Objective To evaluate the efficacy and safety of vitamin D (plain vitamin D or active vitamin D) plus calcium carbonate in elderly osteoporotic patients.Methods Two hundred forty patients over 60 years with osteoporosis were randomly divided into two groups:vitamin D 800 IU/d plus calcium 800 mg/d group (plain D group) and calcitriol 0.5 μg plus calcium 800 mg/d group (plain D group).Participants underwent physical performance tests at onset and after 6 and 12 months:the time of short physical performance battery (SPPB) acted as primary end-point.Fall risk was measured by modified falls efficacy scale (MFES) scores,grip strength estimated by hand-held dynamometer,bone mineral density (BMD) obtained from dual energy X-ray absorptiometry (DXA),and the presence of fall and new fracture were evaluated as well.Results There were 103 patients (man 17,women 86) in plain D group and 105 patients (man 18,women 87) in active D group for follow-up.A significant improvement in the performance of SPPB [plain D group (7.45±2.45),active D group (7.80±2.21)],grip strength [plain D group (21.04±5.66) kg,active D group (21.96±6.12) kg] and MFES [plain D group (7.09±1.62),active D group (7.19±1.63)] tests was observed after 6 months and further increased by the end of the therapeutic intervention in both groups.Active vitamin D showed better improvement than plain vitamin D (P＜0.05).The grip strength was significantly enhanced in two groups during the 12 months of treatment,but no significant differences were found between these two groups.The changes of BMD at spine and hip were not significant either,except that lumbar BMD [(0.790±0.105) g/cm2] were increased during 12 months of treatment with active vitamin D.No severe adverse events related to these medications were found throughout the study.Conclusions Treatment with vitamin D plus calcium for 12 months in elderly osteoporotic patients effectively reduced fall risk through increasing physical performance and muscle strength.Active vitamin D had better effects than plain vitamin D in improving physical function,reducing falls risk and increasing spine BMD.%目的 评估普通维生素D及活性维生素D对老年骨质疏松症患者躯体功能、肌力及跌倒风险的干预效果和安全性.方法 将240例60岁以上、可独立行走的骨质疏松症患者采用数字表法随机平均分为普通维生素D组(钙800 mg+维生素D3800 IU/d)和活性维生素D组(钙800 mg+1,25双羟维生素D30.5 μg/d);随访观察12个月,分别在干预前、干预6个月和12个月后行简易躯体能力测试(short physical performance battery,SPPB)、手持式测力仪(hand-held dynamometer,HHD)测试握力、跌倒效能量表评分(modified falls efficacy scale,MFES)及血钙、血磷、血肌酐检测;在干预前、干预12个月后行骨密度(bonemineral density,BMD)检查;记录12个月跌倒次数、跌倒致骨折发生率及药物不良反应.结果 普通维生素D组获得随访103例(男性17例,女性86例),活性维生素D组获得随访105例(男性18例,女性87例).干预6个月后,两组患者SPPB评分[普通维生素D组(7.45±2.45)分vs.活性维生素D组(7.80±2.21分)]、握力[普通维生素D组(21.04±5.66) kg vs.活性维生素D组(21.96±6.12) kg]及MFES[普通维生素D组(7.09±1.62)分vs.活性维生素D组(7.19±1.63)分]较干预前提高(P＜0.05),组间比较差异无统计学意义(P＞0.05);干预12个月后,与普通维生素D组SPPB (8.01±2.45)分和MFES (7.38±1.61)分相比,活性维生素D组SPPB (9.33±2.18)分和MFES (8.42±1.63)分提高更明显(P＜0.05).干预12个月后,活性维生素D组腰椎BMD (0.790±0.105) g/cm2较干预前(0.756±0.107) g/cm2较干预前改善,差异有统计学意义(P＜0.05);普通维生素D组腰椎及髋部BMD均无明显改善.随访期间无严重不良事件发生.结论 维生素D干预可有效改善老年骨质疏松症患者肌力及躯体能力,降低跌倒风险;活性维生素D改善躯体能力和降低跌倒风险效果更佳,并且能够有效提高骨质疏松症患者腰椎骨量.
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