藥物及腸內營養(yǎng)相互作用的的設計研究進展

1、 藥物與腸內營養(yǎng)相互作用的研究進展綜 述腸內營養(yǎng)(Enteral Nutrition，EN)是經口或管飼由胃腸道提供代謝需要的營養(yǎng)基質及其他各種營養(yǎng)素的支持方式【1】。20世紀80年代，腸內營養(yǎng)開始提供全營養(yǎng)素支持，小腸營養(yǎng)配方及胃食管技術得到長足的發(fā)展。隨著接受各種方式腸內營養(yǎng)的患者增加，藥物營養(yǎng)物質的相互作用（Drug-nutrition interrelations，DNIs）也越來越受到重視。藥物與營養(yǎng)物質發(fā)生的藥劑學、藥動學及藥理學、生理學、病理生理相互作用都有可能使治療結果反轉1。如何全面正確地掌握藥物與其它常用藥物之間的相互作用知識， 并在臨床實踐中加以合理的應用，是擺在醫(yī)藥工作

2、者們面前的一個艱巨而重要的任務。本文針對DNIs的最重要三方面因素綜述如下：1 藥劑學影響藥劑學方面藥物營養(yǎng)物質相互作用主要指藥物的劑型不適當?shù)馗淖円灾滤幬锎┻^胃食管造成不正確的用藥途徑，藥物毒性或胃腸道刺激。液體制劑通常能夠通過喂食管給藥，為某些特殊用途設計的片劑或膠囊劑也同樣可以通過喂食管給藥，而固體劑型必須轉變?yōu)榉勰┗蛐☆w粒后與水混勻方能穿過喂食管。但是在治療過程中，當藥物的劑型遭到不同程度的破壞時，藥物制劑的穩(wěn)定性、安全性和有效性就發(fā)生一定程度的改變。因此，在臨床治療過程中，應選擇最合適的劑型給藥。由于液體制劑易被吸收，而且不大可能造成胃食管阻塞，而通常作為首選，酊劑或混懸劑相對糖漿劑

3、不易與腸內營養(yǎng)發(fā)生結塊而更受青睞3。而只有當液體制劑不適用時才會考慮某些固體制劑，但大多要粉碎后，導致最低限度的藥動學改變。固體制劑中腸衣片與長效片劑最容易發(fā)生藥劑學相互作用。腸溶衣片劑或微囊劑被壓碎通過口服或插管給藥進入機體后，由于去掉了保護膜就會暴露在胃酸中或對機體產生刺激、毒性反應。如果將藥物直接運送到空腸，就不需要腸溶衣。但是，粉碎腸溶衣劑型也可能帶來相互作用等問題。粉碎腸溶衣是件很麻煩的事，其碎片加水后容易成團，堵塞胃食管4。無論何種情況，改變給藥途徑都要比試圖通過胃食管給藥更好。通過研究發(fā)現(xiàn)一些微囊劑可以將制劑中的藥物取出后再通過胃食管。盡管這樣會有部分殘留，除非用酸性液體強烈的沖

4、刷，或者可以將這些殘留浸泡在酸性果汁中，這樣的方法同樣有胃食管阻塞的風險2。無論哪種方法都需要很小的管子，特別是手術用的管子，它可以用碳酸氫鹽10倍地溶解腸溶衣，之后可以壓碎或溶解藥物形成膏狀物。如果藥物設計的劑型是控釋制劑，那么不能為了經胃食管給藥而將其粉碎或在其他方面有所改變，這種劑型在片劑或膠囊里通常包含了幾種劑量的藥物。壓碎或溶解緩釋藥物使其立即釋放，則會出現(xiàn)在開始階段“過量”而幾小時后藥物失去活性的現(xiàn)象。此時，毒性作用會增加。藥物對病情控制也會不穩(wěn)定。例如地爾硫卓（Tiazac, Biovail Pharmaceutical, Morrisville, NC）和維拉帕米（Verela

5、n， UCB Pharma, Smyrna，GA）68。Ferrone等9描述了如何將含有腸溶微球的緩釋胰腺酶膠囊（Pancrecarb MS-4， Digestive Care，Inc., Bethlehem, PA）打開與蘋果醬或蘋果汁混合在一起后由胃食管送下。某些腸溶衣的緩釋劑可以通過大口徑的胃食管給藥。其他包被片（如薄膜衣）即使碾碎也很難從管壁上洗下，同樣很麻煩。然而有文獻報道有些藥物經過一些改變后仍然可以使用10。粘稠性液體制劑（如混懸劑）可能會粘附在胃食管上導致藥物在沖洗后還停留在導管表面，這會直接影響藥物的運送、吸收，產生藥動學相互作用11,12。輔料作為藥物的輔助性添加劑，盡管

