阿伦膦酸钠与活性维生素D3对比防治绝经期前SLE患者GIOP

目的对比观察阿伦膦酸钠与活性维生素D3，对无脆性骨折病史的绝经期前系统性红斑狼疮（SLE）患者糖皮质激素诱导骨质疏松（GIOP）的疗效。方法分别依照大、小剂量两种GCs治疗方案入组绝经期前SLE患者（其中门诊病情稳定，长期服用小剂量糖皮质激素GCs治疗者47例；病房初诊，服用大剂量GCs治疗者44例）。每种方案入组患者随机分为钙剂组、钙剂＋活性维生素D3组及钙剂＋阿伦膦酸钠组治疗，分别于第0、3、6个月监测患者骨代谢血清学指标及骨密度值，并记录治疗过程中骨折及股骨头坏死的发生情况。结果（1）小剂量GCs治疗方案：各用药组血清Ca、PO4、ALP水平治疗前后均无显著差异；血清N—MID及B—CT水平，钙剂联合阿伦膦酸钠组治疗后较治疗前显著降低（P〈0．05）；单用钙剂或钙剂联合活性维生素D3组治疗后较治疗前上升，但仅血清N—MID水平差异有统计学意义（P〈0．05）。骨密度值：单用钙剂组，腰椎、单侧股骨及股骨颈BMD值治疗后较治疗前显著降低（P〈0．05）；钙剂联合活性维生素D3组三处BMD值治疗前后差异无统计学意义（P〉0．05），钙剂联合阿伦膦酸钠组，三处BMD值治疗后较治疗前均显著升高俨〈0．05）。（2）大剂量GCs治疗方案：各用药组血清Ca、PO4、ALP水平治疗前后均无显著差异；血清N—MID及B—CT水平，钙剂联合阿伦膦酸钠组治疗后较治疗前显著降低（P〈0．05），单用钙剂或钙剂联合活性维生素D3组治疗后较治疗前显著上升（P〈0．05）。骨密度值：单用钙剂组及钙剂联合活性维生素D3组，三处BMD值治疗后较治疗前显著降低（P〈0．05），钙剂联合阿伦膦酸钠组，治疗前后差异无统计学意义（P〉0．05）。（3）骨折及股骨头坏死的发生：小剂量GCs治疗方案中，各组均无骨折及股骨头坏死的发生；大剂量GCs治疗方案中，单用钙剂或钙剂联用活性维生素D3组均出现股骨头坏死，而钙剂联用阿伦膦酸钠组则无股骨头坏死的发生。结论对于分别服用大、小两种剂量GCs治疗的绝经期前SLE患者，阿伦膦酸钠较活性维生素D3，可以更好地降低骨转换、提高骨密度值，减少股骨头坏死发生的例数。

The comparison between alendronate and active vitamin D3 in controlling glucocorticoid induced osteoporosis in premenopansal patients with systemic lupus erythematosus

Objective To observe comparatively the efficacies between alendronate and active vitamin D3 in controlling glucocorticoid induced osteoporosis （GIOP） in premenopausal patients with systemic lupus erythematosus （SLE） and without a history of fragility fracture. Methods 91 premenopausal female SLE patients with low-dose glucocorticoids （GCs） therapy or high-dose GCs therapy were divided into 2 groups, including 47 patients who were collected from the outpatient department and received low-dose GCs and 44 patients who were collected from the inpatient department and received high-dose GCs. The patients with either therapy were randomly divided into 3 groups： the calcium group, calcium plus active vitamin D3 group and calcium plus alendronate group. Bone metabolism serological markers and bone mineral density （BMD） values were tested in the first 0, 3 and 6 months. The incidence of fractures and femoral head necrosis was recorded during the treatment process. Results （1） In all groups with low- dose GCs therapy, there was no significant difference in the serum levels of calcium （Ca）, inorganic phosphate （PO4） and alkaline phosphatase （ALP） before and after treatment. The serum levels of N-MID osteocalcin （N-MID） and β collagen decomposition segment （β-CT） significantly decreased after the treatment in the calcium plus alendronate group （P〈0.05）. The serum levels of N-MID and β-CT significantly increased after the treatment in the calcium group and calcium plus active vitamin D3 group （P〈0.05）, and there were statistically significant differences only in the serum level of N-MID （P〈0.05）. In the calcium group, the BMD values in the lumbar spine, unilateral femur and femoral neck significantly decreased after the treatment （P〈0.05）. In the calcium plus active vitamin D3 group, there was no statistically significant difference in the BMD values before and after the treatment （P〉0.05）. In the calcium plus alendronate group, the BMD values significantly increased after the treatment （P〈0.05）. （2） In all groups with high-dose GCs therapy, there was no significant difference in the serum levels of Ca, PO4 and ALP before and after the treatment. The serum levels of N-MID and β-CT significantly decreased after the treatment in the calcium plus alendronate group （P〈0.05）, which significantly increased after the treatment in the calcium group and calcium plus active vitamin D3 group （P〈0.05）. In the calcium group and calcium plus active vitamin D3 group, the BMD values in the lumbar spine, unilateral femur and femoral neck significantly decreased after the treatment （P〈0.05）. In the calcium plus alendronate group, there was no significant difference in the BMD values before and after the treatment （P〉0.05）. （3） There was no fracture and femoral head necrosis in all groups with low-dose GCs therapy. In all groups with high-dose GCs therapy, femoral head necrosis occurred in the calcium group and calcium plus active vitamin D3 group, and meanwhile, there was no femoral head necrosis in the calcium plus alendronate group. Conclusions When premenopausal female SLE patients receive low-dose or high-dose GCs therapy respectively, alendronate can better decrease bone turnover, increase BMD and reduce the incidence of femoral head necrosis, comparing with active vitamin D3.