摘要
目的 研究国产戊酸雌二醇 (E2 V)联合应用醋甲羟孕酮 (MPA)预防绝经近期低骨量妇女骨丢失的作用 ,探讨安全有效的方案。方法 将 92例低骨量绝经 1～ 8年的妇女随机分为 4组 ,给药剂量分别是 :1组 (对照组 ,2 3例 ) :钙 (Ca) 4 0 0mg/d +维生素 (VitD) 2 0 0IU/d ;2组 (2 4例 ) :E2 V1 0mg/d +MPA2mg/d +Ca40 0mg/d ;3组 (2 2例 ) :E2 V1 0mg/d +MPA2mg/d +Ca40 0mg/d +VitD 2 0 0IU/d ;4组 (2 3例 ) :E2 V 1 5mg/d +MPA2mg/d +Ca40 0mg/d +VitD2 0 0IU/d。于用药 0、6、12、18个月应用DEXA法测量腰椎 2～ 4与股骨颈骨密度 ,同时检测骨代谢指标 ,每日记录阴道出血、乳胀等副作用。结果 有 78例 (84 5 % )完成 1年研究 ,77例 (83 7% )完成 1 5年研究。 (1)骨代谢指标 :空腹晨 2h尿钙 /肌酐 (Ca/Cr) :对照组无明显改变 ,3个月时治疗组 2、3、4分别下降 43 8%、33 3%、33 3% ,继续用药变化不大 ;尿Ⅰ型胶原N端肽交联物 /肌酐 (NTX/Cr) :对照组有下降趋势 (P >0 0 5 ) ,3个月时治疗组 2、3、4分别下降 42 2 %、5 3 2 %、2 9 1% ,继续用药下降缓慢 ;血碱性磷酸酶 (ALP) :对照组无明显变化 ,治疗组 6、12个月下降 ,2组分别为 6 8%、14 2 % ,3组分别为 17 0 %、17 9% ,4组分别为 16 4%、2 8 8% 。
Objective To observe the efficacy of estradiol valerate (E 2V) combined with medroxyprogesterone acetate (MPA) in prevention of bone loss among postmenopausal women with osteopenia. Methods Ninety-two women 1～8 years after menopause with osteopenia were randomly divided into 4 groups: 1) control group: 23 cases, taking calcium carbonate (Ca) 400 mg/d + vitamin D 200 IU/D; 2) treatment group 1: 24 cases, taking E 2V 1.0 mg/d+ MPA 2 mg/d+ Ca 400 mg/d; 3) treatment group 2: taking E 2V 1.0 mg/d+ MPA 2 mg/d+ Ca 400 mg/d+ vitamin D 200 IU/d; and 4) treatment group 3: taking E 2V 1.5 mg/d+ MPA 2 mg/d+ Ca 400 mg/d+ vitamin D 200 IU/d. The bone mineral density (BMD) of L 2-4 and neck of femur was measured by DEXA method, and the bone metabolic markers such as serum alkaline phosphatase (ALP) and urine Ca/Cr and Ntx/Cr were examined just before the drug administration and 6, 12, and 18 months after the beginning of experiment. Vaginal bleeding and breast tenderness were recorded by the subjects themselves and examined by investigators. Results Seventy-eight subjects (84.5%) were followed up for I year and 77 of them (83.7%) were followed up for 1.5 years. The fasting morning Ca/Cr remained almost unchanged in the control group, and decreased by 43.8%, 33.3%, and 33.3% by the third month respectively and then remained unchanged in the treatment groups 1, 2, and 3. The urine Ntx/Cr decreased mildly but insignificantly in the control group (P>0.05), and decreased since the 3rd month by 42.2%, 53.2%, and 29.1% respectively in the treatment groups 1～3 and then decreased very slowly. The ALP remained almost unchanged in the control group, and decreased by 6.8%, 17.0%, and 16.4% by the 6th months respectively and by 14.2%, 17.9%, and 28.8% by the 12thmonth and then remained almost unchanged in the treatment groups 1～3. The BMD of L2-4 increased by 7.1%±4.6%, 6.8%±5.3%, and 9.0%±4.0% in the treatment 1～3 by the 18th month. The BMD of neck of femur increased by 4.1%±3.2%, 4.0%±5.9%, and 5.9%±4.8% in the treatment 1～3 by the 18th month. Fracture occurred in 2 cases of the control group and 2 cases of the treatment group because of accidents. The vaginal bleeding rate was the highest in the treatment group 3 (47.4%). The breast tenderness rates were 27.3%～47.6% in the 3 treatment groups. Conclusion Administration of E 2V I mg/d combined with MPA 2 mg/d is an optional regimen for postmenopausal women with intact uterine.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2002年第23期1593-1598,共6页
National Medical Journal of China
基金
国家"九五"重点科技攻关基金资助项目 ( 96-90 6-0 5-06)