6、不與機體發(fā)生反應但有時也產生生理學的影響。有研究表明小麥和玉蜀黍淀粉通常作為片劑的粘合劑可能會引起患者的腸?。ㄈ缈谘仔愿篂a）。Hyams也發(fā)現(xiàn)通常作為增溶劑以防止蔗糖結晶的山梨醇，在20g50g劑量下可作為瀉藥，因此可能引發(fā)患者嚴重痙攣及腹瀉13。藥動學影響藥動學的影響主要指由于營養(yǎng)物質和藥物的相互作用，導致藥物在人體的吸收、分布、代謝、消除等過程的改變。2.1吸收 其與生物利用度直接相關。藥物或營養(yǎng)的吸收的紊亂常會導致它們的吸收的減少14,15。一般情況下，理化不兼容性和胃腸道pH的干擾都與無活性產物的形成有關。另一方面，胃腸運動，分泌物，菌群及粘膜形態(tài)與功能更易誘發(fā)吸收速率的改變。在個別情

7、況下直接將藥物加入到營養(yǎng)配方中引起理化不相容性，從而降低了藥物的吸收，增加胃食管阻塞的風險和潛在的微生物污染1618 。根據(jù)統(tǒng)計數(shù)據(jù)可以看出，吸收似乎與纖維的含量有關。食用纖維能夠增加阿莫西林的吸收速率，但是明顯的降低吸收的總量，因此Chandler等人19 得出這可能是阿莫西林對纖維基質的吸收作用導致的結論。高果膠的膳食中果膠是作為對乙酰氨基酚的吸收劑20。果膠和燕麥麩纖維都能減少洛伐他汀的吸收21。因此，在服用類似藥物時，服藥與進食最好間隔2個小時。在藥物和營養(yǎng)物質相互影響中，絡合是一個不同的機制。例如膳食中的礦物質鋅，鐵，鈣，鎂的可溶性鹽都會與四環(huán)素，喹諾酮和抗酸劑絡合14,20。而包含

8、鋁鎂類的抗酸劑通常會由于不可溶性鋁或鎂的磷酸鹽的產生引起臨床上明顯的磷酸鹽耗竭癥狀14,22。左旋多巴與鐵的螯合會減弱對帕金森病情的控制23。硫酸鋁與膳食中的蛋白質結合易引起不溶性物質（胃腸結石）的產生及藥物療效的降低24。所以，上述藥物都應飯前1小時空腹服用。胃腸道中pH值的改變能影響藥物或營養(yǎng)物質的離子和非離子的形式，從而影響吸收過程20。引起胃腸道PH的降低的藥物（抗酸劑，組胺H2受體拮抗劑和蛋白泵抑制劑）與硫胺、氯鈷胺、和鐵同時服用會引起后者吸收的降低23,25。另一方面，胃內持續(xù)的營養(yǎng)會增加胃腸道的PH，從而阻止異煙肼的溶解與吸收20。硫糖鋁為達到治療效應需要一個酸性的環(huán)境來成為有活

9、性的物質24。酮康唑需要酸性環(huán)境來溶解吸收24-30。相反，環(huán)丙沙星和奧美拉唑在堿性環(huán)境中更易吸收。去羥肌苷（嘌呤核苷類抗艾滋病藥）需要防止酸的催化分解。胃內營養(yǎng)能提高去羥肌苷的吸收總量但是不能提高吸收速率21?？傊?，胃腸道PH值的影響是有爭議的，無論是本能的還是誘導的變化都應對已知的相互作用進行研究，從而避免這種相互作用。2.2分布 藥物與營養(yǎng)物質的分布是與轉運蛋白競爭結合引起的DNI的另一種形式。理論上，高脂肪的膳食能迅速增加血漿中的游離脂肪酸量，瞬間的取代藥物結合與白蛋白上，可能會增加藥物的藥理作用19雖然還沒有相關的臨床案例報道。長期的攝入蛋白不足可能會減少白蛋白的數(shù)量，當藥物的分布與

