尼尔雌醇防治绝经后妇女骨质丢失的初步研究

A Prospective Double-blind One-year Study of Nylestriol (CEE3) on Preventing Bone Loss in Postmenopausal Women

本文用长效雌三醇衍生物——尼尔雌醇(每2周2mg)对90例绝经0.5～21年的汉族妇女进行了一年的前瞻性双盲研究。结果:治疗组3个月后的血碱性磷酸酶、空腹尿钙/肌酐和羟脯氨酸/肌酐比值显著下降(P<0.05),血钙、血磷变化不大,而安慰剂组无显著差异。治疗组的前臂骨密度下降趋势受到抑制,绝经5年以上妇女上升1.0～5.7％。治疗组的FSH下降,仅绝经5年以上组有意义(P<0.01)。各组的LH变化不大。本研究证实尼尔雌醇能有效的防治绝经后骨质疏松症,使用方便,副作用较低。长期疗效有待观察。

A prospective, double-blind clinical study has been carried out in 90 Chinese women with YSM (years since menopause) coverage of 0.5—21 by administering a synthetic longacting estriol derivative-Nylestriol (CEE3) in the dosage of 2mg every 2 weeks for I year (49 treated and 41 placebo). The result were: (1). Serum alkaline phosphatase (ALP); ratios of calcium to creatinine (Ca/Cr) and hydroxyproline to creatinine (Hop/Cr) in fasting morning urine decreased significantly after 3 months of treatment (P<0.05). (2). The menopause-related reduction rates of forearm bone mineral content (PBMC, DBMC) and bone density (PBD, DBD) were restrained, with 1.0～5.7％ increased in those women with YSM beyond 5. (3). FSH were found decreased only in the treated group with YSM beyond 5 (P<0.01); which was in consistent with the change of bone mass. LH did not change significantly in all groups (P>0.05). (4). CEE3 exhibited slight side effects. 7 subjects bad breakthrough bleeding (10.3%). 1/3 of the women with intact uterus had spotly withdrawal bleeding and another 1/3 had moderate amount after the addition of medroxypiogesterone acetate (MPA) 6 mg daily for 7 days at the end of the 12 months of CEE3 treatment. The study has demonstrated that Nylestriol is a kind of effective, convenient and longacting estrogen for preventing postmenopausal bone loss. The long-term application need further observation.