復方苦參注射液治療食管惡性腫瘤臨床應用特征：一項基于醫院信息系統電子醫療數據的真實世界研究

劉亞欣 謝雁鳴+張寅 陳岑 莊嚴

[摘要]運用醫院信息管理系統電子醫療數據，解析真實世界復方苦參注射液治療食管惡性腫瘤臨床應用特征，為復方苦參注射液的臨床合理應用提供參考借鑒。基于中國中醫科學院中醫臨床基礎醫學研究所建立的，醫院信息系統電子醫療數據大型集成數據倉庫，對來自全國范圍22家大型三甲醫院使用復方苦參注射液治療食管惡性腫瘤的2 550例患者電子醫療數據進行提取，對一般特征、診斷特征、品種用藥劑量與療程特征信息、品種聯合用藥特征、出院轉歸特征等進行基于頻數與百分比的描述性分析。結果顯示使用復方苦參注射液治療食管惡性腫瘤的患者平均年齡623歲；男性多于女性；主要由心血管科、腫瘤科、消化內科入院；基于出院轉歸判定的總有效率4715%；單次用藥劑量以10～20 mL居多；療程以4～7 d為主；常見聯用藥物包括地塞米松、復方氨基酸注射液、托烷司瓊注射液、胸腺肽注射液、甲氧氯普胺片等。復方苦參注射液治療食管惡性腫瘤的人群特征明確，符合食管惡性腫瘤疾病的一般規律；其真實世界治療食管惡性腫瘤臨床用藥劑量、療程范圍基本符合品種說明書相關界定；臨床聯合用藥類型較為廣泛。

[關鍵詞]復方苦參注射液； 食管惡性腫瘤； 真實世界； 醫院信息系統； 電子醫療數據

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