摘要
目的探讨抗肿瘤药物不良反应(Adverse drug reaction,ADR)的特点、规律和转归情况,为临床安全用药提供参考依据。方法回顾性分析北京大学肿瘤医院2015年1月-2017年12月期间上报的抗肿瘤药物相关ADR报告。分析患者原发疾病分布,不同药物发生ADR情况,并探究与ADR预后相关的临床因素。结果 787例ADR报告中,患者平均年龄(54.80±12.42)岁,其中男性365例,女性422例,严重ADR 34例。患者发生的ADR经停药或治疗后,痊愈257例,好转484例,未好转11例。原患疾病以肺癌、乳腺癌居多,分别为175例和151例。常见ADR为骨髓抑制和过敏反应/过敏性休克。环磷酰胺患者易发生严重ADR,而多西他赛导致的ADR痊愈率较高,顺铂的ADR痊愈率较低。此外,体重≤60 kg的患者ADR痊愈率较高,胃癌患者ADR预后较好,而肺癌患者ADR预后较差。多因素分析显示,在肺癌、乳腺癌和胃癌患者中,抗肿瘤药物种类、患者ADR数目是ADR的独立预后预测因子。结论不同肿瘤患者临床特征、肿瘤药物的ADR特点和预后不同,临床上应预估ADR风险以供制定治疗方案时参考,并加强治疗后ADR的预防和管理。
Objective To study the characteristics and prognosis of the adverse reactions(ADRs) of antineoplastic drugs, thus provides reference for clinical medication. Methods A retrospective study was performed on the 787 ADR cases of antineoplastic drugs which were included in the ADR report system of our hospital between January 2015 and December 2017. The distribution of primary diseases,characteristics of ADRs caused by different drugs and the clinical factors that were associated with ADR prognosis were analyzed. Results Of the 787 ADR cases, 365 cases were male and 422 cases were female, and the average age was(54.80±12.42) years. There were 34 cases of severe ADR. After drug withdrawal or therapy, 257 cases were cured, 484 cases improved, and 11 cases not improved. The prevalence of ADR in lung cancer and breast cancer were high, with 175 and 151 cases respectively. The common ADRs were myelosuppression and anaphylaxis/anaphylactic shock. Cyclophosphamide trended to be associated with severe ADRs. ADRs caused by docetaxel often had high cure rate, but that by cisplatin had low cure rate. In addition, the prognosis of patients with weight ≤ 60 kg or gastric cancer was favorable, while that of patients with lung cancer was poor. Multiple logistic regression analysis suggested that the kinds of antineoplastic drugs and ADR counts were independent prognostic factors in patients with lung, breast or gastric cancer. Conclusion The characteristics and prognosis of the ADRs were different in patients with different features or resulted from different antineoplastic drugs. Clinically, the risk ADR should be evaluated when making therapeutic decisions and should be prevented after therapy.
引文
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