健脾疏肝方在晚期肝细胞癌介入联合靶向及免疫治疗中的增效减毒作用研究

Study on Efficacy-Enhancing and Toxic-Reducing Effects of Jianpi Shugan Prescription in Targeted Therapy Combined with Immunotherapy for Advanced Hepatocellular Carcinoma

目的:观察健脾疏肝方在晚期肝细胞癌(HCC)介入联合靶向及免疫治疗中增效减毒的作用。方法:选择晚期HCC患者56例,按随机数字表法分为对照组和观察组各28例。2组均给予肝动脉化疗栓塞(TACE)治疗1个周期。观察组予健脾疏肝方加减、甲磺酸仑伐替尼胶囊、替雷利珠单抗治疗;对照组予甲磺酸仑伐替尼胶囊、替雷利珠单抗治疗。2组连续治疗12周。比较2组不良反应、生活质量评分、客观缓解率(ORR)、疾病控制率(DCR)以及血清γ-谷氨酰转肽酶同工酶Ⅱ(GGT-Ⅱ)、甲胎蛋白(AFP)、异常凝血酶原(APT)水平。并随访观察2组的1年与2年生存率。结果:观察组1年生存率为85.71%,高于对照组53.57%(P<0.05);观察组2年生存率为50.00%,高于对照组17.86%(P<0.05)。观察组发热、恶心呕吐、骨髓抑制发生率均低于对照组(P<0.05)。治疗6周、12周后,2组生活质量量表(QOL)评分均较治疗前升高(P<0.05),且观察组QOL评分高于同时间点对照组(P<0.05)。12周疗程后,观察组ORR与DCR分别为50.00%、82.14%,分别高于对照组17.86%、50.00%(P<0.05)。治疗后,2组血清GGT-II、AFP、APT水平较治疗前降低(P<0.05),且观察组血清GGT-Ⅱ、AFP、APT水平低于对照组(P<0.05)。结论:健脾疏肝方在晚期HCC介入联合靶向及免疫治疗中的增效减毒作用明显,可提高患者的生存率,改善患者的生活质量,下调血清GGT-Ⅱ、AFP、APT水平。

Objective:To observe the efficacy-enhancing and toxic-reducing effects of Jianpi Shugan Prescription in targeted therapy combined with immunotherapy for advanced hepatocellular carcinoma(HCC).Methods:A total of 56 cases of patients with advanced HCC were selected and divided into the control group and the observation group according to the random number table method,with 28 cases in each group.Both groups were treated with transcatheter TACE for one cycle;the observation group was treated with modified Jianpi Shugan Prescription,Lenvatinib Mesylate Capsules and Tireilizumab;the control group was treated with Lenvatinib Mesylate Capsules and Tireilizumab.Both groups were treated continuously for 12 weeks.Adverse reactions,quality of life scores,objective response rate(ORR),disease control rate(DCR)and the levels ofγ-glutamyl transferase isoenzyme II(GGT-II),alpha fetoprotein(AFP)and abnormal prothrombin(APT)in serum were compared between the two groups.The one-year and two-year survival rates in the two groups were followed up.Results:The one-year survival rate in the observation group was 85.71%,which was higher than that of 53.57%in the control group(P<0.05).The two-year survival rate in the observation group was 50.00%,higher than that of 17.86%in the control group(P<0.05).The incidence of fever,nausea and vomiting and myelosuppression in the observation group was lower than that in the control group(P<0.05).After 6 and 12 weeks of treatment,the quality of life(QOL)scores in the two groups were increased when compared with those before treatment(P<0.05),and the QOL score in the observation group was higher than that in the control group at the same time point(P<0.05).After 12 weeks of treatment,the ORR and DCR in the observation group were 50.00%and 82.14%respectively,which were higher than those of 17.86%and 50.00%respectively in the control group(P<0.05).After treatment,the levels of GGT-II,AFP and APT in serum in the two groups were reduced when compared with those before treatment(P<0.05),and the levels of GGT-II,AFP and APT in serum in the observation group were lower than those in the control group(P<0.05).Conclusion:Jianpi Shugan Prescription has obvious efficacy-enhancing and toxic-reducing effects in targeted therapy combined with immunotherapy for advanced HCC,which can increase survival rates of patients,improve their quality of life,and down-regulate the levels of GGT-II,AFP and APT in serum.