鲑鱼降钙素鼻喷剂治疗老年骨质疏松症的临床研究

Clinical study of the effect of salmon calcitonin nasal spray on senile osteoporosis

目的观察鲑鱼降钙素鼻喷剂对老年骨质疏松症患者的疗效和安全性。方法本研究将伴有疼痛症状的老年骨质疏松症患者95例,分为治疗组47例;对照组48例,其中对照组维D钙咀嚼片+骨化三醇软胶囊;治疗组在对照组基础上,使用鲑鱼降钙素鼻喷剂。测量治疗前及治疗半年骨密度;抽血检查治疗前及治疗半年的生化指标和骨代谢标志物;评估治疗前及半年疼痛程度;同时观察两组间不良反应发生情况。结果①治疗组治疗半年与治疗前及对照组比较骨密度变化极显著差异(P<0.01);②治疗组治疗半年疼痛缓解总有效率与对照组相比均有极显著差异(P<0.01);③治疗组治疗前后与对照组治疗前后比较血钙水平及BALP水平无显著差异(P>0.05);治疗组治疗前后和对照组治疗前后1,25(OH)2D3水平均有显著提高(P<0.05);治疗后两组1,25(OH)2D3水平无显著差异(P>0.05);治疗组治疗前后和治疗后两组TRACP5b水平极显著差异(P<0.01);但治疗组治疗前后和治疗后两组IL-1水平均无显著改变(P>0.05)。④治疗组不良反应与对照组相比无统计学意义(P>0.05)。结论鲑鱼降钙素鼻喷剂治疗老年骨质疏松症是有效和安全的。

Objective To observe the efficacy and safety of salmon calcitonin nasal spray on senile osteoporosis. Methods Ninety-five patients with senile osteoporosis and pain were divided into two groups： the treatment group （n = 47） and the control group （n = 48）. Patients in the control group were given calcium supplement with vitamin D chewable tablets plus calcitriol daily. With the same treatment in the control group, patients in the treatment group were given daily salmon calcitonin nasal spray additionally. Bone mineral density of patients was detected before the treatment and half a year after the treatment. Biochemical indicators and bone metabolic and biochemical makers were also measured before the treatment and half a year after the treatment. The degree of pain was assessed before the treatment and half a year after the treatment. Adverse reactions of both groups were observed. Results After half a year treatment, the bone mineral density in the treatment group increased significantly, and it had significant difference compared with that in the control group （P 〈 0. 01 ）. The total effective rate of pain relieving in the treatment group was significant different compaired with that in the control group after half a year treatment （P 〈 0. O1 ）. Serum concentrations of calcium and BALP showed no significant changes before and after the treatment in both groups （P 〉 0.05 ） , while the serum levels 1,25-（0H） 2D3 in both groups increased significantly after the treatment （P 〈 0.05）, but no significant difference was observed between the two groups. The serum levels TRACP5b increased significantly before and after the treatment （ P 〈 0.01 ） , and serum levels of TRACPSb in the treatment group were higher than that in the control group （P 〈 0.01 ）. The serum levels of IL-6 showed no significant difference before and after the treatment （P 〉 0. 05 ）. The incidence of adverse reactions in both groups showed no significant difference （P 〉 0. 05）. Conclusion The usage of salmon calcitonin nasal spray in the treatment of senile osteoporosis is effective and safe.