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目的观察益气解毒汤联合CapeOX方案治疗晚期大肠癌的临床疗效和安全性。方法将90例患者随机分为治疗组和对照组(各45例),治疗组采用益气解毒汤联合CapeOX方案治疗,对照组单用CapeOX方案治疗;两组均以21天为1个疗程,共治疗2个疗程;观察临床疗效、中医证候疗效及治疗后生活质量评分、NK细胞、T细胞亚群变化情况;治疗结束1年后,随访观察肿瘤进展时间(TTP)、总生存时间(OS)和1年生存率情况。结果治疗组、对照组临床总有效率(CR+PR)分别为44.44%和37.78%;组间临床疗效比较,差异无统计学意义(P>0.05)。组间临床获益率、肿瘤进展时间、生存时间、1年生存率、中医证候疗效及生活质量(KPS评分)、免疫指标改善情况的差异均有统计学意义(P<0.05)。两组白细胞下降、恶心呕吐发生情况比较,差异有统计学意义(P<0.05)。结论益气解毒汤联合CapeOX方案治疗晚期大肠癌,可控制肿瘤进展,提高患者临床获益率、延长生存期、改善临床症状和生活质量,并能提高免疫功能,减轻化疗的不良反应。
Objective To observe the clinical efficacy and safety of Yiqi Jiedu Decoction combined with CapeOX regimen in the treatment of advanced colorectal cancer. Methods Ninety patients were randomly divided into treatment group and control group (45 cases each). The treatment group was treated with Yiqi Jiedu Decoction and CapeOX regimen, while the control group was treated with CapeOX regimen alone. Both groups were treated with 21 days for one course of treatment, A total of 2 courses of treatment were observed. The clinical curative effect, the TCM syndrome therapeutic effect, the quality of life score after treatment, the changes of NK cells and T cell subsets were observed. One year after the end of treatment, the progress of tumor (TTP), total survival time OS) and 1-year survival rate. Results The total effective rate (CR + PR) of the treatment group and the control group were 44.44% and 37.78% respectively. There was no significant difference in clinical efficacy between the two groups (P> 0.05). The clinical benefit rate, tumor progression time, survival time, 1 year survival rate, TCM syndrome curative effect and quality of life (KPS score) and the improvement of immune indexes were all statistically significant (P <0.05). Two groups of leukopenia, nausea and vomiting, the difference was statistically significant (P <0.05). Conclusions Yiqi Jiedu Decoction combined with CapeOX regimen in the treatment of advanced colorectal cancer can control tumor progression, improve clinical benefit rate, prolong survival, improve clinical symptoms and quality of life, improve immune function and reduce side effects of chemotherapy.