中医综合方案与TACE术治疗巴塞罗那C期肝癌的临床疗效比较
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摘要
目的:比较肝动脉化疗栓塞术(TACE)与中医综合治疗两种治疗方法对巴塞罗那C期(BCLC-C)原发性肝癌的疗效。方法:将98例巴塞罗那C期原发性肝癌患者随机分为TACE组和中医综合治疗组,TACE组采取肝动脉化疗栓塞术进行治疗,中医综合治疗组患者给予华蟾素静滴结合辨证论治中药汤剂口服,观察两组患者疾病进展时间、总生存时间,以及不良反应发生率。结果:中医综合治疗组中位疾病进展时间为4.17个月[95%CI(2.17-6.17)],TACE组中位疾病进展时间为4.27个月[(95%CI(2.55-5.99)],差异无统计学意义(P>0.05);中医综合治疗组的中位生存时间为8.73个月[95%CI(0-18.54)],TACE组中位生存时间为10.33个月[95%CI(4.03-16.63)],差异无统计学意义(P>0.05);中医综合治疗组的纳差、肝区疼痛、腹胀、恶心呕吐的发生率低于TACE组,差异有统计学意义(P<0.01);中医综合治疗组肝功能child-pugh评分分级A期率高于TACE组,差异有统计学意义(P<0.05)。结论:肝动脉栓塞与中医综合治疗BCLC-C期肝癌在延长生存时间与疾病进展时间方面比较无明显差异,同时中医综合治疗的不良反应更小,安全性更高。
Objective: To observe the difference between the treatment of hepatic arterial chemoembolization(TACE) and the combination of TCM and western medicine on primary liver cancer patients with barcelona stage C hepatocellular carcinoma(BCLC-C). Methods: A total of 98 patients with primary liver cancer in barcelona stage C were randomly divided into TACE group and integrative medicine treatment group. Patients in group TACE received interventional therapy with hepatic arterial chemoembolization. Patients in integrative medicine treatment group were treated with the combination of cinobufacini intravenous infusion and traditional Chinese medicine oral decoction. The progession free survival(PFS), overall survival(OS) and the incidence of adverse reactions were observed in the two groups. Results: The median PFS was 4.17 months [95% CI(2.17-6.17)]in the traditional Chinese medicine group and 4.27 months [95% CI(2.55-5.99)] in TACE group, which shows no significant difference(P>0.05). The median OS was 8.73 months [95% CI(0-18.54)] in the traditional Chinese medicine group and 10.33 months [95% CI(4.03-16.63)] in the TACE group, which shows no significant difference(P>0.05). The incidence of appetite loss, liver pain, abdominal distension, nausea and vomiting in sea and vomiting in Chinese medicine treatment group was significantly lower than that in TACE group, and the rate of pateints with a stage A child-Pugh score liver function was higher than that of TACE group(P<0.05). Conclusion: The therapeutic effect on OS and PFS between TACE and chinese medicine treatment with conventional BCLC-C liver cancer shows no significantly difference, the method of comprehensive treatment of traditional Chinese medicine has little adverse reaction and high safety.
Objective: To observe the difference between the treatment of hepatic arterial chemoembolization(TACE) and the combination of TCM and western medicine on primary liver cancer patients with barcelona stage C hepatocellular carcinoma(BCLC-C). Methods: A total of 98 patients with primary liver cancer in barcelona stage C were randomly divided into TACE group and integrative medicine treatment group. Patients in group TACE received interventional therapy with hepatic arterial chemoembolization. Patients in integrative medicine treatment group were treated with the combination of cinobufacini intravenous infusion and traditional Chinese medicine oral decoction. The progession free survival(PFS), overall survival(OS) and the incidence of adverse reactions were observed in the two groups. Results: The median PFS was 4.17 months [95% CI(2.17-6.17)]in the traditional Chinese medicine group and 4.27 months [95% CI(2.55-5.99)] in TACE group, which shows no significant difference(P>0.05). The median OS was 8.73 months [95% CI(0-18.54)] in the traditional Chinese medicine group and 10.33 months [95% CI(4.03-16.63)] in the TACE group, which shows no significant difference(P>0.05). The incidence of appetite loss, liver pain, abdominal distension, nausea and vomiting in sea and vomiting in Chinese medicine treatment group was significantly lower than that in TACE group, and the rate of pateints with a stage A child-Pugh score liver function was higher than that of TACE group(P<0.05). Conclusion: The therapeutic effect on OS and PFS between TACE and chinese medicine treatment with conventional BCLC-C liver cancer shows no significantly difference, the method of comprehensive treatment of traditional Chinese medicine has little adverse reaction and high safety.
引文
[1]TORRE LA T,BRAY F,RL S,et al.Global cancer statistics,2012[J].CA Cancer J CLIN,2015,65(2):87-108.
