基于报告比值比法对利奈唑胺安全警戒信号的挖掘与评价
发布时间：2018-12-29 14:21
【摘要】：目的:挖掘和评价利奈唑胺上市后的安全警戒信号,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对FDA公共数据开放项目(Open FDA)2004-2016年第二季度的药物不良事件(ADE)报告数据进行利奈唑胺警戒信号检测,ROR值95%置信区间(CI)下限1提示出现警戒信号。结果:纳入分析的6 828 534份ADE报告中,以利奈唑胺为怀疑药物的ADE报告7 224份。ADE上报数排序前10位分别为血小板减少症、药物相互作用、血小板减少、恶心、贫血、5-羟色胺综合征、腹泻、热病、药物无效、呕吐。经ROR法检测数量排序前200位ADE报告,共得到120个警戒信号,涉及18个系统器官分类,ADE信号数量按系统器官分类排序前5位分别为医学检查、神经系统疾病、血液及淋巴系统疾病、代谢及营养类疾病、心脏器官病症,其中有临床参考意义的高风险信号包括视神经病变(ROR=56.33)42例、5-羟色胺综合征(ROR=52.86)350例、乳酸性酸中毒(ROR=18.30)162例、心内膜炎(ROR=15.38)31例、血小板减少症(ROR=14.29)566例、骨髓衰竭(ROR=14.20)122例、全血细胞减少症(ROR=11.92)261例、弥散性血管内凝血(ROR=10.91)86例、中毒性表皮坏死松解症(ROR=9.06)58例等。ADE报告数量男性略多于女性,≥45岁年龄组ADE上报数显著多于低年龄组。结论:对Open FDA数据库进行利奈唑胺警戒信号的检测和分析,可有效地为后续药物警戒工作提供参考。
[Abstract]:Objective: to excavate and evaluate the safety warning signal of linazolamide after listing, and to provide reference for rational drug use in clinic. Methods: the report ratio method (ROR) was used to detect the adverse drug events (ADE) reported by FDA Public data Open Project (Open FDA) in the second quarter of 2004 to 2016. The ROR 95% confidence interval (CI) lower bound 1 indicates a warning signal. Results: of the 6 828 534 ADE reports included in the analysis, 7 224 were reported by Linedolidomide as suspected drug ADE. The top 10 ADE reports were thrombocytopenia, drug interaction, thrombocytopenia, nausea and anemia, respectively. Serotonin syndrome, diarrhea, fever, drug failure, vomiting. A total of 120 warning signals were obtained from the first 200 ADE reports by ROR method, involving 18 systematical organ classification. The first 5 positions of ADE signals were classified as medical examination and nervous system diseases, respectively, according to the classification of systematic organs. Blood and lymphoid diseases, metabolic and nutritional diseases, heart organ diseases, including 42 cases of optic neuropathy (ROR=56.33), 350 cases of serotonin syndrome (ROR=52.86), There were 162 cases of lactic acid acidosis (ROR=18.30), 31 cases of endocarditis (ROR=15.38), 566 cases of thrombocytopenia (ROR=14.29), 122 cases of bone marrow failure (ROR=14.20) and 261 cases of whole blood cytopenia (ROR=11.92). There were 86 cases of disseminated intravascular coagulation (ROR=10.91) and 58 cases of toxic epidermal necrolysis (ROR=9.06). The number of ADE reports was slightly higher in males than in females, and the number of ADE reports in the age group 鈮，
本文编号：2394943
[Abstract]:Objective: to excavate and evaluate the safety warning signal of linazolamide after listing, and to provide reference for rational drug use in clinic. Methods: the report ratio method (ROR) was used to detect the adverse drug events (ADE) reported by FDA Public data Open Project (Open FDA) in the second quarter of 2004 to 2016. The ROR 95% confidence interval (CI) lower bound 1 indicates a warning signal. Results: of the 6 828 534 ADE reports included in the analysis, 7 224 were reported by Linedolidomide as suspected drug ADE. The top 10 ADE reports were thrombocytopenia, drug interaction, thrombocytopenia, nausea and anemia, respectively. Serotonin syndrome, diarrhea, fever, drug failure, vomiting. A total of 120 warning signals were obtained from the first 200 ADE reports by ROR method, involving 18 systematical organ classification. The first 5 positions of ADE signals were classified as medical examination and nervous system diseases, respectively, according to the classification of systematic organs. Blood and lymphoid diseases, metabolic and nutritional diseases, heart organ diseases, including 42 cases of optic neuropathy (ROR=56.33), 350 cases of serotonin syndrome (ROR=52.86), There were 162 cases of lactic acid acidosis (ROR=18.30), 31 cases of endocarditis (ROR=15.38), 566 cases of thrombocytopenia (ROR=14.29), 122 cases of bone marrow failure (ROR=14.20) and 261 cases of whole blood cytopenia (ROR=11.92). There were 86 cases of disseminated intravascular coagulation (ROR=10.91) and 58 cases of toxic epidermal necrolysis (ROR=9.06). The number of ADE reports was slightly higher in males than in females, and the number of ADE reports in the age group 鈮，
本文编号：2394943
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