中国临床药理学杂志2026，Vol.42Issue(6)：799-804,6.DOI:10.13699/j.cnki.1001-6821.2026.06.008
维生素D钙片联合骨化三醇治疗2型糖尿病性骨质疏松症的临床研究
Clinical trial of vitamin D calcium tablets combined with calcitriol in the treatment of type 2 diabetic osteoporosis
摘要
Abstract
Objective To observe the clinical efficacy and safety of vitamin D and calcium tablets combined with calcitriol soft capsules in the treatment of type 2 diabetic osteoporosis.Methods Patients with type 2 diabetic osteoporosis were divided into control group and treatment group using a random number table.The control group received oral vitamin D and calcium tablets,each dose containing 750 mg of calcium carbonate and 2.5 μg of vitamin D3,administered once daily.The treatment group received oral calcitriol soft capsules at 0.25 μg per dose,once daily,in addition to the same treatment as the control group.Both groups continued treatment for 6 months.Glycometabolic indices,bone mineral density(BMD),bone metabolism indices,serological indices and clinical efficacy were compared between the two groups,and safety evaluation was conducted.Results A total of 247 cases were screened,and 167 cases were enrolled.In the treatment group,2 cases withdrew due to incomplete treatment and 3 were lost to follow-up;in the control group,3 cases withdrew due to incomplete treatment and 2 were lost to follow-up.Finally,78 and 79 cases were included in control and treatme groups,respectively.After treatment,the fasting plasma glucose(FPG)levels in treatment and control groups were(5.32±0.65)and(6.08±0.79)mmol·L-1,respectively;femoral neck BMD were(0.85±0.14)and(0.79±0.10)g·cm-2,respectively;bone-specific alkaline phosphatase(BALP)were(17.38±2.94)and(13.25±2.16)ng·mL-1,respectively;osteoprotegerin(OPG)were(275.31±29.42)and(238.42±24.56)pg·mL-1,respectively;insulin-like growth factor binding protein-3(IGFBP-3)were(4.37±0.72)and(3.19±0.45)μg·mL-1,respectively;and insulin-like growth factor-1(IGF-1)were(109.35±12.43)and(94.28±10.31)ng·mL-1,respectively.The differences in the above indices between treatment group and control group were all statistically significant(all P＜0.05).The total effective rates in treatment and control groups were 94.94％(75 cases/79 cases)and 84.62％(66 cases/78 cases),respectively,with a statistically significant difference(P＜0.05).The adverse drug reactions in treatment group included low-grade fever,abdominal distension,nausea and vomiting,while the control group experienced abdominal distension,nausea and vomiting.The total incidence of adverse drug reactions in treatment and control groups were 6.33％(5 cases/79 cases)and 5.13％(4 cases/78 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Vitamin D and calcium tablets combined with calcitriol soft capsules are effective in the treatment of type 2 diabetic osteoporosis,improving glycometabolism and bone metabolism,increasing BMD,promoting the expression of serum IGFBP-3 and IGF-1,and demonstrate reliable safety.关键词
维生素D钙片/骨化三醇软胶囊/2型糖尿病/骨质疏松症/临床疗效Key words
vitamin D and calcium tablet/calcitriol soft capsule/type 2 diabetes mellitus/osteoporosis/clinical efficacy分类
医药卫生引用本文复制引用
王伟,张桂香,刘瑞瑞,吴文丽,尹彩君..维生素D钙片联合骨化三醇治疗2型糖尿病性骨质疏松症的临床研究[J].中国临床药理学杂志,2026,42(6):799-804,6.基金项目
宁夏自然科学基金资助项目(2022AAC03381) （2022AAC03381）
