基于文献康艾注射液不良反应研究.docxVIP

基于文献康艾注射液不良反应研究 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。 关键词：康艾注射液；不良反应；文献计量学 DOI： 10. 3969/j. issn. 1005-5304. 2012. 12.008 中图分类号：R2-05文献标识码：A文章编号： 1005-5304 (2012) 12-0020-04 Adverse Drug Reactions of Kang，ai Injection Based on Literature YUAN Xiao-longl, LI Tingl, WANG Qin2 (1. Zhangye Medical College, Zhangye 734000, China； 2. Zhangye Institute for Food and Drug Control, Zhangye 734000, China) Abstract： 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 tota1. 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 ineluded lung cancer and pleuraleffusion. The information of patients such as allergy history was not given comprehensively, only 3 patients from case report provided det ailed informat io n. The solvent and the dose range of KA injection was fit for the information from production introducti