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目的:统计分析成都地区2014~2015年度小牛血清去蛋白注射液的不良反应报告,提高小牛血清去蛋白注射液临床应用的安全性。方法:收集2014~2015年成都市药品不良反应监测中心数据库中小牛血清去蛋白注射液不良反应报告154例,并对患者的基本情况、ADR的合并用药、用法用量、发生时间、临床表现、新的和严重的ADR、预后进行统计分析。结果:154例小牛血清去蛋白注射液不良反应报告经因果关系评价,符合标准的有141例。ADR主要发生于成人和老年人;给药途径均为静脉滴注,日剂量均符合说明书推荐的用药剂量。ADR报告中涉及合并用药的25例,其中18例合并应用了中药注射剂。ADR大多发生在首次输液的1h内,临床表现涉及机体多个器官系统。发生严重的ADR共7例,新的不良反应共15例。结论:小牛血清去蛋白注射液新的不良反应和过敏反应的发生率应作为上市后评价的关注要点。还应加强对各医疗机构ADR报告质量的评估和管理。
OBJECTIVE: To analyze the adverse reaction reports of deproteinization of bovine serum in Chengdu from 2014 to 2015, and to improve the safety of clinical application of deproteinization of bovine serum. Methods: A total of 154 reports of adverse reactions of bovine serum albumin injections were collected from the database of adverse drug reactions monitoring center in Chengdu from 2014 to 2015. The basic conditions, ADR combined medication, dosage, time, clinical manifestations, new And severe ADR, prognosis for statistical analysis. Results: Adverse reactions of 154 cases of deproteinization of bovine serum were evaluated causally. There were 141 cases which met the standard. ADR occurs mainly in adults and the elderly; the route of administration is intravenous drip, the daily dose are in line with the recommended dose of the manual. ADR report involved in the merger of 25 cases, of which 18 cases combined with traditional Chinese medicine injection. ADR occurred mostly in the first infusion of 1h, the clinical manifestations involving the body multiple organ systems. A total of 7 cases of serious ADR, a total of 15 new adverse reactions. CONCLUSIONS: The new adverse reactions and the incidence of anaphylactic reactions in deproteinized bovine serum should be the focus of post-marketing evaluation. The evaluation and management of the quality of ADR reports in various medical institutions should also be strengthened.