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阿仑膦酸盐可预防急性脊髓损伤患者的骨质流失:一项随机、双盲、安慰剂对照研究。

Alendronate prevents bone loss in patients with acute spinal cord injury: a randomized, double-blind, placebo-controlled study.

作者信息

Gilchrist N L, Frampton C M, Acland R H, Nicholls M G, March R L, Maguire P, Heard A, Reilly P, Marshall K

机构信息

Canterbury Geriatric Medical Research Trust, The Princess Margaret Hospital, and Department of Medicine, Christchurch School of Medicine and Health Sciences, New Zealand.

出版信息

J Clin Endocrinol Metab. 2007 Apr;92(4):1385-90. doi: 10.1210/jc.2006-2013. Epub 2007 Jan 16.

DOI:10.1210/jc.2006-2013
PMID:17227802
Abstract

CONTEXT

Patients who sustain an acute spinal cord injury (SCI) experience rapid dramatic reductions in bone mineral density (BMD), especially marked in sublesional areas and sometimes leading to hypercalcemia and hypercalciuria, as well as increased fracture risk.

OBJECTIVE

In this prospective, double-blind, randomized, placebo-controlled study, we evaluated the hypothesis that oral alendronate administration would preserve BMD when administered soon after acute SCI.

PATIENTS AND INTERVENTION

Thirty-one patients with acute SCI were randomly allocated to receive oral alendronate 70 mg/wk or placebo, within 10 d of acute SCI, for 12 months.

MAIN OUTCOME MEASUREMENTS

At entry and at 3, 6, 12, and 18 months, total body bone density, lumbar and hip BMD, ultrasound of the calcaneus, 24-h urinary calcium, and serum C-telopeptide (betaCTX) were measured.

RESULTS

At study entry, patients in the two groups were well matched for age, gender, severity of neurological deficit, BMD, urinary calcium, and betaCTX. BMD indices declined steadily in the placebo group, and this effect was attenuated significantly by alendronate. After 12 months, there was a 5.3% difference (P<0.001) in total body BMD and a 17.6% difference (P<0.001) in the total hip BMD between the two groups. Alendronate compared with placebo induced significant (P<0.001) reductions in urinary calcium excretion and serum betaCTX. No treatment-related side effects were noted.

CONCLUSIONS

We conclude that alendronate therapy, 70 mg/wk, initiated soon after acute SCI, prevents bone loss and is not associated with side effects.

摘要

背景

急性脊髓损伤(SCI)患者的骨矿物质密度(BMD)会迅速显著降低,在损伤部位以下区域尤为明显,有时会导致高钙血症和高钙尿症,同时骨折风险增加。

目的

在这项前瞻性、双盲、随机、安慰剂对照研究中,我们评估了急性脊髓损伤后早期口服阿仑膦酸钠可维持骨密度这一假设。

患者与干预措施

31例急性脊髓损伤患者在急性脊髓损伤后10天内被随机分配接受每周70毫克口服阿仑膦酸钠或安慰剂治疗,为期12个月。

主要观察指标

在入组时以及3、6、12和18个月时,测量全身骨密度、腰椎和髋部骨密度、跟骨超声、24小时尿钙和血清C末端肽(βCTX)。

结果

在研究入组时,两组患者在年龄、性别、神经功能缺损严重程度、骨密度、尿钙和βCTX方面匹配良好。安慰剂组的骨密度指标稳步下降,而阿仑膦酸钠可显著减轻这种影响。12个月后,两组之间全身骨密度差异为5.3%(P<0.001),全髋骨密度差异为17.6%(P<0.001)。与安慰剂相比,阿仑膦酸钠可显著降低尿钙排泄和血清βCTX(P<0.001)。未观察到与治疗相关的副作用。

结论

我们得出结论,急性脊髓损伤后早期开始每周70毫克阿仑膦酸钠治疗可预防骨质流失且无副作用。

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