重组人血小板生成素注射液上市后不良反应监测研究

发布时间：2018-03-14 15:30

  本文选题：血小板生成素　切入点：药物不良反应　出处：《中国新药与临床杂志》2015年08期 　论文类型：期刊论文

【摘要】：目的研究重组人血小板生成素(rh TPO)上市后不良反应发生特点,完善其安全性信息,为临床合理用药提供参考。方法采用全面监测联合重点监测方案,观察实体肿瘤化疗后血小板减少患者及特发性血小板减少性紫癜患者应用rh TPO后的不良反应发生情况,对患者基本信息、原患疾病、合并用药及不良反应发生情况、严重程度、关联性评价、转归等进行分析。结果自2008年5月至2014年4月,共收集了6 829例应用rh TPO患者的信息,其中有87例发生药物相关不良反应,不良反应整体发生率为1.27%,男性、女性患者间不良反应发生率无显著差异(0.95%vs.1.42%,P0.05)。77.01%患者不良反应发生在用药后5 d内,症状以全身症状为主,未发现说明书以外新的不良反应症状。儿童、老年人及妊娠人群中未出现非预期不良反应,≤14岁患儿不良反应发生率高于15~64岁患者组(3.4%vs.1.16%,P0.05)和≥65岁患者组(3.4%vs.1.24%,P0.05)。结论 rh TPO安全性良好,不良反应可控,但应注意对患者用药后的持续监测以应对迟发型不良反应损害。
[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，

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