基于3297例复方苦参注射液治疗乳腺恶性肿瘤患者真实世界临床应用特征研究

Research on clinical application characteristics of compound Kushen Injection in treating breast malignancy: A real-world study based on 3 297 cases

目的:本研究旨在解析真实世界复方苦参注射液治疗乳腺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:基于医院信息系统(HIS)电子医疗数据(EMR)大型集成仓库,对22家大型三甲医院使用复方苦参注射液治疗乳腺恶性肿瘤的3 297例患者EMR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:患者年龄分段主要集中在45~65岁;入院病情以一般居多,主要由普通外科、肿瘤科和乳腺外科入院;单次用药剂量以10~20mL居多;疗程以3~14d为主;临床常见联用药物包括抗肿瘤化疗药、免疫调节药、糖皮质激素药、5-HT受体阻断药、促细胞分化药等。结论:复方苦参注射液治疗乳腺恶性肿瘤的人群特征明确,符合乳腺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。

Objective： To analyze the clinical application characteristics of compound Kushen Injection in treating breast malignancy in the real world, which provides reference for clinical reasonable application of compound Kushen Injection. Methods： To extract the electronic medical data of 3 297 patients with breast malignancy were treated by compound Kushen Injection from 22 large-scale hospitals based on hospital information system （HIS）： a large integrated warehouse of electronic medical records （EMR）. Then, made a descriptive analysis for the general characteristics, diagnostic characteristics, varietal dosage and characteristics of medication information, characteristics of drug combination and discharge outcome characteristics based on frequency and rate. Results： The age of patients that mainly to enter the department of general surgery, oncology and breast surgery was 45-65 years old. The maximum dosage was 10-20mL. The course of treatment was mainly 3-14 days; The clinical common drugs combination includes anti-tumor chemotherapeutics, immunomodulatory drugs, glucocorticoid, 5-HT receptor blockers, promoting cell differentiation, etc. Conclusion： The characteristics of the crowd with breast malignancy using compound Kushen Injection is clear and in line with the general rule of gastric malignant tumors. The clinical dosage and scope of treatment in the real world basically are in line with the related definition of variety specification and the clinical drugs combination type is more extensive.