抗肿瘤药致不良反应15 183例分析

摘要

OBJECTIVE: To investigate the characteristics and regularity of ADR induced by antineoplastic drugs and provide reference for safe drug use in clinic. METHODS: ADR reports induced by antineoplastic drugs reported by 108 hospitals during Jan. 2009-Dec. 2016 were collected from PLA ADR Monitoring Center. ADR reports were analyzed respectively in respects of types of ADR reports, patients ' gender and age, administration route, occurrence time, types of antineoplastic drug, the situation of patients suffering tumor, systems/organs involved in ADR, clinical manifestations, outcome, etc. RESULTS: Among 15 183 ADR reports, there were 462 cases of new ADR and 2 873 cases of severe ADR; there were 8 039 male (52. 95％) and 7 144 female (47. 05％). The proportion of severe ADR in female (20. 00％) was significantly higher than male (17. 96％), with statistical significance (P=0. 001). ADR was mainly induced by intravenous administration (90. 53％), and mainly occurred 2-＜7 d after medication (23. 00％). Top 3 drug categories in the list of ADR were platinum antineoplastic drugs (25. 63％), plant-derived antineoplastic drugs and its derivative (24. 42％) and anti-metabolism drugs (18. 50％). Male patients mainly suffered from lung cancer, colorectal cancer and gastric cancer; female patients mainly suffered from breast cancer, lung cancer and colorectal cancer. Systems/organs involved in ADR were gastrointestinal system, hematological system and systemic damage. Main clinical manifestations were nausea, vomiting, myelosuppression, skin rash and fever. Totally 92. 57％ of ADR cases were cured and recovered after treatment, and 5 cases died. CONCLUSIONS: Antineoplastic drugs have high incidence of ADR with serious damage. Clinic should strengthen the monitoring of key population and key drugs so as to reduce the occurrence of ADR.%目的:了解抗肿瘤药致不良反应(ADR)发生的特点和规律,为临床安全用药提供参考.方法:收集2009年1月-2016年12月108家医院上报至解放军ADR监测中心的抗肿瘤药致ADR报告,对ADR报告类型、患者性别与年龄、给药途径、ADR发生时间、抗肿瘤药类别、患者罹患肿瘤情况、ADR累及系统/器官及临床表现、转归等信息进行回顾性分析.结果:15183例ADR报告中,新ADR有462例,严重ADR有2873例.男性8039例(52. 95％),女性7144例(47. 05％);其中女性严重的ADR发生比例(20. 00％)显著高于男性(17. 96％),差异有统计学意义(P=0. 001).引发ADR的给药途径以静脉给药为主(90. 53％),且多发生于用药后2＜7d(23. 00％).共涉及抗肿瘤药117种,排名前3位的药物类别依次为金属铂类(25. 63％)、植物来源及衍生物类(24. 42％)和抗代谢类(18. 50％).男性患者罹患肿瘤排名前3位的分别为肺癌、结直肠癌和胃癌,女性患者为乳腺癌、肺癌和结直肠癌.ADR累及系统/器官主要为胃肠系统、血液系统和全身性损害,主要临床表现为恶心、呕吐、骨髓抑制、皮疹和发热.92. 57％发生ADR的患者经治疗后痊愈和好转,但有5例患者死亡.结论:抗肿瘤药致ADR较多,且危害严重.临床应加强重点人群、重点药物的监测,以减少ADR的发生.