RESUMEN
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.