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SmofKabiven® peripheral & central Bruce Yu/游振鋆藥師 Clinical Nutrition medical Specialist Fresenius Kabi Taiwan 2013-12-18

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Page 1: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven® peripheral & central

Bruce Yu/游振鋆藥師

Clinical Nutrition medical Specialist

Fresenius Kabi Taiwan 2013-12-18

Page 2: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Contents

Optimisation of energy provision with

supplemental parenteral nutrition in critically

ill patients

Introduction of SMOFkabiven PI & central

Method of administration & Contraindication

Comparing CGMH compounding Formula with

Smofkabiven PI & central

Page 3: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Lancet 2013; 381: 385–93

Page 4: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Methods

This randomized controlled trial was undertaken in two centers in

Switzerland.

We randomly assigned 153 patients to SPN and 152 to EN. 30 patients

discontinued before the study end.

We enrolled patients on day 3 of admission to the ICU who had received

less than 60% of their energy target from EN, were expected to stay for

longer than 5 days, and to survive for longer than 7 days.

We calculated energy targets with indirect calorimetry on day 3, or if not

possible, set targets as 25 and 30 kcal per kg of ideal body weight a day

for women and men, respectively.

The primary outcome was occurrence of nosocomial infection after

cessation of intervention (day 8),measured until end of follow-up (day

28), analyzed by intention to treat.

Page 5: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Trial design

Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial

Lancet 2013; 381: 385–93

Page 6: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Lancet 2013; 381: 385–93

Page 7: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

研究結果

實驗結果:

1. 可以看到使用SPN(EN + PN)的

院內感染發生率較低 (低30%)

2. 使用抗生素的天數較少 (少2天)

3. 可以提早脫離呼吸器 (提早14hr)

Page 8: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Authors Conclusion

如果能在ICU的第四天透過SPN (Supplemental PN) 提供最佳營養:

可以降低院內感染機率

當單獨靠EN仍不足以提供足夠的熱量時, SPN應該是用來改善ICU病患預後

的策略之一

Page 9: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

J Parenter Enteral Nutr. 2012;36:60-68

Page 10: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Conclusions

Optimal nutritional therapy in mechanically ventilated, critically ill patients, defined as protein and energy targets reached, is associated with a decrease in 28-day mortality by 50%, whereas only reaching energy targets is not associated with a reduction in mortality

J Parenter Enteral Nutr. 2012;36:60-68

Page 11: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Peripheral Parenteral Nutrition

Peripheral Parenteral Nutrition; Total Parenteral

Nutrition

2 in1

(Glucose+AA) 醫院調配TPN

3 in1(AIO)

(Glucose+AA+Fat)

SMOFKabiven central

SMOFkabiven Peri

Page 12: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

The New Generation of AIO(All In One)

Page 13: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

The innovation 3-in-1 mix

Page 14: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Evolution of parenteral lipid emulsions

Soybean oil MCT Olive oil Fish oil

Page 15: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Evolution of parenteral lipid emulsions

Page 16: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFlipid®

Components % g/1000ml Characteristics

Soybean oil 30% 60 g 提供亞麻油酸(linoleic acid)、次亞麻油酸 (-linolenic acid )等必須脂肪酸

MCT oil 30% 60 g 中鏈脂肪酸(MCT)可確保快速得到能量,及有效的清除血循環中的三酸甘油酯

Olive oil 25% 50 g 橄欖油提供單元不飽和脂肪酸 (MUFA),降低脂肪乳劑中多元不飽和脂肪酸 (PUFA) 的含量。藉此減少動脈硬化、改善 HDL cholesterol 和降低心血管疾病 與死亡率1

Fish oil 15% 30 g 魚油內含-3 脂肪酸(EPA & DHA),可調節免疫系統、具抗發炎反應。SMOFlipid® 內-6/-3 脂肪酸比值為2.5:1,為符合目前的建議值

