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产品名称:康全力®Diason®糖尿病患者专用肠内营养配方

通用名称:整蛋白纤维型肠内营养混悬液(TPF-DM)

产品特性:

- 减少血糖波动
- 降低HbA1c
- 降低胰岛素抵抗
外科 ICU 肿瘤科 神经外科 消化内科 移植科 老年科 神经内科 烧伤科

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【药品名称】
通用名称:肠内营养混悬液(TPF-DM)
商品名称:Diason
英文名称:Enteral Nutritional Suspension(TPF-DM)
汉语拼音:Changnei Yingyang Hunxuanye(TPF-DM)
【性状】本品为微黄色至黄褐色乳状混悬液,味微甜,久置后液体上层有脂肪层析出,下层有少量沉淀,振摇后允许少量粘壁。
【适应症】本品适用于有部分胃肠道功能,而不能或不愿进食足够数量常规食物以满足机体营养需求,并且需要控制血糖水平的患者,主要适用人群为糖尿病患者。
【规格】0.75kcal/ml
【用法用量】本品可以口服或管饲喂养。管饲喂养时,滴速建议从每小时20ml开始,由慢到快;最高不宜超过每小时125ml。
剂量应由医师或营养师决定,并且根据患者的个体需要不同而调整。作为单一营养来源时:推荐剂量为平均每日25kcal/kg,平均每日2000ml(1500kcal);作为营养补充时:根据患者需要使用,推荐剂量为平均每日1000ml(750kcal).
【不良反应】包括恶心、呕吐、腹泻和腹痛等胃肠道不适应反应。

【禁忌】

1.完全性胃肠道功能衰竭的患者禁用;
2.完全性胃肠道梗5的患者禁用;
3.果糖不耐受的患者禁用;
4.对本品中任一成分过敏的患者禁用;
5.对本品中任一成分有先天性代谢障碍的患者禁用;
6.严重腹腔内感染(严重腹腔内脓毒病)的患者禁用;
7.顽固性腹泻等需要进行肠道休息处理的患者禁用;
8.不适用于不可摄入膳食纤维的患者。

【注意事项】

1.仅供肠内使用,严禁静脉输注;
2.使用前请摇匀;
3.一旦开启,在无菌输注条件下,请于24小时内使用完毕。
4.伴有重度胃麻痹的患者,请实施空肠喂养;
5.在使用过程中,须注意液体平衡,保证足够的液体摄入。以补充由纤维素排泄所带走的水分;
6.肠道功能衰竭的患者慎用;
7.严重肝肾功能不全的患者慎用;

【孕妇及哺乳期妇女用药】未进行该项研究亦无可靠参考文献。
【贮藏】密闭,常温(10-30)保存。已开瓶(袋)但未经使用的产品,可在原瓶(袋)中于4最多存放24小时。
【包装】铝塑复合膜袋装1000ml/袋;玻璃瓶装,500ml/瓶
【有效期】玻璃装15个月;铝塑复合膜袋装12个月。

【执行标准】
袋装:进口药品注册标准:JX20030149

瓶装:国家食品药品监督管理局标准:YBH04962010

【批准文号】

袋装:进口药品注册证号:H20080608

瓶装:国药准字H20103536

详细内容请查阅完整处方资料

Dr. Robert Post, Deputy Director of the Center for Nutrition Policy and Promotion (HHS), called the meeting to order at 9:00 a.m. on Dr. Anand's behalf. He thanked the Committee members and recognized the continued cooperation between USDA and HHS. All Committee members attended via Webinar. He reviewed the Committee’s charge: to inform the Secretaries of USDA and HHS of warranted changes to the Dietary Guidelines that are based on review of scientific and medical evidence published since the last Dietary Guidelines, emphasizing food-based recommendations over nutrient-based recommendations. The DGAC will not translate recommendations into policy or communications documents. The Committee will submit an advisory report of technical recommendations and the recommendations’ rationales to the Secretaries. Dr. Post reviewed information from the Federal Advisory Committee Act (FACA), including the requirements to publish announcements of each meeting in a Federal Register notice in support of open, transparent meetings. To further support transparency, members are not to hold discussions with members of the public or outside groups but are to refer them to Dietary Guidelines Management Team for information. The public was invited to provide written comments and can review archived recording of the meetings at www.dietaryguidelines. gov. Transcripts and meeting summaries will be posted when available.

