左氧氟沙星氯化钠注射液仿制药与原研药安全性监测及分析

Safety monitoring and analysis of generic and original levofloxacin and sodium chloride injection

目的对广州绿十字制药股份有限公司生产的左氧氟沙星氯化钠注射液(仿制药)与第一三共制药(北京)有限公司生产的左氧氟沙星氯化钠注射液(原研药)的安全性进行主动监测及分析。方法本研究资料来自2022年10月1日至2023年9月30日中山大学附属第一医院、广东省人民医院和暨南大学附属第一医院主动监测并上报至国家药品不良反应监测系统数据库的左氧氟沙星氯化钠注射液不良反应报告,收集报告涉及患者的年龄、性别、用药情况、原发疾病、用药至不良反应发生的时间、不良反应临床表现、治疗及转归,严重不良反应发生情况。计算不良反应发生率。结果共收集到左氧氟沙星氯化钠注射液不良反应报告30份,涉及患者30例。仿制药组21例,男性8例、女性13例;年龄20~91岁,中位年龄43岁;严重不良反应报告2例。原研药组9例,男性3例、女性6例;年龄20~96岁,中位年龄56岁;无严重报告。仿制药组21例患者共发生不良反应36例次,原研药组9例患者共发生不良反应13例次;涉及皮肤及附件、消化系统、神经系统、肌肉骨骼系统、泌尿系统及用药部位等,主要以皮肤瘙痒、皮疹等过敏反应最为常见(仿制药组15例次,占比41.7%;原研药组6例次,占比46.2%);仿制药组发生2例严重不良反应,均为过敏性休克。经停药,换用其他抗生素及对症治疗等处理后,仿制药组治愈5例,好转15例,不详1例;原研药组治愈2例,好转7例;仿制药与原研药均无死亡病例。仿制药组门诊和/或住院患者不良反应发生率为0.07%(21/29557),原研药组门诊和/或住院患者不良反应发生率为0.08%(9/10686),2组比较差异无统计学意义(χ^(2)=0.183,P=0.669)。结论主动监测结果显示,左氧氟沙星氯化钠注射液仿制药的安全性与原研药安全性无明显差异。

Objective To actively monitor and analyze the safety of levofloxacin and sodium chloride injection produced by Guangzhou Green Cross Pharmaceutical Co.,Ltd(generic drug).and levofloxacin and sodium chloride injection produced by Daiichi Sankyo(Beijing)Pharmaceutical Co.,Ltd(original drug).Methods The data in this study came from the adverse drug reaction reports on levofloxacin and sodium chloride injection voluntarily monitored and reported to the National Adverse Drug Reaction Monitoring System Database by the First Affiliated Hospital of Sun Yat-sen University,Guangdong Provincial People′s Hospital,and the First Affiliated Hospital of Ji'nan University from October 1,2022,to September 30,2023.The information on patients′age,gender,medication use,primary disease,time from medication to the occurrence of adverse reactions,clinical manifestations,treatment and prognosis of adverse reactions,and the occurrence of serious adverse reactions were collected.The incidence of adverse reactions was calculated.Results A total of 30 adverse reaction reports involving levofloxacin and sodium chloride injection were collected,involving 30 patients.In the generic drug group,there were 21 cases,including 8 males and 13 females,aged from 20 to 91 years with a median age of 43 years;2 cases of serious adverse reactions were reported.In the original drug group,there were 9 cases,including 3 males and 6 females,aged from 20 to 96 years with a median age of 56 years;no serious adverse reactions were reported.In the generic drug group,a total of 36 adverse reactions occurred in 21 patients,while in the original drug group,a total of 13 adverse reactions occurred in 9 patients.These adverse reactions involved the skin and appendages,digestive system,nervous system,musculoskeletal system,urinary system,and medication site,with skin itching and rash being the most common allergic reactions(15 case time in the generic drug group,accounting for 41.7%;6 case time in the original drug group,accounting for 46.2%).Two cases of serious adverse reactions occurred in the generic drug group,and both were anaphylactic shock.After discontinuation of the drug,switching to other antibiotics,and symptomatic treatments,5 cases in the generic drug group were cured,15 cases were improved,and 1 case was unknown.In the original research drug group,2 cases were cured and 7 cases were improved.There were no deaths in either the generic or original drug groups.The incidence of adverse reactions in outpatients and/or inpatients in the generic drug group was 0.07%(21/29557),while that in the original research drug group was 0.08%(9/10686).There was no statistically significant difference between the 2 groups(χ^(2)=0.183,P=0.669).Conclusion The results of active monitoring show that there is no significant difference in safety between the generic and original drugs of levofloxacin and sodium chloride injection.