156例维生素K_1注射液致严重不良反应分析

Analysis of 156 Cases of Serious Drug Adverse Reaction Induced by Vitamin-K_1 Injection

目的:为临床合理使用维生素K1注射液提供参考。方法:收集山东省药品不良反应监测中心数据库中2008-2010年间维生素K1注射液致严重不良反应的数据,并进行统计、分析;采用Instat软件,用χ2检验或确切概率法检验严重不良反应的影响因素。结果:共筛出严重不良反应156例,以呼吸系统损害、全身性损害为主,主要表现为呼吸困难、过敏样反应、紫绀、胸闷、过敏性休克、心悸、潮红等;维生素K1超适应证使用(P<0.0001)、维生素K1静脉给药(P=0.0024)和混合配伍用药(P=0.0001)可能增加严重不良反应发生的危险。结论:应重视和加强维生素K1注射液的合理使用,以减少其不良反应发生。

OBJECTIVE：To provide reference for clinical rational use of Vitamin-K1 injection. METHODS： Serious drug adverse reactions induced by Vitamin-K1 injection were statistical analyzed from 2008 to 2010 in Shandong Center for ADR Monitoring. Chi-square test or Fisher＇s exact test tests detected the influencing factors of serious adverse drug reactions using Instat software. RESULTS： There were 156 serious adverse drug reactions, they were systemic damage and respiratory damage. The main manifestations were dyspnea suffocating, allergic-like reaction, cyanosis, chest tightness, anaphylactic shock, palpitations, flushing, etc. Ultra-label use of Vitamin-K1 （P0.000 1）, intravenous administration of Vitamin-K1（P=0.002 4） and mixed compatibility medication（P=0.000 1） may increase the risk of serious adverse drug reactions. CONCLUSION： Rational use of Vitamin-K1 injection should be strengthened so as to decrease the occurrence of serious adverse drug reactions.