Extra add vitamin E (dl--tocopherol): 200 mg /1000 ml 1Am J Clin Nutr 1998; 67:129-135 Circulation 1970; 41(Suppl 1):11-211 N Engl J Med 1985; 312:805-11 J Lipid Res 1990; 31:1149-72 Am J Clin Nutr 1986; 44:635-42

Page 17: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

額外添加 Vitamin E 的理由 A highly effective antioxidant that maintains the integrity of cell membranes

by inhibiting lipid peroxidation

The peroxidation rate of unsaturated fatty acids is directly related to the number of double bonds. Thus vitamin E requirement increases with a high intake of PUFA

Critically ill patients often show antioxidant deficiency and should be supplemented with vitamin E

Minimum:

50 mg -tocopherol equivalents for ICU patients

Up to:

100-200 mg -tocopherol equivalents in special critically ill patients (e.g.

burns, ARDS)1

80-100 mg -tocopherol daily in critically ill patients 2

1. Berger and Shenkin (2000) Trace elements and vitamins

From nutrition support to pharmacologic nutrition in the ICU

2.Adolph M. Wiener Klinische Wochenschrift 2003

每1,000ml 的SMOFlipid® 含有200mg的Vit E

Page 18: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

不同種類脂肪乳劑內的脂肪酸組成模式

Page 19: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

“...today an n-6/n-3 ratio of about 2:1 to 3:1 is regarded to have

only a minor impact on immune function. This ratio may be achieved

by supplementation of standard lipid emulsions with a fish oil-based lipid emulsion,

or using the latest generation lipid emulsions which include fish oil”

最適當的 -6/-3 比值為何?

Mayer et al. Curr Opin Clin Nutr Metab Care 2006

“ n-6 /n-3脂肪酸比值落在 2:1 至 3:1,對免疫功能的影響最小 ”

A ratio 2.5:1 reduces rectal cell proliferation in patients with colorectal cancer, whereas a ratio of 4:1 with the same amount of omega-3 PUFA had no effect

The lower ω-6/ ω-3 ratio in women with breast cancer was associated with decreased risk

A ratio of 2-3/1 suppressed inflammation in patients with rheumatoid arthritis, whereas a ratio of 10/1 had adverse consequences.

Biomed Pharmacother. 2002 Oct;56(8):365-79

Page 20: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

-6/-3 fatty acid ratio in lipid emulsions for parenteral nutrition

1 Morlion BJ et al Clin Nutr 1997; 16(S1):49

2 Fürst P and Kuhn KS. Clin Nutr 2000; 19:7-14

3 Adolph M. Clin Nutr 2001; 20(S4):11-4

4 Grimm H et al JPEN 1994, 18:417-421

5 Grimm H and Kraus A. Arch Surg 2001; 386:369-376

Kabiven

Oliclinomel

SMOFkabiven

Page 21: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SIRS and CARS in Sepsis

Page 22: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid
Page 23: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Lipid mediator system

Page 24: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFlipid® Versus MCT/LCT

SMOFlipid® Versus olive oil/soybean oil

Page 25: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid
Page 26: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFlipid Versus MCT/LCT 20% Fat Emulsion

SMOFlipid had a better triglyceride-lowering effect

Page 27: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFlipid VS Clinoleic

Lower inflammatory response

Page 28: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFlipid VS Clinoleic

Protect the liver functions

Page 29: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Crit Care 2012 Oct 4; 16(5):R184.

Page 30: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

METHODS

Medline was searched for randomized controlled trials

A total of 23 studies (n = 1502 patients: n = 762 admitted to the ICU)

were included.

Crit Care 2012 Oct 4; 16(5):R184.

Trials

n-3 PUFA-enriched lipid

emulsion

Standard non-enriched lipid

emulsion

soybean oil, MCT/LCT or

olive/soybean oil

Page 31: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

RESULTS

No statistically significant difference in mortality rate(RR= 0.89; 0.59, 1.33)

n-3 PUFA-enriched lipid emulsion statistically and clinically significant reduction in the infection rate (RR =0.61; 0.45, 0.84)

n-3 PUFA-enriched lipid emulsion: reduced the lengths of stay, both in the ICU (-1.92; -3.27, -0.58) and in hospital overall (-3.29; -5.13, -1.45)

n-3 PUFA-enriched lipid emulsion

n-3 PUFA-enriched lipid emulsion: reduced markers of inflammation, improved lung gas exchange, liver function, antioxidant status and fatty acid composition of plasma phospholipids

Crit Care 2012 Oct 4; 16(5):R184.

