【摘要】 目的探讨维生素K₁注射液所致不良反应的规律特点,挖掘和评价维生素K₁注射液安全警戒信号,分析临床实际使用情况,为临床合理安全应用提供参考。方法回顾性调取新疆维吾尔自治区药品不良反应监测中心2007-2017年使用维生素K₁注射液致不良反应的报告,分析维生素K₁注射液临床应用情况,评估出现不良反应的风险因素以及说明书安全性信息所涉及的严重ADR。结果新疆地区维生素K₁注射液使用警戒信号包括给药剂量、给药途径、临床适应证用药和患者自身因素等。结论基于对真实世界ADR信号研究有助于开展药物的安全性评价,临床医务人员应严格把握维生素K₁注射液的适应证及用法用量,特别是连续使用时应加强监测。更多还原

【Abstract】 Objective To determine the characteristics of adverse reactions（ADR） caused by vitamin K₁ injection, to explore and evaluate the safety warning signal of vitamin K₁ injection, and to provide reference for clinical rational application. Methods We retrospectively retrieved reports of ADR, caused by vitamin K₁ injection in Xinjiang Uygur Autonomous Region Adverse Drug Reaction Monitoring Center from 2007 to 2017. Assessed the risk factors for ADRs and severe ADRs corresponding the safety information in the instructions. Results The warning signs of vitamin K₁ injection included the dose, route of administration, clinical indications, and patients factors. Conclusion Real world study of ADR signals helps improve drug safety evaluation. Clinical medical staff should strictly follow the instructions of vitamin K₁ injection before and during drug treatment, especially for continuous use, and the monitor of ADRs should be strengthened.更多还原