摘要
目的 了解绝经后骨质疏松患者应用唑来膦酸注射液后不良反应发生情况并探讨相关因素。方法收集2012年10月至2015年5月在首都医科大学宣武医院内分泌科住院并应用唑来膦酸注射液治疗的绝经后骨质疏松患者病历资料，记录患者的年龄，是否有骨折史，治疗前是否服用过骨吸收抑制剂，用药后第3和14天出现发热、流感样症状、头痛、肌肉痛、关节痛等不良反应发生情况，用药前与用药后第3天ALT、AST、Scr和BUN水平。采用多因素Logistic回归分析上述不良反应的相关因素。结果纳入分析的患者为105例，年龄49—83岁，平均（69±9）岁；有骨折病史者17例；服用过骨吸收抑制剂者79例。所有患者均静脉滴注唑来膦酸注射液5mg／100ml。患者用药后第3天，不良反应总体发生率和发热、流感样症状、头痛、关节痛和肌肉痛发生率分别为45．7％（48／105）和39．O％（41／105）、37．1％（39／105）、26．7％（28／105）、32．4％（34／105）、32．4％（34／105）。第14天，不良反应总体发生率和发热、流感样症状、头痛、关节痛和肌肉痛发生率分别为2．9％（3／105）和0、0、1．0％（1／105）、1．9％（2／105）、1．0％（1／105）。用药后第14天不良反应总体发生率和单项症状发生率均明显低于用药后第3天（均P〈0．001）。用药后第3天患者ALT、AST、Scr、BUN水平与用药前比较，差异均无统计学意义（均P〉0．05）。多因素Logistic回归分析显示，患者年龄与发热、流感样症状和肌肉痛呈负相关，与头痛及关节痛无相关性。应用唑来膦酸注射液之前服用骨吸收抑制剂与发热、流感样症状、头痛、关节痛或肌肉痛等5种不良反应的发生均呈负相关。年龄≥60岁的患者不良反应总体发生率和上述5种不良反应发生率均低于年龄〈60岁者（P〈0．01，P〈0．05）。结论应用唑来膦酸注射液治疗绝经后骨质疏松症常见的不良反应为发热、流感样症状、头痛、关节痛和肌肉痛，年龄和应用过骨吸收抑制剂与上述不良反应的发生呈负相关。
Objective To analyze the adverse reactions and the correlative factor of zoledronic acid injection in postmenopausal osteoporosis patients. Methods The clinical data of postmenopausal osteoporosis patients who were hospitalized in endocrinology department of Xuanwu Hospital during October 2012 to May 2015 were collected. The patients＇ age, with or without history of bone fracture, with or without receiving bone resorption inhibitors before treatment, the occurrence of adverse reactions including fever, influenza-like symptoms, headache, myalgia, arthralgia on day 3 and 14 after receiving zoledronic acid injection, and the levels of alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, serum creatinine （Scr） and urea nitrogen （BUN） before and 3 days after receiving zoledronic acid injection were recorded. The related factor of the above-mentioned adverse reactions was analyzed by muhifactor logistic regression method. Results A total of 105 medical records of postmenopausal osteoporosis patients were enrolled into the study. The patients＇ages ranged from 49-83 years, and the average age was （69 -＋9） years. There were 17 cases with history of bone fracture, and 79 cases who received bone resorption inhibitors before treatment. All the patients received IV infusion of zoledronic acid 5 rag/100 ml. On day 3 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 45.7% （48/105） and 39.0% （41/105）, 37.1% （39/ 105）, 26.7% （28/105）, 32.4% （34/105）, 32.4% （34/105）, respectively. On day 14 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 2.9% （3/105）, 0, 0, 1.0% （ 1/105）, 1.9% （2/105）, 1.0% （ 1/105）, respectively. The overall incidence on day 14 after receiving zoledronic acid injection was obviously lower than that on day 3 （P 〈 0.001 ）. The difference of levels of patients＇ ALT, AST, Scr, and BUN before medication and 3 days after medication were not statistically significant （all P 〉 0.05）. The result of multivariate logistic regression analysis showed that the age was negatively correlated with fever, influenzalike symptoms, and myalgia, and irrelevance to headache and arthralgia. Taking bone resorption inhibitors before receiving zoledronic acid injection was negatively correlated with the five kinds of adverse reactions mentioned above. The overall incidence and the above-mentioned five kinds of adverse reactions in patients age ≥ 60 years were lower than those in the patients aged 〈 60 years （P 〈 0.01, P 〈 0.05, respectively）. Conclusions The common adverse reactions of zoledronic acid injection in postmenopausal osteoporosis patients are fever, influenza-like symptoms, headache, myalgia, and arthralgia. The age and the history of receiving bone resorption inhibitors are negatively related to the above-mentioned adverse reactions.
出处
《药物不良反应杂志》
CSCD
2016年第2期116-120,共5页
Adverse Drug Reactions Journal
关键词
唑来膦酸
骨质疏松
绝经后
药物毒性
危险因素
Zoledronic acid
Osteoporosis, postmenopausal
Drug toxicity
Risk factors
