目的：基于医院信息系统电子医疗数据，解析复方苦参注射液治疗淋巴恶性肿瘤真实世界临床用药人群特征，为其合理应用提供参考。方法：提取3 674例使用复方苦参注射液治疗淋巴恶性肿瘤患者电子医疗数据，对其一般信息、诊断信息、用药信息进行基于频数与率的描述性分析。结果：患者平均年龄54.95岁；男性多于女性；主要来源科室为肿瘤科、血液科；基于出院转归判定的住院患者临床治疗总有效率66.15%；单次用药剂量以10-20 mL居多；疗程以4-14天为主；联用西药常见品种包括地塞米松、托烷司琼注射液、甲氧氯普胺片、胸腺肽注射液、环磷酰胺注射液等；联用西药常见药理作用包括抗肿瘤化疗药、免疫调节药、糖皮质激素药、抗生素类药等。结论：复方苦参注射液治疗淋巴恶性肿瘤真实世界临床用药剂量、疗程基本符合说明书界定，用药人群特征符合品种定位及淋巴恶性肿瘤疾病规律；基于出院转归判定的住院患者临床疗效较为确切；联合用药类型广泛。

This study was aimed to analyze the clinical characteristics of Compound Kushen Injection in the treatment ofpatients with malignant lymphoma in the real world based on the electronic medical record, and to provide a reference forits rational application. The electronic medical data of 3 674 patients with malignant lymphoma using Compound KushenInjection was extracted. General information, diagnostic information, and medication information were analyzed on thebasis of frequency and rate of descriptive analysis. The results showed that the average age of patients was 54.95 yearsold, with more males than females. Patients were mainly from the department of oncology and hematology. Based onhospital outcomes in hospitalized patients, the clinical total effective rate was 66.15%. The single medication dosage wasmostly 10-20 ml. The course of treatment was mainly 4-14 days. The common western medications in combinationincluded dexamethasone, tropisetron injection, metoclopramide tablet, thymopolypeptides injection, cyclophosphamideinjection, and etc. Common pharmacological effects of combined western medicine included anti-tumor chemotherapydrugs, immunomodulatory drugs, glucocorticoid drugs, antibiotic drugs and so on. It was concluded that the clinicaldosage, scope of malignant lymphoma treatment using Compound Kushen Injection in the real world were consistent withthe specification. And characteristics of the crowd using Compound Kushen injection is clear and in line with the generalrule of malignant lymphoma and clinical positioning of varieties. Based on the hospital outcomes, the clinical efficacy isdetermined to have precise effect on hospitalized patients. The drug combination type is extensive.

国家“重大新药创制”科技重大专项（2015ZX09501004-001-002）：中药安全风险早期发现与控制关键技术研究，负责人：谢雁鸣；国家“重大新 药创制”科技重大专项（2015ZX09501004-001-009）：中药安全风险早期发现与控制关键技术研究，负责人：谢雁鸣；北京市中医药科技发展专 项（JJ2014-53）：中西药联合应用评价及机制的方法研究，负责人：王连心；中国中医科学院自主选题项目（Z0472）：10万例以上恶性肿瘤真实 世界中西医结合临床用药方案挖掘与评价，负责人：张寅；中国中医科学院自主选题项目（PY1303）：中药上市后临床再评价关键技术创新团 队，负责人：谢雁鸣；国家自然科学基金面上项目（81473514）：中药注射剂不良反应随机森林信号模型建立及免疫毒理学评价方法研究，负责 人：荆志伟