我院单抗类抗肿瘤药致不良反应148例分析

Analysis of 148 Cases of ADR Induced by Monoclonal Anticancer Drugs in Our Hospital

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1.176 5∶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 selected 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 disease, 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 induced 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.