基于医院信息系统电子医疗数据的复方苦参注射液治疗卵巢恶性肿瘤真实世界应用特征研究

摘要

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.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.%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.