喜炎平注射液上市后安全性再评价  

Post-marketing safety reevaluation of Xiyanping injection（喜炎平注射液）

作　　者：邓剑雄[1] 王志飞[2] 谢雁鸣[2] 李兵 马麟[4] 王金存 章新晶[6] 吴慧 

机构地区：[1]广东省药品不良反应监测中心,广州510080 [2]中国中医科学院中医临床基础医学研究所,北京100700 [3]广东省东莞康华医院药剂科,523080 [4]广东省中医院医教科,广州510120 [5]郑州大学第一附属医院药剂科,450052 [6]南昌大学第二附属医院药学部,330006 [7]江西省赣州市赣县人民医院儿科,341100

出　　处：《药物不良反应杂志》2018年第1期15-22,共8页Adverse Drug Reactions Journal

摘　　要：目的对喜炎平注射液上市后的安全性进行再评价。方法采用前瞻性医院集中监测方法，牵头单位为广东省药品不良反应监测中心和中国中医科学院中医临床基础医学研究所，参研医院为我国东北、华中、华南、西南地区6个省/直辖市的21家医院，监测对象为2012年3月1日后在21家医院住院期间使用喜炎平注射液的全部患者，设定样本量不少于3万例。对每例使用喜炎平注射液的患者均由参研人员手工填写“喜炎平注射液上市后再评价筛选卡”（筛选卡）；对用药后出现不良反应的患者由临床药师手工填写 “喜炎平注射液上市后再评价监测表”（监测表），各医院每月上报筛选卡和监测表至广东省药品再评价上报管理系统（再评价系统），筛选卡满3万份后监测终止。汇总上报数据，计算喜炎平注射液不良反应发生率并分析不良反应临床特征。结果截至2015年1月23日，再评价系统收到的筛选卡超过3万份，监测终止。有5家医院因收集的病例无连续性于2013年3至8月先后停止参与本研究，最终16家医院上报的30 759例患者筛选卡和23例患者监测表纳入汇总分析。30 759例患者中男性18 295例（59.48%），女性12 464例（40.52%）；年龄1 d^103岁，其中＜4岁者占53.64%（16 501例）；用药途径为肌内注射者214例，静脉滴注者30 545例，均按说明书规定的剂量使用喜炎平注射液。静脉滴注用药患者使用的溶媒按品种共计31 163例次，其中2 810例次（9.02%）未使用说明书规定溶媒。30 759例患者中有29 728例（96.65%）同时联合应用其他药物。合并用药种类居前4位者依次为抗微生物药、电解质酸碱平衡药及营养药、呼吸系统用药和消化系统用药。30 759例患者中共23例发生与喜炎平注射液相关不良反应，发生率为0.75‰（95%CI： 0.47‰～1.12‰）；关联性评价为“很可能”者12例（52.17To revalue the post-marketing safety of Xiyanping injection.MethodsThe research was carried out by prospective hospital based monitoring method. The leading organizations were Guangdong Medicine Adverse Reaction Monitoring Center and Chinese of Basic Research in Clinical Medicine Institute. The participants were 21 hospitals in 6 provinces/municipality directly under the Central Government which located in Northeast China, Central China, South China, and Southwest China. Monitoring objects were all patients who used Xiyanping injection when they were hospitalized. The set sample size was not fewer than 30 000 cases. Every patient who used Xiyanping injection filled in Xiyanping injection screening card （screening card） by research staff manually. The patient who developed adverse reactions （ADR） after using Xiyanping injection filled in Xiyanping injection monitoring table （monitoring table） by clinical pharmacist manually. All the hospital should report the screening card and the monitoring table to Guangdong Provincial Drug Reevaluation Report Management System （Reevaluation Report Management System） every month.The monitoring study ended when the number of screening cardrunning up to 30 000. The reported data were collected and the incidence rate of Xiyanping injection were calculated. The clinical characteristics of adverse reactions were analyzed.ResultsData were collected through the Reevaluation Report Management System till January 23, 2015. The monitoring study ended. Five hospitals stopped participation in the monitoring study because of discontinuity of cases′ data from March to August, 2013. A total of 30 759 screening cards and 23 monitoring tables which were from 16 hostipals were collected finally. There were 18 295 （59.48%） male and 12 464 （40.52%） female in 30 759 patients. Of them the number of patients whose age 〈4 years were 16 501 （53.64%）. The patients′primary diseases were mainly respiratory disease, infectious disease, parasitic disease, and digestive sy

关 键 词：药物评价 喜炎平注射液 

分 类 号：R95[医药卫生—药学]