Dietary Guidelines Advisory Committee Meeting

April 13-14,2010

Results: After the intervention period, the diabetes specific formula resulted in a significantly lower postprandial rise in blood glucose concentrations at 0.5 hour (P <0.05) and 1 hour (P <0.01); significantly lower peak height of plasma glucose (P =0.05); significantly lower plasma insulin concentrations at 0.5 hour (P<0 01), 1 hour (P <0.01) and 2 hours (P <0.01); and a significantly lower plasma insulin peak compared to controls; both OGTT and a standard test meal (P <0.05). The glucose and insulin area under the curve after the diabetes specific formula compared to the standard formula were significantly lower. The C peptide level was lower after 6 days of both nutrition formulas compare to 75 g OGTT, but not different from the standard mixed meal. Both formulas were well tolerated.
Conclusions: In summary the diabetes specific formula with a relatively high monounsaturated fatty acid and high multi fiber proportion significantly improved glycemic control. On top of this, the insulin sensitivity (HOMA-IS) was significantly improved and may therefore directly improve the impact on long term complications. The disease specific formula should therefore be the preferred option to be used by diabetic and hyperglycemic patients in need of nutritional support.

Beneficial effects of a diabetes specific formula on insulin sensitivity and free fatty acid in patients with type 2 diabetes mellitus

Li YX, Zeng JB, Yu K, Chin Med J (Engl). 2008 Apr 20;121(8):691-5.

目的:探讨饮食治疗并且添加可溶性膳食纤维对老年2型糖尿病的影响。方法:采用自身对照法,对 20例老年2型糖尿病患者进行正规饮食治疗7 d,然后添加可溶性膳食纤维7 天,分别检测饮食治疗前及治疗后的第 7天、第14天的空腹血糖(FBG)、餐后2 h血糖(2h BG)、血淸甘油三酯(TG)、胆固醇(TC)。结果:患者饮食治疗后 FBG和2h BG均下降(P <0.05),添加可溶性膳食纤维后较治疗前下降更显著(P<0.01) 。TG和TC水平均无明 显变化(P> 0.05)。结论:严格的饮食治疗并辅助可溶性膳食纤维对糖尿病的临床治疗及并发症的预防具有重要意义。

食物中添加水溶性膳食纤维对老年2型糖尿病的影响

肖桂珍罗海吉 实用医学杂志 2005, 21(23)

Objective: The aim of our work was to carry out a randomized clinical trial with two diets, one enriched in fiber (total fiber 30 g and soluble fiber 4 g) to investigate the effect on lipid and glucose levels in healthy subjects. Research design and methods: Fifty-three subjects were prospectively randomized to two groups (see Table 1). Group I received a diet with 10.4g of fiber given as 1.97 g soluble fiber (pectins, gums and mucilages) and 8.13 g of insoluble liber (hemicelullose. cellulose and lignins) and Group II received a diet with 30.5 g of fiber of which 4.11 g were soluble fiber and 25.08 g insoluble fiber. Prospective serial assessment of weight and nutritional intake (3 days written food records) were made. These determinations were performed at baseline and at 3 months. All enrolled subjects underwent the following examinations; fasting blood samples were drawn for measurement of total cholesterol, triglyceride concentrations and other lipid fractions, low density lipoprotein (LDL-cholesterol), high density lipoprotein (HDL-cholesterol), glucose, and insulin. Results: Total caloric and fat consumption were lower than recommended in both groups (calories; group I 1633 ±417kcal per day versus group II 1707.5 ±579kcal per day:ns) and (fats; group I 73.4 ± 22.7 g per day versus group II 72.6 ± 28 g per day:ns). without differences in fatty acid intake profile. Total fiber intake did not reach that recommended in both diets but it was higher in group II (9.06 ± 2.7 g per day versus 25.95 ± 7.12 g per day: P < 0.05). Soluble fiber intake did not reach that recommended in both diets but it was higher in group II (1.7 ± 0.58 g per day versus 3.5 ± 0.96 g per day: P < 0.05). Body weight did not change in both groups during treatment. During treatment, in group II a significant change was detected from baseline in LDL-cholesterol and fasting glucose levels. LDL-cholesterol decreased by 12.8% (P < 0.05) and glucose decreased by 12.3% (P < 0.05). No statistical differences were detected among triglycerides, HDL-cholesterol, and insulin levels. Conclusions: Modest increases in soluble fiber intake in healthy subjects improved LDL cholesterol and glucose levels.

Effects of soluble fiber intake in lipid and glucose leves in healthy subjects

Aller R, de Luis DA, Izaola O. Diabetes Res Clin Pract. 2004 Jul;65(1):7-11.

