首次使用唑来膦酸治疗骨质疏松症急性期反应及其危险因素分析

Risk Factors of Acute-phase Response Following the First-dose Administration of Zoledronic Acid in the Treatment of Osteoporosis

目的探讨首次使用唑来膦酸静脉输注治疗骨质疏松症致急性期反应(APR)发生概况及其危险因素。方法对四川大学华西医院内分泌科2009年1月至2012年11月首次使用唑来膦酸5mg治疗骨质疏松症的住院患者临床资料进行回顾性分析,比较有急性期反应组(APR+)与无反应组(APR-)患者年龄、体质指数(BMI)、合并用药、合并症、实验室指标的差异。结果 178例患者中108例(60.7%)出现了APR,其中发热80例(44.9%),畏寒、寒战14例(9.6%),肌肉关节酸痛48例(27.0%),消化道症状19例(10.7%),头晕头痛10例(5.6%),心悸7例(3.9%),皮疹3例(1.7%)。51例(63.8%)发热患者需要对症处理。APR+和APR-组的血清25羟维生素D、抗酒石酸酸性磷酸酶(TRACP-5b)、新发椎体骨折差异有统计学意义(P<0.05)。logistic回归分析发现TRACP-5b≥4.15U/L和新发椎体骨折是APR的主要危险因素,相对危险度(OR)分别为3.3倍和2.5倍。结论首次使用唑来膦酸治疗骨质疏松症出现急性期反应发生率较高,高TRACP-5b水平和新发椎体骨折是发生APR的危险因素。

Objective To explore the risk factors of acute-phase response （APR） following the first-dose administration of zoledronic acid in the treatment of osteoporosis. Methods We reviewed the clinical data of the patients receiving the first use of zoledronic acid 5 mg treatment of osteoporosis from January 2009 to November 2012, and divided the patients into acute phase response group （APR＋） and no response group （APR--）. The age, body mass index （BMI）, concomitant medications, comorbidities, laboratory parameters between the two groups were compared and analyzed. Results A total of 178 patients were eligible for inclusion in the study, of which 108 patients experienced APR. In APR group, there were 80 （44.9%） patients developed fever, 14 （9.6%） chills, 48 （27.0%） musculoskeletal pain, 19 （10. 7%） gastrointestinal symptoms, 10 （5. 6%） headache and dizziness, 7 （3.9%） palpitation,and 3 （1.7%） rash. APR was more common in the patients with higher baseline tartrate-resistant acid phosphatase 5b （TRACP-Sb） and new-onset vertebral compression fractures （new-onset VCF）. Stepwise logistic regression showed that the odds ratio （OR） of APR in higher baseline TRACP-Sb and new VCF was 3.3 and 2. 5 respectively. Conclusion The first use of zoledronic acid in the treatment of osteoporosis appears high incidence of APR. High TRACP-Sb levels and new vertebral fracture are risk factors for APR.