孙凯 谢雁鸣 张寅 陈岑 庄严

摘要：目的  分析真實世界复方苦参注射液干预恶性肿瘤腹腔积液的临床应用特征，为临床合理应用复方苦参注射液提供参考。方法  基于医院信息系统大型集成数据仓库，提取全国范围三级甲等中医或中西医结合医院收治的采用复方苦参注射液干预的恶性肿瘤腹腔积液患者电子医疗数据。对纳入数据一般特征、诊断特征、品种用药剂量与疗程特征、品种联合用药特征等进行描述性分析。结果  纳入数据涉及22家医院、1147例患者，以男性为主，平均年龄61.45岁，一般以门诊收入肿瘤科、消化内科进行住院治疗。药物单次及日用量一般为10～19 mL，平均用药疗程为13.94 d。常见联用西药类型为利尿药、抗生素类药、抗肿瘤化疗药、营养支持药、免疫调节药等。结论  复方苦参注射液干预的恶性肿瘤腹腔积液患者特征符合该病患病人群固有特点，品种用药剂量、疗程基本符合说明书规定，联合用药特征符合恶性肿瘤腹腔积液的常规治疗方案特点。

关键词：复方苦参注射液;恶性肿瘤;腹腔积液;真实世界;医院信息系统

DOI：10.3969/j.issn.1005-5304.2018.10.021

中图分类号：R273;R259.72    文献标识码：A    文章编号：1005-5304（2018）10-0096-05

Study on Characteristics of Clinical Application of Compound Kushen Injection in Treatment of Malignant Tumor Peritoneal Effusion in Real World

SUN Kai^1，2， 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， China; 2. Wangjing Hospital of China Academy of Chinese Medical Sciences， Beijing 100102， China; 3. School of Statistics Renmin University of China， Beijing 100872， China; 4. The PLA Navy General Hospital， Beijing 100048， China

    Abstract： Objective To analyze the characteristics of clinical application of compound Kushen Injection in the treatment of malignant tumor peritoneal effusion in the real world; To provide references for the rational application of compound Kushen Injection in clinic. Methods Based on the hospital information system electronic medical data integration database， electronic medical data from patients with malignant tumorperitoneal effusions treated with compound Kushen Injection in national third-grade TCM or integrated traditional Chinese and Western medicine hospitals were extracted. General characteristics， diagnostic characteristics， characteristics of variety dosage and treatment course， and characteristics of variety combination were included for descriptive analysis. Results The data included 22 hospitals and 1147 patients， mainly male， with an average age of 61.45 years. They were generally treated with outpatient oncology and gastroenterology. The single and daily dosage of medicine was generally 10 to 19 mL， and the average medication duration was 13.94 d. Common combinations of Western medicine included diuretics， antibiotics， anti-tumor chemotherapy medicine， nutritional supplements， immunomodulators and so on. Conclusion The characteristics of patients with malignant tumor peritoneal effusion treated with compound Kushen Injection are inline with the inherent characteristics of the patient population. The dosage and course of treatment of the variety basically conform to the specifications of the manual， and the characteristics of combination medication are consistent with the characteristics of conventional treatment plan for malignant tumor peritoneal effusion.

Keywords：compoundKushen Injection; malignant tumor; peritoneal effusion; real world; hospital information system

腹腔积液是多种原因所引起的腹膜腔内游离液体过量聚积，其发病机制复杂，临床根据病因及相关鉴别手段可将其分为良性积液和恶性积液^[1-2]。恶性肿瘤腹腔积液常见于晚期恶性肿瘤患者，是其严重并发症之一。临床可见患者呈现腹压增高、腹痛胀满不适、恶心呕吐甚至呼吸困难等症状，严重影响患者的生存和生活质量^[3-4]。……