1、第 29 卷第 5 期2023年 3 月Vol.29，No.5Mar.，2023中国实验方剂学杂志Chinese Journal of Experimental Traditional Medical Formulae基于中医真实世界数据的鳖甲煎丸治疗原发性肝癌的疗效评价王靖雯1，邵明义1*，符宇1，陈晓琦1，赵瑞霞1，邢云飞1，张容容2，赵云霞2，李蔓2，邵范雷2（1.河南中医药大学 第一附属医院，河南省中医药循证医学中心，郑州 450000；2.河南中医药大学，郑州 450046）摘要 目的：基于中医真实世界数据评价鳖甲煎丸治疗原发性肝癌的疗效及影响因素。方法：收集河南省 5家三甲医院的医
2、疗电子数据库中原发性肝癌患者的临床诊疗数据，按照服用鳖甲煎丸30 d为暴露组，未服用或服用30 d为非暴露组。运用倾向性评分法按照 1 1 遗传匹配法进行匹配，以均衡混杂因素，运用 Kaplan-Meier 法进行生存分析，绘制生存曲线，Log-rank检验组间生存率的差异，鳖甲煎丸治疗原发性肝癌的单因素分析采用 Kaplan-Meier法结合 Log-rank检验，将有统计学意义的因素（P0.05）及倾向性评分匹配法未均衡的因素结合，同时考虑临床常识及文献查询相关的预后影响因素，纳入Cox比例风险回归模型中进行多因素分析。结果：研究收集病例 2 207例，其中暴露组（鳖甲煎丸组）174例，非
3、暴露组 2 033例，经倾向性评分匹配后暴露组、非暴露组各 174例。对匹配后的数据运用 Kaplan-Meier法进行生存分析，Log-rank检验结果显示鳖甲煎丸治疗组原发性肝癌患者的生存率高于对照组（2=12.193，P0.01）。Cox比例风险回归模型分析，结果显示鳖甲煎丸治疗的回归系数-0.9164，风险比（HR）95%置信区间（CI）=0.4（0.239 50.668 0），P0.01，射频消融治疗回归系数-0.976 5，HR（95%CI）=0.376 6（0.172 80.821 1，P0.05）；纤维蛋白原（FIB）异常回归系数 0.481 4，HR（95%CI）=1.618
4、4（1.022 02.562 9，P0.05）。结论：鳖甲煎丸可延长原发性肝癌患者的生存期；射频消融治疗是影响鳖甲煎丸治疗原发性肝癌的独立保护因素，FIB异常是影响鳖甲煎丸治疗原发性肝癌的独立危险因素。关键词 原发性肝癌；鳖甲煎丸；真实世界研究；回顾性队列研究；倾向性评分中 图 分 类 号 R242；R2-031；R287；R979.1；R256.4 文 献 标 识 码 A 文 章 编 号 1005-9903（2023）05-0158-07doi 10.13422/ki.syfjx.20230591 网络出版地址 https:/ 2022-10-29 17:48:20Efficacy Eval
5、uation of Biejiajianwan in the Treatment of Primary Liver Cancer Based on Real-world Data of Traditional Chinese MedicineWANG Jingwen1，SHAO Mingyi1*，FU Yu1，CHEN Xiaoqi1，ZHAO Ruixia1，XING Yunfei1，ZHANG Rongrong2，ZHAO Yunxia2，LI Man2，SHAO Fanlei2（1.Henan Center for Evidence-based Medicine of Tradition
6、al Chinese Medicine，The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450000，China；2.Henan University of Chinese Medicine，Zhengzhou 450046，China）Abstract Objective：To evaluate the efficacy and influencing factors of Biejiajianwan in the treatment of primary liver cancer
7、 based on real-world data of traditional Chinese medicine（TCM）.Method：Clinical diagnosis and treatment data of patients with primary liver cancer admitted to five Grade-A tertiary hospitals in 收稿日期 2022-08-11基金项目 国家中医药管理局重大专项课题（2019ZYZD03）第一作者 王靖雯，在读硕士，从事中西医结合消化系统疾病研究，E-mail：通信作者 *邵明义，博士，主任医师，从事中西医结
8、合消化系统疾病研究，E-mail：158第 29 卷第 5 期2023年 3 月中国实验方剂学杂志Chinese Journal of Experimental Traditional Medical FormulaeVol.29，No.5Mar.，2023Henan Province from January 2015 to December 2020 were collected from the medical electronic database.The patients treated with Biejiajianwan for 30 days were assigned to
9、the exposure group and those without treatment with Biejiajianwan or treated with Biejiajianwan for 30 days to the non-exposure group.The propensity score matching model was used to balance confounding factors between the two groups according to the 1 1 genetic matching method.Kaplan-Meier method wa
10、s used for survival analysis and survival curve plotting.Log-rank was used to test the difference in survival rate between the two groups.Univariate analysis of Biejiajianwan in the treatment of primary liver cancer was performed by Log-rank test combined with the Kaplan-Meier method.The factors wit
11、h statistical significance（P0.05）were combined with unbalanced factors by the propensity score matching model，and at the same time，clinical common sense and relevant prognostic factors by literature search were considered，which were subjected to multivariate analysis by Cox proportional hazards regr
12、ession model.Result：A total of 2 207 electronic cases were collected，including 174 cases in the exposure group（Biejiajianwan group）and 2 033 cases in the non-exposure group.After propensity score matching，there were 174 cases in the exposure group and 174 cases in the non-exposure group.The Kaplan-M
13、eier method was used for survival analysis on the matched data，and the Log-rank test results showed that the survival rate of patients with primary liver cancer in the Biejiajianwan group was higher than that in the control group（2=12.193，P0.01）.Cox proportional hazards regression model analysis sho
14、wed that the regression coefficient of Biejiajianwan was-0.916 4 with the hazard ratio（HR）95%confidence interval（CI）=0.4（0.239 5-0.668 0），P0.01，and the regression coefficient of radiofrequency ablation treatment was-0.976 5 with HR（95%CI）=0.376 6（0.172 8-0.821 1，P0.05）.Fibrinogen（FIB）abnormal regres
15、sion coefficient was 0.481 4 with HR（95%CI）=1.618 4（1.022 0-2.562 9），P0.05.Conclusion：Biejiajianwan can prolong the survival period of patients with primary liver cancer.Radiofrequency ablation is an independent protective factor for Biejiajianwan in the treatment of primary liver cancer，while abnor
16、mal FIB are independent risk factors for Biejiajianwan in the treatment of primary liver cancer.Keywords primary liver cancer；Biejiajianwan；real-world study；retrospective cohort study；propensity score models原发性肝癌（PLC）是发病率和死亡率均居前列的恶性肿瘤之一，研究表明，原发性肝癌发病率、死亡率分别居恶性肿瘤的第 6位、第 3位1。原发性肝癌在中医学中无明确病名，但“肝积”“积聚”“癥瘕”“积块”“臌胀/鼓胀”“胁痛”等疾病症状与原发性肝癌接近。临床实践表明，中医药防治原发性肝癌疗效确切能够改善患者临床症状、提高生存质量、延长生存期2-4，但在临床决策中缺乏证据5-6。鳖甲煎丸是 金匮要略 中治疗“癥瘕”“积聚”的经典方，现代临床中常用于治疗肝纤维化、肝硬化、肝癌等多种疾病7-9。基于此，课题组开展了基于医院管理信息系统（HIS）的回顾性队列研究，应用倾向性评分匹配法控制混杂因