艾迪注射液联合FOLFOX4方案治疗复发转移性大肠癌的疗效观察

目的观察和比较艾迪注射液联合FOLFOX4（亚叶酸钙＋氟尿嘧啶＋奥沙利铂）方案与单纯FOLFOX4方案治疗转移性或复发性晚期大肠癌的疗效及毒副反应。方法将经病理组织学及影像学确诊为转移性或复发性晚期大肠癌患者108例作为研究对象,将其分为艾迪注射液联合FOLFOX4方案组（联合治疗组）56例及单纯FOLFOX4方案组（对照组）52例。每例患者至少治疗2个周期进行疗效评价。结果联合治疗组可评价疗效56例：完全缓解（CR）2例,部分缓解（PR）22例,稳定（SD）24例,有效率为42.86%,临床获益率（CR＋PR＋SD）为85.71%,疾病进展时间（TTP）为（8.4±0.2）个月,中位生存期（MST）为15.6个月;对照组可评价疗效52例：CR 1例,PR 18例,SD 21例,有效率为36.54%,CR＋PR＋SD为76.92%,TTP为（7.9±0.6）个月,MST为14.9个月;两组疗效比较差异无统计学意义（P〉0.05）。联合治疗组生活质量Karnofsky评分提高率为78.57%,对照组提高率为55.69%,两组比较差异有统计学意义（P〈0.05）。联合治疗组白细胞减少的发生率、消化道反应（恶心呕吐、腹泻）发生率显著少于对照组（P〈0.05）。结论复发转移性大肠癌使用FOLFOX4方案化疗时加用艾迪注射液,虽在临床疗效上未见明显提高,但患者的化疗不良反应明显减轻。

Observation of curative effect on Aidi Injection in combination with FOLFOX4 regimen chemotherapy in the treatment of patients with advanced colorectal cancer

Objective To observe and compare the efficacy and toxicity of Aidi Injection in combination with FOLFOX4 regimen（L-OHP plus 5-Fu/Lv） and FOLFOX4 regimen in the treatment of patients with advanced colorectal cancer.Methods 108 patients with advanced colorectal cancer diagnosed pathologically and imageology were divided into 56 cases of Aidi Injection in combination with FOLFOX4 regimen group（coalition group） and 52 cases of FOLFOX4 regimen group（con trol group）.Each patient was given at least 2 cycles and the efficacy and toxicity were then evaluated.Results 56 cases could be evaluated in coalition group：there were 2 cases of CR,22 cases of PR,24 cases of SD,the effective rate was 42.86%,CR＋PR＋SD was 85.71%,TTP was（8.4±0.2） months,MST was 15.6 months;52 cases could be evaluated in control group：there were 1 case of CR,18 cases of PR,21 cases of SD,the effective rate was 36.54%,CR＋PR＋SD was 76.92%,TTP was（7.9±0.6） months,MST was 14.9 months.In coalition group,the overall response rate was 41.07% and that was 36.54% in control group.The difference of effect between the two groups was insignificant（P0.05）.Karnofsky score increase rate of life quality in coalition group was 78.57% and that was 55.69% in control group,with significant difference（P0.05）.The incidence rates of leucopenia,gastrointestinal reaction,hepatotoxicity and renal toxicity in coalition group were significantly lower than those in control group（P0.05）.Conclusion Aidi Injection can reduce toxic effects of FOLFOX4 regimen chemotherapy while enhancing patients＇ tolerance to chemotherapy and improving patients＇ quality of life.