十一味参芪胶囊联合XELOX方案治疗晚期结直肠癌临床研究

Effect of Shiyiwei Shenqi Capsules Combined with XELOX Regimen in Treatment of Advanced Colorectal Cancer

目的探讨十一味参芪胶囊联合XELOX方案(卡培他滨+奥沙利铂)治疗晚期结直肠癌的临床疗效。方法将82例晚期结直肠癌患者随机分为观察组和对照组,对照组均给予XELOX方案治疗:卡培他滨片每次1250 mg/m^2,2次/d,第1~14天;注射用奥沙利铂每次130 mg/m^2,第1天,3周为1个周期,共治疗6个周期。观察组则在对照组的基础上另给予十一味参芪胶囊,5粒/次,3次/d,治疗时间与化疗时间保持一致。治疗后,评价两组临床疗效。治疗前后,采用癌症治疗功能评价量表观察两组生活质量指标,包括情感状况评分、社会/家庭状况评分、附加关注评分、功能状况评分及生理状况评分。治疗前后,观察两组的中医症状评分,主要观察指标包括腹痛腹胀、便血、腹部肿块、面色萎黄及四肢不温。治疗前后,检测两组肿瘤标记物,包括糖类抗原724(Carbohydrate Antigen 724,CA724)、糖类抗原125(Carbohydrate Antigen 125,CA125)、血管内皮生长因子(Vascular Endothelial Growth Factor,VEGF)及癌胚抗原(Carcino Embryonic Antigen;CEA)。治疗期间,密切观察两组的不良反应,主要观察项目包括心脏毒性、肝毒性、肾毒性、胃肠道反应、骨髓抑制、神经毒性及皮疹等。结果治疗后,观察组客观缓解率及疾病控制率均明显高于对照组(P<0.05)。治疗后,观察组附加关注、情感状况、功能状况、社会/家庭状况及生理状况评分均显著高于对照组(P<0.05),腹痛腹胀、便血、腹部肿块、面色萎黄及四肢不温则均显著低于对照组(P<0.05),而CA724、CA125、VEGF及CEA均显著低于对照组(P<0.05)。治疗期间,观察组心脏毒性、肝毒性、肾毒性、胃肠道反应、骨髓抑制、神经毒性及皮疹的发生率均明显低于对照组(P<0.05)。结论十一味参芪胶囊联合XELOX方案治疗晚期结直肠癌疗效确切,值得进行深入研究。

Objective To explore the effect of Shiyiwei Shenqi Capsules combined with XELOX regimen(capecitabine+oxaliplatin)in the treatment of advanced colorectal cancer.Methods Eighty-two cases of patients with advanced colorectal cancer were divided into the control group and observation group.The control group was treated by XELOX regimen:capecitabine tablet 1250 mg/(m^2·time),2 times/day,1~14 days;oxaliplatin 130 mg/(m^2·time)for injection,on 1 st day,3 weeks/cycle,a total of 6 cycles.The observation group was given Shiyiwei Shenqi Capsules on the basis of control group,5 pellets/time,3 time/day,and the treatment time was consistent with the chemotherapy time.After treatment,the clinical efficacy of two groups was evaluated.Before and after treatment,the quality of life of the two groups was observed by using the cancer therapeutic function evaluation scale,which mainly included additional attention,emotional status,functional status,social/family status and physiological status.Before and after treatment,the traditional Chinese medicine symptom scores of the two groups were observed,and the main observation indexes included abdominal pain and distension,hematoea,abdominal mass,sallow complexion and lukewarm limbs.Tumor markers in the two groups were detected by enzyme-linked immunoassay before and after treatment,and the main detection indexes included Carbohydrate Antigen 724(CA724)and Carbohydrate Antigen 125(CA125)and vascular endothelial growth factor(VEGF)and carcinoembryonic Antigen(CEA).During the treatment,the toxic and side effects of the two groups were closely observed,including cardiac toxicity,hepatotoxicity,renal toxicity,gastrointestinal reactions,myelosuppression,neurotoxicity and rash.Results After treatment,the objective remission rate and disease control rate were significantly higher in observation group than those in the control group(P<0.05).After treatment,the scores of additional attention,emotional status,functional status,social/family status and physiological status were significantly higher in the observation group than those of the control group(P<0.05),while the scores of abdominal pain and distension,hematoea,abdominal mass,sallow complexion and lukewarm limbs were significantly lower than those of the control group(P<0.05),and levels of CA724,CA125,VEGF and CEA were significantly lower than those of the control group(P<0.05).During the treatment,the rates of cardiotoxicity,hepatotoxicity,nephrotoxicity,gastrointestinal reactions,myelosuppression,neurotoxicity and rash were significantly lower in the observation group than that of the ontrol group(P<0.05).Conclusion Shiyiwei Shenqi Capsules combined with XELOX regimen in the treatment of advanced colorectal cancer has a good clinical curative effect,worthy of further study.