5mg唑来膦酸静滴治疗骨质疏松症24h安全性及不良反应的临床研究

Clinical study on the safety and adverse reaction of 5mg zoledronic acid in the treatment of osteoporosis

目的探讨5 mg唑来膦酸静滴治疗骨质疏松症24小时的安全性及不良反应。方法本研究回顾性分析2016年5月至2017年2月于我院我科就诊、收治且符合纳入标准的骨质疏松症患者17例,年龄57~83岁,平均年龄70.12±7.53岁,男4例,女13例,其中4例曾口服阿仑膦酸钠治疗骨质疏松症。所有患者均予以5 mg唑来膦酸静滴治疗,骨化三醇及钙片600 mg口服,收集患者静滴唑来膦酸前及静滴后24小时后肝肾功能、血常规、CRP、ESR等生化指标、临床不良反应进行统计分析。结果静滴5 mg唑来膦酸前及静滴后24小时体温、钙、磷、中性粒细胞百分比和淋巴细胞百分比差异具有统计学意义,值均<0.001,其中静滴5 mg唑来膦酸后24小时的体温和中性粒细胞百分比较静滴前升高,钙、磷和淋巴细胞百分比较较静滴前稍有下降;CRP、肌酐有统计学差异,其中CRP较静滴前升高,肌酐较静滴前降低。白细胞总数在静滴前后的差异没有统计学意义。临床出现发热11例,占64.71%,其中最高温度39.3℃;心慌伴厌食1例,占5.89%;乏力、肌痛等流感症状2例,占11.76%;2~3天电话随访均恢复正常,未再出现临床症状。结论 5 mg唑来膦酸静滴治疗骨质疏松症对机体无明显不良影响,且使用方便,适合推广,可以在门诊推荐使用,提高骨质疏松症治疗的依从性以及治疗效果。

Objective To study the safety and adverse effects of 5 mg zoledronic acid in the treatment of osteoporosis. Methods From May 2016 to Feb 2017, 17 patients with osteoporosis, aged from 57 to 83 years, with an average age of 70.12±7.53 years, were enrolled in this study. 4 males and 13 females, of which 4 cases had oral administration of alendronate sodium in the treatment of osteoporosis. All patients were treated with intravenous zoledronic acid 5mg, calcitriol and calcium tablets 600mg orally, patients before intravenous zoledronic acid and 24 hours after intravenous infusion of liver and kidney function, blood, CRP, ESR, etc. Biochemical index and clinical adverse reaction were analyzed statistically. Results The percentage of body temperature, calcium, phosphorus, neutrophil percentage and percentage of lymphocytes in the intravenous infusion of 5 mg zoledronic acid before and after intravenous infusion was statistically significant （P 〈0.001, respectively）, the intravenous infusion of 5 mg zoledronic acid 24 hours after the body temperature and neutrophil percentage increased intravenous infusion, calcium, phosphorus and lymphocyte percentage slightly more intravenous drop slightly; CRP, creatinine were statistically significant, in which CRP increased intravenously before the intravenous infusion of creatinine low. There was no statistically significant difference in the total number of white blood cells before and after intravenous infusion. Clinical manifestations of fever in 11 cases, accounting for 64.71%, of which the maximum temperature of 39.3℃; palpitation with anorexia in 1 case, accounting for 5.89%; fatigue, myalgia and other flu symptoms in 2 cases, accounting for 11.76%; 2-3 days follow, no recurrence of clinical symptoms. Conclusion 5mg zoledronic acid intravenous treatment of osteoporosis without obvious adverse effects on the body, and easy to use, suitable for outreach and can be recommended to promote the use and improve compliance and treatment of osteoporosis treatment.