唑来膦酸治疗绝经后骨质疏松早期药物不良反应分析

Early side effects of zoledronic acid in treating postmenopausal osteoporosis

目的:为了解唑来膦酸注射液治疗绝经后骨质疏松后早期不良反应情况及发生率,分析骨密度、合并骨折、应用钙剂、骨吸收抑制剂与早期不良反应的相关性。方法:对2009年-2010年12月期间行5mg唑来膦酸注射液治疗绝经后骨质疏松58例患者进行随访,记录用药后30 d内不良反应及其发生率,并进行分析。结果:唑来膦酸用药后早期不良反应主要表现为发热、肌肉痛、流感样症状、头痛、关节痛等症状,其发生率分别为48.3%,25.9%,31.0%,41.4%,24.2%。总不良反应率为60.3%。多为一过性,用药后30 d内均完全缓解。经比较发现骨密度差异、是否合并骨折与不良反应发生率无明显统计学差异;治疗前是否应用钙剂在头痛、肌肉痛、关节痛的发生率反面有明显统计学差异(P<0.05)。治疗前是否应用骨吸收抑制剂药物史的患者与治疗后头痛、肌肉痛、关节痛的发生率有明显统计学差异(P<0.05)。结论:5 mg唑来膦酸注射液治疗早期安全性较高,不良反应症状多为一过性,早期不良反应发生率与骨密度、合并骨折无关,可能与钙剂、骨吸收抑制剂有关。用药前后应及时预防治疗,早期观察无严重后遗症。

Objective：To analyze early side effects of zoledronic acid in treating postmenopausal osteoporosis.Methods： Totally 58 postmenopausal osteoporosis patients treated with 5 mg zoledronic acid injection were followed-up between Mar 2009 and Dec 2010.The bone mineral density（BMD）,osteoporosis fracture,application of calcium preparations and bone resorption inhibitors,and rate of early side effects within 30 days were analyzed.Results： The early side effects of zoledronic acid included fever（48.3%）,muscle pain（25.9%）,influenza-like symptoms（31.0%）,headache（41.4%）,and joint pain（24.2%）.Total rate of side effects was 60.3%.They were transient,and vanished within 30 days after injection.BMD and osteoporosis fracture were irrelevant to the rates of side effects.However,application of calcium preparations and bone resorption inhibitors before injection was relevant to rates of headache,muscle pain and joint pain（P0.05）.Conclusion： Zoledronic acid injection（5 mg） was relatively safe in early phase after injection.Most side effects are transient;the rates of side effects are irrelevant to BMD and osteoporosis fracture,but relevant to application of calcium preparations and bone resorption inhibitor before injection.