ENEVO配制的肠内液体——15年来首次获批准的新肠内营养物（用于口服和管状使用）

エネーボ配合経腸用液

药物分类名称
蛋白质氨基酸配方
批准日期：2014年5月
商標名
ENEVO
组成和性质
构成组成
每1毫升这种药物的热值是1.2千卡。本产品含有下列成分/量（1罐）（250毫升，300千卡）。另外，作为添加剂，包含稳定剂（结晶纤维素/羧甲基纤维素钠），pH调节剂（氢氧化钾，柠檬酸水合物）和香料（香草醛，乙基香兰素和丙二醇）。
成分:
1罐含：250毫升（300千卡）
分离的牛奶蛋白12.6克
浓缩乳清蛋白1.7克
分离的大豆蛋白1.5克
高油酸葵花籽油5.3克
菜籽油2.2克
中链脂肪酸甘油三酯1.3克
鱼油0.10克
大豆卵磷脂0.46克
糊精26.8克
纯化的白糖8.7克
难消化的糊精3.5克
低聚果糖1.7克
大豆多糖0.30克
视黄醇棕榈酸酯0.31毫克
β-胡萝卜素0.16毫克
胆钙化醇2.8微克
维生素E醋酸酯12毫克
Phytonadione 29μg
抗坏血酸63毫克
硫胺盐酸盐0.57mg
核黄素0.80毫克
盐酸吡哆醇0.94毫克
氰钴胺0.88微克
氯化胆碱0.25克
叶酸68微克
烟酸酰胺4.5毫克
泛酸钙2.7毫克
生物素13微克
牛磺酸45毫克
左旋肉碱32毫克
氯化钠0.11克
0.79克柠檬酸钠水合物
氯化钾0.25克
柠檬酸钾0.48克
磷酸一氢镁0.38g
磷酸氢钙82毫克
硫酸铁水合物22毫克
硫酸锌水合物20毫克
四水合氯化锰4.9mg
硫酸铜1.9毫克
氯化铬六水合物0.16毫克
钼酸二钠二水合物85μg
硒酸钠49微克
营养成分
本产品含有以下营养成分/量
（1罐）（250毫升）。
营养成分1可以在250毫升（300千卡）
蛋白质13.5克
脂肪9.6克
碳水化合物39.6克
低聚果糖1.7克
维生素A 190微克RE
维生素D 2.8微克
**维生素E 11毫克
维生素K 29微克
维生素C 63毫克
维生素B1 0.51毫克
维生素B2 0.80毫克
维生素B6 0.77毫克
维生素B12 0.88μg
胆碱0.21克
叶酸68微克
烟酸4.5毫克
泛酸2.5毫克
生物素13微克
牛磺酸45毫克
左旋肉碱32毫克
钠0.23克
钾0.30克
氯0.25克
钙0.29克
磷0.25克
镁52毫克
锰1.4毫克
铜0.48毫克
锌4.5毫克
铁4.4毫克
铬31微克
钼34微克
硒20微克
注）本剂（250mL）中1罐的盐当量为0.586g。
药效药理
1.蛋白质
（1）本发明的药剂的蛋白质源，考虑到氨基酸补充有效和高效利用，乳蛋白（乳清蛋白和乳蛋白）和大豆分离蛋白90.5：通过在9.5的比例混合获得，250毫升的13.5克（能量组成比18％）。
（2）NPC / N比（非蛋白质卡路里/氮的比例）为116（基于分析值）。
2.碳水化合物
在环糊精和纯化蔗糖（蔗糖）的代理的主要碳水化合物源，含有39.6克（能量混合比53％）的250mL。
3.脂质
（1）本发明的药剂的主要脂质源是高油酸向日葵油，油菜油和中链脂肪酸甘油三酯，含有9.6克（能量混合比29％）的250mL。
此外，它具有均匀的优良和稳定的悬架，容易消化。
（2）EPA衍生的鱼油，含有DHA，ω-3基，.omega.6系统并包含良好平衡的ω9系列脂肪酸。
4.含水量
该试剂250mL中的水含量为203mL。
适应病症
用于手术后的病人的营养保存，难以摄取食物，尤其是长时间的时候，用于气管插管。
剂量和剂量
通常，作为标准剂量，每天向成人每天口服1,000至1,667毫升（1,200至2,000千卡）。 对于静脉内给药，这种药物以每小时62.5至104毫升（75至125千卡）的速率连续给药或每天数次给药。当口服摄取时，可以每天口服一次或分几次。
然而，通常初始给药量为333毫升/天（400千卡/天）作为指导，并以低速率（约41.7毫升/小时（50千卡/小时）或更低）给药。此后，根据患者的状况逐渐增加，并使其达到标准量。 另外，取决于年龄，体重和症状，剂量，给药浓度和给药速率适当增加或减少。特别是在给药初期，也考虑用水稀释给药。
临床结果
食管癌手术或全胃切除术后需要营养支持的59例患者，口服食物摄入困难且需要气管插管的患者，应从术后第三天起施行 主要终点的快速转换蛋白（RTP）在第12天施用药物或比较对照药物10天的III期比较研究中显示出类似的趋势。
包装
混合肠内溶液:（250毫升，300千卡）24罐

