注射用头孢噻肟钠的真实世界安全性研究  

Safety of Cefotaxime Sodium for Injection:A Real-World Study

作　　者：李秋荣 傅苗青 周白水 李翠 萧晓彤 俞玉萍 应鹏 LI Qiurong;FU Miaoqing;ZHOU Baishui;LI Cui;XIAO Xiaotong;YU Yuping;YING Peng(Guangdong Jincheng Jinsu Pharmaceutical Co.,Ltd.,Zhongshan,Guangdong,China 528437)

机构地区：[1]广东金城金素制药有限公司,广东中山528437

出　　处：《中国药业》2024年第16期125-130,共6页China Pharmaceuticals

基　　金：广东金城金素制药有限公司课题[RWS-2201]。

摘　　要：目的提高注射用头孢噻肟钠临床使用(尤其是特殊人群中使用)的安全性。方法纳入某制药公司2019年1月至2022年12月收集的全国范围内自发报告的关于注射用头孢噻肟钠的个例安全性报告(ICSR)1984例,并对其药品不良反应(ADR)的类型及影响因素进行分析。结果1984例ICSR中有1279例(64.47%)纳入特殊人群组,有705例(35.53%)纳入非特殊人群组。涉及ADR3001例次。ADR类型组间比较,差异无统计学意义(P>0.05),且均以一般ADR为主(1388例,69.96%)。按首选语(PT)例次数统计,系统器官分类(SOC)排前3的分别为皮肤及皮下组织类疾病(1715例次)、胃肠系统疾病(369例次)、全身性疾病及给药部位各种反应(228例次),其中特殊人群组分别为1135,228,124例次。两组ADR发生时间、转归比较,差异均有统计学意义(P<0.05),且发生时间均主要集中于用药后30 min内,转归均主要为痊愈或好转。Logistic回归分析结果显示,患者年龄段、是否为特殊人群、人群类别、联合用药情况、超剂量用药、给药持续时间、皮试情况、临床不合理用药、既往过敏史与ADR史均为致注射用头孢噻肟钠ADR的危险因素(P<0.05)。其中,是否为特殊人群和人群类别是累及全身性疾病及给药部位各种反应、各类神经系统疾病ADR的独立危险因素。结论致注射用头孢噻肟钠ADR的危险因素较多,临床应重视并注意识别其ADR相关的影响因素,并在用药过程中对特殊人群患者予以重点监护,从而尽可能地规避患者的用药风险,提高患者用药安全性。Objective To improve the safety of clinical use of Cefotaxime Sodium for Injection,especially in special populations.Methods A total of 1984 cases of individual case safety report(ICSR)on Cefotaxime Sodium for Injection spontaneously reported nationwide collected by a pharmaceutical company from January 2019 to December 2022 were included,and the types and influencing factors of adverse drug reactions(ADRs)were analyzed.Results Among 1984 cases of ICSR,1279 cases(64.47%)were included in the special population group,and 705 cases(35.53%)were included in the non-special population group.A total of 3001 case times of ADR were involved.The ADR types were similar between the two groups(P>0.05),and those were mainly general ADRs(1388 cases,69.96%).The system organ classification(SOC)with most case times of preferred term(PT)was skin and subcutaneous tissue diseases(1715 case times),followed by gastrointestinal system diseases(369 case times),systemic diseases and various reactions at administration site(228 case times),involving 1135,228,124 case times in the special population group respectively.The occurrence time of ADRs and outcome were significantly different between the two groups(P<0.05),the occurrence time of ADRs was mainly within 30 min after medication,and the outcome was mainly recovery or improvement.The Logistic regression analysis showed that patients′age group,whether special population or not,population category,combined medication,overdose,duration of administration,skin test results,clinical irrational drug use,past allergy history and ADR history were all the risk factors for Cefotaxime Sodium for Injection-related ADRs(P<0.05);among them,whether special population or not and population category were the independent risk factors for the ADRs involving systemic diseases,various reactions at the administration site,and various neurological diseases.Conclusion There are many risk factors for Cefotaxime Sodium for Injection-related ADRs.In clinical practice,we should pay attention to identifying the i

关 键 词：注射用头孢噻肟钠 药品不良反应 多因素LOGISTIC回归分析 真实世界研究 

分 类 号：R969.3[医药卫生—药理学] R978.1[医药卫生—药学]