参芪地黄汤调节晚期肾癌患者自身免疫应答促进舒尼替尼靶向治疗疗效的研究

Clinical study on regulation of the autoimmune response and promotion of the efficacy of sunitinib targeted therapy by Shenqi Dihuang Decoction in patients with advanced renal cell carcinoma

目的探讨参芪地黄汤联合舒尼替尼对晚期肾癌的治疗效果、不良反应及对患者自身免疫应答的调节。方法选取上海中医药大学附属曙光医院泌尿中心收治的82例晚期肾癌患者,通过简单随机分组的方法将患者随机分为对照组和试验组,每组41例。对照组给予舒尼替尼标准治疗,试验组在此基础上加用参芪地黄汤治疗,比较两组患者的客观缓解率、疾病控制率、不良反应以及外周血NK细胞及T淋巴细胞亚群(CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))水平的变化情况。结果两组患者均完成3个疗程的连续治疗。试验组和对照组的客观缓解率分别为60.98%和31.71%,疾病控制率分别为87.80%和53.66%,试验组客观缓解率和疾病控制率显著优于对照组,差异有统计学意义(P<0.01)。两组患者主要的不良反应为乏力、头痛、恶心呕吐、皮疹和手足综合征,试验组同时并发3种及以上不良反应的情况显著低于对照组,差异有统计学意义(P<0.05)。此外,试验组可显著提高NK细胞[试验组(36.78±12.89)%,对照组(28.87±13.02)%]和CD4^(+)T细胞[试验组(56.82±14.48)%,对照组(45.05±13.74)%]水平,提高CD4^(+)/CD8^(+)比值[试验组(1.81±0.56)%,对照组(1.43±0.69)%]。结论晚期肾癌患者在给予舒尼替尼治疗基础上加用参芪地黄汤可以显著提高临床疗效,降低相关不良反应的发生风险并能调节肿瘤免疫应答,改善各项免疫指标。

Objective To investigate the therapeutic effect,adverse reactions and regulation of autoimmune response of Shenqi Dihuang Decoction combined with sunitinib in patients with advanced renal cell carcinoma.Methods A total of 82 patients with advanced renal cell carcinoma from the Center of Urology,Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine were selected,and the patients were randomly assigned to the control group and the experimental group by simple randomization,with 41 cases in each group.The control group was given sunitinib standard treatment,and the experimental group was additionally treated with Shenqi Dihuang Decoction.The differences in objective response rate(ORR),disease control rate(DCR)and adverse reactions were compared between the two groups,as well as the changes in the levels of peripheral blood NK cells and T lymphocyte subsets(CD3^(+),CD4^(+),CD8^(+),CD4^(+)/CD8^(+))in the two groups.Results Both groups completed 3 courses of continuous treatment.The objective remission rates of the experimental group and the control group were 60.98%and 31.71%,respectively,and the disease control rates were 87.80%and 53.66%,respectively.The objective remission rate and disease control rate of the experimental group were significantly better than those of the control group,and the difference was statistically significant(P<0.01).The main adverse reactions in the two groups were fatigue,headache,nausea and vomiting,rash,hand-foot syndrome and so on.The experimental group was significantly lower in the incidence of suffering from multiple(≥3)adverse reactions simutaneously than the control group,and the difference was statistically significant(P<0.05).In addition,the addition of Shenqi Dihuang Decoction to the sunitinib targeted therapy in the experimental group could significantly increase the levels of NK cells[Test group(36.78±12.89)%,Control group(28.87±13.02)%]and CD4^(+)T cells[Test group(56.82±14.48)%,Control group(45.05±13.74)%],and increase the CD4^(+)/CD8^(+)ratio[Test group(1.81±0.56)%,Control group(1.43±0.69)%].Conclusions The addition of Shenqi Dihuang Decoction to sunitinib treatment in patients with advanced renal cell carcinoma can significantly improve the clinical efficacy,reduce the risk of related adverse reactions,regulate tumor immune response,and improve various immune indicators.