10、蛋白結合基有關時就會影響藥物的分布。2.3代謝 其與營養(yǎng)配方和藥物的代謝形式有關14。由于營養(yǎng)物質影響代謝酶的合成與活性，同樣，同時服用藥物與營養(yǎng)物質會影響肝微粒體復合功能氧化酶活性的激活或抑制14,28。高蛋白攝入能刺激微粒體復合功能氧化酶系統(tǒng)活性，對某些藥物的清除作用會升高。煙酸、維生素B2大劑量的維生素C也能增加微粒體復合功能氧化酶系統(tǒng)活性。而且，這些影響通常與肝血流量的改變有關28。很多文獻都報道了當病人將高蛋白或是低碳水化合物的飲食與茶堿同服后茶堿的半衰期能明顯的降低19,28,29,30；而同時服用高脂的飲食會產生茶堿的毒性癥狀14。然而，膳食中蛋白質和脂肪能刺激內臟的肝血流量，這

11、與藥物的肝提取率有關，如普萘洛爾和拉貝洛爾14,20,28。但是，在對這些觀察結果的臨床影響做出任何結論性的論斷之前，還需要更多的研究。大多數(shù)關于飲食對微粒體復合功能氧化酶系統(tǒng)活性的影響都進行了動物實驗研究。2.4排泄 飲食與藥物都可引起尿酸或是尿堿14。低蛋白飲食會導致尿液PH值增加。堿化尿液可以增加呋喃妥因的排泄及其效應。此外，當呋喃妥因與食物同食時，會引起其耐受性及吸收的增加31。低蛋白飲食可能會增加腎臟對喹諾酮的重吸收，增加藥物的毒性。相似的飲食也能促進腎小管對別嘌呤醇的主要代謝物（奧昔嘌醇）的重吸收，導致對于老年人具有重要實際意義的毒性作用14。相反，高蛋白飲食引起的尿酸會增加陽離子

12、表面活性劑類藥物的排泄，例如：阿密曲替林高蛋白飲食也會增加腎臟的血流量和由胰高血糖素介導的腎小球濾過率14,19。藥理學影響當一個藥物的作用機制會干擾營養(yǎng)物質的吸收，或者引起腸道喂食不耐受時，即發(fā)生了藥理學相互作用。服用能刺激胃腸道活動能力的藥物，像阿托品、紅霉素、東莨菪堿等配方特性，通過延遲或加速胃排空的時間而影響腸內營養(yǎng)的吸收。對于早期的危重病人胃排空的改善更傾向于給予腸內營養(yǎng)。Ritz和他的同事32隨機挑選了35名機械通氣患者（平均健康狀況評分19），進行了給予紅霉素70克或200克或安慰劑的隨機化雙盲實驗。他們發(fā)現(xiàn)給予70克或200克的實驗組的胃排空比安慰劑組的更快。接著他們又比較了7

13、0克和200克型和型糖尿病易致胃輕癱的并發(fā)癥，Nguyen等人33將12名危重的2型糖尿病患者和15名非糖尿病患者在年齡和性別上相匹配進行試驗，發(fā)現(xiàn)糖尿病病人的胃排空比非糖尿病病人的胃排空更快，幾乎和健康受試者排空相似。但是由于樣本的數(shù)目的相對比較小，所得結果可能存在偏差，還有待于對其進行大樣本更細致的研究。而對于腸內營養(yǎng)中的配方組分也能通過影響機體的某些生理機制而干擾藥物的作用機制藥物的。最典型的例子就是較高維生素K含量的腸內營養(yǎng)配方拮抗華法林抗凝作用。華法林通過以致維生素K依賴性凝血因子（、和）在肝臟發(fā)揮作用，對于接受華法林治療的患者只要謹慎的選擇小腸配方就可以很好的避免這一相互作用。因此

14、在臨床選擇藥物時，必須考慮藥物藥理作用對胃腸道的影響，以最大限度的減少不良影響。結論以上幾方面都受到醫(yī)學界的廣泛關注，接受腸內營養(yǎng)治療患者發(fā)生DNI的影響因素，即藥劑學、藥動學、藥理學三方面的因素，雖是重點內容，但仍然是研究不是很充分的。比如苯妥英是發(fā)現(xiàn)與小腸配方有明顯相互作用的第一個藥物，雖然距其發(fā)現(xiàn)已將近30年，但是對于相互作用的產生原因及臨床表征依然存在爭議，那些數(shù)據(jù)只能證明它們之間存在著相互作用34,35。并且由于鑒定藥物和小腸營養(yǎng)配方成分之間相互作用的資料太少，并且常常是矛盾的，給藥技術也太少。同樣用于控制DNI的技術也是有限的。國內對腸內營養(yǎng)的研究更少，國外相對多但是資料也是太陳舊

