摘要
目的探讨不同类型维生素D3治疗原发性骨质疏松症的疗效和安全性。方法筛选出符合临床研究要求的90例骨质疏松症患者,随机分为3组。分别为:骨化三醇组30例,给予骨化三醇胶丸(罗盖全)0.5ug/日和阿仑膦酸钠(福善美)70 mg/周;普通维生素D3组30例,给予维生素D滴剂胶囊(普通维生素D3)800IU/日和阿仑膦酸钠(福善美)70mg/周;阿仑膦酸钠-维D3组30例,给予阿仑膦酸钠-维D3片(福美加)70mg/5600IU/周;所有患者均给予碳酸钙片1.5g/日(含元素钙600mg)。分别于干预前及干预6个月后:测量腰椎及左髋BMD;骨转换指标骨钙素(OC)、血清I型胶原交联羧基末端肽(CTX);钙激素指标甲状旁腺激素(PTH)、降钙素(CT),分析各组治疗前后及组间差异;测量血清钙、磷、24h尿钙、血常规、生化等指标,评估整体安全性。结果干预6个月后:三组腰椎和左髋BMD均升高,普通维生素D3组、阿仑膦酸钠-维D3组腰椎及左髋BMD增加均优于骨化三醇组(P<0.05),普通维生素D3组与阿仑膦酸钠-维D3组组间无统计学差异(P>0.05);骨转换指标骨化三醇组OC、CTX下降均优于普通维生素D3组、阿仑膦酸钠-维D3组(P<0.05),普通维生素D3组与阿仑膦酸钠-维D3组组间无统计学差异(P>0.05);三组血清PTH水平均轻微上升,血磷、降钙素、24小时尿钙均较基线期下降,血钙无明显改变,三组间无统计学差异(P>0.05),且未见高钙血症、高尿钙血症、维生素D中毒等严重不良事件。结论骨化三醇或普通维生素D3联合阿仑膦酸钠均可提高骨质疏松合并维生素D不足患者BMD水平,均未见严重不良反应,普通维生素D3疗效优于骨化三醇。
Objective To investigate the efficacy and safety of Different types of Vitamin D3 in the treatment of primary osteoporosis.Methods 90 patients with osteoporosis were screened out to meet the clinical research requirements and were randomly divided intothree groups. 30 cases of calcitriol group were given calcitriol capsule 0.5μg/day (Rocaltrol) and alendronate sodium 70mg/week(Fosamax). 30 patients of Vitamin D3 group were given vitamin D drops capsules 800IU/day (vitamin D3)and alendronate sodium70mg/week (Fosamax);30 cases of alendronate - vitamin D3 group were given tablet containing alendronate 70mg and cholecalciferol5600IU(Fu Mei jia)once a week. All patients were given calcium carbonate tablets 1.5g/day (including elemental calcium 600mg).Before intervention and after six months of intervention, the lumbar spine and left hip BMD, bone turnover markers Osteocalcin(OC),serum type I collagen cross- linked carboxy terminal peptides (CTX), calcium hormone indicators parathyroid hormone (PTH)andcalcitonin(CT)were measured, and the differences of each group before and after treatment were analyzed. Results After six months ofintervention, lumbar spine and left hip BMD among three groups were all increased significantly(P < 0.01),but their values at the vitaminD3 group and alendronate- vitamin D3 group were better than those at rocaltrol group((P < 0.05). And there was no difference between thevitamin D3 group and alendronate- vitamin D3 group (P > 0.05). The levels of OC and CTX in the rocaltrol group were significantly lowerthan those in the normal vitamin D3 group and the alendronate- vitamin D3 group (P < 0.05), and there was no difference between thenormal vitamin D3 group and the alendronate- vitamin D3 group (P > 0.05). Serum PTH levels were slightly increased in three groups.Blood phosphorus, calcitonin, 24- hour urinary calcium were lower than the baseline. There were no significant changes in serum calcium,and there were no significant differences between the three groups (P > 0.05). In three groups, hypercalcemia, hypercalcemia, vitamin Dpoisoning and other serious adverse events did not happen. Conclusions The Calcitriol or vitamin D3 combined with alendronate canimprove the level of BMD in patients with osteoporosis and deficiency of vitamin D. No serious adverse reaction was found. and the effect of vitamin D3 is better than that of the Calcitriol.
作者
张礼超
薛青
周奕
ZHANG Li chao;XUE Qing;ZHOU Yi(Department of Gerontology,The Fifth Affiliated Hospital of SUN YAT-SEN University,Guangdong,Zhuhai,519000,China)
出处
《新疆医学》
2019年第7期690-693,共4页
Xinjiang Medical Journal