Background and aims: Assess longer-term (12 weeks) effects of a diabetes-specific feed on postprandial glucose response, glycaemic control (HbAl c). lipid profile, (pre)-albumin, dinical course and tolerance in diabetic patients.
Methods: In this randomized, controlled, double-blind, parallel group study 25 type 2 diabetic patients on tube feeding were included. Patients received a soy-protein based, multi-fibre diabetes-specific feed or isocaloric, fibre-containing standard feed for 12 weeks, while continuing on their anti-diabetic medicatioa At the beginning, after 6 and 12 weeks, several (glycaemic) parameters were assessed. Results: The postprandial glucose response (iAUC) to the diabetes-specific feed was lower at the 1st assessment compared with the standard feed (p = 0.008) and this difference did not change over time. HbAlc decreased over time in the diabetes-specific and not in the standard feed group (treatment*time:p = 0.034): 6.9± 0.3X (mean 土 SEM) at baseline vs. 6.2 土0.4* at 12 weeks in the diabetes-specific group compared to 7.9 ± 0.3% to 8.7 土 0.4* in the standard feed group. No significant treatment*time effect was found for fasting glucose, insulin, (pre-) albumin or lipid profile, except for increase of HDL in the diabetes-specific group. Conclusions: The diabetes-specific feed studied significantly improved longer-term glycaemic control in diabetic patients. This was achieved in addition to on-going anti-diabetic medication and may affect clinical outcome.

Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients*-*

Vaisman N, Lansink M, Rouws CH, Waitzberg DL, Morley JE.Clin Nutr. 2009 Oct;28(5):549-55

Aims: Study the effect of several boluses of a new diabetes-specific formula (DSF) during the day on 24 h glucose profile.
Methods: In this randomized, controlled, double-blind, cross-over study 12 ambulatory type 2 diabetic patients were included. Subjects received a new DSF and an isocaloric standard fibre-containing formula (SF) while continuing their anti diabetic medication. Subjects received 100% of their calculated daily energy requirements as bolus feeding every 3 h (5 time/day, starting at 8.00 a.m. 士 1 h).
Results: Glucose profiles were significantly better after administration of DSF compared with SF determined as mean glucose concentration (士SEM) (8.7 士 0.S versus 9.6 士 0.6 mmol/L. p< 0.05 during 24 h; 9.4 士 0.6 versus 10.7 士O.6mmoI/L,p <0.001 during daytime) or as incremental area under the curve during daytime (-44%; p< 0.05). Subjects receiving DSF experienced less hyperglycacmic time over 24 h (-26%; p< 0.05) and during daytime (-30%; p< 0.05). Furthermore, lower individual and mean (delta) peak glucose levels were found (p < 0.05). No clinically relevant differences in gastrointestinal tolerance were observed. Concluaons: Using DSF resulted in significantly better 24 h and postprandial glucose profiles than fiber-containing SF after bolus administration and may therefore help to improve glycaemic control in diabetic patients.

Administration of a new diabetes-specific enteral formula results in an improved 24 h glucose profile in type 2 diabetic patients

Ceriello A, Lansink M, Rouws CH. Diabetes Res Clin Pract. 2009 Jun;84(3):259-66.

Results: A lower postprandial glucose response (iAUC) was observed at the 1st assessment to DSF as compared with SF (difference in intercept: p = 0.008) and this difference did not significantly change in time (treatment*time: p= 0.601). Similar results were found for (delta) peak glucose levels. Tube feeding with DSF resulted in a reduction in HbA1c over time compared with SF (treatment time: p = 0.034). Estimated marginal mean HbA1c (士SEM) decreased in the DSF group (6.9土0.3% at baseline, 6.2土0.4% at 12 weeks), whereas it increased in the SF group (7.9士0.3% to 8.7土0.4%). No significant treatment time effect was found for fasting glucose, insulin, (pre-)albumin or lipid profile, except for HDL (increase in DSF group). No clinically relevant differences in tolerance were observed.
Conclusion: In addition to anti-diabetic medication, the DSF can further improve overall glycaemic control (HbA1c) and can result in lower postprandial glucose responses in diabetic patients. This could have beneficial implications to the clinical course of their illness.

Twelve weeks tube feeding with a diabetes-specific feed improves glycaemic control in Type 2 diabetes patients

N. Vaisman1. M. Lansink2,K.M.J. van Laere2,

Background & aims: A major treatment goal in patients with diabetes and/or hyperglycaemia is to achieve normalized plasma glucose and triglyceride levels, also for those receiving nutritional support. The aim of this study was to assess the short-term effect of continuous application of different tube feeds on postprandial glucose and triglyceride levels.
Methods: In a double blind, cross-over study 12 adult type 2 diabetic patients randomly received three different tube feeds by continuous nasogastric tube feeding for 6h (A standard formula (49E% CHO, 21E% MUFA); B diabetes specific formula Diason™ (45E% CHO, 26E% MU FA); C test formula (35E% CHO, 34E% MUFA)). Plasma glucose concentrations were determined at t = 0 (baseline), 15, 30,45, 60, and every further 30min until 360min. Triglycerides were measured every 60min.
Results: Diabetes specific tube feed B and test feed C showed significantly (p<0.05) lower glucose peak height (corrected for baseline) and iAUC when compared with standard tube feed A. Furthermore, tube feeds B and A showed significantly (p<0.05) lower triglyceride levels at 180, 240, 300 and 360 min when compared with test feed C.
Conclusions: This cross-over study indicates that tube feed B (DiasonTM ) is the preferred option in supporting metabolic control in diabetic patients requiring tube feeding.