Page 32: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

CONCLUSIONS

n-3 PUFAs-enriched parenteral nutrition regimens are safe and effective in reducing the infection rate and hospital/ICU stay in surgical and ICU patients.

Crit Care 2012 Oct 4; 16(5):R184.

Page 33: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid
Page 34: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid
Page 35: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid
Page 36: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

The innovation 3-in-1 mix

Page 37: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

The innovative 3-in-1 mix containing

Glucose 42% – The carbohydrate for provision of energy in the recommended

glucose-lipid ratio 50:50

Aminoven® 10% – Contains high amounts of amino acids and the

• conditionally essential nutrient: taurine

Ratio nitrogen to energy is 1:108 and within the recommendations3 of

1:100-150 (ESPEN)

Page 38: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Aminoven® 10%- Composition

Well-balanced standard amino acid solution

– Meets the requirements for

• Essential AA (41.4 %)

• Branched chain AA (18.6 %)

– Nitrogen content: 16.2 g/ l

– Supply of taurine Conditionally Essential

Tyrosine 0.4

Taurine 1.0

Non-Essential

Alanine 14.0

Arginine 12.0

Histidine 3.0

Glycine 11.0

Proline 11.2

Serine 6.5

Ess AA 41 %

BC AA 19 %

Essential

Leucine 7.4

Isoleucine 5.0

Valine 6.2

Lysine 6.6

Phenylalanine 5.1

Methionine 4.3

Tryptophan 2.0

Threonine 4.4

Aminoven® 10% contains the conditionally essential nutrient taurine

Amino acid pattern (g/l)

Page 39: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Reasons for Deficiency (short-term):

– Metabolic stress leads to insufficient endogenous synthesis as shown in:

• Sepsis (Askanazi 1980)

• Trauma (Askanazi 1980, Paauw 1990)

• Surgery (Neary 1997)

• Chemotherapy/Radiation (Desai 1992)

SmofKabiven® -Taurine

Pharmacological component necessary for various metabolic functions such as:

– Immune cell function

– Production of bile salts and maintenance of bile flow

Page 40: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Need of Taurine in PN

Reduces TPN induced post-operative cholestasis (Wang 1991)

Has immunemodulatory effects (Redmont 1998)

Diabetes , provides different beneficial effects (C. De la Puerta 2010)

– Antioxidant activities, specially relevant when exerted at cellular mitochondria.

– Anti-inflammatory effects.

– Osmoregulatory actions.

– Effects on glucose homeostasis.

Page 41: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

The effect of taurine on chronic heart failure

Takashi Ito et al 2013

Page 42: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Zinc

Conditioned deficiency in patients

– Malabsorption syndrome, liver disease, chronic renal disease, sickle cell disease,

and other chronic illnesses.

Major clinical problems

– Growth retardation; cell-mediated immune dysfunction, and cognitive

impairment.

>300 enzymes and >1000 transcription factors require zinc for their

activities.

Second messenger of immune cells, and intracellular free zinc in these

cells participate in signaling events.

Not only modulates cell-mediated immunity but is also an

antioxidant and anti-inflammatory agent.

Adv Nutr 2013 Mar; 4(2):176-90.

