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

Efficacy Evaluation of Biejiajianwan in the Treatment of Primary Liver Cancer Based on Real-world Data of Traditional Chinese Medicine

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(P<0.05)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(χ^(2)=12.193,P<0.01)。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 5~0.668 0),P<0.01],射频消融治疗回归系数-0.976 5,HR(95%CI)=0.376 6(0.172 8~0.821 1,P<0.05);纤维蛋白原(FIB)异常回归系数0.481 4,HR(95%CI)=1.6184(1.022 0~2.562 9,P<0.05)。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。

Objective:To evaluate the efficacy and influencing factors of Biejiajianwan in the treatment of primary liver cancer 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 Henan 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 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 was 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 with statistical significance(P<0.05) 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 regression 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-Meier 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(χ^(2)=12.193, P<0.01). Cox proportional hazards regression model analysis showed 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), P<0.01, 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, P<0.05). Fibrinogen(FIB) abnormal regression coefficient was 0.481 4 with HR(95% CI)=1.618 4(1.022 0-2.562 9),P<0.05. 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 abnormal FIB are independent risk factors for Biejiajianwan in the treatment of primary liver cancer.