目的 研究艾迪注射液上市后用药安全性，为临床合理用药提供参考。方法 对武汉科技大学附属孝感医院2012年1月-2016年12月使用艾迪注射液的住院患者的基本信息、用药信息及出现药物不良反应（ADR）的患者临床特征、ADR发生时间、临床表现及转归进行详细纪录。结果 共纳入研究患者2 173例，发生ADR 41例，ADR发生率为1.89%。艾迪注射液的ADR发生率与患者性别、溶媒种类、单次给药剂量均无显著相关性。ADR发生率前3位的原患疾病分别为恶性淋巴瘤、血液病恶性肿瘤和鳞状上皮肿瘤，艾迪注射液与中药注射剂、抗菌药物及增强免疫药物联合用药发生不良反应较多，主要累及器官以皮肤及附件、中枢及神经系统和呼吸系统常见。多数ADR在首次用药60 min内出现，所有不良反应给以相应对症干预措施后明显好转，无加重或死亡患者。结论 临床中应严格按照艾迪注射液说明书中推荐的用法用量使用，尽量避免与中药注射剂、抗菌药物和增强免疫药物联用。同时，建议厂家及时完善说明书。

Objective To evaluate the post-marketing safety of Aidi Injection, and in order to provide reference for clinical rational use of drugs. Methods The basic information and medication of inpatients, clinical features of patients with adverse drug reactions (ADR), occurrence time of ADR, clinical manifestation, and outcome were recorded. Results Total of 2 173 patients were included, and 41 cases of patients had ADR. The rate of ADR was 1.89%. There was no significant correlation between ADR rate of Aidi Injection and patient's gender, solvent type, and administration dosage. Patients with malignant lymphoma, hematopathy malignant tumor, and squamous epithelial tumor had the first three ADR cases. Aidi Injection combined with other traditional Chinese medicine injection, antibacterial drugs and immune enhancing drugs were prone to ADR. ADR induced by Aidi Injection mainly were skin and accessories system, central nervous system, and respiratory system. Most ADR were occurred within 60 min after the first administration. All ADR were significantly improved after symptomatic intervention, no aggravation or death. Conclusion Aidi Injection should be used in accordance with drug instructions, and as far as possible not in combined with other traditional Chinese medicine injection, antibiotics drugs and immune enhancing drugs. Meanwhile suggest manufacturers promptly improve the drug instruction.