利塞膦酸钠治疗老年慢性肾脏病伴骨质疏松的疗效与安全性评价  

Evaluation of the efficacy and safety of risedronate for the treatment of osteoporosis in elderly patients with chronic kidney disease

作　　者：刘锋[1] 周广宇[1] 王雪婷[1] 郭莹[1] 吴晨[1] 

机构地区：[1]吉林大学中日联谊医院肾内科,吉林长春130033

出　　处：《中国骨质疏松杂志》2016年第6期735-740,共6页Chinese Journal of Osteoporosis

基　　金：国家自然科学基金面上项目(81370810)

摘　　要：目的评价利塞膦酸钠治疗老年慢性肾脏病（CKD）伴骨质疏松症的临床疗效及安全性。方法回顾性分析65例老年CKD2期或3期合并骨质疏松症患者的临床资料,分为应用利塞膦酸钠联合碳酸钙D3咀嚼片的治疗组32例及单独口服碳酸钙D3咀嚼片的对照组33例,疗程均为6个月。通过检测治疗前、后两组患者的骨密度、骨代谢指标如总1型胶原氨基端延长肽（t-P1NP）、N-端中段骨钙素（N-MID OC）、β-胶原降解产物（β-CTx）、25-羟基维生素D（25-OH-VD）等,对利塞膦酸钠的有效性进行评估,并评价其安全性。结果治疗6个月后两组患者T值及腰2～4、股骨颈的骨密度均显著升高（分别为P〈0.01和P〈0.05）,且治疗组治疗后腰2～4、股骨颈的骨密度明显高于对照组治疗后（P〈0.05）。治疗组骨密度改善的总有效率（84.38%）显著高于对照组（60.61%）（P〈0.05）。治疗组治疗后t-P1NP、N-MID OC、β-CTx水平显著下降,25-OH-VD明显升高,与治疗前和对照组比较差异有统计学意义（P〈0.05）。治疗组治疗6个月后VAS评分显著下降（P〈0.01）,且显著低于对照组（P〈0.05）。治疗组新骨折发生率显著低于对照组（P〈0.05）。治疗中未出现与药物相关的严重不良反应。结论利塞膦酸钠对于估算肾小球滤过率（e GFR）≥30 m L/（min·1.73m2）的老年CKD伴骨质疏松症的治疗有效,优于单用钙剂,且安全性较好。Objective To evaluate the efficacy and safety of risedronate on the treatment of osteoporosis（ OP） in elderly patients with chronic kidney disease（ CKD）. Methods Sixty-five elderly patients with CKD stage 2 or 3 and OP were retrospectively analyzed. They were randomly divided into the treatment group（ n = 32） and the control group（ n = 33）. Patients in the treatment group received risedronate 5 mg per day and calcium carbonate 0. 6 g and vitamin D3 125 IU daily. Patients in the control group received calcium carbonate 0. 6 g and vitamin D3 125 IU daily. The treatment lasted for 6 months. The efficacy was evaluated by the measurement of bone mineral density（ BMD） and bone metabolism indexes including serum total N-terminal propeptide of type I procollagen（ t-P1NP）,N-terminal mid-fragment of osteocalcin（ N-MID OC）,β-collagen specific sequences（ β-CTx）,and 25-hydroxyl vitamin D（ 25-OH-VD） before and after treatment. The safety of risedronate in elderly patients with CKD and OP was also assessed. Results T-score and BMD in the lumbar vertebrae（ L2-4） and femoral neck after the treatment were significantly higher than those before the treatment in both groups（ P〈 0. 01 and P〈 0. 05,respectively）. The BMD in L2-4 and femoral neck in the treatment group was significantly higher than that in the control group after treatment（ P〈 0. 05）. Total efficacy of BMD improvement group was 84. 38% in the treatment and 60. 61% in the control group,respectively,and the difference was statistically significant（ P〈 0. 05）. The serum levels of t-P1 NP,N-MID OC,and β-CTx significantly decreased,but the level of 25-OH-VD significantly elevated after treatment in the treatment group comparing with those before treatment and the control group（ P 〈0. 05）.The visual analog score（ VAS） dropped significantly after treatment in treatment group（ P 〈0. 01）. The VAS and the incidence of newfracture in the treatment group was significantly lower than those in the control

关 键 词：老年 慢性肾脏病 骨质疏松症 利塞膦酸钠 

分 类 号：R692.5[医药卫生—泌尿科学]