Comparative Study on Post-marketing Safety of Four Monoclonal Anti-tumor Drugs Including Bevacizumab Injection

OBJECTIVE To conduct a post-marketing safety comparison study of four monoclonal antibody anti-tumor drugs including bevacizumab injection, so as to promote the improvement of rational drug use.

METHODS Use the Medical Dictionary of Regulatory Activities (MedDRA) to code adverse drug reactions(ADR); the comprehensive standard method was used to carry out signal detection and retrospective analysis to compare the demographic factors, ADR characteristics, adverse reaction signals and adverse reaction outcomes.

RESULTS Adverse reactions of various varieties of monoclonal antibody anti-tumor drugs were more common in patients over 50 years of age. The proportion of female ADR patients with bevacizumab injection was higher than that of male patients, and the proportion of male ADR patients with rituximab injection, carrellizumab injection and sindillizumab injection was higher than that of female patients; there were differences in the clinical manifestations of the main adverse reactions; the effects of different varieties on organs of the same system were different; the occurrence time of adverse reaction signal was different in different varieties; the adverse reaction outcome of different varieties was good.

CONCLUSION The clinical use risk of each variety in this study is controllable; it is recommended to pay attention to female patients over 40 years old for bevacizumab injection and male patients over 50 years old for rituximab injection, carrellizumab for injection and sindillizumab injection; it is suggested that combining adverse reaction analysis and signal detection, the monitoring work should be focused on different ADRs of different varieties in different time periods.