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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%,P>0.05)。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%,P<0.05)和≥65岁患者组(3.4%vs.1.24%,P<0.05)。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。
Objective To study the characteristics of adverse reactions of recombinant human thrombopoietin (rh TPO) after its listing, improve its safety information and provide reference for clinical rational drug use. Methods A comprehensive monitoring combined with key surveillance program was used to observe the adverse reactions after thrombocytopenic patients and idiopathic thrombocytopenic purpura patients treated with rh TPO after solid tumor chemotherapy. The patients’ basic information, original disease, combination medication and adverse reactions Occurrence, severity, relevance evaluation, prognosis and other analysis. Results From May 2008 to April 2014, a total of 6 829 patients with rh TPO were collected, of whom 87 had adverse drug reactions and the overall incidence of adverse reactions was 1.27%. Male and female patients were poor No significant difference in the incidence of response (0.95% vs.1.42%, P> 0.05). 77.01% of patients with adverse reactions occurred within 5 days after treatment, the symptoms of systemic symptoms, found no new adverse reactions outside the instructions symptoms. No adverse reactions were found in children, the elderly and pregnant women. The incidence of adverse reactions in children ≤14 years of age was higher than those in patients aged 15-64 years (3.4% vs. 1.16%, P <0.05) and in patients ≥65 years (3.4% vs 1.24%, P <0.05). Conclusions rh TPO is safe and its adverse reactions are controllable. However, continuous monitoring of the patients after treatment should be taken to cope with the delayed adverse reactions.