Page 43: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven® - Zinc

– Physiological function

• Wound-healing and tissue repair (Berger, Shenkin 1998)

• Protein synthesis (Chandra 1994, Berger, Shenkin 1998)

• Immune response (Baumgartner 1993, Chandra 1994)

• Antioxidative capacity (Shenkin 1998)

• Prevents impairments in glucose tolerance

Zinc supply may affect patient‘s outcome

Page 44: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Suggested Daily IV Zn Intake

1) NAG: Nutrition Advisory Group 2) AMA: American Medical Association Departments of Foods and Nutrition

Trace Element Previous Recommendations

(NAG1/AMA2, 1979)

Recent Recommendations

(ASPEN, 2004) GI Losses

Zinc 2.5-4.0 mg 2.5-5 mga Addb

aAdditional 2mg/d to hypermetabolic patients

bAdd 12mg/L of small bowel losses and 17 mcg/kg of stool or ileostomy losses

• SmofKabiven peri 1.5L provides Zinc 1.95mg • SmofKabiven central 1.5L provides Zinc 3.9mg

Page 45: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Infusion rate

The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for fat 0.15 g/kg bw/h.

The infusion rate should not exceed 3.0 ml/kg bw/h (corresponding to 0.21 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h).

The recommended infusion period is 14-24 hours.

Page 46: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Pregnancy and lactation

There are no data available on exposure of SmofKabiven peripheral in pregnant or breast-feeding women.

There are no studies available on reproductive toxicity in animals.

Parenteral nutrition may become necessary during pregnancy and lactation.

SmofKabiven peripheral should only be given to pregnant and breast-feeding women after careful consideration.

Page 47: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

副作用

常見>1/100及<1/10

不常見>1/1000及<1/100 罕見>1/10000及<1/1000

心血管疾病 心跳過速

呼吸、胸廓及縱膈疾病

呼吸困難

胃腸道疾病 缺乏食慾、噁心、嘔吐

代謝與營養疾病 血中肝酵素濃度升高

血管疾病 血栓性靜脈炎 低血壓、高血壓

一般疾病與注射部位問題

體溫略微升高 寒顫、暈眩、頭痛

過敏反應(如:過敏性或類過敏性反應、皮膚紅疹、蕁麻疹、潮紅、頭痛)、感覺熱或冷、蒼白、發紺、頸部、背部、骨頭、胸部或腰部疼痛

Page 48: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

禁忌症

對魚、蛋、大豆或花生的蛋白質過敏或對本品的任何有效成分或賦形劑過敏者嚴重高血脂症

重度肝功能不全

(TG>400 mg/dL)

(Child’s classification class C, or Ammonia abnormal)

(Restriction on protein: Encephalopathy — Moderate to severe; Ascites — Moderate to severe)

嚴重血液凝集疾病

先天性胺基酸代謝異常

重度腎功能不全,且未進行血液過濾或透析治療

(creatinine clearance<25ml/min)

急性休克

無法控制的高血糖

血中電解質(本品所含之任何一種)濃度有病理性升高的情形

輸注治療的一般禁忌:急性肺水腫、體內水分過多及喪失代償功能的心臟功能不全

血液吞噬作用症候群(Hemophagocytotic syndrome)

不穩定狀況(例如:嚴重的創傷後狀況、無法代償的糖尿病、急性心肌梗塞、中風、栓塞、代謝性酸中毒、嚴重敗血症、低張性脫水及高滲透性昏迷)

Page 49: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Drug Interaction

某些醫藥產品,如:胰島素,可能會干擾身體的脂肪分解酶系統,然而,這一類的交互作用在臨床上的重要性似乎相當有限。

投予臨床劑量的肝素(heparin)會造成暫時性的脂蛋白脂肪分解釋出至血液中。這在最初可能造成血漿的脂肪分解作用增加,接著三酸甘油酯的清除速率呈暫時性的減少。

大豆油含有天然的維生素K1成分,然而,SmofKabiven Peripheral裡所含的維生素K1濃度過低,不致對使用香豆素(coumarin)衍生物的病人之血液凝集過程產生重大影響。

Page 50: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

儲存

未開封之保存期限

2年

混合後之保存期限

經證實本品混合三腔室內容物後的化學與物理安定性在25°C下可維持36小時。基於微生物學考量,混合後應立即使用本品。若未立即使用,使用者有責任注意使用中的儲存時間與使用前的儲存條件,通常在25°C的環境下不得超過24小時。

