Chesnut C H, Nelp W B, Baylink D J, Denney J D
Metabolism. 1977 Mar;26(3):267-77. doi: 10.1016/0026-0495(77)90073-7.
To assess the efficacy of methandrostenolone in the treatment of osteoporosis a 26-mo double-blind study was performed with 13 treated and 13 control (placebo) postmenopausal osteoporotic females. Drug effect was assessed primarily by determinations of total body calcium (TBC) by neutron activation analysis, essentially a measurement of total bone mineral mass. Results in the 16 patients completing the study (10 treated and 6 placebo), as well as in all 26 patients participating in the study, showed significant (p less than 0.01) differences in the change in TBC between treated and control groups. In patients dropping out, TBC changes through the time of dropout were similar to those in patients completing the study. In those patients completing the study, TBC increased 2% in the treated group and decreased 3% in the placebo group. An approximate sixfold difference in extraskeletal calcium balance would be required to explain the magnitude of the observed intergroup TBC difference. The drug effect appeared to persist throughout the 26-mo observation period. Thus these data strongly suggest that long-term use of methandrostenolone in postmenopausal osteoporosis prevented bone loss; the possibility that it increased bone mass above initial values is less certain.
为评估甲基雄烯醇酮治疗骨质疏松症的疗效,对13名接受治疗的绝经后骨质疏松女性和13名对照(安慰剂)绝经后骨质疏松女性进行了一项为期26个月的双盲研究。药物疗效主要通过中子活化分析测定全身钙(TBC)来评估,本质上是对总骨矿物质质量的测量。16名完成研究的患者(10名接受治疗,6名服用安慰剂)以及所有26名参与研究的患者的结果显示,治疗组和对照组之间TBC变化存在显著差异(p<0.01)。在退出研究的患者中,直至退出时的TBC变化与完成研究的患者相似。在那些完成研究的患者中,治疗组的TBC增加了2%,安慰剂组的TBC减少了3%。需要骨骼外钙平衡大约六倍的差异才能解释观察到的组间TBC差异的幅度。药物疗效似乎在整个26个月的观察期内持续存在。因此,这些数据有力地表明,绝经后骨质疏松症患者长期使用甲基雄烯醇酮可预防骨质流失;其是否能使骨量增加至高于初始值尚不确定。