摘要
目的:本研究采用单中心、前瞻性随机对照研究,观察TACE局部微创治疗基础上联合三氧化二砷、扶正散结方治疗BCLC B或C期原发性肝细胞癌的疗效及安全性。方法:选取符合标准的80例原发性肝细胞癌患者,按随机数字法随机分为治疗组和对照组,每组各40例。入组患者均接受常规抗病毒、保肝、营养支持等基础治疗。对照组在基础治疗基础上,行TACE治疗2次,每次为1个疗程,每个疗程间隔2个月,TACE术后第3天患者开始接受三氧化二砷注射液(哈尔滨伊达药业公司生产)治疗,1次/d,连续10d,间隔14d,连续2次为1个疗程。治疗组在对照组基础上加用扶正散结方。结果:对80例患者进行总生存率进行评价,随访时间4~18个月。治疗组和对照组一年生存率分别为75%和55%;2组生存率的差异有统计学意义(P<0.05);治疗后,治疗组中医证候积分明显低于对照组,KPS评分明显高于对照组,差异有统计学意义(P<0.05),治疗前后未见明显肝肾功能损害,无严重不良反应发生,对三氧化二砷的耐受性较好。结论:扶正散结方、三氧化二砷联合TACE可以提高中晚期肝癌患者的一年生存率及生活质量,无严重不良反应。
Objective:This study adopted a single-center,prospective randomized controlled study to observe the efficacy and safety of TACE combined with arsenic trioxide and Fuzheng Sanjie Recipe in the treatment of BCLC stage B or C primary hepatocellular carcinoma based on local minimally invasive treatment.Methods:Select 80 patients with primary hepatocellular carcinoma that meet the criteria and randomly divide them into treatment group and control group according to the random number method,with 40 cases in each group.All patients in the group received basic treatments such as conventional antiviral,liver protection,and nutritional support.On the basis of basic treatment,the control group received TACE treatment twice,each time was a course of treatment,and each treatment course was separated by 2 months.On the third day after TACE,the patient began to receive arsenic trioxide injection (produced by Harbin Yida Pharmaceutical Company) Treatment,1 time/d,continuous 10d,interval of 14d,2 consecutive times is a course of treatment.The treatment group added Fuzheng Sanjie Recipe on the basis of the control group.Results:The overall survival rate of 80 patients was evaluated,and the follow-up time was 4 to 18 months.The one-year survival rates of the treatment group and the control group were 75% and 55%,respectively.The difference in survival rate between the two groups was statistically significant (P<0.05).After treatment,the TCM syndrome score of the treatment group was significantly lower than that of the control group,and the KPS score was significantly higher than that of the control group,the difference was statistically significant (P<0.05).There was no significant liver and kidney damage before and after treatment,no serious adverse reactions occurred,and the tolerance to arsenic trioxide was good.Conclusion:Fuzheng Sanjie Recipe,arsenic trioxide combined with TACE can improve the one-year survival rate and quality of life of patients with advanced liver cancer without serious adverse reactions.
作者
万迁迁
郭晨旭
时良慧
吴胜兵
万旭英
WAN Qianqian;GUO Chenxu;SHI Lianghui;WU Shengbing;WAN Xuying(The Third Affiliated Hospital of Second Military Medical University,Shanghai 201805,China)
出处
《中医药临床杂志》
2021年第3期502-507,共6页
Clinical Journal of Traditional Chinese Medicine
基金
上海市科委引导类项目(NO.15401932100)。
关键词
肝癌
扶正散结方
三氧化二砷
TACE
总体生存率
Primary hepatocellular carcinoma
Fuzheng Sanjie decoction
Arsenic trioxide
Conventional TACE
Overall survival rate