Diabetes specific tube feed results in improved glycaemic and triglyceridaemic control during 6 h continuous feeding in diabetes patients

Zandrie Hofman, Mirian Lansink e-SPEN, the European e-Journal of Clinical Nutrition and Metabolism (2007) 2, 44-50

Background This prospective, randomized, controlled study was designed to investigate the effects of a diabetes specific formula (Diason low energy: 313.8 kJ/100 ml), compared with a standard formula, on insulin sensitivity, serum C peptide, serum lipids and free fatty acid (FFA) in type 2 diabetics.
Methods In total of 71 type 2 diabetics completed the study. Enteral formulas were given orally as the sole source of nutrition to the subjects for 6 days. Venous blood samples (0.5, 1, 2,3 hours) were collected at day -7 after a 75 g oral glucose tolerance test (OGTT), day 1 after a standard test meal (1673.6 kJ) and after 6 days of either the test diabetes specific formula or a standard formula. Plasma glucose, serum insulin,C peptide and lipids were measured.
Results After the intervention period, the diabetes specific formula resulted in a significantly lower postprandial rise in blood glucose concentrations at 0.5 hour (P <0.05) and 1 hour (P <0.01); significantly lower peak height of plasma glucose (P =0.05); significantly lower plasma insulin concentrations at 0.5 hour (P<0.01), 1 hour (P <0.01) and 2 hours (P <0.01); and a significantly lower plasma insulin peak compared to controls; both OGTT and a standard test meal (P <0.05). The glucose and insulin area under the curve after the diabetes specific formula compared to the standard formula were significantly lower. The C peptide level was lower after 6 days of both nutrition formulas compare to 75 g OGTT, but not different from the standard mixed meal. Both formulas were well tolerated.
Conclusions In summary the diabetes specific formula with a relatively high monounsaturated fatty acid and high multi fiber proportion significantly improved glycemic control. On top of this, the insulin sensitivity (HOMA-IS) was significantly improved and may therefore directly improve the impact on long term complications. The disease specific formula should therefore be the preferred option to be used by diabetic and hyperglycemic patients in need of nutritional support.

Beneficial effects of a diabetes specific formula on insulin sensitivity and free fatty acid in patients with type 2 diabetes mellitus

LI Yu-xiu,ZENG Jing-bo, YU Kang Chin Med J 2008;121(8):691-695

Recommendations 
A-Level evidence
Foods containing carbohydrate from whole grains, fruits, vegetables, and low-fat milk should be included in a healthy diet.
With regard to the glycemic effects of carbohydrates, the total amount of carbohydrate in meals or snacks is more important than the source or type.
As sucrose does not increase glycemia to a greater extent than isocaloric amounts of starch, sucrose and sucrose-containing foods do not need to be restricted by people with diabetes; however, they should be substituted for other carbohydrate sources or, if added, covered with insulin or other glucose-lowering medication.
Non-nutritive sweeteners are safe when consumed within the acceptable daily intake levels established by the Food and Drug Administration. 
Recommendations 
B-Level evidence
In persons with controlled type 2 diabetes, ingested protein does not increase plasma glucose concentrations, although protein is just as potent a stimulant of insulin secretion as carbohydrate.
For persons with diabetes, especially those not in optimal glucose control, the protein requirement may be greater than the Recommended Dietary Allowance, but not greater than usual intake.

Nutrition Principles and Recommendations in Diabetes

American Diabetes Association Diabetes Care, volume 27,Supplement 1,January 2004

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    管饲喂养是ICU患者进行营养支持的首选途径,应在血流动力学稳定后24h内开始。

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    身患多种疾病的老年人通常会因营养摄入不足病情加重。

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  • 神经外科

    不能经口正常摄食的危重昏迷患者,一旦胃肠道功能允许,应该优先考虑给与肠内营养治疗。

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    烧伤患者的营养支持首选EN,应在血流动力学稳定后,尽早实施。

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    炎性肠病、短肠综合征、胰腺炎和肝病等患者都应定期评估营养状况,及时给予营养支持。

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