Objective The general rule and characteristics of 360 cases of adverse reactions to small molecule kinase inhibitors were analyzed to provide basis for rational drug use in clinic. Methods A total of 360 ADR cases of small molecule kinase inhibitors reported to Shaanxi Institute of Food and Drug Control by medical and health institutions at all levels from 2016 to 2020 were collected, and analyzed statistically from gender, age, route of administration, drug type, clinical outcome and system/organ involved in adverse reactions. Results Among 360 ADR patients, male patients were more than female patients, and the incidence was more common in middle-aged and elderly patients over 40 years old. Digestive system was the main system/organ involved in ADR, followed by skin and accessories, blood system and cardiovascular system. The drug that caused the most adverse reactions was ibrutinib. In clinical outcome, recovery and improvement accounted for 59.5%. One "new" adverse reaction presented as systemic skin darkening, and whether it was related to this kind of drugs remains to be further studied. Conclusion The occurrence of adverse reactions of small molecule kinase inhibitors is closely related to the patient's age, gender, drug type and so on, and involves multiple systems or organs. Therefore, effective preventive measures should be taken according to specific drug use in clinical use to reduce or avoid the occurrence of ADR, so as to optimize rational drug use and ensure drug safety of patients.

R979.1

陜西省創(chuàng)新人才推進(jìn)計(jì)劃-青年科技新星項(xiàng)目(2021KJXX-23);陜西省重點(diǎn)研發(fā)計(jì)劃項(xiàng)目(2021ZDLSF01-07);北京康盟慈善基金會(huì)醫(yī)學(xué)科研發(fā)展基金項(xiàng)目(7B202010)