贞芪扶正胶囊联合化疗治疗胃肠道肿瘤疗效观察

目的：观察贞芪扶正胶囊联合化疗治疗胃肠道肿瘤的有效性和安全性。方法：经病理组织学检查确诊的胃肠道肿瘤患者60例,随机分为2组,每组30例。实验组接受贞芪扶正胶囊联合化疗方案的治疗。其中贞芪扶正胶囊1.4g,每日2次,至化疗结束,同时联合FOLFOX4方案化疗,14天为1个周期。对照组只接受FOLFOX4方案化疗。按照RECIST标准评价近期疗效,参照Kamofsky评分（KPS）变化评价生活质量（QOL）,按照NCICTC310版标准评价不良反应。用药1周期即可评价不良反应,2周期后方可评价疗效。结果：实验组食欲减退、疲乏、卧床时间等生活质量改善明显好于对照组（P〈0.05）。实验组总缓解率（50.0%）高于对照组（43.3%）,疾病控制率（90.0%）高于对照组（86.7%）,但差异无显著性（P〉0.05）。实验组患者不良反应如白细胞计数减少、乏力的发生率比对照组低（P〈0.05）。其余不良反应比对照组略低。结论：贞芪扶正胶囊联合化疗可以改善和稳定胃肠道肿瘤患者的生活质量,疗效确切,其毒性低,安全性好,值得临床推广和进一步研究。

Efficacy of Zhenqifuzheng Capsules Combined with Chemotherapy for Gastroenteric Tumors

OBJECTIVE：To evaluate the efficacy and safety of Zhenqifuzheng capsules combined with chemotherapy for gastroenteric tumor.METHODS：60 patients with gastroenteric tumor confirmed by histopathologic examination were randomly divided into two groups of 30 each.The trial group received FOLFOX4 chemotherapy plus Zhenqifuzheng capsules（1.4 g） t.i.d in combination with chemotherapy for 14 days（=one cycle of treatment）;the control group received FOLFOX4 chemotherapy alone.The short-term efficacy was evaluated after 2 cycles in accordance with RECIST criteria,and quality of life（QOL） was evaluated according to Kamofsky scores;the toxicity was evaluated after 1 cycle according to NCI CTC 310 version criteria.RESULTS：The quality of life（QOL）（decreased food appetite,fatigue and in-bed time） in the trial group had better improvement than in the control group（P〈0.05）.The remission rate was higher in the trial group（50.0%） than in the control group（43.3%）,so was the disease control rate（90.0% for trial group vs.86.7% for control group）,but the difference was nonsignificant（P〉0.05）.The incidences of adverse reactions such as leucopenia and debilitation were lower in the trial group than in the control group（P〈0.05）;as for the other adverse reactions,the incidence was slightly lower in the trial group than in the control group.CONCLUSION：Zhenqifuzheng capsules combined with chemotherapy can improve and stabilize the QOL of the patients with gastroenteric tumors,and which has confirmed efficacy,low toxicity and good safety,thus deserving clinical popularization and further study.