基于真实世界数据的磷酸奥司他韦临床使用情况及安全性分析

doi:10.19803/j.1672-8629.2021.03.09

摘要/Abstract

摘要： 目的调查磷酸奥司他韦临床使用情况及安全性,分析其药品不良反应（ADR）的发生特点,为合理用药提供参考。方法回顾性分析我院2016年2月1日至2018年2月28日门诊及住院患者使用磷酸奥司他韦的病例用药情况,对适应证、用药目的、用法用量、联合用药及ADR进行统计分析,重点关注其用药合理性及安全性。探讨ADR与年龄、过敏史、基础疾病、联合用药之间的关系,寻找危险因素。结果使用磷酸奥司他韦的成年患者共计1 795例,儿童患者共计3 199例。其中治疗性应用：成年组1 481例（82.5%）,儿童组2 602例（81.3%）;主要临床诊断用于上呼吸道感染、支气管炎及肺炎,其中通过病毒学检查确诊为流感病毒感染者仅767人,其余全部为疑似流感病例和临床诊断流感病例。预防性用药：成年组314例（17.5%）,儿童组597例（18.7%）,评估发现存在预防用药指征不足情况。流感症状开始48 h内给药率：住院儿童组109例（79.0%）,住院成人组169例（60.1%）,儿童组高于成人组。药物用法用量、疗程较规范,但联合用药缺乏依据。ADR 106例（发生率2.12%）,无严重ADR,主要表现为消化系统反应,其次为神经精神系统反应。统计学分析ADR发生率与年龄、联合用药品种数相关。结论磷酸奥司他韦临床使用存在过度预防用药、适应证不规范情况。该药安全性高,主要ADR为消化系统反应,但需注意年龄、联合用药、过敏体质为其ADR发生的主要危险因素,尤其应关注儿童用药安全。

关键词: 磷酸奥司他韦, 流行性感冒, 合理用药, 药品不良反应

Abstract: Objective To investigate the clinical use and safety of oseltamivir phosphate, analyze the characteristics of its adverse drug reactions (ADR), and provide reference for rational use of drugs. Methods Data on the use of oseltamivir phosphate in our hospital between February 2016 and February 2018 was retrospectively analyzed in terms of indications, use of drugs, usage and dosage, combined use of drugs and adverse reactions. The rationality and safety of drug use was highlighted. The relationships between adverse reactions and age, allergy history, underlying diseases and combined medication were explored to identify the risk factors. Results There were a total of 1 795 adult patients and 3 199 children who took oseltamivir phosphate. As far as the therapeutic use was concerned, there were 1 481 cases (82.5%) in the adult group, and 2 602 cases (81.3%) in the child group. This drug was prescribed mainly for upper respiratory tract infections, bronchitis and pneumonia, but 767 of these cases were diagnosed with influenza virus infection via virology examination, and the rest were suspected influenza cases or clinically diagnosed cases of influenza. As for preventive medication: the adult group consisted of 314 cases (17.5%), compared with 597 cases (18.7%) in the child group. A lack of indications related to preventive medication was found. Administration started within 48 hours of onset of influenza symptoms, with 109 cases (79.0%) in the child group, and 169 cases (60.1%) in the adult group, Drug usage and dosage, courses of treatment were up to standards, but combined medication was not well-grounded. There were 106 cases of adverse drug reactions, but there was no case of serious adverse drug reactions. Statistical analysis showed that the rate of adverse drug reactions was related to the age of patients and the number of types of combined drugs. Conclusion Excessive use of preventive drugs and inappropriate indications have been found in the clinical use of oseltamivir phosphate. This drug is quite safe and the main adverse reactions involve the digestive system, but the age of patients, combination of drugs and allergy may be regarded as the main risk factors for adverse reactions. The safety of drug use in elderly patients and children has become a concern.

Key words: qseltamivir phosphate, influenza, rational use of drugs, adverse drug reaction

中图分类号:

R969.3

李晟, 郑磊. 基于真实世界数据的磷酸奥司他韦临床使用情况及安全性分析[J]. 中国药物警戒, 2021, 18(3): 250-255.

LI Sheng, ZHENG Lei. Clinical Use and Safety of Oseltamivir Phosphate[J]. Chinese Journal of Pharmacovigilance, 2021, 18(3): 250-255.

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