基于医院信息管理系统电子医疗数据，分析真实世界复方苦参注射液治疗适应症（恶性肿瘤）的临床应用特征，为复方苦参注射液的临床合理应用提供参考。提取全国范围22家大型三甲医院44 588例使用复方苦参注射液治疗适应症患者电子医疗数据，对一般信息、西医诊断、用药剂量、用药疗程、联合用药、出院转归等特征，进行基于频数与率的描述性分析。复方苦参注射液治疗适应症人群平均年龄57.30岁；男性多于女性；以肿瘤科、门诊入院为主，入院病情多为一般；西医诊断常见肺、肝、胃、结肠、乳腺等恶性肿瘤；单次用药剂量10～20 mL；疗程4～7 d最为多见；临床常联用药物包括抗肿瘤化疗药、免疫调节药、抗生素类药、糖皮质激素类药、5-羟色胺（5-HT）受体阻断药等。复方苦参注射液在不同系统、不同病情恶性肿瘤的临床治疗中得到较为广泛的应用；其适应症人群特征明确，符合恶性肿瘤疾病一般规律；其真实世界用药剂量、疗程范围基本符合品种说明书相关界定，联合用药类型较为广泛。

To analyze the clinical application of Fufang Kushen Injection in treating indication (therioma) in the real world based on hospital information system (HIS) database, and provide references for clinical application of Fufang Kushen Injection. A total of 44 588 patients with therioma were extracted from the electronic medical data using Fufang Kushen Injection from 22 large-scale 3A hospitals based on HIS. We have made a descriptive analysis based on frequency and rate of general information, western medicine diagnosis, dosage, course of treatment, combination medication, and discharge outcomes. The average age of patients treated with Fufang Kushen Injection for therioma was 57.30 years old; The male patients were more than females; Oncology and outpatient admissions were the main criteria, and most of the admissions were general; The frequency distribution of western medicine diagnosis with Fufang Kushen Injection were lung, liver, stomach, colon, breast, and other malignant tumors; The maximum dosage was 10-20 mL; The common course of treatment was 4-7 d; The combination of clinical common drugs include antineoplastic chemotherapeutic agents, immunomodulatory drugs, antibiotics, glucocorticoid drugs, 5-HT receptor blockers, etc. Fufang Kushen Injection has been widely used in the clinical treatment of therioma with different systems and different conditions. The characteristics of the indication population are clear, and it conforms to the general rule of therioma; The clinical dosage and course of treatment basically meet the requirements of the variety specification, and the type of combination drugs is more extensive.

国家“重大新药创制”科技重大专项（2015ZX09501004-001-002，2015ZX09501004-001-009）；北京市中医药科技发展专项（JJ2014-53）；中国中医科学院自主选题项目（PY1303）