重组人血小板生成素注射液上市后不良反应监测研究

Post-marketing study of recombinant human thrombopoietin injection for adverse drug reaction monitoring

目的研究重组人血小板生成素（rhTPO）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rhTPO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6829例应用rhTPO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5d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rhTPO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。

AIM To investigate the characters of adverse drug reactions （ADRs） and safety profiles of recombinant human thrombopoietin （rhTPO） METHODS The ADRs of patients who thrombocytopenic purpura were observed by , so as to provide reference for the rational use of drugs. used rhTPO with thrombocytopenia after chemotherapy and active surveillance toolkit. The patients＇ information, original disease, drug combination, and the severity, relevance evaluation and outcome of ADRs etc. were analyzed. RESULTS From May 2008 to April 2014, there were totally 6 829 cases monitored and 87 ADRs related reports were collected. The total ADRs rate was 1.27%. There was no significant difference of ADRs rate between male and female （0.95% vs. 1.42%, P 〉 0.05） and 77.01% ADRs occured within 5 days. The main ADR symptoms were systemic symptoms and no new off-label ADRs were found. Some children and elderly were involved in this study and no unexpected ADR were found. The ADRs rate of younger group （ ≤ 14 years） was significantly higher than mid-age group （15 - 64 years） （3.4% vs. 1.16%, P 〈 0.05） and older group （ ≥ 65 years） （3.4% vs. 1.24%, P 〈 0.05）. CONCLUSION rhTPO has a good safety profile and ADRs of rhTPO are limited and controllable. However, special attention should be paid to continuous monitoring in order to reply the damage of late onset ADRs.