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目的观察清热解毒方配合TACE治疗中晚期肝癌的临床疗效。方法采用前瞻性随机对照研究,将60例中晚期肝癌患者随机分为治疗组和对照组,每组30例。对照组单纯行TACE术,治疗组于TACE术后3~7日口服中药清热解毒方。两组疗程均为2个月,评价近期肿瘤疗效,观察生活质量评分及术后不良反应情况;疗程结束后随访1年,统计生存率。结果 1治疗组和对照组有效率分别为6.7%、3.3%,控制率分别为70.0%、63.33%;组间近期肿瘤疗效差异无统计学意义(P>0.05)。2治疗前后组内比较,治疗组躯体功能、总体健康状况、恶心呕吐积分差异有统计学意义(P<0.05),对照组恶心呕吐、食欲减退积分差异有统计学意义(P<0.05);组间治疗后比较,疲倦、恶心呕吐、食欲减退、便秘积分差异有统计学意义(P<0.05)。3治疗组、对照组白细胞计数减少发生率分别为26.7%、30.0%,消化系统不良反应发生率分别为23.3%、50.0%;组间消化系统不良反应发生率差异有统计学意义(P<0.05)。4治疗组、对照组的6个月生存率分别为73.3%、53.3%,1年生存率分别为46.7%和36.7%;组间6个月、1年生存率比较,差异均有统计学意义(P<0.05)。结论清热解毒方配合TACE能改善中晚期肝癌患者的生存质量,减轻不良反应,提高6个月与1年的生存率。
Objective To observe the clinical efficacy of Qingre Jiedu Fang combined with TACE in the treatment of advanced liver cancer. Methods A prospective randomized controlled trial, 60 patients with advanced liver cancer were randomly divided into treatment group and control group, 30 cases in each group. The control group was treated with TACE only. The treatment group was given oral detoxification of traditional Chinese medicine 3 to 7 days after TACE. Two courses of treatment were 2 months, evaluate the efficacy of the recent cancer, quality of life scores and postoperative adverse reactions were observed; after the end of treatment for 1 year, the statistical survival rate. Results The effective rates of treatment group and control group were 6.7% and 3.3%, respectively, and the control rates were 70.0% and 63.33% respectively. There was no significant difference in the efficacy of the two groups between the two groups (P> 0.05). There were significant differences in body function, general health status and nausea and vomiting scores between the two groups before and after treatment (P <0.05), the difference of nausea and vomiting and loss of appetite in the control group was statistically significant (P <0.05) After treatment, fatigue, nausea and vomiting, loss of appetite, constipation score difference was statistically significant (P <0.05). The incidences of adverse reactions in the treatment and control groups were 26.7% and 30.0%, respectively, and the rates of adverse reactions in the digestive system were 23.3% and 50.0% respectively. The incidence of adverse reactions in the digestive system was statistically significant (P <0.05 ). The 6-month survival rates of the treatment group and the control group were 73.3% and 53.3% respectively, and the 1-year survival rates were 46.7% and 36.7% respectively. There was significant difference in the 6-month and 1-year survival rates between the two groups (P <0.05). Conclusion Qingrejiedu prescription combined with TACE can improve the quality of life of patients with advanced liver cancer, reduce adverse reactions and improve the survival rate of 6 months and 1 year.