阿法骨化醇六个月治疗对肌肉力量、平衡以及跌倒者数量和跌倒次数的影响。

Effect of a six-month therapy with alfacalcidol on muscle power and balance and the number of fallers and falls.

作者信息

Dukas Laurent, Schacht Erich, Runge Martin, Ringe Johann D

机构信息

Department of Medicine, Institut für Hausarztmedizin IHAMB, Basel, Switzerland.

出版信息

Arzneimittelforschung. 2010;60(8):519-25. doi: 10.1055/s-0031-1296321.

DOI:10.1055/s-0031-1296321

PMID:20863009

Abstract

PURPOSE

In an open observational prospective multicentered study on a cohort of patients with a creatinine clearance of < or = 65 ml/min and diagnosed with the "Esslinger Fall Risk Assessment" to be at an increased risk for falls the effect of daily treatment with 1 microg alfacalcidol (CAS 41294-56-8; Alpha-D3) on muscle power, balance and number of fallers and falls was investigated.

METHODS

In this open prospective study on 237 participants recruited in Germany, 16.9% men and 83.1% women with a mean age of 75.9 years and a mean body mass index (BMI) of 26.3 kg/m2 underwent at the beginning and after 3 and 6 months different muscle strength and balance tests such as the Timed-up and Go Test (TUG), the Tandem Stand Test (TST) and the Chair Rising Test (CRT). A successful performance in these tests has been associated with a significantly lower risk for falls and non-vertebral fractures in elderly patients (successful test performance: TUG < 12 s, TST > 10 s, CRT < 10 s).

RESULTS

Controlled for age, gender and BMI, treatment with alfacalcidol was associated with a significantly increased performance in all three muscle and balance tests already after 3 months. This effect increased after six months of therapy and a significant increase in the number of participants who were able to successfully perform the different tests was observed: plus 74.9% for the TUG (p < .0001), plus 112% for the TST (p < .0001) and plus 108% for the CRT (p < .0001). After six months the mean time used for the TUG was decreased by 2.01 s, by 2.29 s for the CRT, and increased by 2.02 s for the TST. Controlled for age, gender, BMI and CrCI, treatment with alfacalcidol for six moths resulted in a significant 48.1% (p _< or = .0001) decrease in the absolute number of fallers and a significant 51.3% (p .0001) decrease in the absolute number of falls, compared to the 6 months prior to alfacalcidol therapy.

CONCLUSIONS

Treatment with alfacalcidol increases muscle power and balance as measured with three different muscle power and balance tests and leads to a highly significant decrease in the number of fallers and falls.

摘要

目的

在一项开放性观察性前瞻性多中心研究中，对一组肌酐清除率≤65 ml/分钟且经“埃斯林格跌倒风险评估”诊断为跌倒风险增加的患者，研究每日服用1微克阿法骨化醇（化学物质登记号41294 - 56 - 8；α-D3）对肌肉力量、平衡能力以及跌倒者数量和跌倒次数的影响。

方法

在这项针对德国招募的237名参与者的开放性前瞻性研究中，男性占16.9%，女性占83.1%，平均年龄75.9岁，平均体重指数（BMI）为26.3 kg/m²。在研究开始时以及3个月和6个月后，他们接受了不同的肌肉力量和平衡测试，如计时起立行走测试（TUG）、串联站立测试（TST）和椅子起立测试（CRT）。在这些测试中表现成功与老年患者跌倒和非椎体骨折风险显著降低相关（测试表现成功标准：TUG＜12秒，TST＞10秒，CRT＜10秒）。

结果

在对年龄、性别和BMI进行校正后，服用阿法骨化醇治疗3个月后，所有三项肌肉和平衡测试的表现就显著提高。治疗6个月后这种效果增强，并且观察到能够成功完成不同测试的参与者数量显著增加：TUG测试增加74.9%（p＜.0001），TST测试增加112%（p＜.0001），CRT测试增加108%（p＜.0001）。6个月后，TUG测试的平均用时减少了2.01秒，CRT测试减少了2.29秒，TST测试增加了2.02秒。在对年龄、性别、BMI和肌酐清除率进行校正后，与服用阿法骨化醇治疗前6个月相比，服用阿法骨化醇6个月导致跌倒者绝对数量显著减少48.1%（p≤.0001），跌倒次数绝对数量显著减少51.3%（p.0001）。