中国药物警戒 ›› 2022, Vol. 19 ›› Issue (11): 1206-1212.
DOI: 10.19803/j.1672-8629.20220045

• 基础与临床研究 • 上一篇    下一篇

真实世界榄香烯乳状注射液治疗恶性肿瘤联合用药规律

魏瑞丽, 赵晓晓, 席俊羽, 谢雁鸣*   

  1. 中国中医科学院中医临床基础医学研究所,北京 100700
  • 收稿日期:2022-02-21 发布日期:2022-11-17
  • 通讯作者: *谢雁鸣,女,研究员•博导,主任医师,中医药真实世界研究与循证研究。E-mail:ktzu2018@163.com
  • 作者简介:魏瑞丽,女,在读博士,中药上市后安全性及有效性评价。
  • 基金资助:
    中国中医科学院科技创新工程重大攻关项目(CI2021A00702); 国家重点研发计划(2018YFC1707400)

Regularity of combined medication of elemene emulsion injection in the treatment of malignant tumors in the real world

WEI Ruili, ZHAO Xiaoxiao, XI Junyu, XIE Yanming*   

  1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2022-02-21 Published:2022-11-17

摘要: 目的 基于数据挖掘技术探讨真实世界榄香烯乳状注射液治疗恶性肿瘤的联合用药规律。方法 从2003年1月1日至2019年7月31日医院信息系统(HIS)纳入3 671例至少使用过1次榄香烯乳状注射液的恶性肿瘤患者,使用R软件完成统计分析。描述恶性肿瘤人群的临床特征,采用Apriori算法对恶性肿瘤患者联合用药方案进行关联分析,采用Louvain聚类方法挖掘1 233例优效人群核心治疗方案的复杂网络。结果 榄香烯乳状注射液治疗恶性肿瘤,其中男性(2 244例,61.13%)高于女性(1 281例,34.90%)(性别记录缺失146例);46~65岁年龄段患者最多(1 705例,46.45%);疾病诊断为肺恶性肿瘤最多(4 145例次,15.95%),常合并有高血压、糖尿病等;联合使用西药的频率显著高于中成药,用药例次排前3位的西药是维生素类、地塞米松、注射用胰岛素类,用药例次排前3位的中成药是复方苦参注射液、康艾注射液、参芪扶正注射液;关联规则分析结果为榄香烯乳状注射液联合利多卡因、肝素类的用药方案支持度最高(46.46%),联合中成药的支持度普遍低于联合西药的支持度。优效人群复杂网络分析结果榄香烯乳状注射液联合肝素的权重(2 419)最高,核心用药方案为榄香烯乳状注射液联合肝素、利多卡因和地塞米松,此外常合并心血管系统、呼吸系统和消化系统治疗药物。结论 榄香烯乳状注射液联合手术、放化疗治疗多种恶性肿瘤,联合药物特征提示要重视患者基础疾病,尤其是心血管疾病、血糖的管理;对于肿瘤常见并发症(如恶心、呕吐、静脉血栓、便秘等)可在西医对症治疗的基础上,辨证选用各类中成药,改善患者生存质量。

关键词: 榄香烯乳状注射液, 恶性肿瘤, 真实世界, 联合用药, 关联规则, 聚类分析

Abstract: Objective To explore the combined drug use law of Elemene emulsion injection in the treatment of malignant tumors in the real world based on data mining technology. Methods 3 671 malignant tumor patients who had used elemene injection at least once were included in hospital information system (HIS) from January 1, 2003 to July 31, 2019. The statistical analysis was completed by R software. This paper describes the clinical characteristics of malignant tumor population, uses Apriori algorithm to analyze the association of combined drug regimens for malignant tumor patients, and uses Louvain clustering method to mine the complex network of core treatment regimens of 1 233 excellent effect people. Results There were 146 cases of missing sex records in patients with malignant tumors treated with elemene emulsion injection. Male (2 244 cases, 61.13%) was higher than female (1 281 cases, 34.90%). The patients aged 46~65 years were the most (1 705 cases, 46.45%). The most common diseases are lung cancer(4 145 cases, 15.95%), with hypertension and diabetes. The frequency of combined use of Western medicines was significantly higher than that of Chinese patent medicines. The top three Western medicines were vitamins, dexamethasone and insulin for injection, and the top three Chinese patent medicines were compound Sophora flavescens injection, Kang’ ai injection and Shenqi Fuzheng injection. Compound Matrine injection is the most used Chinese patent medicine. Association rule analysis showed that elemene emulsion injection combined with lidocaine and heparin had the highest support (46.46%), and the support of combined Chinese patent medicine is generally lower than that of combined Western medicine. The results of complex network analysis of dominant population showed that elemene emulsion injection combined with heparin had the highest weight. The core anti-tumor drug regimen was elemene injection combined with heparin, lidocaine and dexamethasone. In addition, it was often combined with therapeutic drugs for cardiovascular system, respiratory system and digestive system. Conclusion Elemene injection combined with surgery, radiotherapy and chemotherapy in the treatment of a variety of malignant tumors. The combined drug characteristics suggest that we should pay attention to the management of patients’ basic diseases, especially cardiovascular disease and blood glucose. For the common complications of tumor (such as nausea, vomiting, venous thrombosis, constipation, etc.), based on the symptomatic treatment of Western medicine, various Chinese patent medicines are selected according to syndrome differentiation to improve the quality of life of patients.

Key words: elemene emulsion injection, malignant tumor, the real world, combination medication, association rules, cluster analysis

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