槲芪癥消方对TACE治疗后Ⅲ期乙型肝炎相关性原发性肝癌正气不足、毒瘀内结证患者生存率及生活质量的影响

The Effects of Huqi Zhengxiao Formula(槲芪癥消方)on the Survival Rate and Quality of Life of Patients of StageⅢHepatitis B-Associated Primary Liver Cancer with Syndrome of Healthy Qi Deficiency,Toxic Stasis Accumulation After Transcatheter Arterial Chemoembolisation Treatment

目的观察槲芪癥消方内服对经导管动脉化疗栓塞(TACE)治疗后Ⅲ期乙型肝炎相关性原发性肝癌正气不足、毒瘀内结证患者的生存率及生活质量的影响。方法选取TACE治疗后辨证为正气不足、毒瘀内结证的Ⅲ期乙型肝炎相关性原发性肝癌患者126例,采用随机数字表法按1∶1比例分配至试验组和对照组各63例,对照组给予西医内科对症支持治疗,试验组在对照组基础上加服槲芪癥消方。所有患者均接受为期48周的治疗,在治疗过程的第4、8、12、24、36、48周进行随访。主要疗效指标为一年生存率,次要疗效指标为卡氏评分和中医证候评分。采用Kaplan-meier法进行生存分析,用Log-rank检验比较各组生存曲线间的差异。结果试验组脱落6例,对照组脱落7例,最终试验组57例、对照组56例患者纳入统计分析。试验组患者一年生存率为56.1%(32/57),高于对照组的33.9%(19/56)(P=0.033)。试验组平均生存时间为(275.30±15.50)天,高于对照组的(227.16±17.11)天(P=0.039)。试验组32例、对照组19例患者完成各时间点卡氏评分和中医证候评分。两组患者在第4、8、12、36周时,卡氏评分比较差异均无统计学意义(P>0.05);在第24、48周时,试验组的卡氏评分高于同时间点对照组(P<0.05);重复测量的方差分析发现,试验组卡氏评分下降趋势缓于对照组(F=4.47,P=0.037)。两组患者在各随访观察时点的中医证候评分比较差异均无统计学意义(P>0.05);两组患者中医证候评分都有升高趋势,但重复测量的方差分析发现两组差异亦无统计学意义(F=0.31,P=0.58)。结论槲芪癥消方内服可提高TACE治疗后Ⅲ期乙型肝炎相关性原发性肝癌正气不足、毒瘀内结证患者的生存率,延长患者生存时间,提高生活质量。

Objective To observe the effects of Huqi Zhengxiao Formula(槲芪癥消方)on the survival rate and quality of life of patients with stageⅢhepatitis B-associated primary liver cancer(PLC)with syndrome of healthy qi deficiency and toxic stasis accumulation after transcatheter arterial chemoembolisation(TACE)treatment.Methods One hundred and twenty-six patients with stageⅢhepatitis B-associated PLC who were identified as syndrome of healthy qi deficiency and toxic stasis accumulation after TACE treatment were selected,and were randomly assigned to 63 cases each of the treatment group and the control group in a ratio of 1∶1 by using the random number table method;the control group was given symptomatic supportive treatments with western internal medicine,and the treatment group was given the addition of Huqi Zhengxiao Formula on the basis of the control group.All patients were treated for a period of 48 weeks,and were followed up at weeks 4,8,12,24,36,and 48 of the treatment process.The pri⁃mary effectiveness index was the 1-year survival rate,and the secondary effectiveness index was the Karnofsky score and the traditional Chinese medicine(TCM)syndrome score.Survival analysis was performed using the Kaplan-meier method,and Log-rank test was used to compare the differences between the survival curves of each group.Results Six withdrawals in the treatment group and seven withdrawals in the control group,and finally 57 patients in the test group and 56 patients in the control group were included in the statistical analysis.The 1-year survival rate of patients in the treatment group was 56.1%(32/57),which was higher than that of 33.9%(19/56)in the control group(P=0.033).The mean survival time was(275.30±15.50)days in the treatment group,higher than(227.16±17.11)days in the control group(P=0.039).Thirty-two patients in the treatment group and 19 patients in the control group completed the Karnofsky score and TCM symptom score at each time point.At weeks 4,8,12 and 36,the difference in the Karnofsky score between the two groups was not statistically significant(P>0.05);at weeks 24 and 48,the Karnofsky score in the treatment group was higher than that in the control group at the same time point(P<0.05);analysis of variance of repeated measurements found that the downward trend of the Karnofsky score in the treatment group was slower than that in the control group(F=4.47,P=0.037).The difference between the TCM symptom scores of the two groups at each follow-up observation point was not statistically significant(P>0.05);there was a tendency for the TCM symptom scores of the two groups to increase,but the ANOVA of repeated measurements found that the difference between the two groups was not statistically significant either(F=0.31,P=0.58).Concusion The oral administration of Huqi Zhengxiao Formula can improve the survival rate,prolong the survival time,and improve the quality of life of patients with stageⅢhepatitis B-associated PLC with syndrome of healthy qi deficiency and toxic stasis accumulations after TACE treatment.