ABSTRACT
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.