血府逐瘀汤防治食管癌同步放化疗所致急性放射性食管炎的临床研究

Clinical Effect of Xuefu Zhuyu Decoction in Prevention and Treatment of Acute Radiation-induced Esophagitis Caused by Concurrent Chemoradiotherapy for Esophageal Cancer

目的观察血府逐瘀汤防治食管癌同步放化疗所致急性放射性食管炎(acute radiation induced esophagitis,ARIE)的临床疗效。方法将86例同步放化疗的局部晚期食管癌患者,按照血府逐瘀汤干预与否分为治疗组和对照组,每组43例。比较两组患者临床疗效、各级ARIE累积发生率、中医症状评分、体力状况、免疫炎症指标[白细胞介素-4(interleukin-4,IL-4)、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)、干扰素γ(interferon-γ,IFN-γ)水平,CD4^(+)/CD8^(+)、Th1/Th2比值]、不良反应发生情况。结果两组患者临床疗效比较,差异无统计学意义(P>0.05);两组Ⅰ~Ⅲ级ARIE累积发生率比较,治疗组均显著低于对照组(P<0.05);与治疗前比较,治疗后两组患者中医症状评分均显著降低(P<0.05),但两组中医症状评分比较,差异无统计学意义(P>0.05)。与治疗前比较,治疗后两组患者美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)评分显著降低(P<0.05),卡式功能状态(Karnosky performance status,KPS)评分显著升高(P<0.05),且治疗组ECOG评分降低程度和KPS评分升高程度较对照组更明显(P<0.05)。与治疗前比较,治疗后两组患者血清IL-4、TNF-α、IFN-γ水平,Th1/Th2均显著下降(P<0.05),CD4^(+)/CD8^(+)显著提高(P<0.05),且治疗组IL-4、IFN-γ、TNF-α、Th1/Th2降低程度和CD4^(+)/CD8^(+)升高程度均大于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论血府逐瘀汤能防止食管癌患者同步放化疗期间I~Ⅲ级ARIE向Ⅳ级进展,缓解临床症状,恢复机体免疫力,从而提高患者体力状态与生存质量。

Objective To investigate the clinical effect of Xuefu Zhuyu Decoction in the prevention and treatment of acute radiation-induced esophagitis(ARIE)caused by concurrent chemoradiotherapy for esophageal cancer.Methods A total of 86 patients with locally advanced esophageal cancer who underwent concurrent chemoradiotherapy were enrolled,and according to the presence or absence of intervention with Xuefu Zhuyu Decoction,they were divided into treatment group and control group,with 43 patients in each group.The two groups were compared in terms of clinical outcome,the cumulative incidence rate of different grades of ARIE,the remission of TCM syndrome,performance status score,immune and inflammatory indicators[interleukin-4(IL-4),tumor necrosis factor-α(TNF-α),interferon gamma(IFN-γ),CD4^(+)/CD8^(+),and Th1/Th2],and adverse events.Results There was no significant difference in clinical outcome between the two groups(P>0.05).The treatment group had a lower cumulative incidence rate of gradeⅠ-ⅢARIE than the control group(P<0.05).Both groups had a significant reduction in TCM syndrome score after treatment(P<0.05),but there was no significant difference in TCM syndrome score between the two groups after treatment(P>0.05).After treatment,both groups had a significant reduction in ECOG score(P<0.05)and a significant increase in KPS score(P<0.05),and compared with the control group,the treatment group had a significantly greater increase in KPS score and a significantly greater reduction in ECOG score(P<0.05).After treatment,both groups had significant reductions in IL-4,TNF-α,IFN-γ,and Th1/Th2 and a significant increase in CD4^(+)/CD8^(+)percentage(P<0.05),and compared with the control group,the treatment group had significantly greater reductions in IL-4,IFN-γ,TNF-α,Th1/Th2 and a significantly increase in CD4^(+)/CD8^(+)(P<0.05).There was no significant difference in the incidence rate of adverse events between the two groups(P>0.05).Conclusion Xuefu Zhuyu Decoction can prevent the progression of gradeⅠ-ⅢARIE to gradeⅣARIE,alleviate clinical symptoms,and restore immunity of the body during radiotherapy for esophageal cancer,thereby improving the performance status and quality of life of patients.