基于真实世界肝炎患者人群特点和茵栀黄颗粒治疗的用药特征分析

Population Characteristics and Medication Characteristics of Hepatitis Patients Treated with Yinzhihuang Granules Based on the Real World

目的:基于真实世界电子病历数据分析茵栀黄颗粒治疗肝炎患者的人群特点及用药特征。方法:选取中国中医科学院中医临床基础医学研究所基于国内16家三甲医院的医院信息系统(HIS)数据库构建的医疗数据集成仓库,从中抽取2010年6月至2016年6月中至少使用1次茵栀黄颗粒治疗肝炎患者的信息进行统计分析。结果:共纳入1383例肝炎患者,男女比例约3∶1,年龄45~65岁。在诊断信息显示乙型病毒性肝炎(675例,61.69%)及湿热内蕴证候(67例,53.17%)患者最多。给药途径为口服,单日剂量12~18 g,疗程为3 d较多。合并西药主要为甘草酸、胸腺肽、泮托拉唑联合使用,合并中药主要为苦黄注射液,感冒清热颗粒、柴胡注射液。关联规则结果显示,茵栀黄颗粒+苦黄注射液+甘草酸+胸腺肽用于治疗急性黄疸型病毒性肝炎、病毒性肝炎高胆红素血症;茵栀黄颗粒+苦黄注射液+甘草酸+亮菌甲素用于肝内胆汁淤积肝炎;清热剂多与肝、胆疾病治疗药,系统抗菌药,免疫促进药,与胃酸分泌药,系统抗病毒药等合并使用。结论:真实世界中茵栀黄颗粒常用于中老年人群的病毒性肝炎的治疗,临床可与清热剂的中药和肝胆病药物、抗菌药、免疫促进药等西药联合使用,对改善病毒肝炎等临床症状、恢复肝功能及预防病并发症有明显疗效。

Objective:To analyze the population characteristics and medication characteristics of hepatitis patients treated with Yinzhihuang Granules based on real-world electronic medical records.Methods:The present study adopted the integrated warehouse of medical data constructed by the Institute of Basic Research in Clinical Medicine,Chinese Academy of Chinese Medical Sciences based on the hospital information system(HIS)of 16 tertiary hospitals in China,and extracted the information of hepatitis patients who received Yinzhihuang Granules at least once from June 2010 to June 2016 for statistical analysis.Results:A total of 1383 cases of hepatitis aged 45~65 years were included,with the male to female ratio of 3∶1.As shown in the diagnostic information,the patients with viral hepatitis B(n=675,61.69%)and dampness-heat internal accumulation syndrome(n=67,53.17%)accounted for large proportions.In terms of administration route and dosage,the protocol of oral administration of Yinzhihuang Granules at 12~18 g per day with the course of treatment of 3 days was frequently employed.Yinzhihuang Granules were mainly used in combination with western medicines,such as glycyrrhizic acid,thymosin,and pantoprazole,and Chinese medicines such as Kuhuang Injection,Ganmao Qingre Granules,and Chaihu Injection.According to the association rule results,the drug combination of Yinzhihuang Granules+Kuhuang Injection+glycyrrhizin+thymosin was used against acute icteric viral hepatitis and viral hepatitis hyperbilirubinemia,and Yinzhihuang Granules+Kuhuang Injection+glycyrrhizic acid+armillarisin A against intrahepatic cholestatic hepatitis.Heat-clearing agents were mostly used in combination with drugs for hepatobiliary diseases,systemic antibacterial agents,immune boosters,drugs for gastric acid secretion,and systemic antiviral agents.Conclusion:In the real world,Yinzhihuang Granules are often used in the treatment of viral hepatitis in the middle-aged and elderly people,and show good efficacy in relieving clinical symptoms,improving liver functions,and preventing disease complications in combination with heat-clearing Chinese medicines and western medicines such as drugs for hepatobiliary diseases,antibacterial agents,and immune boosters.