4826例免疫抑制剂及相关器官移植用药致药品不良反应自发报告分析

目的:了解免疫抑制剂及相关器官移植用药致药品不良反应(adverse drug reaction,ADR)的发生特点与规律,为临床合理用药提供参考。方法:采用回顾性研究方法,对2009年1月1日至2019年1月1日中国人民解放军ADR监测中心收集的免疫抑制剂相关ADR报告进行统计分析。结果:共收集到来自151家医院的4826例免疫抑制剂致ADR报告,男女患者之比为1∶1;发生严重的ADR患者中,≥60岁患者所占比例较高;ADR发生时间以用药后2~<7 d为主;引发ADR的药物主要涉及糖皮质激素、抗体和烷化剂;ADR累及器官和(或)系统主要为胃肠系统及全身性损害,严重的ADR主要累及血液系统;经过治疗,4314例患者(占89.39%)痊愈或好转;有4例死亡报告(1例与移植相关)。其中,442例ADR与器官移植术后用药相关,男女患者之比为2∶1;ADR发生时间以用药后≥15 d为主;引发ADR的药物主要涉及钙调磷酸酶抑制剂、抗体和抗代谢/增殖药;经过治疗,379例患者(占85.75%)痊愈或好转。结论:免疫抑制剂治疗窗较窄,但疗效无法替代,应加强患者治疗期间尤其是器官移植术后的临床用药安全性监测,并及时有效地干预,尽可能防止严重的ADR发生。

Spontaneous Reports of 4826 Cases of Adverse Drug Reactions Induced by Immunosuppressant and Medication in Related Organ Transplantation

OBJECTIVE:To investigate the characteristics and regularity of adverse drug reactions(ADR)induced by immunosuppressant and medication in related organ transplantation,so as to provide references for clinical rational medication.METHODS:Retrospectively research was adopted to analyze the immunosuppressant related ADR reports collected by ADR monitoring center of China PLA during Jan.1st 2009 to Jan.1st 2019.RESULTS:A total of 4826 cases of ADR induced by immunosuppressant were collected from 151 hospitals,with the male to female ratio was 1∶1;among the patients with severe ADR,the proportion of patients aged≥60 years was higher;the occurrence time of ADR was mainly 2-<7 days after medication;the ADR-inducing drugs were mainly involved glucocorticoids,antibodies and alkylating agents;the ADR involved organs and(or)systems were mainly gastrointestinal system and systemic damage,the severe ADR mainly involved blood system;after treatment,4314 patients(89.39%)were cured or turned better;there were 4 deaths reported(1 case related to organ transplantation).Of which 442 cases of ADR were related to medication after organ transplantation,with the male to female ratio was 2∶1;the occurrence time of ADR was mainly≥15 days after medication;the ADR-inducing drugs were mainly involved calcineurin inhibitor,antibodies and Anti-metabolites/anti-proliferation;after treatment,379 patients(85.75%)were cured or turned better.CONCLUSIONS:The therapeutic window of immunosuppressant is narrow,but its efficacy cannot be replaced.The clinical medication safety monitoring for patients,especially after organ transplantation,should be strengthened,timely and effective interventions should be conducted to prevent the occurrence of severe ADR as much as possible.