Chaouat D, Belange G, Danan S, De Vernejoul M C, Faures Quenet B, Chaouat Y
Service de Médecine Interne, Fondation Rothschild, Paris.
Rev Rhum Ed Fr. 1993 May;60(5):353-8.
This prospective, controlled, nonrandomized, one-year trial in women included less than ten years after menopause was designed to compare the preventive efficacy on postmenopausal bone loss of replacement percutaneous 17 beta estradiol versus intermittent disodium etidronate. Twenty-five patients took oral disodium etidronate in a daily dosage of 200 mg in two-month courses separated by two-month intervals, with 1 g/day elemental calcium. Twenty-three patients used percutaneous 17 beta estradiol in daily dosage of 1.5 mg for the first twenty days of each month, then 20 mg oral dydrogesterone for the remaining ten days. At baseline the two groups were comparable as concerns age, mean time since menopause (5.1 versus 4.3 years), weight, height, and lumbar bone mineral density as measured by dual-photon X-ray absorptiometry. After one year of treatment, in both groups, bone mineral density was unchanged as compared with baseline, whereas serum alkaline phosphatase levels were significantly reduced. In the estrogen group, biochemical markers for bone turnover showed no significant changes, where as in the etidronate group urinary calcium and urinary hydroxyproline were significantly reduced. These data suggest that disodium etidronate is a satisfactory alternative to estrogens for the short-term prevention of postmenopausal bone loss when hormone replacement therapy is contraindicated or refused by the patient and when preventive therapy is warranted on the basis of measurable risk markers.
这项针对绝经后不到十年的女性进行的前瞻性、对照、非随机的一年期试验,旨在比较经皮替代 17β-雌二醇与间歇性依替膦酸二钠对绝经后骨质流失的预防效果。25 名患者口服依替膦酸二钠,每日剂量 200 毫克,每两个月为一个疗程,疗程间隔两个月,并补充每日 1 克元素钙。23 名患者每月头 20 天使用经皮 17β-雌二醇,每日剂量 1.5 毫克,其余 10 天口服 20 毫克地屈孕酮。在基线时,两组在年龄、绝经后平均时间(5.1 年对 4.3 年)、体重、身高以及通过双能 X 线吸收法测量的腰椎骨密度方面具有可比性。治疗一年后,两组的骨密度与基线相比均无变化,而血清碱性磷酸酶水平显著降低。在雌激素组中,骨转换的生化指标无显著变化,而在依替膦酸钠组中,尿钙和尿羟脯氨酸显著降低。这些数据表明,当激素替代疗法被患者禁忌或拒绝,且基于可测量的风险指标有必要进行预防性治疗时,依替膦酸二钠是绝经后骨质流失短期预防中雌激素的一种令人满意的替代药物。