與添加物混合後之保存期限

基於微生物學考量,添加完成後應立即使用本品。若未立即使用,使用者有責任注意使用中的儲存時間與使用前的儲存條件,通常在25°C的環境下不得超過24小時。

儲藏處不得超過25°C。不可冷凍。儲藏於外袋中。

Page 51: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven® Peri VS Central

Bag Size [l] 1.5 peri Central 1.5

Volume [ml] 1,448 1477

kcal 1,000 1,600

kcal NP 800 1,300

g N/bag 7.4 12

g AA/bag 46 75

g Lipids/bag 41 56

g anhydrous Gluc/bag 103 187

Ratio non-protein energy [kcal]:N[g]

108:1 108:1

Energy Lip:Gluc 50:50 42:58

Osmolarity [mosm/l] 850 1,500

pH 5.6 5.6

Page 52: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven® Peri VS Central

Bag Size [l] Recommend Electrolytes /day

1.5 peri Central 1.5

Sodium [meq] 60-150 36 60

Potassium[meq] 40-100 28 45

Magnesium [meq] 8-24 9.2 15

Calcium [meq] 5-15 4.6 7.6

Phosphate[mmol] 10-30 11.9 19

Chloride[meq] - 32 52

Acetate[meq] - 96 157

Zinc[mg] 2.5-5mg 1.95 3.9

Taurine (g) 0.46 0.75

Page 53: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven®central 1.5L- Electrolyte limit per bag

Bag Size [l] Original limit

Sodium [meq] 60 225

Potassium[meq] 45 225

Magnesium [meq] 15 15

Calcium [meq] 7.6 15

Phosphate[mmol] 19 22.5

Chloride[meq] 52 450

Acetate[meq] 157 225

Zinc[mg] 3.9 16.25

Page 54: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

CGMH Adult Parenteral Nutrition

Parenteral nutrition

Standard TPN

Hi-Nitrogen TPN

Heptic TPN Renal TPN

Peripheral PN

Page 55: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

CGMH TPN formula適應症

Standard TPN – 所使用的胺基酸屬於標準配方,其必需與非必需胺基酸的比例為1 :1。

Hepatic TPN – 則使用較高濃度的必需性支鏈胺基酸,如Isoleucine、Leucine及Valine以及較低濃

度的芳香環胺基酸,如Methionine、Phenylalanine及Tryptophane,適合肝功能不全病人。

HN TPN – 使用與Standard TPN相同成分的胺基酸,但提供較高的濃度(6%) ,適用於蛋白質

需求較高的病人。

Renal TPN – 使用高濃度必需胺基酸(60%),適合未洗腎的腎功能不全病患使用。

Peripheral TPN – 是2 in 1適合週邊靜脈給予之TPN製劑。

Page 56: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Peripheral PN - the range

Bag Size [l]

Peripheral PN 1200mL+20%

SMOFlipid 250mL

Smofkabiven peri 1448ml

Type 2 in 1 3 in1

Volume [ml] 1450 1,448

kcal 908 1000

kcal NP 950 800

g AA/bag 30 46

g N/bag 4.8 7.4

g Lipids/bag 50 41

g Gluc/bag 120 103

non-protein energy :g N ratio 198:1 110:1

Energy Lip:Gluc 52:48 50:50

Page 57: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Peripheral PN - the range

Bag Size [l]

Peripheral PN 1200mL+20%

SMOFlipid 250mL

Smofkabiven peri 1448ml

Sodium[meq] 48 36

Potassium[meq] 24 28

Magnesium [meq] 4.8 9.2

Calcium [meq] 7.2 4.6

Phosphate[mmol] 10.8 11.9

Chloride[mmol] 55.9 32

Acetate[mmol] 18 96

Zinc[mg] 3.4 1.95

Page 58: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

CGMH Standard 與High Nitrogen TPN

Standard TPN 1000mL

High Nitrogen TPN 1000mL

kcal 1020 801

10%Moriamin-SN添加量

425mL 600mL

Final AA Conc. 4.25% 6%

g AA/bag 42.5 60

50% Glucose添加量

500mL 330mL

Final Glucose conc 25% 16.5%

g Gluc/bag 250 165

Electrolyte content

均相同 Vitamins

Zn *

Page 59: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFkabiven central與 CGMH Standard TPN+20% Fat emulsion 250mL

