辽宁省头孢哌酮与头孢哌酮/舒巴坦不良反应报告分析  

Analysis of adverse drug reactions related to cefoperazone and cefoperazon/sulbactam spontaneously reported in Liaoning province

作　　者：王瑜歆[1] 杨月明[1] 王立刚[1] 魏晶[1] 

机构地区：[1]辽宁省药品不良反应监测中心,沈阳110003

出　　处：《中国新药杂志》2013年第12期1473-1476,共4页Chinese Journal of New Drugs

摘　　要：目的:本文通过分析自发报告系统中收集到的头孢哌酮与头孢哌酮/舒巴坦不良反应报告,比较两种药物安全性特点。方法:数据来自于辽宁省2004-2011年自发报告系统,两组药物间的比较采用t检验或χ2检验,信号检测方法采用综合标准法(MHRA)。结果:患者基本信息分析表明,头孢哌酮组的合并用药和儿科患者比例显著高于头孢哌酮/舒巴坦组(P<0.05)。头孢哌酮/舒巴坦组的全身性损害严重报告比例和头孢哌酮组的胃肠系统损害严重报告比例较高(P<0.05)。MHRA信号检测方法也显示了头孢哌酮致胃肠道出血病和头孢哌酮/舒巴坦致过敏性休克的风险。结论:两种药物的安全性特点不同,临床使用应当关注相关风险。Objective： To analyze the suspected adverse drug reactions （ADR） of eefoperazone （CPZ） and eefoperazone/sulbaetam （CPZ/SB） spontaneously reported in a Liaoning database in order to compare their safety profiles. Methods： Data were retrieved from the spontaneous reports collected by Liaoning Centre for ADR monitoring from 2004 to 2011. The ADR difference between CPZ and CPZ/SB was compared using X2 or Student＇s t-test. MHRA method was used for signal detection. Results： Characteristics of the two groups of patients affected by ADR revealed higher proportions of patient number with combined drug therapies and pediatric patient number in CPZ group. The ratio of serious systematic reactions was higher in CPZ/SB group, and the ratio of gastrointestinal system reactions was higher in CPZ group. Anaphylactic shock induced by CPZ and gastrointestinal bleeding in- duced by CPZ/SB also emerged from MHRA analysis. Conclusion： The safety profiles of the two selected drugs are different, so the risks should be taken into account before prescribing these drugs.

关 键 词：头孢哌酮 头孢哌酮 舒巴坦 不良反应 

分 类 号：R978.1[医药卫生—药品]