基于文献的康艾注射液不良反应分析  

Adverse Drug Reactions of Kang'ai Injection Based on Literature

作　　者：袁小龙[1] 李婷[1] 王勤 

机构地区：[1]张掖医学高等专科学校,甘肃张掖734000 [2]张掖市食品药品检验所,甘肃张掖734000

出　　处：《中国中医药信息杂志》2012年第12期20-23,共4页Chinese Journal of Information on Traditional Chinese Medicine

摘　　要：目的评价康艾注射液的安全性。方法计算机检索EMBASE、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊数据库,同时辅助其他检索,纳入有关康艾注射液的临床研究,对报道的不良反应情况进行分析。结果本研究共纳入与康艾注射液相关的临床研究147篇,合计34例药物不良反应(ADR)病例。142篇临床研究文献中,104篇(73.3%)文献未提及是否出现ADR,38篇文献中仅提及ADR;7篇(18.4%)描述了康艾注射液的ADR(27例)。5篇不良反应报告类文献报道了7例ADR病例。其所涉及的ADR主要为过敏反应、皮疹、静脉炎以及高热等,且大多属于轻型ADR,但也不排除出现Ⅰ、Ⅱ级的可能性。原患疾病方面,以肺癌和恶性胸腔积液多见。7例不良反应报告中仅有3例患者提及过敏史情况。溶媒介质以及剂量均基本符合其产品说明书中的要求。大多数ADR在首次用药后出现,出现时间15 min～15 d不等。结论康艾注射液的ADR报道的文献量及ADR数量的限制,不能对康艾注射液ADR发生情况进行深入分析。Objective To analyze the adverse drug reactions （ADR） of Kang＇ai （KA） injection. Methods We searched clinical studies and ADR reports of KA injection from EMBASE, VIP, CBM and CNKI, etc. We also traced the related references and experts in this field to obtain more information. All of the literatures which reported clinical studies and case report of KA injection were included. Result A total of 147 studies were included, which had 34 patients in total. Among 142 clinical studies, 104 studies （73.3%） did not provide whether ADR had happened. 38 studies reported relative information of ADRs and 7 studies （18.4%） gave appearance of ADRs （27 patients）. 5 case reports included 7 patients of ADR totally. The type of ADRs were anaphylaxis, rash, phlebitis and fever, etc. Most of ADRs were slightly, however, the serious ADRs might appear. The basic disease included lung cancer and pleuraleffusion. The information of patients such as allergy history was not given comprehensively, only 3 patients from case report provided detailed information. The solvent and the dose range of KA injection was fit for the information from production introduction. Most of ADRs appeared at the first administration which ranged 15 rain to 15 d. Conclusion Due to the limited ADR reports and clinical studies of KA injection, we can＇t analyze ADR deeply.

关 键 词：康艾注射液 不良反应 文献计量学 

分 类 号：R2-05[医药卫生—中医学]