刘亚欣 谢雁鸣+张寅 陈岑 庄严

[摘要]運用医院信息管理系统电子医疗数据，解析真实世界复方苦参注射液治疗食管恶性肿瘤临床应用特征，为复方苦参注射液的临床合理应用提供参考借鉴。基于中国中医科学院中医临床基础医学研究所建立的，医院信息系统电子医疗数据大型集成数据仓库，对来自全国范围22家大型三甲医院使用复方苦参注射液治疗食管恶性肿瘤的2 550例患者电子医疗数据进行提取，对一般特征、诊断特征、品种用药剂量与疗程特征信息、品种联合用药特征、出院转归特征等进行基于频数与百分比的描述性分析。结果显示使用复方苦参注射液治疗食管恶性肿瘤的患者平均年龄623岁；男性多于女性；主要由心血管科、肿瘤科、消化内科入院；基于出院转归判定的总有效率4715%；单次用药剂量以10～20 mL居多；疗程以4～7 d为主；常见联用药物包括地塞米松、复方氨基酸注射液、托烷司琼注射液、胸腺肽注射液、甲氧氯普胺片等。复方苦参注射液治疗食管恶性肿瘤的人群特征明确，符合食管恶性肿瘤疾病的一般规律；其真实世界治疗食管恶性肿瘤临床用药剂量、疗程范围基本符合品种说明书相关界定；临床联合用药类型较为广泛。

[关键词]复方苦参注射液； 食管恶性肿瘤； 真实世界； 医院信息系统； 电子医疗数据

Clinical application features of Fufang Kushen injection in treating malignant

esophageal tumor： real world study based on hospital information system

LIU Yaxin1，2， XIE Yanming1， ZHANG Yin1*， CHEN Cen3， ZHUANG Yan4

（1Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China；

2Wangjing Hospital of China Academy of Chinese Medical Sciences， Beijing 100102， China；

3School of Statistics， Renmin University of China， Beijing 100872， China；

4The PLA Navy General Hospital， Beijing 100048， China）

[Abstract]To analyze the clinical application features of Fufang Kushen injection in treating malignant esophageal tumors in the real world by using hospital information system database， and provide reference for clinical application of Fufang Kushen injection The electronic medical data from 2 550 patients with malignant esophageal tumors using Fufang Kushen injection from 22 largescale hospitals nationwide were extracted based on the hospital information system （HIS） established by Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences Then the descriptive analysis based on frequency and rate was conducted for general characteristics， diagnostic characteristics， characteristics of dosage and medication information， characteristics of drug combination， and discharge outcome characteristics The results showed that the average age of patients treated with Fufang Kushen injection for malignant esophageal tumors was 623 years old； more males than females； admitted to hospital mainly in department of cardiology， oncology and digestology first The total efficiency was 4715% based on the discharge outcome characteristics； the most common dosage was 1020 mL for single use； the course of treatment was mainly 47 d； and the common drugs in drug combinations included dexamethasone， tropisetron injection， thymosin injection， compound amino acid injection， pantoprazole sodium injection， fluorouracil， et al The characteristics of the crowd using Fufang Kushen injection to treat the malignant esophageal tumors were clear and in line with the general rule of malignant esophageal tumors； its clinical dosage and scope of treatment for malignant esophageal tumors in the real world were basically consistent with the specification； and the types of clinical drug use combinations were more extensive