Standard TPN 1250mL+20% fat emulsion250mL

SMOFkabiven central 1500mL

Volume [ml] 1500 1,477

kcal 1775 1,600

kcal NP 1562 1,300

g N/bag 8.5 12

g AA/bag 53 75

g Lipids/bag 50 56

g Glucose/bag 312 187

Ratio N[g]:non-protein energy [kcal]

1:183 1:108

Energy Lipid:Glucose 32:68 42:58

Page 60: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFkabiven central與 CGMH HN TPN+20% Fat emulsion 250mL

HN TPN 1250mL+20% fat emulsion250mL

SMOFkabiven central 1500mL

Volume [ml] 1500 1,477

kcal 1501 1,600

kcal NP 1201 1,300

g N/bag 12 12

g AA/bag 75 75

g Lipids/bag 50 56

g Glucose/bag 206 187

Ratio N[g]:non-protein energy [kcal]

1:100 1:108

Energy Lipid:Glucose 41.7:58.3 42:58

Page 61: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFkabiven central與 CGMH Standard TPN+20% Fat emulsion 250mL

Electrolytes Average supply per day

Standard TPN 1250mL+20% fat emulsion250mL

SMOFkabiven central 1500mL

Sodium [meq] 60-150 37.5 60 Potassium[meq] 40-100 35 45 Magnesium [meq] 8-24 12.5 15 Calcium [meq] 5-15 2.5 7.6 Phosphate[mmol] 10-30 16.9+4 19 Chloride[meq] - 47.8 52 Acetate[meq] - 31.9 157 Zinc[mg] 2.5-5 3.5 3.9

Page 62: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Advantage of SmofKabiven central

1. 可節省醫療人員計算處方的時間

2. 較少的醫療錯誤

3. 省去藥師測試溶液的穩定度及相容度之工作

4. 較少的調劑錯誤率

5. 有較佳的正氮平衡(Nitrogen含量較高)

6. 有較佳的營養利用率,以及可促進病患對營養液的耐受性(N: Non protein kcal=1:100-150)

7. 可及時在週末假日供給

8. 可供應給更多病患使用

9. 方便居家靜脈營養

Page 63: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Advantage of SmofKabiven central

10. 可節省藥師調配的時間,讓藥師有更多時間參與TPN臨床工作。

11. 可減少TPN的退藥量及成本。

12. TPN施打時管路接觸點愈少,愈能降低管路感染的併發症。

13. 病患施打較不易產生高血糖(Non protein kcal中 Lipid:Glucose=42:58),可節省Insulin使用量,降低感染機率。

Page 64: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven®peri- dosage Recommended bag sizes according to patient‘s amino acid requirements

Page 65: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SmofKabiven®central- dosage Recommended bag sizes according to patient‘s amino acid requirements

Page 66: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Handling– Easy and Safe 操作簡單安全

混合步驟

步驟1 步驟3 步驟2 1 2 3

(步驟1) 將袋子放在桌面上, 右手先將袋子右側由上往下捲動, 將液體朝左方壓

(步驟2) 右手持續壓住, 換左手捲動袋子左側, 液體壓力持續增加, 直到最後將葡萄糖與胺基酸中間的垂直

熱封線壓開

(步驟3) 兩手一齊向下捲動, 最後混合脂肪乳劑

備註1. 三腔室液體完全混合後, 垂直熱封線會完全裂開, 而水平熱封線還存在 為正常,不要將水平線撕開

Page 67: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFkabiven在外科病患的好處

Department Benefits

一般外科 SMOFlipid-配方均衡且具抗發炎與免疫調節的脂肪乳劑 Taurine-促進膽汁分泌,減少靜脈營養所造成的膽汁鬱積 Zinc-促進術後傷口癒合,加強免疫功能及有助血糖調節 創傷科

