The First Hospital of Changsha, Changsha, China.
Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Clin Pharmacol Ther. 2020 Oct;108(4):791-797. doi: 10.1002/cpt.1866. Epub 2020 May 26.
To evaluate the incidence, type, and risk factors associated with adverse drug reactions (ADRs) among patients with coronavirus disease 2019 (COVID-19) by Hospital Pharmacovigilance System (CHPS). A retrospective analysis was performed on 217 patients with COVID-19 admitted to the First Hospital of Changsha in China, from January 17, 2020, to February 29, 2020. The active monitoring model in CHPS was used to detect ADR signals of the hospital information system. The risk factors for the ADRs were classified using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system. Univariate and multivariate logistic regressions were carried out to analyze the risk factors of ADRs. Our results showed that the prevalence of ADRs was 37.8% in the patients, which was predominated by drug-induced gastrointestinal disorders and liver system disorders (23.0% vs. 13.8%). The ADR could be explained by the use of lopinavir/ ritonavir and umifenovir by 63.8% and 18.1%, respectively. There were 96.8% of ADRs that occurred within 14 days of hospitalization. Multivariable analysis showed that length of stay (odds ratio (OR): 2.02; 95% confidence interval (CI) 1.03-3.96; P = 0.04), number of drugs used in the hospital (OR: 3.17; 95% CI 1.60-6.27; P = 0.001) and underlying basic diseases (OR: 2.07; 95% CI 1.02-4.23; P = 0.04) were independent risk factor for ADRs in the patients. Together, the incidence of ADRs was significantly high during the treatment period. Moreover, the active monitoring of the CHPS system reflected ADRs during COVID-19 treatment in the real world, which provided reference for safe medication in the clinic.
通过医院药物警戒系统（CHPS）评估 2019 年冠状病毒病（COVID-19）患者中不良药物反应（ADR）的发生率、类型和相关风险因素。对 2020 年 1 月 17 日至 2 月 29 日期间入住中国长沙市第一医院的 217 例 COVID-19 患者进行回顾性分析。采用 CHPS 中的主动监测模型检测医院信息系统的 ADR 信号。采用世界卫生组织-乌普萨拉监测中心（WHO-UMC）系统对 ADR 的风险因素进行分类。采用单因素和多因素逻辑回归分析 ADR 的风险因素。结果显示，患者 ADR 发生率为 37.8%，以药物引起的胃肠道紊乱和肝系统紊乱为主（23.0%比 13.8%）。使用洛匹那韦/利托那韦和乌米酚的患者 ADR 发生率分别为 63.8%和 18.1%。96.8%的 ADR 发生在住院后 14 天内。多变量分析显示，住院时间（比值比（OR）：2.02；95%置信区间（CI）：1.03-3.96；P=0.04）、住院期间使用的药物数量（OR：3.17；95%CI：1.60-6.27；P=0.001）和基础疾病（OR：2.07；95%CI：1.02-4.23；P=0.04）是患者发生 ADR 的独立危险因素。综上所述，治疗期间 ADR 发生率显著升高。此外，CHPS 系统的主动监测反映了 COVID-19 治疗期间的 ADR，为临床安全用药提供了参考。
