复方苦参注射液治疗结肠恶性肿瘤真实世界临床应用特征研究

Research on Clinical Application of Fufang Kushen Injection in Treating Colonic Malignant Tumor in the Real World

目的:基于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结肠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。方法: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结肠恶性肿瘤的3 328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率的描述性分析。结果:使用复方苦参注射液治疗结肠恶性肿瘤的患者平均年龄61.85岁;男性多于女性;主要由消化内科、肿瘤科入院;单次用药剂量以10-20 m L居多;疗程以4-7天为主;临床常见联用药物包括托烷司琼注射液、胸腺肽注射液、奥沙利铂注射液、氟尿嘧啶、亚叶酸钙注射液等;基于出院转归判定的总有效率39.78%。结论:复方苦参注射液治疗结肠恶性肿瘤的人群特征明确,符合结肠恶性肿瘤疾病的一般规律;其真实世界临床用药剂量、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。

This study was aimed to analyze the clinical application of Fufang Kushen （FFKS） injection in treating colonic malignant tumors in the real world based on the hospital information system （HIS） database, in order to provide references for clinical application of FFKS injection. The electronic medical records were extracted from 3328 patients with colonic malignant tumors using FFKS injection from 22 large-scale triple-A hospitals nationwide based on the data warehouse of HIS established by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences. The descriptive analysis of frequency and rate was made on general characteristics, diagnostic characteristics, dosage and characteristics of medication information, characteristics of drug combination, characteristics of discharge outcome and etc. The results showed that the average age of patients treated with FFKS injection for colonic malignant tumors was 61.85 years old, with more males than females. Patients were mainly hospitalized from the department of digestology and oncology. The single dose of medication was usually 10-20 ml. The main course of treatment was 4-7 days. Common clinical medications in combination included Tropisetron injection, thymus peptide injection, oxaliplatin injection, fluorouracil, leucovorin injection and etc. The total efficiency was 39.78% based on the discharge outcomes. It was concluded that the population characteristics of using FFKS injection to treat colonic malignant tumors were clear and in line with the general rule of colonic malignant tumors. The clinical dosage and scope of FFKS injection in the real world of colonic malignant tumors treatment basically meet the medication instruction. The clinical drug combination type is more extensive.