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目的:系统评价《国家基本药物目录》(2004年版)中的中药注射剂致不良反应/事件(ADR/ADE)类型构成情况,为其合理使用与安全警戒以及风险管理工作提供参考。方法:采用系统性评价及回顾性分析等方法来描述性分析中药注射剂致ADR/ADE类型,并应用帕累托图进行分析。结果与结论:中药注射剂各类ADR/ADE中,皮肤及其附件损害、全身性损害、胃肠系统损害例数分别为2160、1035、446例,构成比分别为46.11%、22.10%、9.52%,累计构成比为77.73%,落在46%～80%区间,为主要类型。临床应重视中药注射剂的ADR/ADE,尤其是上述几类主要的ADR/ADE,促进中药注射剂合理使用。
OBJECTIVE: To systematically evaluate the ADR / ADE type composition in the “National Essential Drugs List” (2004 edition), and provide reference for its rational use and safety alert and risk management. Methods: A systematic analysis and retrospective analysis were used to descriptively analyze the types of ADR / ADE induced by traditional Chinese medicine injections. Pareto charts were used for analysis. RESULTS AND CONCLUSION: In the ADR / ADE of Chinese medicine injection, the number of skin and its accessory damage, systemic injury and gastrointestinal system damage were 2160, 1035 and 446, respectively, with the proportions of 46.11%, 22.10% and 9.52% , The cumulative composition ratio of 77.73%, fell 46% to 80% range, as the main type. Clinical should pay attention to the Chinese medicine injection of ADR / ADE, especially the above several types of major ADR / ADE, promote the rational use of traditional Chinese medicine injection.