全优膳用于恶性肿瘤患者营养支持的前瞻性、开放标签、非干预性、多中心的临床观察性研究报告

Ayunutri in nutritional support for patients with malignant tumors:A prospective,open-label,non-interventional,multi-center clinical observational study

目的营养不良是恶性肿瘤患者常见的并发症之一,往往对患者的临床表现和疾病预后产生诸多不利影响。本研究旨在评估国人恶性肿瘤患者服用添加免疫营养素的肠内营养补充剂全优膳后的营养状态和生活质量变化。方法本研究为前瞻性、单臂、开放标签、全国多中心的临床观察性研究。自2018年5月1日至2019年8月31日,按照统一的纳入和排除标准,参与的10家研究中心入组多种中晚期恶性肿瘤患者共206例,以特医食品全优膳作为营养补充制剂,推荐用量为每天2罐,持续服用30天。记录患者服用全优膳期间的实验室检查指标、营养状态评分以及生活质量评分等,统计分析患者的体重、体质量指数(BMI)、血红蛋白、前白蛋白、白蛋白、血脂水平、主观整体营养状况量表(PG-SGA)评分、QLQ-C30 V3.0评分、血清免疫球蛋白水平、依从性和不良反应发生情况。结果服用全优膳30天后,患者的体重和BMI均有明显的增加(均P<0.05),PG-SGA评分状况明显好转,生活质量评分亦较前升高。患者血红蛋白、前白蛋白和白蛋白水平有所升高,但差异未达到统计学意义。发生率较高的不良事件依次为轻度恶心、腹泻和腹痛。结论对于国人恶性肿瘤合并营养不良的患者,口服特医食品全优膳,具有良好的营养补充作用且耐受性好,值得在临床上进一步研究和推广应用。

Objective Malnutrition is one of the most common complications of patients with malignant tumors,which often has many adverse effects on the clinical manifestations and prognosis of patients.To investigate the changes in nutritional status and quality of life in Chinese patients with malignant tumors after taking an enteral nutrition supplement(Ayunutri)supplemented with immunonutrients.Methods In this multi-center,prospective,non-interventional clinical observational study,according to uniform inclusion and exclusion criteria,206 patients with advanced malignant tumors in 10 research centers were enrolled from May 1st,2018 to August 31st,2019.Patients took Ayunutri as nutritional supplementation following the recommended dosage of 2 cans per day for 30 consecutive days.During the nutritional supplementation,the laboratory test results,nutritional status score and quality of life score were recorded.Additionally,body weight,body mass index(BMI),hemoglobin,prealbumin,albumin,blood lipid level,patient generated subjective global assessment(PG-SGA)score,QLQ-C30 V3.0 score,serum immunoglobulin level,compliance and occurrence of adverse reactions were counted and analyzed.Results After taking Ayunutri for 30 consecutive days,the body weight and BMI increased significantly(P<0.05).The PG-SGA score improved and the quality of life score increased significantly than before.Levels of hemoglobin,prealbumin albumin and albumin did not reach statistical differences.The higher incidence of adverse events in this study were mild nausea,diarrhea and abdominal pain.Conclusion Ayunutri is more safe and effective for nutritional support in Chinese patients with malignant tumors,and Ayunutri can be used as an important choice for supplementary nutrition therapy in clinical treatment,worth to be further studied and widely used in routine clinical practice.