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目的:分析中药注射剂不良反应(ADR)的发生特点、规律，为指导临床安全合理用药提供依据。方法:利用EXCEL数据透视表、自动Σ等功能，对2011年2月至2020年2月淮南市药品不良反应监测中心收集上报的2 575例中药注射剂ADR进行统计分析。结果:中药注射剂ADR高发年龄段为>40～80岁，占78.2%(2 014/2 575)；其余年龄段ADR报告数占21.8%(561/2 575)。ADR：严重的占2.0%(52/2 575)，一般的占98.0%(2 523/2 575)，新的占26.5%(683/2 575)。ADR涉及中药注射剂68个品种，ADR报告前10位的药品，不良反应报告占总数的53.5%(1 378/2 575)。其中，参麦注射液引起的ADR最多，占14.5%(372/2 575)。临床表现以皮肤及其附件损害居首位，占31.8%(995/3 127)，其次为全身性损害，占24.6%(769/3 127)。结论:中药注射剂ADR的发生可能与患者年龄、用药品种、不合理用药、中药成分复杂、含有杂质、相关物质、增溶性辅料以及药品说明书安全性信息不完善等因素有关。应加强中药注射剂ADR监测，特别是加强严重ADR预警，严格遵循合理用药原则，做到辨证施治，减少ADR发生，保障用药安全。“,”Objective:To analyze the occurrence characteristics, rules and causes of adverse drug reactions (ADR) of traditional Chinese medicine injections, and to provide a basis for guiding clinical safe and reasonable medication.Methods:From February 2011 to February 2020, the 2 575 cases of ADR of traditional Chinese medicine injections which were collected and reported by Adverse Drug Reaction Monitoring Center of Huainan were statistically analyzed by using the functions such as EXCEL pivot table and automatic Σ.Results:The high incidence of Chinese medicine injection ADR was >40-80 years old, accounting for 78.2% (2014/2 575). The remaining age group accounted for 21.8% (561/2 575). ADR types: 2.0% (52/2 575) of severe types, 98.0% (2523/2 575) of general types, and 26.5% (683/2 575) of new ones.ADR involved 68 varieties of traditional Chinese medicine injections, and the top 10 ADR reports accounted for 53.5% (1378/2 575). Among them, Shenmai injection caused the most ADR, accounting for 14.5% (372/2 575). The clinical manifestations of skin and its appendages ranked first, accounting for 31.8% (995/3 127), followed by systemic damage, accounting for 24.6% (769/3 127).Conclusion:The occurrence of ADR of traditional Chinese medicine injection may be related to factors such as the patients’ age, medication variety, unreasonable medication, complex Chinese medicine composition, impurities, related substances, solubilizing excipients, and incomplete safety information in the drug manual.ADR monitoring of traditional Chinese medicine injections should be strengthened, in particular, severe ADR monitoring and early warning should be strengthened, strictly follow the principle of reasonable medication, and implement treatment based on syndrome differentiation, reduce the occurrence of ADR, and ensure the safety of medication.