我院单抗类抗肿瘤药致不良反应148例分析

摘要

目的：分析单抗类抗肿瘤药致药品不良反应（ADR）发生的特点及规律，为临床安全用药提供参考。方法：收集我院2012年11月－2016年2月单抗类抗肿瘤药致ADR 148例，统计患者的性别、年龄、原患疾病、药品名称、ADR发生时间、临床表现、治疗及转归等信息。结果：148例ADR中，男性80例，女性68例，男女比例为1.1765∶1；高发年龄为50～59岁（占32.43％）；原患疾病中非霍奇金淋巴瘤的比例最高（占37.84％）；共涉及到5种药物，其中利妥昔单抗注射液致ADR的比例最高（为47.97％）；ADR发生时间＜1 d的最多（占54.73％）；主要累及消化系统（占41.89％），临床表现为慢性肝纤维化、食欲减退、便秘、恶心、呕吐等；严重的ADR 9例（占6.08％），新的一般的ADR 5例（占3.38％），新的严重的ADR 2例（占1.35％）。经对症处理后，总有效率为98.65％。结论：单抗类抗肿瘤药致ADR可出现在各个年龄阶段，原患疾病较广，且累及多个器官/系统，临床表现复杂，危害大，因此需给予高度重视，加强合理用药监护，做好应对措施，以提高患者用药的安全性。%OBJECTIVE:To analyze the characteristics and laws of ADR induced by monoclonal antitumor drugs,and to provide reference for clinical medication safety. METHODS:148 cases of ADR induced by monoclonal antitumor drugs were se-lected from our hospital during Jan. 2012-Feb. 2016,and analyzed statistically in respects of patients’gender and age,primary disease,drug kind,the occurrence of ADR,clinical manifestations,treatment and outcome,etc. RESULTS:Among 148 ADR cases,there were 80 male and 68 female with ratio of 1.176 5∶1. High-risk aged 50 to 59 years old(32.43%);of primary dis-ease,the proportion of non-Hodgkin lymphoma was the highest(37.84%);5 kinds of drugs were involved,among which ADR induced by Rituximab injection took up the highest proportion (47.97%);most of ADR occurred within 1 d after medication (54.73%);ADR mainly involved digestive system(41.89%);main clinical manifestations were chronic hepatic fibrosis,loss of appetite,constipation,nausea and vomiting;there were 9 severe ADR cases(6.08%),5 new general ADR cases(3.38%)and 2 new severe ADR cases (1.35%). After symptomatic treatment,the total effective rate was 98.65%. CONCLUSIONS:ADR in-duced by monoclonal antitumor drugs appear in all ages,the primary disease is wide;it causes multiple systems/orgars involved and complex clinical manifestations,great harm. Therefore,great importance should be attached to rational drug use monitoring and countermeasures in order to improve the safety of drug use.