磷酸氯喹治疗新型冠状病毒肺炎的药品不良反应/事件分析及风险管理建议

Risk Management of Adverse Drug Reactions/Events Induced by Chloroquine Phosphate in COVID-19 Patients

目的通过分析磷酸氯喹治疗新型冠状病毒肺炎(简称新冠肺炎)出现的药品不良反应/事件(ADR/AE)报告,为新冠肺炎临床用药安全提供参考。方法对深圳市2020年1月1日至3月6日期间上报的磷酸氯喹治疗新冠肺炎不良反应病例报告进行统计分析。结果根据追踪获知共有32位患者使用了磷酸氯喹治疗新冠肺炎,对收到的21例怀疑药品为磷酸氯喹的新冠肺炎ADR/AE进行了统计分析:其ADR/AE发生率为65.62%,男女比例1∶1.1;30~39岁及50~59岁年龄段发生的ADR/AE比例较高,分别为38.10%、23.81%;发生率较高依次为:消化系统、循环系统(含心脏)、神经肌肉系统、眼睛损害;心律失常是磷酸氯喹可致命的ADR/AE类型;肝损周期较短,平均3.5天;联合有潜在肝损伤的中药汤剂时可能增加肝损伤风险;ADR/AE最短当天发生,最长用药后9天发生,多发生在用药后2~7天。结论临床在使用磷酸氯喹治疗新冠肺炎的过程中,应避免联用禁忌的药物,尽量减少不必要的联合用药,密切观察ADR/AE,一旦发现应积极处理,从而保障患者的用药安全。

Objective To analyze adverse drug reactions/events caused by chloroquine phosphate in COVID-19 patients in order to provide reference for safe use of drugs for COVID-19.Methods Case reports of ADR/AE caused by chloroquine phosphate in COVID-19 patients in Shenzhen between January 1,2020 and March 6,2020 were analyzed.Results The incidence of ADR/AE induced by chloroquine phosphate was 65.62%.Totally 21 cases were included.The male/female ratio was 1:1.1.Patients aged 30 to 39 and 50 to 59 were the most susceptible to ADR/AE,and the percentage was 38.10%and 23.81%respectively.Thirty-two COVID-19 patients were treated with chloroquine phosphate.ADR/AE were more likely to occur in the digestive system,circulatory system(including heart),neuromuscular system and eyes.Arrhythmia caused by chloroquine phosphate was deadly.The duration of liver injury was relatively short,3.5 days on average.The risk of liver damage could be increased when chloroquine phosphate was combined with traditional Chinese medicine decoctions.ADR/AE could occur the day chloroquine phosphate was taken or as late as 9 days later,most of which occurred in 2 to 7 days after treatment.Conclusion In the process of treating COVID-19 with phosphate chloroquine,we should avoid using contraindicated drugs,minimize the combination of drugs,and closely observe adverse reactions/events that have to be dealt with without delay so as to ensure the safety of patients.