阿法骨化醇与雷奈酸锶治疗老年绝经期骨质疏松症的疗效与安全性比较

Comparison of the Efficacy and Safety of Alfacalcidol and Strontium Ranelate in the Treatment of Senile Menopausal Osteoporosis

目的：比较阿法骨化醇与雷奈酸锶治疗老年绝经期骨质疏松症的疗效和安全性。方法：158例老年绝经期骨质疏松症患者随机分为对照组（79例）和观察组（79例）。所有患者给予碳酸钙D3片1片,口服,每日1次。在此基础上,对照组患者给予阿法骨化醇软胶囊2粒,口服,每日1次;观察组患者给予雷奈酸锶干混悬剂1袋,睡前口服,每日1次。两组疗程均为12个月。观察两组患者治疗前及治疗6、12个月后的腰2-4椎体（L2-4）和股骨颈的骨密度（BMD）、骨钙素、总Ⅰ型胶原氨基端延长肽（TPINP）、视觉模拟法（VAS）评分及不良反应发生情况。结果：治疗前,两组患者L2-4和股骨颈的BMD、骨钙素、TPINP、VAS评分比较,差异均无统计学意义（P〉0.05）。对照组患者治疗12个月和观察组患者治疗6、12个月后L2-4的BMD、股骨颈的BMD均显著高于同组治疗前,随治疗时间的延长逐渐升高,且观察组高于对照组;对照组患者治疗12个月后和观察组患者治疗6、12个月后TPINP、VAS评分均显著低于同组治疗前,随治疗时间的延长逐渐降低,且观察组低于对照组,差异均有统计学意义（P〈0.05）;两组患者骨钙素水平均显著高于同组治疗前,随治疗时间的延长逐渐升高,差异均有统计学意义（P〈0.05）,但两组间比较差异无统计学意义（P〉0.05）。两组患者治疗期间均未见明显不良反应发生。结论：在常规治疗的基础上,雷奈酸锶治疗老年绝经期骨质疏松症的疗效显著优于阿法骨化醇,且安全性相当。

OBJECTIVE：To compare the efficacy and safety of alfacalcidol and strontium ranelate in the treatment of senile menopausal osteoporosis. METHODS：158 elderly menopausal patients with osteoporosis were randomly divided into control group（79 cases）and observation group（79 cases）. All patients were orally given 1 Calcium carbonate D3 tablet,once a day. Based on it,control group was given 2 Alfacalcidol soft capsules,once a day. Observation group was additionally given 1 bag of Strontium ranelate dry suspension,orally before bedtime,once a day. The treatment course for both groups was 12 months. L2-4 and BMD of femoral neck,osteocalcin,TPINP and VAS and ADR before and after 6 and 12 months in 2 groups were observed. RESULTS：Before treatment,there were significant differences in the BMD of L2-4 and femoral neck,osteocalcin,TPINP and VAS scores between 2 groups（P〉0.05）. BMD of L2-4 and femoral neck in control group after 12 months and in observation group after 6 and12 months were significantly higher than before,and it gradually increased be time in observation,observation group was higher than control group;TPINP and VAS scores in control group after 12 months and in observation group after 6 and 12 months were significantly lower than before,and it gradually decreased be time,observation group was lower than control group,the differences were statistically significant（P〈0.05）;osteocalcin levels in 2 groups were significantly higher than before,and it gradually increased be time,the difference was statistically significant（P〈0.05）,but there was no significant difference between 2 groups（P〉0.05）. There were no ADR during treatment. CONCLUSIONS：Based on the conventional treatment,the efficacy of alfacalcidol and strontium ranelate is superior to alfacalcidol alone in the treatment of senile menopausal osteoporosis,with similar safety.