β-内酰胺酶抑制剂复方制剂致ADR影响因素的多因素Logistic回归分析  

Multifactorial Logistic regression analysis on influencing factors of adverse drug reactions caused byβ-lactamase inhibitor compound preparations

作　　者：张艳 简榕 叶立新 ZHANG Yan;JIAN Rong;YE Lixin(Department of Pharmacy,Guangzhou Medical University Affiliated Huizhou Hospital/Huizhou Third People′s Hospital,Guangdong Province,Huizhou 516002,China)

机构地区：[1]广州医科大学附属惠州医院/惠州市第三人民医院药学部,广东省惠州市516002

出　　处：《临床合理用药杂志》2024年第33期5-9,共5页Chinese Journal of Clinical Rational Drug Use

基　　金：惠州市科技计划(医疗卫生)项目(2021WC0106167)。

摘　　要：目的分析医院β-内酰胺酶抑制剂复方制剂致药品不良反应(ADR)发生的影响因素,提出相应的用药注意事项,促进临床合理用药。方法从中国医院药物警戒系统医院端中收集2018年2月—2023年6月广州医科大学附属惠州医院/惠州市第三人民医院上报的β-内酰胺酶抑制剂复方制剂致ADR报告410份(包含患者410例),统计患者使用β-内酰胺酶抑制剂复方制剂的临床特点及ADR相关因素,并对ADR影响因素进行多因素Logistic回归分析。结果410例患者中男246例,女164例;发生ADR的患者年龄<1个月~97岁,>60岁患者ADR发生率最高,共222例(占54.15%)。ADR报告涉及医院使用的9种β-内酰胺酶抑制剂复方制剂,其中注射用头孢哌酮钠舒巴坦钠(2∶1)是ADR发生率最高的抗菌药物品种,共142例(占34.63%),>60岁患者使用注射用头孢哌酮钠舒巴坦钠(2∶1)发生严重ADR 65例。发生的ADR类型为一般和新的一般分别为239例和5例;出现严重和新的严重ADR分别为159例和7例,其不良反应主要累及系统/器官为血液系统和皮肤及其附件损伤。多因素Logistic回归分析结果,年龄是全身性反应、血液系统及泌尿系统相关ADR的影响因素(P<0.05或P<0.01);用药疗程是消化系统、呼吸系统、心血管系统及血液系统相关ADR的影响因素(P<0.05或P<0.01);性别是泌尿系统相关ADR的影响因素(P<0.01)。结论临床使用β-内酰胺酶抑制剂复方制剂时应严格把握适应证,医护人员在用药过程中应充分了解其致ADR的影响因素,加强ADR监测并及时处理,同时对患者进行用药教育,加强用药监护,从而减少ADR发生,保障临床用药安全。Objective To investigate the influencing factors of ADR caused byβ-lactamase inhibitor compound preparations in a hospital,propose relevant medication precautions,and foster prudent and secure clinical drug practices.Methods A total of 410 cases of ADR caused byβ-lactamase inhibitor compound preparations were collected from Guangzhou Medical University Affiliated Huizhou Hospital/Huizhou Third People′s Hospital from February 2018 to June 2023,as reported by the China Hospital Pharmacovigilance System.The clinical characteristics of patients usingβ-lactamase inhibitor combination preparations and factors related to ADR were analyzed statistically.Multifactorial Logistic regression analysis was performed to determine the influencing factors of ADR caused byβ-lactamase inhibitor compound preparations.Results There were 246 males and 164 females in the 410 patients.The age of patients with ADR ranged from<1 month to 97 years old,the incidence of ADR was highest in patients>60 years old,with a total of 222 cases(54.15%).The ADR report involved 9 kinds ofβ-lactamase inhibitor compound preparations used in a hospital,of which cefoperazone sodium sulbactam sodium for injection(2∶1)was the antimicrobial drug variety with the highest ADR rate,with 142 cases(34.63%),and 65 cases of serious ADR occurring in patients>60 years old used cefoperazone sodium sulbactam sodium for injection(2∶1).The types of ADR that occurred were general(239 cases)and new(5 cases).There were 159 cases of serious ADR and 7 cases of new serious ADR,and the main systems involved in ADR were the hematologic system and skin and its accessory injuries.The results of multifactorial Logistic regression analysis showed that,age was the influencing factor of systemic response,hematologic system and urinary system-related ADR(P<0.05 or P<0.01);The course of medication was the influencing factor of the digestive system,respiratory system,cardiovascular system and blood system related ADR(P<0.05 or P<0.01);Gender was the influencing factor of urinar

关 键 词：β-内酰胺酶抑制剂复方制剂 不良反应 影响因素 LOGISTIC回归分析 合理用药 

分 类 号：R978.1[医药卫生—药品]