15、或是不適用于現(xiàn)在使用的產品。但藥物與營養(yǎng)物質的DNI確實存在，且嚴重的影響人類的健康，因此需要醫(yī)學界的廣泛關注，在今后的臨床實踐當中能夠盡量的降低患者發(fā)生DNI的風險，并減少不良反應的發(fā)生。參考文獻：1 HYPERLINK /mn/searchApp?searchWord=%E4%B8%AD%E5%8D%8E%E5%8C%BB%E5%AD%A6%E4%BC%9A 中華醫(yī)學會.臨床診療指南:腸外腸內營養(yǎng)學分冊(2008版) . 北京:人民衛(wèi)生出版社,2009:352 HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Williams%20N

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25、ubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Hoskins LA, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Bernard%20AC%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Bernard AC . Enteral nutrition and drug administration, interacti

26、ons, and complications. HYPERLINK javascript:AL_get(this,%20jour,%20Nutr%20Clin%20Pract.); Nutr Clin Pract. 2005 Dec;20(6):618-24Beckwith MC, Feddema SS, Barton RG et al. A guide to drug therapy in patients with enteral feeding tubes: dosage form selection and administration methods.Hosp Pharm. 2004

27、; 39:225-37.Gilbar PJ. A guide to enteral drug administration in palliative care. J Pain Symptom Manage. 1999; 17:197-207.Mitchell JF. Institute for Safe Medication Practices Oral dosage forms that should not be crushed. Farm Clin. 1998; 5: 324-338Ferrone M, Raimondo M, Scolapio JS. Pancreatic enzym

28、e parmacotherapy. harmacotherapy. 2007; 27:910-2010.Mitchell JF, Oral dosage forms that should not be crushed. Hosp Pharm 2002; 35: 553-567.Clark-Schmidt AL, Garnett WR, Lowe DR, et al. Loss of carbamazepine susupengsion through nasogastic feeding tubes. J. Hosp. Pharm. 1990; 47:2034-2037.McGoodwin

29、PE, Seifert CF, Bradberry JC, Recovery of phenytion form a percutaneous endoscopic gastrostomy pezzar catheter following in vitro delivery of multiple doses of phenytoin suspension and phenytoin capsules. Pharmacotherapy 1990; 10: Hyams JS. Sorbitol intolerance. An unappreciated cause of functional

30、gastrointestinal complaints. Gastroenterology 1983; 84:30-33.Utermohlen V. Shills ME, Olson JA, Diet, nutrition and drug interactions. Modern nutrition in health and disease. 1999:1619-1641.Palleja A M, Pera D, Falga S J, A.Managing drug therapy in patients receiving enteral and parenteral nutrition

31、. Farm Clin. 1988; 5: 324-338.Kumpf VJ, Chessman KH. et al. Pharmacotherapy: a pathophysiologic approach. Enteral nutrition; 2005:2615-34.Gora ML, Tschampel MM, Visconti JA. Considerations of drug therapy in patients receiving enteral nutrition. Nutr. Clin. Pract. 1989; 4:105-10.Thomson FC, Naysmith

32、 MR, Lindsay A. Managing drug therapy in patients receiving enteral and parenteral nutrition. Hosp Pharmacist. 2000; 7:155-64.Chandler M H, Blouin R A,. Applied pharmacokinetics. Principles of therapeutic drug monitoring. Vancouver: Applied Therapeutics, 1992;12-1: 12-16.Thomas J A. Drug-nutrient in

33、teractions. Nutr. Rev. 1995; 53:271-282.Gibaldi. Drug interactions: part II. Ann Pharmacoth 1992; 26: 829-834Knapp H. In: Zigler E E, Filer L J Present knowledge in nutrition. Nutrient-drug interactions, 1996; 540-546.Mason P. Nutrition and dietary advice in the pharmacy. Drug-nutrient interaction,

34、1994; 223-237.Johnson D R, Nyffeler M S. Drug-nutrient considerations for enteral nutrition. In: American Society for Parenteral and Enteral Nutrition (eds) The ASPEN nutrition support practice manual. 1 st ed. Silver Spring: American Society for Parenteral and Enteral Nutrition 1998; 61: 6-20.Marcu

35、ard S P, Albernaz L, Khazanie P G. Omeprazole therapy causes malabsorption of cyanocobalamin. Ann Intern Med 1994; 120: 211-215.Thomson C A, Rollins C J, Rolandelli R H, Enteral and tube feeding, Nutrient-drug interactions.1997: 523-539.Yuk J H, Nightingale C H. Relative bioavailability in healthy v

