目的 对注射用益气复脉（冻干）应用情况及不良反应进行分析，为临床应用提供参考。方法 采用医院集中监测的方法，对2017年11月—2018年10月期间郑州市中医院应用注射用益气复脉（冻干）的住院患者病历，进行统计分析。结果 共收集到998份使用注射用益气复脉（冻干）的病历，其中50.69%为70岁以上老年患者；适应证、用法用量和疗程均比较规范，基本符合药品说明书规定；不良反应发生率为0.2%，比较轻微，且多为一过性，不需特别处理，对原疾病无明显影响。结论 注射用益气复脉（冻干）不良反应低，安全性较好，但临床使用应注意使用疗程和滴注浓度，特别是有过敏史的患者，更应谨慎使用。医院集中监测能够全面、准确的收集到药品的不良反应情况，但需要开展多中心、大规模的医院集中监测，以便对中药注射剂不良反应发生情况和影响因素进行更深入研究。

Objective To analyze the application and adverse reactions of Yiqi Fumai Lyophilized Injection, and provide reference for clinical application. Methods A centralized hospital monitoring method was used to analyze the inpatients' medical records of Yiqi Fumai Lyophilized Injection in Zhengzhou Municipal Hospital of TCM from November 2017 to October 2018. Results A total of 998 medical records of Yiqi Fumai Lyophilized Injection were collected, of which 50.69% were elderly patients over 70 years old. The indications, usage, dosage and course of treatment were relatively standardized, which basically met the requirements of the drug instructions. The adverse reaction rate was 0.2%, which is relatively mild. And most of the cases are transient, needing no special treatment and causing no significant impact on the original disease. Conclusion Yiqi Fumai Lyophilized Injection has low probability of adverse reactions and good safety. However, clinical use should pay attention to the course of treatment and instillation concentration, especially in patients with a history of allergies. The centralized hospital monitoring can comprehensively and accurately collect the adverse reactions of drugs. However, it is necessary to carry out multi-center, large-scale centralized monitoring of hospitals in order to conduct deeper research on the occurrence and influencing factors of adverse reactions of traditional Chinese medicine injections.