唑来膦酸治疗绝经后妇女骨质疏松的不良反应分析

Investigation and analysis of toxicity caused by zoledronic acid in the treatment of postmenopausal women with osteoporosis

目的观察唑来膦酸治疗绝经后妇女骨质疏松的安全性。方法对90例绝经后骨质疏松患者给予5 mg唑来膦酸注射液,观察用药后1个月内不良反应的发生情况,根据是否发生不良反应将患者分为发生组及未发生组,对不良反应发生的影响因素进行Logistic回归分析。结果 90例患者用药后发热、头痛、肌肉痛、关节痛、白细胞减少、轻微肾功能损害的发生率分别为21.11%、14.44%、11.11%、13.33%、4.44%、2.22%,总发生率为45.56%;发生组与未发生组骨钙素水平、钙剂、骨吸收抑制剂、内分泌调节药物使用率比较差异有统计学意义(P<0.05);Logistic回归分析显示使用内分泌调节药物(OR=0.71,P<0.05)是不良反应发生的危险因素,使用钙剂(OR=0.83,P<0.05)、骨吸收抑制剂(OR=1.23,P<0.05)是不良反应发生的保护性因素。结论唑来膦酸治疗绝经后骨质疏松患者的不良反应发生率较高,但程度较轻,辅之以钙剂、骨吸收抑制剂治疗可减少不良反应。

Objective To investigate the toxicity caused by zoledronic acid in postmenopausal women with osteoporosis. Methods 90 postmenopausal women with osteoporosis were treated with 5 mg zoledronic acid,the occurrence of adverse reactions within a month were observed,then patients were divided into toxicity group（ group T） and no toxicity group（ group N） depending on whether adverse reactions occured or not,Logistic regression analysis was carried out for the related factors of toxicity. Results The incidences of fever,headache,muscle pain,joint pain,neutropenia,mild renal impairment were 21. 11%,14. 44%,11. 11%,13. 33%,4. 44% and 2. 22%,the total incidence rate was 45. 56%. There were significant differences in the osteocalcin levels,calcium,bone resorption inhibitors,endocrine regulation drug use between the 2 groups（ P 〈 0. 05）. Logistic regression analysis showed that the endocrine regulation drugs use（ OR = 0. 71,P 〈 0. 05） was the risk factor for adverse reactions,while the use of calcium（ OR = 0. 83,P 〈0. 05） and bone resorption inhibitors（ OR = 1. 23,P 〈 0. 05） were the protective factors. Conclusion Zoledronic acid has a high incidence of toxic reactions in the treatment of postmenopausal women with osteoporosis,while the degree of the toxicity is light,supplement with calcium and bone resorption inhibitors could reduce the toxicities.