36、olunteers of ciprooxacin administered through a nasogastric tube with and without enteral feedings. Antimicrob Agents Chemother 1989; 33: 1118-1120.Walter-Sack I, Klotz U. Influence of diet and nutritional status on drug metabolism. Clin. Pharmacokinet 1996; 31: 47-64.Strom J G, Miller S W. Stabilit

37、y of drug with enteral nutrient formulas. Ann Pharmacother 1990; 24: 130-134.Varella L, Jones E, Meguid M M. Drug-nutrient interactions in enteral feeding: a primary care focus. Nurse Practitioner 1997; 22:98-104.Rosenberg I, Berry E. Basic principles in therapeutics. Nutrition 1992: 248-269.Ritz MA

38、, Chapman MJ, Fraser RJ, Erythromycin dose of 70 mg accelerates gastric emptying as effectively as 200 mg in the critically ill. Intensive Care Med. 2000; 31: 949954.Nguyen NQ, Chapman M, Fraser RJ, Long-standing type II diabetes mellitus is not a risk factor for slow gastric emptying in critically

39、ill patients. Intensive Care Med. 32:13651370.Aueung SC Ensom M.H., Phenytoin and enteral feedings: does evidence support an interaction. Ann. Pharmaceutics. 2000; 34:896.Gilbert, S., How to minimize interaction between phenytoin and enteral feedings: two approaches-a strategic approach, Nutr.Clin.

40、Prac. 1996; 11:28. HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Gago%20S%C3%A1nchez%20AI%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Gago Snchez AI, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Garzas%20Mart%C3%ADn

41、%20de%20Almagro%20C%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Garzas Martn de Almagro C, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22C%C3%A1rdenas%20Aranzana%20M%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_

42、ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Crdenas Aranzana M, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Cala%C3%B1as%20Continente%20A%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Calaas Continente A, HYPER

43、LINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Calleja%20Hern%C3%A1ndez%20MA%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Calleja Hernndez MA .Pharmaceutical care for patients with enteral nutrition. HYPERLINK javascript:AL_get(th

44、is,%20jour,%20Farm%20Hosp.); Farm Hosp. 2006 Jan-Feb;30(1):44-8.OBJECTIVE: To detect potential complications and interactions between drugs and enteral nutrition (EN) as to describe the interventions carried out by the pharmacist in those circumstances and to propose strategies of improvement. METHO

45、D: Prospective assessment of patients admitted to hospital candidates to receive EN. The pharmacist worked as part of the team of Endocrinology and Nutrition for one month. A data collection form was designed for the study in which the following information had to be recorded: NE indications, nutrit

46、ion characteristics (type, route of administration, infusion rate), pharmacological therapy, drug/EN interaction and complications. RESULTS: The study included 14 patients (mean age of 50 +/- 13 years) in which digestive (35.7%) and neurological (28.6%) complications were the most frequent indicatio

47、ns for EN. Eleven patients (78.57%) reported complications associated to EN, mostly digestive (57.14%). The main cause for consultation was related to the administration of drugs via NGT (nasogastric tube). A total of 77 drugs were prescribed, 23 of which were administered in this way, so a guidelin

48、es for the administration of drugs via nasogastric tube was prepared. CONCLUSIONS: The hospital pharmacist can actively cooperate with nutritional support units, given the need to assess the nutritional support administered and to manage potential complications and interactions between nutritional s

49、tatus, drugs and artificial nutrition. The pharmacist also plays a significant role in the prevention and identification of problems related to the administration of drugs via NGT.臨床藥師作用: HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Cerulli%20J%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubm

50、ed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Cerulli J, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Malone%20M%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Malone M. Assessment of drug-related problem

51、s in clinical nutrition patients. HYPERLINK javascript:AL_get(this,%20jour,%20JPEN%20J%20Parenter%20Enteral%20Nutr.); JPEN J Parenter Enteral Nutr. 1999 Jul-Aug;23(4):218-21 HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Anoz%20Jim%C3%A9nez%20L%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed

52、.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Anoz Jimnez L, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Borr%C3%A1s%20Almenar%20C%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Borrs Almenar C, HYPERLINK /sites/entrez?Db=pubmed&Cmd=Search&Term=%22Cavera%20Rodrigo%20E%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus Cavera Rodrigo E. Pharmace