是由于与治疗无关的原因退出。所有有症状的女性在第1个月后症状均有改善，到治疗第3个月时几乎所有人都无症状，这种情况一直持续到试验结束，每日潮热平均次数较治疗前水平下降了96%。47%的患者出现闭经，78%的患者闭经且有少量阴道出血，但重新出现出血的患者中有28%出现无周期出血。大多数患者出现子宫内膜萎缩，未发现非典型子宫内膜增生。血糖或肝酶未观察到显著变化。血清胆固醇、甘油三酯、高密度脂蛋白（HDL）胆固醇、低密度脂蛋白（LDL）以及LDL/HDL比值相对于基线的平均百分比变化分别为-6%、+32%（p<0.001）、-16%（p<0.05）、+15%（p<0.05）和-23%（p<0.05）。该方案临床有效，其明显缺乏重大副作用、对子宫内膜的保护作用、少量阴道出血的额外优势以及对脂质/脂蛋白水平的有益作用，提供了一种有吸引力的疗法，并提高了绝经后激素替代疗法的依从性。
