地舒单抗注射液治疗骨质疏松症的单中心回顾性分析

A Single-Center Retrospective Analysis of Denosumab Injection in the Treatment of Osteoporosis

目的:了解地舒单抗注射液的用药现状,并分析其用药合理性,为临床合理用药提供参考。方法:回顾性、连续纳入本院2021年6月1日~12月31日期间使用地舒单抗注射液(60mg/支)的患者,对患者的性别、年龄、诊断、给药方案、联合用药、用药前后血钙水平的监测、药品不良反应、超说明书用药情况等进行描述性分析,并点评分析其合理性。结果:共纳入符合标准的患者164例,其中104例(63.41%)患者明确诊断为骨质疏松症,56例(34.15%)患者为重度骨质疏松症,49例(29.88%)患者为骨质疏松性骨折;所有患者均为首次接受地舒单抗注射液治疗,160例(97.56%)患者遵从说明书中的给药方案(60mg单次皮下注射);141例(85.98%)患者联合使用其他抗骨质疏松症药物,66例(40.24%)患者同时使用了碳酸钙和骨化三醇,50例(30.49%)患者同时使用了碳酸钙、骨化三醇和鲑降钙素;147例(89.63%)患者用药前监测血钙,64例(39.02%)患者用药后随访监测血钙,其中4例(2.44%)患者发生低钙血症,未见其他不良反应报告。结论:本院地舒单抗注射液(60mg/支)的使用存在超说明书用药、用药前后未监测血钙水平、用药过程中未充分补充钙剂和维生素D等情况,提示本院临床药师应重视地舒单抗注射液的用药监测,及时干预,减少临床不合理用药及不良反应发生。

Objective:To explore the current utilization status of denosumab injection and analyze its rationality,so as to provide references for rational drug use in clinic.Methods:Patients administered with denosumab injection(60 mg/dose)in our hospital from June 1to December 31,2021 were retrospectively and consecutively enrolled.We conducted descriptive analysis on patients’gender,age,diagnosis,dosage regimen,concomitant drug,serum calcium level before and after administration,adverse drug reactions as well as off-label use.Also,we carried out clinical audit of its rationality.Results:A total of 164 patients meeting the eligibility criteria were included.104(63.41%)patients had defi nite diagnosis of osteoporosis,56(34.15%)were severe osteoporosis and 49(29.88%)were diagnosed with osteoporotic fracture.All patients received denosumab for the first time,and 160 patients(97.56%)followed the dosage regimen(60 mg single subcutaneous injection)as described in the instructions.141 patients(85.98%)received other antiosteoporotic drugs in combination,66 patients(40.24%)received calcium carbonate and calcitriol,and 50 patients(30.49%)received calcium carbonate,calcitriol and salmon calcitonin concomitantly.147 patients(89.63%)had serum calcium monitored before administration,while only 64 patients(39.02%)had followup serum calcium level after administration.Four patients(2.44%)had hypocalcemia reported,and no other adverse reactions were detected.Conclusion:During the application of denosumab injection(60 mg/dose)in our hospital,there were off-label drug use of denosumab,neglected blood calcium monitoring before and after drug use,as well as insuffi cient supplementation of calcium and vitamin D during drug use.It is suggested that pharmacists in our hospital should pay attention to the monitoring of denosumab and timely intervene to reduce the occurrence of irrational drug use and adverse reactions.