中国药物警戒 ›› 2024, Vol. 21 ›› Issue (1): 107-110.
DOI: 10.19803/j.1672-8629.20230207

• 安全与合理用药 • 上一篇    下一篇

326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析

陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明*   

  1. 广东医科大学附属医院药学部,广东 湛江 524001
  • 收稿日期:2023-04-10 出版日期:2024-01-15 发布日期:2024-01-18
  • 通讯作者: *蔡伟明,女,本科,主任药师,临床药学。E-mail: caiweiming830@163.com
  • 作者简介:陈华炎,男,硕士,主管药师,临床药学。
  • 基金资助:
    湛江市非资助科技攻关专题（2020B1074）

Safety of nirmatrelvir/ritonavir in the treatment of novel coronavirus infections

CHEN Huayan, JIANG Dongbo, GUO Chunlian, YANG Jiaqi, LI Yuxin, CAI Weiming*   

  1. Department of Pharmacology, Affiliated Hospital of Guangdong Medical University, Zhanjiang Guangdong 524001, China
  • Received:2023-04-10 Online:2024-01-15 Published:2024-01-18

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摘要： 目的 探讨奈玛特韦片/利托那韦片（Paxlovid）治疗新型冠状病毒感染（COVID-19）的安全性,为临床用药提供参考。方法 通过电子病历系统收集2022年12月15日至2023年2月15日在某院住院并应用Paxlovid治疗COVID-19的成年患者病历资料,对Paxlovid的不良反应发生情况（发生时间、临床表现、严重程度、处理措施和转归）进行回顾性分析,并比较有不良反应组和无不良反应组患者的临床特征。结果 纳入患者326例,男性225例（69.02%）,女性101例（30.98%）。55例患者出现56例次药品不良反应,发生率16.87%;消化系统损害29例次,肝功能异常17例次,神经系统损害4例次,呼吸系统损害3例次,其他3例次;其中有1例患者同时出现呼吸系统损害和消化系统损害。药品不良反应严重程度为1级18例（32.73%）,2级37例（67.27%）,无严重（≥3级）。大部分药品不良反应经对症治疗或停药后症状均能缓解,28例（50.91%）治愈,24例（43.64%）好转,3例（5.45%）不详,转归良好。有不良反应组和无不良反应组的患者临床特征（性别、年龄以及各种合并疾病）的差异均无统计学意义（P>0.05）。结论 Paxlovid治疗COVID-19的安全性较好,不良反应以腹泻和肝功能异常多见,症状轻微,患者耐受良好。

关键词: 新型冠状病毒感染, 奈玛特韦, 利托那韦, 奈玛特韦片/利托那韦片, 抗病毒药物, 药品不良反应, 安全性

Abstract: Objective To investigate the safety of nirmatrelvir/ritonavir in the treatment of novel coronavirus infections (COVID-19), and to provide reference for clinical use. Methods The medical records of adult patients infected with COVID-19 who were admitted to the Affiliated Hospital of Guangdong Medical University between December 15, 2022 and February 15, 2023 and treated with Paxlovid were retrospectively investigated via the electronic medical record system. The data on adverse reactions related to paxlovid, including the time of occurrence, clinical manifestations, severity, management and outcomes was analyzed before the clinical characteristics of patients with and without adverse reactions were compared. Results A total of 326 patients were enrolled, including 225 males (69.02%) and 101 females (30.98%). Fifty-six adverse drug reactions occurred in 55 patients, so the incidence was 16.87%, including 28 cases of digestive system injury, 17 cases of liver dysfunction, 4 cases of nervous system injury, 3 cases of respiratory system injury, and 3 other cases. Among them, one patient experienced both respiratory and digestive system injury. There were 18 cases (32.73%) of grade 1, 37 cases (67.27%) of grade 2, and no serious (grade ≥3) adverse drug reactions according to the grading of severity. The clinical outcomes were generally good after drug withdrawal/reduction and symptomatic treatment. Twenty-eight of these cases (50.91%) were cured, 24 cases (43.64%) improved, and 3 cases (5.45%) were out of contact. There was no statistically significant difference in the clinical characteristics (gender, age, and various comorbidities) between patients with and without adverse reactions (P>0.05). Conclusion Paxlovid is safe in the treatment of COVID-19, with mild symptoms of adverse reactions manifested as diarrhea and liver function abnormalities, and is well tolerated by patients.

Key words: novel coronavirus infection, nirmatrelvir, ritonavir, nirmatrelvir/ritonavir, antiviral drug, adverse drug reactions, safety

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