2012～2018年我国内地甘露醇注射液严重不良反应文献源病例分析  

Literature Evaluation of Serious Adverse Drug Reactions of Mannitol Injection in China's Mainland from 2012 to 2018

作　　者：王竞[1] 周文犁 周延安[1] Wang Jing;Zhou Wenli;Zhou Yan'an(Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院

出　　处：《药物流行病学杂志》2019年第11期769-772,共4页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:分析2012~2018年我国内地甘露醇注射液严重不良反应(ADR)文献源病例的特点。方法:采用文献计量学方法,收集2012~2018年我国内地医药学学术期刊中甘露醇注射液严重ADR病例,统计患者性别年龄与原发病、甘露醇注射液用法用量与用药合理性、ADR发生时间、类型、临床表现与转归等。结果:共检索获得55篇文献,1553例ADR病例,其中严重的ADR 1166例。男性673例(57.72%),女性426例(36.54%),性别不详67例(5.74%)。患者年龄范围1~87岁,40~69岁占81.22%;脑出血、脑梗死及颅脑损伤3种原发病的病例数合计占病例总数的83.54%。静脉注射1121例,口服用药45例,用法用量均符合规定。严重ADR主要表现为渗透性肾病363例(31.13%)、急性肾衰232例(19.9%)、水与电解质紊乱163例(13.98%)、神经系统损害191例(16.38%),口服给药导致肠梗阻45例(3.86%)。新的严重ADR为低颅压反应、过敏性哮喘。1166例严重ADR病例中死亡51例,均由急性肾衰所致,其余病例均恢复正常。结论:甘露醇注射液的严重ADR仍然较多,应当加强临床合理用药及用药监护,确保患者用药安全。Objective:To analyze the characteristics and regularities of reported cases of severe adverse reactions of mannitol injection in China's Mainland from 2012 to 2018.Methods:According to the bibliometrics method,the clinical cases of severe adverse reactions of mannitol injection were classified according to the published periodicals.The distribution of primary diseases,general characteristics of patients,the outcome of adverse reaction and the evaluation of rational drug use were also discussed.Results:A total of 1553 ADR cases of mannitol injection were retrieved from 55 clinical literatures,Among them,1166 cases were serious ADR.There were 673 males(57.72%),426 females(36.54%).And 67 cases(5.74%)were gender unknown.The age range of patients ranged from 1 to 87 years,with 81.22%aged 40 to 69 years.The 3 primary diseases were cerebral hemorrhage,cerebral infarction and craniocerebral injury accounted for 83.54%.There were 1121 cases of intravenous injection and 45 cases of oral administration,usage and dosage were in accordance with regulations.The main adverse drug reactions mainly manifest as 363 cases(31.13%)of osmotic nephropathy,232 cases(19.9%)of acute renal failure,163 cases(13.98%)of water and electrolyte disorders,191 cases(16.38%)of severe nervous system damage reaction,45 cases(3.86%)of intestinal obstruction.The new severe adverse reactions were low cranial pressure response and allergic asthma.There were 51 death cases in the whole 1166 ADR cases,caused by acute renal failure,the others were recovered.Conclusion:The serious ADR of mannitol injection was still more,so it was necessary to strengthen clinical rational medication and medication monitoring to ensure the safety of medication for patients.

关 键 词：甘露醇注射液 严重药品不良反应 急性肾功能衰竭 合理用药 安全用药 

分 类 号：R977.7[医药卫生—药品]