广州医院门诊使用香雪抗病毒口服液不良反应调查  

Adverse Drug Reaction Monitoring of Xiangxue Kangbingdu Oral Liquid:Preliminary Reports of a Telephone Survey in Guangzhou

作　　者：李晓彦 于涛[2] 温泽淮 洪晓丹[3] 杨辉[4] 林岱 黎月玲 LI Xiaoyan;YU Tao;WEN Zehuai;HONG Xiaodan;YANG Hui;LIN Dai;LI Yueling(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120 Guangdong, China;Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;The First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080 Guangdong,China;Panyu Central Hospital,Guangzhou 511400 Guangdong, China;Hexian Memorial Affiliated Hospital of Southern Medical University, Guangzhou 511400 Guangdong,China;Guangzhou Red Cross Hospital,Guangzhou 510220 Guangdong,China)

机构地区：[1]广州中医药大学第二附属医院临床研究方法学重点研究室,广东广州510120 [2]广州中医药大学DME中心,广东广州510405 [3]中山大学附属第一医院药学部,广东广州510080 [4]广州市番禺中心医院药学部,广东广州511400 [5]广州番禺何贤纪念医院药剂科,广东广州511400 [6]广州市红十字会医院药学部,广东广州510220

出　　处：《中药新药与临床药理》2019年第2期245-250,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家科技重大专项-重大新药创制项目(2012ZX09303009-003)

摘　　要：目的通过收集广州市一段时间内服用香雪抗病毒口服液患者的不良反应/事件,了解不良反应的发生情况和原因,为临床安全用药提供依据。方法采用医院集中监测的方式,通过电子病历系统收集使用香雪抗病毒口服液的门诊病人,以电话随访的方式进行调查。结果共纳入患者10 089例,不良反应的发生率为0.93%,主要以胃肠系统损害、皮肤及其附件损害为主;对可能影响因素的分析发现,年龄分段组间比较有显著性差异,随年龄增大不良反应的发生数逐渐减少。结论该药品的不良反应发生属于偶见范围。在使用时应注意预防胃肠功能紊乱及过敏性症状的发生。其在7岁及以下的婴儿和儿童中使用率较高,尤其是2岁以下婴幼儿,应注意该药的用量、用法,以避免不良反应发生。Objective We aimed to investigate the incidence of adverse drug reactions (ADRs) from Xiangxue Kangbingdu Oral Liquid (XKOL) in Guangzhou,to characterize the clinical features,causality,and severity of these ADRs,and to explore risk factors. Methods This study was a hospital-based observational study designed to monitor ADRs by telephone interviews. Results The incidence of ADRs was 0.93% in 10 089 cases. The main ADR manifestations were gastrointestinal symptoms, lesions on the skin and appendages. Univariate and multivariable analysis showed that age was significant in the statistical model. As age increased, the incidence of ADRs significantly reduced. Conclusion The incidence of ADRs was classified as uncommon. When administering XKOL, attention should be paid to avoid gastrointestinal dysfunction and allergic symptoms. To avoid ADRs,more attention should be paid to usage and dosage of drugs among children under the age of 7 years,especially those under 2 years old.

关 键 词：不良反应 抗病毒口服液 中成药 安全性 

分 类 号：R288[医药卫生—中药学]