中国药物警戒 ›› 2022, Vol. 19 ›› Issue (9): 929-934.
DOI: 10.19803/j.1672-8629.2022.09.01

• 基于真实世界的中成药用药规律挖掘专栏 • 上一篇    下一篇

榄香烯乳注射液治疗肝癌患者的真实世界联合用药分析

苏鑫鑫, 赵晓晓, 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:2021-11-24 出版日期:2022-09-15 发布日期:2022-09-16
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中药上市后评价。E-mail: ktzu2018@163.com
  • 作者简介:苏鑫鑫,女,在读本科,中成药上市后评价。
  • 基金资助:
    国家重点研发计划(2018YFC1707400); 中国中医科学院科技创新工程项目(CI2021A00702); 国家自然科学基金资助项目(81973982); 中央级公益性科研院所基本科研业务费专项资金资助(Z0737)

Real-world analysis of combined administration of elemene emulsion injection in patients with liver cancer

SU Xinxin, ZHAO Xiaoxiao, XIE Yanming*   

  1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Sciences, Beijing 100700, China
  • Received:2021-11-24 Online:2022-09-15 Published:2022-09-16

摘要: 目的 分析真实世界中榄香烯乳注射液肝癌患者联合用药特征。方法 基于2003年1月1日至2019年7月31日医院信息系统(hospital information system, HIS)数据库中全国21家医院,对使用榄香烯乳注射液中441例肝癌患者进行描述分析,通过采用Apriori算法建立模型和clementine12.0进行关联分析,分析肝癌患者人群特征和榄香烯乳注射液联合用药特征。结果 肝癌患者人群特征结果为肝癌患者的西医诊断为肝恶性肿瘤760例次(合并患者各次诊断结果),占比最多(22.66%),无中医诊断病例;入院科室中肿瘤诊疗中心102例,占比最多(23.13%);使用榄香烯乳注射液的肝癌患者男性多于女性;平均年龄为58.39岁,46~65岁患者数206例,占比最多(46.71%);患者住院时间中位数为24 d,28 d患者数占比最多(40.36%);104例出现病危,病危持续时间在≤1 d者100例(22.68%),269例出现病重,病重持续时间中位数为11 d;给药途径为静脉滴注占比最多;单次用药剂量≤200 mg患者数390例,占比最多(99.49%)。榄香烯乳注射液联合用药特征为其合并用药品种主要有维生素类、地塞米松、谷胱甘肽、康艾注射液、氨基酸类等;合并用药类别主要为血液代用品和灌注液、抗肿瘤药、免疫促进药、抗菌药、矿物质补充剂。同时通过复杂网络分析结果验证,榄香烯乳注射液联合用药结果与用药特征分析结果一致性较好。榄香烯乳注射液联合用药规律主要为辅助抗肿瘤和平衡体内基本需求的作用。结论 通过对使用榄香烯乳注射液的肝癌患者进行用药特征及复杂网络分析,均得出其一般与维生素类、地塞米松、谷胱甘肽、康艾注射液、氨基酸类等联合使用,根据联合用药的特征得出相关联合用药规律,可为药物的临床使用和深入分析提供指导。

关键词: 榄香烯乳注射液, 肝癌, 真实世界, 医院信息系统, 联合用药, 特征分析

Abstract: Objective To analyze the way in which elemene emulsion injection is used in combination with other drugs among liver cancer patients in the real world. Methods Based on the hospital information system (HIS) database of 21 hospitals in China, 441 patients with liver cancer who used elemene emulsion injection were described and analyzed. By using the Apriori algorithm to establish a model and clementine12.0 to carry out association analysis, the characteristics of liver cancer populations and combined use with elemene emulsion injection were analyzed. Results 760 cases of malignant tumors of the liver were diagnosed based on Western medicine, accounting for 22.66% of the total. No cases were diagnosed via TCM. 102 patients (23.13%) were diagnosed at the Tumor Diagnosis and Treatment Center. More female patients with liver cancer were treated with elemene emulsion injection than female ones. There were 206 patients (46.71%) aged 46 to 65, with an average of 58.39 years. The median length of hospital stay was 24 days and the percentage of patients who had been hospitalized for 28 days was the highest (40.36%). 104 patients were critically ill, 100 of whom (22.68% of the total) were critically ill for one day or longer. 269 patients were seriously ill for a median 11 days. The administration route was mostly intravenous drip. The number of patients whose single dose was 200 mg or above was 390 (99.49%). Drugs that were often used in combination with elemene emulsion injection were vitamin, dexamethasone, glutathione, Kangai injection and amino acid as well as blood substitutes and infusions, antitumor drugs, immune stimulants, antibacterial drugs and mineral supplement. The results of elemene emulsion injection combinations were consistent with the results of analysis of drug properties based on complex network analysis. The major reason elemene emulsion injection was used in combination with other drugs was to help combat tumors and balance the basic needs of the body. Conclusion Based on the analysis of properties of elemene emulsion injection and of liver cancer patients,via the complex network, it has been found that elemene emulsion injection is generally used in combination with vitamins, dexamethasone, glutathione, Kangai injection and amino acids. This study is expected to provide evidence for clinical drug use and in-depth analysis.

Key words: elemene emulsion injection, liver cancer, real-world, hospital information system, combined drug use, property analysis

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