摘要
目的探索真实世界榄香烯乳状注射液在肺癌患者中的应用特征,为临床肺癌患者规范使用榄香烯乳状注射液提供参考。方法本研究从中国中医科学院中医临床基础医学研究所建立的电子病历多维数据仓库中提取2003年1月1日至2019年7月31日的21家医院电子病历,筛选至少使用1次榄香烯乳状注射液的肺癌患者数据,分析患者的基本特征、榄香烯乳状注射液临床使用情况和合并用药情况,统计疑似不良反应(包括疑似肝、肾功能损伤和疑似过敏反应)患者数量。另提取患者出院记录为“治愈”“好转”者,并采用Louvain聚类方法对其药物复杂网络进行分析,提取核心用药。结果共收集1856例使用榄香烯乳状注射液的肺癌患者,其中男性1149例(61.91%)、女性686例(36.96%)、缺失21例(1%~13%);46~65岁患者共851例(45.85%),占比最高。榄香烯乳状注射液给药方式基本符合说明书规定,但存在医嘱开立不规范的情况。1856例患者中存在疑似肝功能损伤12例,疑似肾功能损伤8例,疑似过敏反应患者10例。1856例患者合并用药频次显示榄香烯乳状注射液常与肝素、利多卡因、氯化钾、维生素、地塞米松、胸腺肽等西药合并应用,与复方苦参注射液、参芪扶正注射液、感冒清热颗粒等中药制剂合并应用,且结果经关联规则分析进一步验证。“治愈”“好转”患者复杂网络分析显示,核心处方包括榄香烯乳状注射液、肝素类、利多卡因、地塞米松、氯化钾、胸腺肽、维生素、氨溴索等药物。结论榄香烯乳状注射液治疗肺癌的合并用药以抗肿瘤、抗菌、调节免疫、营养支持和改善肺功能为主,临床应用多数符合说明书用药规范,但本研究中发现临床医嘱显示存在超说明书用药,提醒临床注意规范医嘱开立。此外疑似不良反应混杂因素多,不能明确是否与榄香烯乳状注射液相关,需进一步分析。
Objective To explore the ways in which elemene emulsion injection is used in the treatment of lung cancer in the real world and to provide reference for standardized use of elemene emulsion injection among lung cancer patients.Methods In this study,the electronic cases of 21 hospitals collected between January 1,2003 and July 31,2019 were retrieved from the multi-dimensional data warehouse of electronic cases established by the Institute of Traditional Chinese Medicine,Chinese Academy of Chinese Medical Sciences.Lung cancer patients who had used this injection were screened from the database.Basic information about these patients,the usage of elemene emulsion injection and concomitant medications were analyzed,and the number of patients with suspected adverse reactions(including patients with suspected liver and kidney function damage and suspected allergic reactions)was calculated.In addition,the discharge records of patients who were regarded as“cured”and“improved”,were retrieved and the complex network of drugs was analyzed using the Louvain clustering method to identify the core drugs.Results A total of 1856 patients with lung cancer who had received elemene emulsion injection were collected,including 1149(61.91%)males and 686(36.96%)females.There were 851 patients aged 46 to 65,accounting for 45.85% of the total.The routes of administration were basically consistent with the instructions,but there were sub-standard prescriptions.There were 12 cases of suspected liver function damage,8 cases of suspected renal function damage,and 10 cases of suspected allergic reactions.Elemene emulsion injection was often used in combination with such Western medicines as heparin,lidocaine,potassium chloride,vitamins,dexamethasone and thymosin and with other traditional Chinese medicine preparations.The results were further verified by association rule analysis.Conclusion The combined medications with elemene emulsion injection in the treatment of lung cancer are intended to combat tumors and bacteria,regulate immunity,provide nutritional support and improve lung function.Most of the clinical applications comply with the instructions,but there are some cases of off-label use.More studies are needed on the correlations between adverse drug reactions and the use of this injection.
作者
赵晓晓
谢雁鸣
王连心
ZHAO Xiaoxiao;XIE Yanming;WANG Lianxin(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《中国药物警戒》
2022年第9期940-946,共7页
Chinese Journal of Pharmacovigilance
基金
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)。
关键词
榄香烯乳状注射液
肺癌
真实世界
用药规律
关联规则
聚类分析
elemene emulsion injection
lung cancer
the real world
usage of drugs
association rules
clustering analysis
