间断和周期性羟乙膦酸二钠防治绝经后骨质疏松观察

Observations on Intermittent Cyclical Etidronate Therapy Treating Postmenopausal Osteoporosis

目的：观察羟乙膦酸二钠间断和周期性防治绝经后骨质疏松的；临床疗效。方法：７２例腰椎（Ｌ２～４）骨矿密度（ＢＭＤ）低于本地区 ２０～４０岁健康女性均值减１．０标准差的绝经后妇女，双盲随机分为两组各３６例。羟乙膦酸二钠治疗组 ３６例，给予羟乙膦酸二钠４００ｍｇ／日，连服 ２周，停药 １０周，重复 ３次共 ３６周。对照组服安慰剂，程序同治疗组。观察期间两组均每日加服钙剂和维生素Ｄ。试验前后用双能Ｘ线吸收法（ＤＥＸＡ）测定腰椎和股骨ＢＭＤ，同时测定血钙（Ｃａ）、磷（Ｐ）、碱性磷酸酶（ＡＬＰ）、抗酒石酸盐酸性磷酸酶（ＴＲＡＰ）、空腹尿钙／肌酐比值（Ｃａ／Ｃｒ）和羟脯氨酸／肌配比值（Ｈｙｐ／Ｃｒ）。根据腰椎 ＢＭＤ变化和骨癌症状改善情况综合判断疗效。结果：治疗组 ４个部位ＢＭＤ均增加（Ｐ＜０．０５或０．０１），血ＴＲＡＰ降低（Ｐ＜０．０１），综合总有效率为９１．７％。结论：羟乙膦酸二钠防治绝经后骨质疏松有明显疗效。

Objective: To investigate the therapeutic efficacy of intermittent cyclical etidronate treatment for postmentopausal osteoporosis. Method:Seventy-two postmenopausal women with L2-4 BMD at least lower than subtract 1.0 standard deviation from the mean value of BMD in normal young adults. The studied patients were randomly divided into two groups of 36 each treated with oral etidronate 400mg or placebo per day for 2 weeks respectively, followed by stopping medications for 10 weeks, This treatment cycle was repeated 3 times for a total pened of 36 weeks. Daily Oral supplements calcium and vitamin D were given throughout the observation period in both groups. BMD of L2 - 4 and femur were measured by DEXA, and serum Ca, P, ALP, tartrate resistant acid phosphatase(TRAP), fasting urinary Ca/Cr and hydroxyproline (Hyp /Cr ) were an alysed before and after the observation. Results: The total effectiveness rate was 91.7% demonstrated by the changes of BMD of L2-4 and the diminution of bone pain. In etidronate group, the BMD of all sites increased(P < 0.05 or 0.01 ). TRAP decreased(P< 0. 01 ). Conclusions: The intermittent cyclical etidronate therapy is efficacious on preventing and treating optmenopausal osteoporosis.