李澄 谢雁鸣 张寅 陈岑 庄严

摘要：目的 解析真实世界中使用复方苦参注射液治疗卵巢恶性肿瘤患者的人群特征、诊断特征、用药特征，为复方苦参注射液临床合理用药提供参考。方法 基于全国范围内39家大型三甲中医医院及综合性医院信息系统电子医疗数据构建的大型集成数据仓库，提取2003年8月-2014年12月使用复方苦参注射液治疗卵巢恶性肿瘤的电子医疗数据。采用SAS9.3统计软件，对人口学信息、诊断信息、医嘱用药信息等进行分析。结果 共纳入22家医院数据，涉及1510例患者，平均年龄（54.93±12.75）岁。入院科室以妇产科和肿瘤科为最多，入院方式以门诊入院最为常见。单次用药剂量为（14.53±4.24）mL，疗程为（6.62±5.49）d。联用西药主要为抗肿瘤化疗药、免疫调节药、保肝药、H1受体拮抗药、电解质平衡调节药。联用中药主要为清热解毒剂、回阳救逆剂、益气扶正剂、理气剂、止血剂。基于出院转归判定的治疗总有效率为47.85%。结论 复方苦参注射液治疗卵巢恶性肿瘤的人群特征明确，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，临床联合用药类型广泛。

关键词：复方苦参注射液；卵巢恶性肿瘤；真实世界；医院信息系统；电子医疗数据

DOI：10.3969/j.issn.1005-5304.2018.01.019

中图分类号：R2-05；R273.731 文献标识码：A 文章编号：1005-5304（2018）01-0089-05

Application of Real World Fufang Kushen Injection in Treatment of Ovarian

Malignant Tumor Based on Electronic Medical Data of Hospital Information System

LI Cheng1，2， XIE Yan-ming1， ZHANG Yin1， CHEN Cen3， ZHUANG Yan4

1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700； 2. Shandong University of Traditional Chinese Medicine， Jinan 250014， China； 3. School of Statistics， Renmin University of China， Beijing 100872， China； 4. Navy General Hospital of PLA， Beijing 100048， China

Abstract： Objective To analyze the population characteristics， diagnostic characteristics and drug characteristics of patients with ovarian malignant tumor in the real world； To provide references for the clinical rational use of Fufang Kushen Injection. Methods Based on the electronic medical data warehouse of hospital information system of 39 hospitals from nationwide， the use of Fufang Kushen Injection in the treatment and diagnosis of electronic health data in patients with ovarian malignant tumor from August 2003 to December 2014 were extracted. Analysis of frequency and rate were based on the description of the demographic information， diagnosis information， records information such as the characteristics of prescription drugs. Result Data of 22 hospitals， including 1510 cases of patients with ovarian malignant tumor. The average age of patients was （54.93±12.75） years old， and obstetrics and gynecology department and oncology department had the most hospitalized patients， and outpatient admission is the most common hospitalized way. The single dose was （14.53±4.24）mL， and the course of treatment was （6.62±5.49）d.

基金項目：国家科技重大专项-重大新药创制（2015ZX09501004-001-002、2015ZX09501004-001-009）；北京市中医药科技发展资金项目（JJ2014-53）；中国中医科学院自主选题项目（Z0472、PY1303）

通讯作者：张寅，E-mail：coolzhangyin@sina.com

In the treatment of ovarian malignant tumors， combined western medicines were mainly anti-tumor chemotherapy drugs， immunomodulators， hepatoprotective agents， H1 receptor antagonists and electrolyte balance regulator， while combined TCM were clearing heat and antidote medicine， tonifying yang qi medicine， tonifying qi medicine， regulating qi medicine， and hemostatic medicine. The total effective rate was 47.85%. Conclusion Population characteristics of Fufang Kushen Injection in the treatment of ovarian malignant tumors are clear； and the real world clinical dosage， course of treatment with instructions related to define the scope of the basic varieties. Clinical combination has a wide range of drugs.

Keywords： Fufang Kushen Injection； ovarian malignant tumor； realworld； hospital information system； electric medical records

复方苦参注射液（岩舒）于1995年上市，其以苦参为君药，清热、解毒、燥湿，白土苓为臣……