基于医院信息系统数据对复方苦参注射液真实世界临床应用特征的研究

Research on Characteristics of Clinical Application of Fufang Kushen Injection(复方苦参注射液):A Real-World Study Based on Hospital Information System Database

目的分析复方苦参注射液真实世界临床应用特征。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集成数据仓库,提取2002年8月至2014年12月全国22家三级甲等医院49 597例使用复方苦参注射液患者的电子医疗数据,对患者入院信息、临床诊断及用药情况、联合用药、出院转归等信息进行描述性分析。结果复方苦参注射液真实世界用药患者年龄主要在46~65岁之间(50.84%),住院天数集中在15~28天(27.93%),使用科室前3位的分别为肿瘤科、消化内科、心血管科。广泛用于肺恶性肿瘤(24.29%)、肝恶性肿瘤(11.66%)、胃恶性肿瘤(9.23%)的临床治疗;单次用药剂量、每日用药剂量均以10~20 ml、20~30 ml为主,用药疗程以4~14天为主。常与地塞米松、托烷司琼注射液、胸腺肽注射液联合使用,合并用药个数以10种左右最为常见。共有1994例患者出院转归为死亡,死亡原因前3位的疾病为肺部感染、电解质代谢紊乱、肺恶性肿瘤。结论复方苦参注射液主要适应症为恶性肿瘤,真实世界用药人群以中老年患者居多,符合适应症人群疾病的一般规律;用药剂量、疗程基本符合说明书规定,临床联合用药广泛,疗效确切。

Objective To analyze the characteristics of clinical application of Fufang Kushen Injection (复方苦参注射液~） in the real world. Methods The electronic medical data from 49597 patients using Fufang Kushen Injec-tion from 22 large-scale hospitals nationwide based on the hospital information system （HIS） established by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences were extracted. A descriptive analysis was performed in admission information, clinical diagnosis and medication status, combination medication, discharge outcomes, etc. Results In the real world of the HIS database, the age of the patients was mainly 46 to 65 years old （50. 84%), with 15 to 28d （27.93%） hospitalization. The top 3 departments of medication were de-partment of oncology, gastroenterology and cardiovascular. It was widely applied in clinical treatment of lung malig-nancies （24. 29%), hepatic malignancy （11.66%）, gastric malignancy （9.23%） ; the single dose and daily dose were 10 to 20 ml and 20 to 30 ml, with medication course of 4 to 14d. It is often used in combination with dexametha-sone, tropisetron injection, and thymosin injection. The number of combined drugs was about 10 in the most com-mon. A total of 1994 patients were discharged to death. The top three causes of death were pulmonary infections, electrolyte metabolism disorders, and lung malignancies. Conclusion The main indication of Fufang Kushen Injec-tion is malignant tumors. The majority of patients in the real world are middle-aged and old patients, which conforms to the general rule of diseases of indications (malignant tumors） ; the dose and course of treatment basically meet the specifications of package insert, and the clinical combination is widely used with exact curative effect.