目的 分析360例小分子激酶抑制剂不良反应（ADR）发生的一般规律和特点，为临床合理用药提供依据。方法 收集陕西省2016—2020年各级医疗卫生机构上报至陕西省食品药品研究院的360例小分子激酶抑制剂ADR报告，从性别、年龄、给药途径、药物种类、临床转归和ADR累及系统/器官进行统计分析。结果 在360例ADR患者中，男性多于女性，好发于40岁以上的中老年人。ADR累及系统/器官以消化系统为主，其次为皮肤及附件、血液系统、心血管系统。引起ADR最多的药品是伊布替尼。在临床转归方面，痊愈和好转占59.5%。1例“新的”ADR表现为全身皮肤变黑，其是否与该类药物有关有待进一步研究。结论 小分子激酶抑制剂ADR的发生与患者年龄、性别、药物种类等密切关联，并且涉及多个系统或器官，临床使用时应根据具体用药情况采取有效预防措施，以减少或避免ADR的发生，从而优化合理用药，确保患者用药安全。

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

陕西省创新人才推进计划-青年科技新星项目(2021KJXX-23);陕西省重点研发计划项目(2021ZDLSF01-07);北京康盟慈善基金会医学科研发展基金项目(7B202010)