伊班膦酸钠联合骨化三醇治疗老年骨质疏松症的临床研究

Clinical study on sodium ibandronate combined with calcitriol in treatment of senile osteoporosis

目的探讨伊班膦酸钠注射液联合骨化三醇胶丸治疗老年骨质疏松症的临床疗效。方法选取2016年11月—2017年12月在上海市第三康复医院和第二军医大学附属公利医院收治的123例老年骨质疏松症患者作为研究对象,将患者随机分为骨化三醇组、伊班膦酸钠组、联合组,每组各41例。骨化三醇组患者口服骨化三醇胶丸,2粒/次,1次/d;伊班膦酸钠组患者静脉滴注伊班膦酸钠注射液,2 mg溶于0.9%氯化钠溶液250 mL中,滴注时间大于2 h,1次/3个月;联合组给予伊班膦酸钠注射液联合骨化三醇胶丸,用法用量同上。3组患者均连续治疗12个月。观察3组患者的临床疗效,比较3组患者治疗前后的数字疼痛评分(NRS)、骨密度(BMD)、血磷、血钙、抗酒石酸酸性磷酸酶5b(TRAP-5b)、骨源性碱性磷酸酶(BALP)水平和不良反应。结果治疗后,骨化三醇组、伊班膦酸钠组、联合组的总有效率分别为82.93%、85.37%和95.12%,联合组总有效率显著优于骨化三醇组和伊班膦酸钠组,差异具有统计学意义(P<0.05)。治疗6、12个月后,3组患者的NRS评分值均显著降低,平均腰椎BMD和平均股骨颈BMD均显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);治疗6、12个月后,联合组患者的NRS评分值显著低于同期骨化三醇组和伊班膦酸钠组,而平均腰椎BMD和平均股骨颈BMD均明显高于同期骨化三醇组和伊班膦酸钠组,差异具有统计学意义(P<0.05)。治疗后,3组患者血钙、血磷相较于治疗前差异无统计学意义,且联合组患者的血钙、血磷较其他两组差异均无统计学意义。治疗6、12个月后,3组患者TRAP-5b、BALP水平均显著降低,同组治疗前后比较差异具有统计学意义(P<0.05);治疗6、12个月后,联合组患者TRAP-5b、BALP水平显著低于同期骨化三醇组和伊班膦酸钠组,差异具有统计学意义(P<0.05)。3组患者的不良反应发生情况差异无统计学意义。结论伊班膦酸钠注射液联合骨化三醇胶丸治疗老年性骨质疏松症具有较好的临床疗效,能够改善骨密度,减少疼痛,维持骨生化指标,具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Sodium Ibandronate Injection combined with Calcitriol Soft Capsules in treatment of senile osteoporosis.Methods Patients(123 cases)with senile osteoporosis in Shanghai NO.3 Rehabilitation Hospital and Gongli Hospital Affiliated to Second Military Medical University from November 2016 to December 2017 were randomly divided into calcitriol group,sodium ibandronate group,and combined treatment groups,and each group had 41 cases.Patients in the calcitriol group were po administered with Calcitriol Soft Capsules,2 grains/time,once daily.Patients in the sodium ibandronate group were iv administered with Sodium Ibandronate Injection,2 mg added into 0.9%sodium chloride solution 250 mL,and the dripping time was more than 2 h,once every 3 months.Patients in the combined treatment group were given Sodium Ibandronate Injection and Calcitriol Soft Capsules,and usage and dosage were the same as the above.Patients in two groups were treated for 12 months.After treatment,the clinical efficacy was evaluated,and the NRS,BMD,serum phosphorus,serum calcium,TRAP-5 b,and BALP levels in three groups before and after treatment were compared.Results After treatment,the clinical efficacies in the calcitriol group,sodium ibandronate group,and combined treatment group were 82.93%,85.37%,and 95.12%,respectively,and there was difference among three groups(P<0.05).After treatment for 6 and 12 weeks,the NRS in three groups were significantly decreased,but the average BMD of lumbar and femoral neck were significantly increased,and the difference was statistically significant in the same group(P<0.05).After treatment for 6 and 12 weeks,the NRS in the combined treatment group were significantly lower than those in the calcitriol and sodium ibandronate groups,but the average BMD of lumbar and femoral neck were higher than those in the calcitriol and sodium ibandronate groups,with significant difference among three groups(P<0.05).After treatment,there was no significant difference in serum calcium and phosphorus among three groups before treatment,and there was no significant difference in serum calcium and phosphorus between the combined group and the other two groups.After treatment for 6 and 12 weeks,the levels of TRAP-5 b and BALP in three groups were significantly decreased,and the difference was statistically significant in the same group(P<0.05).After treatment for 6 and 12 weeks,the levels of TRAP-5 b and BALP in the combined treatment group were significantly lower than those in the calcitriol and sodium ibandronate groups,with significant difference among three groups(P<0.05).Conclusion Sodium Ibandronate Injection combined with Calcitriol Soft Capsules has a good clinical effect in treatment of senile osteoporosis,can improve the BMD of patients,relieve the pain,and maintain bone biochemical indicators,which has a certain clinical application value.