肠内营养对食管癌同步放化疗患者营养状况、不良反应和近期疗效影响——前瞻性、多中心、随机对照临床研究(NCT02399306)

摘要

Objective To investigate the influence of enteral nutrition on body weight,nutritional status,treatment toxicities,and short-term outcomes in esophageal carcinoma patients treated with concurrent chemoradiotherapy(CCRT). Methods Eligible esophageal carcinoma patients were randomly assigned(2:1) to receive either CCRT combined with enteral nutrition (study group) or CCRT alone (control group). The primary endpoint was changes in the body weight during and after radiotherapy. The secondary endpoints were nutrition-related hematological parameters,the toxicities of chemoradiotherapy,the completion rate of treatment,and short-term outcomes. The differences was using χ2 or t-test. Results Between September 2014 and June 2017,203 patients were included in the study,consisting of 139 patients in the study group and 64 patients in the control group. Compared with the control group,the study group had significantly less body weight loss during and after radiotherapy (P<0.05) and significantly less decreases in serum albumin and hemoglobin (P<0.05),but there was no significant difference in the reduction in total lymphocyte count between the two groups (P>0.05).The study group had significantly lower incidence rates of grade ≥3 myelosuppression and infection and a significantly higher completion rate of chemoradiotherapy compared with the control group (P<0.05).The incidence of radiation pneumonitis and esophagitis showed no significant difference between the two groups (P>0.05).The study group had an insignificantly higher objective response rate than the control group (P>0.05). Conclusions For esophageal carcinoma patients treated with CCRT,enteral nutrition can reduce body weight loss during and after radiotherapy,improve nutritional status and treatment tolerance,and reduce toxicities.%目的 探讨肠内营养对食管癌同步放化疗患者体重、营养状况、不良反应和近期疗效的影响.方法 符合入组条件的食管癌患者按2 : 1随机分为试验组(同步放化疗联合肠内营养组)和对照组(同步放化疗组).主要研究终点为放疗过程中及放疗后体重变化.次要研究终点包括营养相关血液学指标、放化疗不良反应、治疗完成率和近期疗效等.采用χ2或t检验差异.结果2014—2017年共入组203例患者,其中试验组139例,对照组64例.试验组放疗中及放疗后体重丢失明显低于对照组(P<0.05).试验组血红蛋白、血清白蛋白的降低明显低于对照组(P<0.05),但淋巴细胞总数减少两组患者无差异(P>0.05).试验组≥3级骨髓抑制和感染发生率明显低于对照组,而放化疗完成率高于对照组(P<0.05).放射性肺炎、放射性食管炎发生率两组患者无差异(P>0.05).试验组肿瘤客观缓解率高于对照组,但无统计学差异(P>0.05).结论 对于食管癌同步放化疗患者,肠内营养有利于保持患者放疗过程中和放疗后体重,改善营养状况,提高治疗完成率,降低不良反应.