Reid I R, King A R, Alexander C J, Ibbertson H K
Department of Medicine, University of Auckland, New Zealand.
Lancet. 1988 Jan 23;1(8578):143-6. doi: 10.1016/s0140-6736(88)92721-3.
In a prospective, randomised, placebo-controlled trial comparing the effect of (3-amino-1-hydroxypropylidene)-1,1-bisphosphonate (APD) (150 mg/day) plus calcium (1 g/day) with that of calcium alone on the bone mass of patients receiving long-term glucocorticoid therapy, the mean metacarpal cortical area in patients receiving APD increased by 1.2% between 0 and 6 months (p less than 0.06) and then remained stable between 6 and 12 months. In contrast, this index progressively declined in the placebo group (p less than 0.05 at 12 months). The two groups differed significantly in the changes at both 6 and 12 months (p less than 0.01). Mean vertebral mineral density, as measured by quantitative computed tomography, increased by 19.6% over 12 months in the APD group (p less than 0.02) but showed a non-significant decline of 8.8% in controls. The differences between the changes were again significant (p less than 0.005). Biochemical indices and bone histomorphometry indicated a reduction in bone resorption and bone formation but there was no evidence of osteomalacia. APD may thus prevent bone loss in glucocorticoid-treated patients over a year.
在一项前瞻性、随机、安慰剂对照试验中,比较了(3-氨基-1-羟基亚丙基)-1,1-二膦酸盐(APD)(150毫克/天)加钙(1克/天)与单纯补钙对长期接受糖皮质激素治疗患者骨量的影响。接受APD治疗的患者,其掌骨皮质面积在0至6个月间平均增加了1.2%(p<0.06),然后在6至12个月间保持稳定。相比之下,安慰剂组该指标逐渐下降(12个月时p<0.05)。两组在6个月和12个月时的变化有显著差异(p<0.01)。通过定量计算机断层扫描测量,APD组的平均椎体矿物质密度在12个月内增加了19.6%(p<0.02),而对照组则有8.8%的非显著性下降。变化之间的差异再次显著(p<0.005)。生化指标和骨组织形态计量学表明骨吸收和骨形成减少,但没有骨软化的证据。因此,APD可能在一年内预防糖皮质激素治疗患者的骨质流失。