存储方法·到期日期等
存储方法
在室温下储存
到期日期
制造后：12个月
制造商
雅培日本有限公司
注：以上中文资料不够完整，使用者以原处方为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/3259119S1029_1_05/
Acquired approval for manufacture and marketing of "ENEVO ™ formulated enteral liquid" for new enteral nutrients (for oral and tubular use) for the first time in 15 years
Enebo ™ formulated enteral solution can be used for maintaining nutrition of patients after surgery, but in particular, it is used for intubation feeding when it is difficult to ingest diet for a long period of time. It is a medicinal enteral nutritional supplement. As a nutritional ingredient for the first time as a pharmaceutical enteral nutrient, selenium
* 1 and L-carnitine involved in lipid metabolism
* 2, focusing on fructooligosaccharides which can expect intestinal action
* 3, chromium related to sugar metabolism
* 4, Molybdenum which is a component of the enzyme
* 5, taurine involved in digestion and absorption of lipids
* 6 was formulated.
Mr. Hideyuki Takeda, Managing Executive Officer, Nutrition Products Product Division, Abbott Japan Co., Ltd. responds to the needs of the Japanese market, such as "Enebo ™ formulated enteral solution", due to aging, prolonged nutritional control period, and advances in nutrition By adding new ingredients such as selenium which are not formulated with existing pharmaceutical enteral nutritional supplements, it is possible to meet the needs of Japanese physicians and patients who have not been satisfied until now I am convinced that we can further contribute by raising the quality of life (QOL) of patients and their families. "
The aging of Japan is progressing rapidly, and it is expected that in 2025, elderly people aged 65 and older will reach 30%. In modern medical fee reimbursement, emphasis is placed on expanding home healthcare, and this trend is increasingly increasing the needs of enteral nutrients for pharmaceuticals. Medicinal enteral nutritional supplements containing vitamins and minerals, ultra trace elements and conditional essential nutrients that are reported to have deficiency in existing pharmaceutical enteral nutritional supplements as long as nutritional therapy of elderly people in home medical care is prolonged It was done. At Abbott, we will contribute to medical treatment in Japan by providing new Enebo ™ -containing enteral solution to such unique market needs of Japan.
Reference material
"Enebo TM formulated enteral liquid" Product outline
※ 1 About selenium
Selenium is regarded as a trace element which exerts a role of antioxidant action in tissues and can not be maintained for health maintenance. There are reports of deficiency in cases with long enteral nutrition period, typical symptoms of deficiency include decline in heart function due to cardiomyocyte organization and fibrosis, muscle weakness in lower limbs, muscle pain, change in nail white.
※ 2 About L-carnitine
L-carnitine is a conditional essential nutrient involved in lipid metabolism. L-carnitine is contained in a small amount in normal diet and can be ingested from food, but there are reports of deficiency in patients with chronic diseases, trauma, burns etc. As typical symptoms of deficiency, high ammonia encephalopathy, low Ketonic hypoglycemia and cardiomyopathy.
※ 3 About Fructooligosaccharide
Fructooligosaccharide is a component expected to have an intestinal action due to the proliferation effect of bifidobacteria. It is known to maintain a healthy intestinal microflora in in vitro tests, and patients who have not used the intestinal tract for a long period of time before or after surgery or postoperative fasting or intravenous nutrition are promptly normal and healthy intestinal It has been reported to restore and maintain the bacterial flora.
※ 4 About chrome
Chromium is regarded as a trace element related to sugar metabolism. Deficiency is reported in highly calorie infusion controlled patients without chromium addition, and representative symptoms of deficiency include weight loss, impaired glucose tolerance and the like.
※ 5 About Molybdenum
Molybdenum is a trace element essential for the components of enzymes (xanthine oxidase, sulfite oxidase and aldehyde oxidase). There are reports of deficiency in highly calorie infusion controlled patients who hardly contain molybdenum, and representative symptoms of deficiency include heart rate increase and respiratory rate increase, headache, night blindness and the like.
※ 6 About Taurine
Taurine is a nutrient that is conjugated with bile acid, the major component of bile, and is involved in the digestion and absorption of lipids, in particular. There is no report of deficiency in taurine. In Japan, it is widely used as a main ingredient of drink medicines due to medicinal effects such as improvement of liver function and regulation of excitement of myocardium.