目的 研究艾迪注射液上市后用藥安全性，為臨床合理用藥提供參考。方法 對武漢科技大學(xué)附屬孝感醫(yī)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、用藥信息及出現(xiàn)藥物不良反應(yīng)（ADR）的患者臨床特征、ADR發(fā)生時間、臨床表現(xiàn)及轉(zhuǎn)歸進(jìn)行詳細(xì)紀(jì)錄。結(jié)果 共納入研究患者2 173例，發(fā)生ADR 41例，ADR發(fā)生率為1.89%。艾迪注射液的ADR發(fā)生率與患者性別、溶媒種類、單次給藥劑量均無顯著相關(guān)性。ADR發(fā)生率前3位的原患疾病分別為惡性淋巴瘤、血液病惡性腫瘤和鱗狀上皮腫瘤，艾迪注射液與中藥注射劑、抗菌藥物及增強(qiáng)免疫藥物聯(lián)合用藥發(fā)生不良反應(yīng)較多，主要累及器官以皮膚及附件、中樞及神經(jīng)系統(tǒng)和呼吸系統(tǒng)常見。多數(shù)ADR在首次用藥60 min內(nèi)出現(xiàn)，所有不良反應(yīng)給以相應(yīng)對癥干預(yù)措施后明顯好轉(zhuǎn)，無加重或死亡患者。結(jié)論 臨床中應(yīng)嚴(yán)格按照艾迪注射液說明書中推薦的用法用量使用，盡量避免與中藥注射劑、抗菌藥物和增強(qiáng)免疫藥物聯(lián)用。同時，建議廠家及時完善說明書。

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.