[2]SHU Y,WANG Y,LM T,et al.Curative effect of transcatheter hepatic arterial chemoembolization combined with microwave ablation for large liver cancer[J].Pract J Cancer,2014,29(8):996-998.
[3]张一平,许绍雄,尚国燕.肝动脉化疗栓塞与肝功能损害及预后[J].实用医技杂志,2005,4(12):982.
[4]FORNER A,ME R,CR D L,et al.Current strategy for staging and treatment:the BCLC update and future prospects[J].Semin Liver Dis,2010,30(1):61-74.
[5]European Assocciation for the study of the Liver,European Organisation for Research and Treatment of Cancer.EASLEORTC clinical practice guidelines:management of hepatocellular carcinoma[J].J Hepatol,2012,56(4):908-943.
[6]吴洪梅,朱德增,凌昌全,等.华蟾素肝动脉插管栓塞化疗治疗肝癌临床观察[J].辽宁中医杂志,2000,27(3):127-128.
[7]苏永华,黄雪强,张大志,等.华蟾素注射液中蟾毒内酯类成分含量检测[J].中成药,2003,25(1):24-27.
[8]苏永华,尹西才,谢觉民,等.三种蟾毒单体对SMMC-7721和BEL-7402人肝癌细胞生长的抑制作用[J].第二军医大学学报,2003,24(4):393-395.
[9]中华人民共和国卫生和计划生育委员会医政医管局.原发性肝癌诊疗规范(2017年版)[J].中华消化外科杂志,2017,16(7):705-720.
[10]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[11]凌昌全,刘庆,李东涛,等.原发性肝癌常见中医基本证候定性诊断规范的研究[J].中西医结合学报,2005,3(2):95-98.
[12]Eisenhauer EA,Therasse P,Bogaerts J,et al.New response evaluationeriteria in solid tumours:revised recist guideline(version1.1)[J].Eur J Cancer,2009,45(2):228-47.
[13]叶胜龙,YEShenglong.原发性肝癌研究当前面临的挑战[J].临床肝胆病杂志,2015,31(6):819-823.
[14]LENCIONI R.Chemoembolization in patients with hepatocellular[J].Liver Cancer,2012,1(1):41-50.
[15]Forner A,Gilabert M,Bruix J,et al.Treatment of intermediate-stage hepatocellular carcinoma[J].Nature Reviews Clinical Oncology,2014,11(9):525.
[2]SHU Y,WANG Y,LM T,et al.Curative effect of transcatheter hepatic arterial chemoembolization combined with microwave ablation for large liver cancer[J].Pract J Cancer,2014,29(8):996-998.
[3]张一平,许绍雄,尚国燕.肝动脉化疗栓塞与肝功能损害及预后[J].实用医技杂志,2005,4(12):982.
[4]FORNER A,ME R,CR D L,et al.Current strategy for staging and treatment:the BCLC update and future prospects[J].Semin Liver Dis,2010,30(1):61-74.
[5]European Assocciation for the study of the Liver,European Organisation for Research and Treatment of Cancer.EASLEORTC clinical practice guidelines:management of hepatocellular carcinoma[J].J Hepatol,2012,56(4):908-943.
[6]吴洪梅,朱德增,凌昌全,等.华蟾素肝动脉插管栓塞化疗治疗肝癌临床观察[J].辽宁中医杂志,2000,27(3):127-128.
[7]苏永华,黄雪强,张大志,等.华蟾素注射液中蟾毒内酯类成分含量检测[J].中成药,2003,25(1):24-27.
[8]苏永华,尹西才,谢觉民,等.三种蟾毒单体对SMMC-7721和BEL-7402人肝癌细胞生长的抑制作用[J].第二军医大学学报,2003,24(4):393-395.
[9]中华人民共和国卫生和计划生育委员会医政医管局.原发性肝癌诊疗规范(2017年版)[J].中华消化外科杂志,2017,16(7):705-720.
[10]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[11]凌昌全,刘庆,李东涛,等.原发性肝癌常见中医基本证候定性诊断规范的研究[J].中西医结合学报,2005,3(2):95-98.
[12]Eisenhauer EA,Therasse P,Bogaerts J,et al.New response evaluationeriteria in solid tumours:revised recist guideline(version1.1)[J].Eur J Cancer,2009,45(2):228-47.
[13]叶胜龙,YEShenglong.原发性肝癌研究当前面临的挑战[J].临床肝胆病杂志,2015,31(6):819-823.
[14]LENCIONI R.Chemoembolization in patients with hepatocellular[J].Liver Cancer,2012,1(1):41-50.
[15]Forner A,Gilabert M,Bruix J,et al.Treatment of intermediate-stage hepatocellular carcinoma[J].Nature Reviews Clinical Oncology,2014,11(9):525.