目的 基于美國食品藥品監(jiān)督管理局不良事件呈報系統(tǒng)（FAERS），挖掘藥物在0～18歲兒童臨床使用中引起血小板減少癥的警戒信號，為判斷和治療臨床不明原因血小板減少提供參考。方法 用Open Vigil 2.1軟件對FAERS數(shù)據(jù)庫進(jìn)行藥源性血小板減少癥不良反應(yīng)數(shù)據(jù)挖掘，以“thrombocytopenia”為首選術(shù)語進(jìn)行檢索，采用比例報告比（PRR）和報告比值比法（ROR）對藥源性血小板減少癥警戒信號進(jìn)行數(shù)據(jù)分析和處置。結(jié)果 根據(jù)預(yù)定義的納入標(biāo)準(zhǔn)，2 510例不良事件（ADE）報告涉及鑒定出435種疑似藥物，經(jīng)過數(shù)據(jù)挖掘，生成54種藥源性血小板減少癥的陽性風(fēng)險信號，其中36種是抗腫瘤藥物。報告最多的藥物是甲氨蝶呤（n＝113）、其次是丙戊酸（n＝ 67）、多柔比星（n＝ 52）、阿糖胞苷（n＝ 51）和依托泊苷（n＝46）。地西他濱（PRR＝27.18，ROR＝32.5）、硫鳥嘌呤（PRR＝22.96，ROR＝26.62）、吉西他濱（PRR＝17.85，ROR＝19.94），和奧沙利鉑（PRR＝16.79，ROR＝18.63）與血小板減少的關(guān)系比其余的藥物更強。結(jié)論 引起兒童藥源性血小板減少癥的藥物主要包括抗腫瘤藥物、神經(jīng)系統(tǒng)藥物及抗感染藥物3大類，關(guān)注其引起兒童藥源性血小板減少癥的特點，對相關(guān)藥物風(fēng)險進(jìn)行識別與比較，持續(xù)監(jiān)測該ADE，進(jìn)而有效降低臨床用藥風(fēng)險。

Objective To explore the risk assessment of drugs use in children aged 0—18 years induced thrombocytopenia in the clinical, and provide a reference for judgment and treatment of clinical thrombocytopenia of unknown cause using the data of the US Food and Drug Administration’s Adverse Event Reporting System (FAERS). Methods Drug induced thrombocytopenia data mining was performed in FAERS database by OpenVigil 2.1 software, “thrombocytopenial” were used as the preferred terms for retrieval, and the thrombocytopenia caused by antitumor and antiepileptic medicines was detected by proportional reporting ratio (PRR) and reported ratio method (ROR). Results Based on predefined inclusion criteria, 2 510 ADE reports involving 435 suspected drugs were identified. After data mining, 54 drugs generated positive risk signals for drug-induced thrombocytopenia, of which 36 were antitumors for systemic use. The top reported drug was methotrexate (n=113), followed by valproic acid (n=65), doxorubicine (n=51), cytarabine (n=48) and etoposide (n=44). Decitabine (PRR=27.18, ROR=32.5), thioguanine (PRR=22.96, ROR=26.62), gemcitabine (PRR=17.85, ROR=19.94) and oxaliplatin (PRR=16.79, ROR=18.63) showed stronger associations with DIT than the remaining drugs. Conclusion Through the mining and analysis of FAERS date, it was found that drugs causing thrombocytopenia in children include antitumor drugs, nervous system drugs and antibacterial drugs. Pay attention to the characteristics of drug induced thrombocytopenia in children, identify and compare the risks of related drugs, and continuously monitor the adverse events, so as to effectively reduce the risk of clinical drug use.

R973