抗癌2号方加减联合高强度聚焦超声治疗原发性肝癌的生存分析

Survival Analysis of Modified Anti-cancer Decoction 2 Combined with High Intensity Focused Ultrasound in Treatment of Primary Liver Cancer

[目的]探讨中医药联合高强度聚焦超声(HIFU)对原发性肝癌患者生存期的影响.[方法]回顾性分析434例经临床或病理确诊为原发性肝癌的患者,根据是否应用HIFU和中药饮片治疗分成4组,分别为HIFU治疗组99例、中药治疗组98例、中药加HIFU治疗组116例和对照组121例.观察各组患者6个月、1年、2年生存率和中位生存期,并通过单因素分析和COX多因素回归分析筛选原发性肝癌预后因素.通过倾向性评分匹配法均衡组间协变量,进一步评价中医药联合HIFU治疗原发性肝癌之优势.[结果](1)中药加HIFU治疗组中位生存期341 d,6个月、1年、2年生存率为76.7%、49.1%、28.4%;中药治疗组中位生存期272 d,6个月、1年、2年生存率为66.3%、40.8%、25.5%;HIFU治疗组中位生存期206 d,6个月、1年、2年生存率为53.5%、27.3%、9.1%;对照组中位生存期123 d,6个月、1年、2年生存率为40.5%、28.1%、12.4%.组间比较,中药加HIFU治疗组的6个月、1年和2年生存率均较HIFU治疗组和对照组明显提高,中位生存期均较HIFU治疗组和对照组明显延长,差异均有统计学意义(P<0.01),但与中药治疗组比较,差异均无统计学意义(P>0.05).(2)经单因素分析和COX多因素回归分析,结果显示:肿瘤分期、胸腺肽、中药饮片、手术、肝硬化与原发性肝癌的预后存在相关性.(3)经倾向性匹配后,结果显示:中药加HIFU治疗组在延长肝癌患者生存期方面,近期和远期疗效均优于单一手段治疗者(P<0.05).[结论]中药饮片辨证施治及胸腺肽等蕴含扶正思想的治疗手段对改善原发性肝癌患者的预后有积极意义.中药与HIFU联合相比单一手段治疗原发性肝癌可更显著地延长生存期,使患者获益更多.

Objective To observe the effect of traditional Chinese medicine(TCM)Anti-cancer Decoction 2 combined with high-intensity focused ultrasound(HIFU)on the survival time of primary liver cancer patients.Methods A retrospective study was performed in 434 patients with the clinical or pathological diagnosis of primary liver cancer.The patients were divided into 4 groups according to the application of HIFU and Chinese herbs or not,namely HIFU group(n=99),TCM group(n=98),TCM plus HIFU group(n=116),and control group(n=112).The 6-month,one-year and 2-year survival rates and median survival time in various groups were calculated,and the prognostic factors of primary liver cancer were screened by one-way analysis of variance(ANOVA)and COX multivariate regression analysis.The advantage of TCM combined with HIFU in the treatment of primary liver cancer was further evaluated by propensity score matching(PSM)for balancing the covariates between the two groups.Results(1)The median survival time was 341 d,and the 6-month,one-year and 2-year survival rates were 76.7%,49.1%,28.4%respectively in the TCM plus HIFU group.The median survivaltime was 272 d,and the 6-month,one-year and 2-year survival rates were 66.3%,40.8%,25.5% respectivelyin the TCM group. The median survival time was 206 d,and the 6-month,one-year and 2-year survival rateswere 53.5%,27.3%,9.1% respectively in the HIFU group. The median survival time was 123 d,and the 6-month,one-year and 2-year survival rates were 40.5%,28.1%,12.4% respectively in the control group. Theinter-group comparison showed that the 6-month, one-year and 2-year survival rates in the TCM plus HIFMgroup were markedly higher and the median survival time was longer than those in the HIFU group and controlgroup,the difference being significant(P<0.01). However,the difference between TCM plus HIFM group andTCM group was insignificant(P>0.05). (2)The results of one-way ANOVA and COX multivariate regressionanalysis showed that TNM stage, thymosin, sliced Chinese Medicine treatment, surgery and cirrhosis werecorrelated with the prognosis of primary liver cancer.(3)After matching,the results showed that the short-termand long-term efficacy of TCM plus HIFU group in prolonging the survival time were stronger than that of HIFU orTCM treatment alone(P<0.05). Conclusion Syndrome differentiation and treatment with Chinese herbs andthymosin which contain the thought of strengthening healthy Qi have positive significance in improving theprognosis of patients with primary liver cancer. TCM combined with HIFU can significantly prolong the survivaltime of primary liver cancer patients,and its effect is stronger than that of the single treatment.