本文選題：血小板生成素　切入點(diǎn)：藥物不良反應(yīng)　出處：《中國(guó)新藥與臨床雜志》2015年08期 　論文類(lèi)型：期刊論文

【摘要】：目的研究重組人血小板生成素(rh TPO)上市后不良反應(yīng)發(fā)生特點(diǎn),完善其安全性信息,為臨床合理用藥提供參考。方法采用全面監(jiān)測(cè)聯(lián)合重點(diǎn)監(jiān)測(cè)方案,觀察實(shí)體腫瘤化療后血小板減少患者及特發(fā)性血小板減少性紫癜患者應(yīng)用rh TPO后的不良反應(yīng)發(fā)生情況,對(duì)患者基本信息、原患疾病、合并用藥及不良反應(yīng)發(fā)生情況、嚴(yán)重程度、關(guān)聯(lián)性評(píng)價(jià)、轉(zhuǎn)歸等進(jìn)行分析。結(jié)果自2008年5月至2014年4月,共收集了6 829例應(yīng)用rh TPO患者的信息,其中有87例發(fā)生藥物相關(guān)不良反應(yīng),不良反應(yīng)整體發(fā)生率為1.27%,男性、女性患者間不良反應(yīng)發(fā)生率無(wú)顯著差異(0.95%vs.1.42%,P0.05)。77.01%患者不良反應(yīng)發(fā)生在用藥后5 d內(nèi),癥狀以全身癥狀為主,未發(fā)現(xiàn)說(shuō)明書(shū)以外新的不良反應(yīng)癥狀。兒童、老年人及妊娠人群中未出現(xiàn)非預(yù)期不良反應(yīng),≤14歲患兒不良反應(yīng)發(fā)生率高于15~64歲患者組(3.4%vs.1.16%,P0.05)和≥65歲患者組(3.4%vs.1.24%,P0.05)。結(jié)論 rh TPO安全性良好,不良反應(yīng)可控,但應(yīng)注意對(duì)患者用藥后的持續(xù)監(jiān)測(cè)以應(yīng)對(duì)遲發(fā)型不良反應(yīng)損害。
[Abstract]:Objective to study the occurrence characteristics of adverse reactions of recombinant human thrombopoietin rh TPO( rh TPO), improve its safety information, and provide reference for rational drug use in clinic. To observe the occurrence of adverse reactions in patients with thrombocytopenia and idiopathic thrombocytopenic purpura after chemotherapy for solid tumors, the basic information of patients, the primary diseases, the combination of drugs and adverse reactions, and the severity. Results from May 2008 to April 2014, the information of 6 829 patients with Rh TPO was collected. Among them, 87 cases had adverse drug reactions, the overall incidence of adverse reactions was 1. 27%. There was no significant difference in the incidence of adverse reactions among female patients. There was no significant difference in the incidence of adverse reactions between female patients (0.95vs.1.42g / kg). 77.01% of the patients had adverse reactions within 5 days after treatment. The main symptoms were systemic symptoms, and no new adverse reactions outside the instructions were found in children. There were no unexpected adverse reactions in the elderly and pregnant women. The incidence of adverse reactions in children 鈮，

本文編號(hào)：1611817