儿童使用氨基比林发生药品不良反应及不良事件文献分析

Literature cluster analysis of adverse drug reactions and adverse drug events in children using aminopyrine

目的系统评价儿童使用氨基比林不同制剂发生药品不良反应(ADR)或药品不良事件(ADE)在人体器官、严重程度的分布、构成及影响因素。方法在知网、维普、万方、中国生物医学文献数据库、Pubmed、Embase中检索,检索词为氨基比林、安乃近、去痛片等,加不良反应、不良事件、过敏等自由词进行综合检索。按纳入与排除标准选择文献、提取数据,并按不同类别(年龄、过敏史、涉及系统、联合用药等)统计发生在胎儿期至青春期的儿童使用氨基比林不良反应发生总数、构成比。结果①共纳入中文文献484篇,包括555个病例,其中发生在儿童的有205例。②共纳入英文献70篇,包括73个病例,其中发生在儿童的有34例。③中、英文报道的药品不良反应/事件主要涉及血液系统、皮肤黏膜系统、泌尿系统、循环系统导致发生休克等全身反应;预后各不相同,有174例痊愈(72.80%),30例死亡(12.55%),还有14例(5.86%)的结局分别为骨髓移植、指及趾截肢、胃大部切除等严重ADR;另有21例(8.79%)预后不详。④多数ADR的用药剂量为常规剂量,但也有医务人员超剂量给药引起的ADE。结论使用氨基比林可能引起儿童造血系统、泌尿系统等严重伤害,每年都有较多严重ADR甚至死亡案例报道。应尽快淘汰氨基比林这个可能给儿童带来致死毒性的药物。

Objective To systematically evaluate the adverse drug reactions(ADR)and the Adverse drug events(ADE)of children using different aminopyrine in order to know the distribution of ADR and ADE,including the organ distribution,severity distribution,composition and influential factors of ADR and ADE.Methods Literature was retrieved in electronic databases covering CNKI,VIP,WANFANG data,CBM,Embase and PubMed,aminopyrine,analgin,medicine with the components of aminopyrine,and adverse drug reactions,adverse drug events,allergies etc.were taken as free words for comprehensive search.According to the criteria of inclusion and exclusion,the data were selected and collected.The total number and composition ratio of aminopyrine s ADR and ADE were calculated and the differences between the analgin,compound aminopyrine and the components of aminopyrine were analyzed according to different categories(age,drug allergy history,organ system involved,combination therapy,etc.).Results①A total of 484 Chinese literatures were included,including 555 cases,there were 205 cases of children;②A total of 70 English literatures were included,including 73 cases,there were 34 cases of children;③The ADR/ADE reported in Chinese and English literatures mainly involving the hematopoietic system,mucocutaneous system,urinary system,circulatory system which led to systemic reactions such as shock.The prognosis varies,with 174 cases recovered(72.80%),30 cases death(12.55%)and 14 cases(5.86%)of the outcome were bone marrow transplantation,finger and toe amputation,subtotal gastrectomy and other serious adverse reactions.④most of the adverse reactions of the dose for the regular dose,but there were also over-dose medical staff caused by adverse events.Conclusion The use of aminopyrine might cause serious damage to children s hematopoietic system and urinary system,with serious adverse reactions and even deaths reported annually.It was suggested that aminopyrine as a potentially lethal drug should be withdrawal quickly.