机构地区:[1]广东省中西医结合医院,广东佛山528200 [2]广州中医药大学,广东广州510405
出 处:《辽宁中医药大学学报》2020年第11期18-22,共5页Journal of Liaoning University of Traditional Chinese Medicine
基 金:佛山市科技局科研项目(2017AB000802)。
摘 要:目的观察肝积方联合阿帕替尼对中晚期肝癌患者的不良反应、总生存期(OS)的影响,并分析其生存获益因素。方法入组符合标准的57例患者,随机分为对照组28例和治疗组29例,对照组予阿帕替尼单药靶向治疗,治疗组在对照组基础上加用肝积方加减治疗,对两组进行不良反应发生的观察及记录,并运用Microsoft Excel及SPSS 19.0软件建立数据库,采用寿命表法统计患者的生存率;采用Kaplan-Meier法计算OS,并进行单因素分析,差异经Log-rank检验进行组间比较;将经单因素分析有统计学意义的因素纳入Cox回归模型进行多因素分析,筛选出中晚期肝癌患者预后相关因素。结果①两组不良反应发生率比较,实验组手足综合征、蛋白尿、血小板减少、高血压的发生率明显低于对照组,其中手足综合征组间对比差异具有统计学意义(P<0.05);②实验组中位OS为4.9个月,对照组组中位OS为3.5个月,两组中位OS比较差异无统计学意义(P=0.054);③影响该病患者OS的独立保护因素为中药治疗(P=0.012)及TACE(P=0.000),中药治疗的风险比是0.469(95%CI:0.260~0.845),TACE的风险比是0.301(95%CI:0.160~0.567)。结论实验组与对照组在总生存期方面差异无统计学意义;以肝积方为主的中医药辨证治疗在一定程度上减轻阿帕替尼导致的不良反应,特别体现在手足综合征方面;以肝积方为主的中医药辨证治疗及TACE是改善中晚期肝癌预后的有效保护性因子。Objective To observe the effects of Ganji Decoction combined with apatinib on toxic side effects and total survival(OS)of advanced hepatocellular carcinoma,and analyze the factors of survival benefit. Methods In accord with a standard set of 57 patients,28 cases were randomly divided into control group and treatment group 29 cases,control group to the path for single drug targeted therapy,the treatment group in the control group on the basis of the total liver volume and subtract treatment,observation of the two groups of adverse reaction and records,and using Microsoft Excel and SPSS 19.0 software to establish the database,using the life table method in survival statistics;Kaplan-meier method was used to calculate OS,and univariate analysis was conducted. The differences were compared between groups by log-rank test. The factors with statistical significance after univariate analysis were included into Cox regression model for multi-factor analysis to screen out the prognostic factors of patients with advanced hepatocellular carcinoma. Results ①The incidence of adverse reactions between the two groups,the experimental group hand and foot syndrome,proteinuria,thrombocytopenia,hypertension incidence was significantly lower than the control group,among which the difference between hand and foot syndrome group has statistical significance(P<0.05);②The median OS of the experimental group was 4.9 months,and that of the control group was 3.5 months. There was no statistically significant difference between the two groups(P=0.054);③The independent protective factors affecting OS of patients with this disease were TCM treatment(P=0.012)and TACE(P=0.000),the risk ratio of TCM treatment was 0.469(95% CI:0.260-0.845),and the risk ratio of TACE was 0.301(95% CI:0.160-0.567). Conclusion There was no statistical difference in total survival time between the experimental group and the control group. Traditional Chinese medicine syndrome differentiation based on liver prescription can alleviate the side effects caused by a
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