Walsh Stephen B, Altmann Paul, Pattison James, Wilkie Martin, Yaqoob Muhammad M, Dudley Christopher, Cockwell Paul, Sweny Paul, Banks Linda M, Hall-Craggs Margaret, Noonan Kate, Andrews Christopher, Cunningham John
The Centre for Nephrology, Royal Free Hospital, London, UK.
Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.
Kidney transplantation is associated with an increased risk of bone fracture and rapid loss of bone mineral density after kidney transplantation.
Randomized controlled trial.
SETTING & PARTICIPANTS: Patients were randomly assigned to treatment (n = 46) or control (no treatment; n = 47) groups. Patients were stratified according to parathyroid hormone level and sex. Those with parathyroid hormone level less than 150 pg/mL were excluded.
The treatment and control groups received pamidronate, 1 mg/kg, perioperatively and then at 1, 4, 8, and 12 months or no treatment, respectively. All received calcium (500 mg) and vitamin D (400 units) daily. Immunosuppression was cyclosporine and prednisolone, with no difference in dosing between the 2 groups.
OUTCOMES & MEASUREMENTS: Bone mineral density was evaluated by means of dual-energy x-ray absorptiometry of the lumbar spine and hip at baseline and 3, 6, 12, and 24 months, with the primary end point at 1 year of percentage of change in bone mineral density from baseline. Clinical fractures were recorded and also evaluated by means of spinal radiographs at baseline and 1 and 2 years.
Pamidronate protected bone mineral density at the lumbar spine; bone mineral density increased by 2.1% in the treatment group and decreased by 5.7% in the control group at 12 months (P = 0.001). Protection was also seen in Ward's area of the hip (P = 0.002) and the total hip (P = 0.004). There was no difference in femoral neck bone mineral density loss between the 2 groups. Fracture rates in the treatment and control groups were 3.3% and 6.4% per annum, respectively.
This study was not powered to detect differences in fracture rates.
Pamidronate protects against posttransplantation bone loss at the lumbar spine and Ward's area of the hip.
肾移植与骨折风险增加以及肾移植后骨矿物质密度快速流失有关。
随机对照试验。
患者被随机分配至治疗组（n = 46）或对照组（不治疗；n = 47）。患者根据甲状旁腺激素水平和性别进行分层。甲状旁腺激素水平低于150 pg/mL的患者被排除。
治疗组和对照组分别在围手术期接受1 mg/kg的帕米膦酸盐，然后在1、4、8和12个月时再次接受该药物治疗，或不接受治疗。所有患者均每日补充钙（500 mg）和维生素D（400单位）。免疫抑制采用环孢素和泼尼松龙，两组给药剂量无差异。
在基线以及3、6、12和24个月时，通过腰椎和髋部的双能X线吸收法评估骨矿物质密度，主要终点为1年时骨矿物质密度相对于基线的变化百分比。记录临床骨折情况，并在基线以及1年和2年时通过脊柱X线片进行评估。
帕米膦酸盐可保护腰椎的骨矿物质密度；治疗组在12个月时骨矿物质密度增加了2.1%，而对照组下降了5.7%（P = 0.001）。在髋部的沃德三角区（P = 0.002）和全髋部（P = 0.004）也观察到了保护作用。两组之间股骨颈骨矿物质密度的流失没有差异。治疗组和对照组的骨折发生率分别为每年3.3%和6.4%。
本研究的样本量不足以检测骨折发生率的差异。
帕米膦酸盐可预防移植后腰椎和髋部沃德三角区的骨质流失。
