【摘要】：目的:挖掘和評(píng)價(jià)利奈唑胺上市后的安全警戒信號(hào),為臨床合理用藥提供參考。方法:采用報(bào)告比值比法(ROR)對(duì)FDA公共數(shù)據(jù)開(kāi)放項(xiàng)目(Open FDA)2004-2016年第二季度的藥物不良事件(ADE)報(bào)告數(shù)據(jù)進(jìn)行利奈唑胺警戒信號(hào)檢測(cè),ROR值95%置信區(qū)間(CI)下限1提示出現(xiàn)警戒信號(hào)。結(jié)果:納入分析的6 828 534份ADE報(bào)告中,以利奈唑胺為懷疑藥物的ADE報(bào)告7 224份。ADE上報(bào)數(shù)排序前10位分別為血小板減少癥、藥物相互作用、血小板減少、惡心、貧血、5-羥色胺綜合征、腹瀉、熱病、藥物無(wú)效、嘔吐。經(jīng)ROR法檢測(cè)數(shù)量排序前200位ADE報(bào)告,共得到120個(gè)警戒信號(hào),涉及18個(gè)系統(tǒng)器官分類,ADE信號(hào)數(shù)量按系統(tǒng)器官分類排序前5位分別為醫(yī)學(xué)檢查、神經(jīng)系統(tǒng)疾病、血液及淋巴系統(tǒng)疾病、代謝及營(yíng)養(yǎng)類疾病、心臟器官病癥,其中有臨床參考意義的高風(fēng)險(xiǎn)信號(hào)包括視神經(jīng)病變(ROR=56.33)42例、5-羥色胺綜合征(ROR=52.86)350例、乳酸性酸中毒(ROR=18.30)162例、心內(nèi)膜炎(ROR=15.38)31例、血小板減少癥(ROR=14.29)566例、骨髓衰竭(ROR=14.20)122例、全血細(xì)胞減少癥(ROR=11.92)261例、彌散性血管內(nèi)凝血(ROR=10.91)86例、中毒性表皮壞死松解癥(ROR=9.06)58例等。ADE報(bào)告數(shù)量男性略多于女性,≥45歲年齡組ADE上報(bào)數(shù)顯著多于低年齡組。結(jié)論:對(duì)Open FDA數(shù)據(jù)庫(kù)進(jìn)行利奈唑胺警戒信號(hào)的檢測(cè)和分析,可有效地為后續(xù)藥物警戒工作提供參考。
[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，

本文編號(hào)：2394943