| 李雅楠,常杰,黄柳,等.左氧氟沙星注射液导致不良反应发生的临床特征与风险因素研究[J].安徽医药,待发表. |
| 左氧氟沙星注射液导致不良反应发生的临床特征与风险因素研究 |
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| 投稿时间：2026-07-06 录用日期：2026-08-06 |
| DOI： |
| 中文关键词: 左氧氟沙星注射液 药品不良反应 合理用药 药物监测 影响因素 |
| 英文关键词: |
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| 中文摘要: |
| 目的 调查左氧氟沙星注射液致药品不良反应（ADR）的发生特点及其影响因素，促进临床合理用药。方法 研究设计为双中心前瞻性研究，按照预先制定的“输液反应处置流程”及“药品不良反应上报流程”，对2025年2月至9月在上海市2家三甲医院急诊/发热门诊输液室接受左氧氟沙星注射液静滴治疗的600例患者中发生ADR的患者情况进行分析。结果 600例患者均接受左氧氟沙星注射液单药治疗或合并维生素C补液治疗，在本研究条件下，ADR的发生率为14.83%（89例）。76.4%（68/89）的ADR发生于首次用药的输液首日；从单次给药的时间分布看，89.89%（80/89）发生在用药60分钟内、57.30%（51/89）在用药20分钟内。ADR主要累及皮肤及附件（44.94%）和消化系统（40.45%），神经系统和心血管系统也有涉及。与未发生ADR患者相比，发生ADR患者的输液量大、肠胃炎为主，二元Logistic回归分析显示输液时空腹、反复穿刺、既往有过敏史、输液速度调节不当是发生ADR的独立危险因素。结论 左氧氟沙星注射液ADR发生风险较高，主要集中在输液首日和用药后60分钟内，主要表现为皮肤及附件和消化系统的不良反应。临床用药中应提高警惕，加强用药监测，确保患者用药安全。 |
| 英文摘要: |
| Objective To investigate the clinical characteristics and influencing factors of adverse drug reactions (ADRs) induced by levofloxacin injection, thereby promoting rational clinical use. Methods A dual-center prospective study was conducted. According to pre-established “Infusion Reaction Management Procedures” and “Adverse Drug Reaction Reporting Procedures,” patients who experienced ADRs were analyzed among 600 individuals subjected to intravenous infusion of levofloxacin injection in the emergency department and fever clinics of two tertiary hospitals in Shanghai from February to September 2025. Results All 600 patients received levofloxacin injection as monotherapy or in combination with vitamin C infusion. Under the conditions of this study, the incidence of adverse drug reactions (ADRs) was 14.83% (89 cases). Among these, 76.4% (68/89) of ADRs occurred on the first day of the initial medication infusion; In terms of the time distribution following individual administrations,89.89% (80/89) occurred within 60 minutes of administration, and 57.30% (51/89) occurred within 20 minutes. ADRs primarily involved the skin and its appendages (44.94%) and the digestive system (40.45%), with the nervous and cardiovascular systems also being affected. Compared with patients who did not experience ADRs, those who developed ADRs had larger infusion volumes and a higher proportion of gastroenteritis diagnoses. Binary logistic regression analysis identified fasting state during infusion, repeated venipuncture, a history of allergies, and improper adjustment of infusion rate as independent risk factors for ADRs. Conclusion Levofloxacin injection is associated with a relatively high risk of ADRs, predominantly occurring on the first day of infusion and within the first 60 minutes of administration. The most common manifestations are adverse reactions involving the skin and its appendages, as well as the digestive system. Heightened vigilance and enhanced therapeutic drug monitoring are warranted during clinical use to ensure patient safety. |
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