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| 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 |
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| DOI：10.3969/j.issn.1006-7108.2016.06.017 |
| 中文关键词: 老年 慢性肾脏病 骨质疏松症 利塞膦酸钠 |
| 英文关键词:Elderly Chronic kidney disease Osteoporosis Risedronate |
| 基金项目:国家自然科学基金面上项目（81370810） |
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| 中文摘要: |
| 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（eGFR）≥30 mL/(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。 |
| 英文摘要: |
| 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-P1NP, 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 new fracture in the treatment group was significantly lower than those in the control group (P<0.05). Severe side effect related to risedronate was not observed. Conclusion Risedronate is effective and safe in the treatment of elderly osteoporosis with CKD as eGFR was greater than or equal to 30 mL/(min?1.73m2). |
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