神經外科 DHA和Taurine具有神經保護的功能

直肛科 低 Omega-6/omega-3 ratio可減少癌細胞分化增生

心胸外科 Omega-3和Taurine具有抗發炎,抗氧化及保護心臟的功能

Page 68: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

SMOFkabiven在內科病患的好處

Department Benefits

胸腔內科 針對急性肺損傷和呼吸窘迫的病患,Omega-3可降低死亡率,減少呼吸器使用及縮短住院天數

肝膽腸胃科 Taurine促進膽汁分泌,減少靜脈營養造成的膽汁鬱積,肝功能不良的病患常缺乏Zinc

腫瘤科

Omega-3 可調節血液惡病質所產生的食慾不振,維持病患的體重,增進生活品質及增強化療的耐受性

taurine在接受化療的病患會缺乏

腎臟科 Taurine具有抗氧化及保護腎臟的功能

Page 69: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

© Copyright Fresenius Kabi AG

Page 70: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

Fresenius Kabi Baxter

品名 SMOFKabiven PI Oliclinomel N4-550E PI

溶液量 / 健保價 1448ml / 883元 1500ml / 919元

CHO% 103 g

(41%)

120 g

(53%)

AA% 46 g

(18%)

33 g

(14%)

Fat% 41 g

(41%)

30 g

(33%)

Total calorie 1006 kcal 910 Kcal

Calorie density 0.7 kcal/ml 0.6 kcal/ml

Fatty acids profile SMOFlipid: 黃豆油 (30%)

MCT Oil (30%) 橄欖油 (25%) 魚油 (15%)

- EPA (2.4 wt%)

- DHA (2.2 wt%)

100% LCT (20% soybean oil, 80%

olive oil)

SmofKabiven 1448ml 與 一般市售AIO比較表

Page 71: SmofKabiven® peripheral & central · SMOFlipid® Components % g/1000ml Characteristics Soybean oil 提供亞麻油酸30% 60 g (linoleic acid)、次亞麻油酸 ( -linolenic acid

產品 SmofKabiven Oliclinomel

三合一所使用的脂肪乳劑 衛生署核准成人、兒童、新生兒、早產兒使用之適應症 (富含EPA, DHA, 可促進嬰兒腦部與視力的發育)

衛生署只核准成人、兒童使用之適應症

Zinc Sulfate(Zn) 6 mg (1.95mg) 0 Supplementation of zinc prevents disturbances

in wound healing and impairments in immune

function & glucose tolerance

Taurine 0.46 g 0

Taurine作用:

1. Reduces TPN induced post-operative

cholestasis (Wang 1991)

2. Has immunemodulatory effects (Redmont

1998)

3. Influences hyperglycemia (Nakaya 2000, Wu

1999, Franconi 1995)

Nitrogen : Non Protein Calorie 1 : 110 1 : 158 Recommendation: 1:100-150

linoleic acid 亞麻油酸 8.64 g 5.10 g 必須脂肪酸是人體細胞膜主要組成份之一. 缺乏時會發生脂漏性皮膚炎, 生長遲滯, 生育損害, 脂肪肝等症狀. 急重症病患每日至少需要8-10公克必須脂肪酸 (ESPEN guideline)

α- linolenic acid 次亞麻油酸 1.33 g 0.72 g

必須脂肪酸含量 9.97 g 5.82 g (不足)

三合一週邊劑型所使用之脂肪乳劑濃度 20% 10% 10%脂肪乳劑的PL/TG比值較高, 施打之

後TG廓清率較差, 容易造成體內膽固醇及TG上升 PL/TG ratio 0.06 0.06

ω6/ω3 ratio 2.5 : 1 9 :1 ω6/ω3建議比值 2~ 4 : 1

必須氨基酸 / 非必須氨基酸 45/55 40/60

(必須胺基酸少) 必須胺基酸較多有利體內蛋白質合成