Korean J Gastroenterol Vol. 63 No. 2, 99-106 http://dx.doi.org/10.4166/kjg.2014.63.2.99 pissn 1598-9992 eissn 2233-6869 ORIGINAL ARTICLE 경장영양이필요한환자에서경장영양펌프의효과 : 체계적문헌분석 모진아 1,2, 이선희 1, 전미혜 1, 김경식 3, 김화순 2, 장재영 4, 이명덕 5 한국보건의료연구원 1, 인하대학교의과대학간호학과 2, 연세대학교의과대학외과학교실 3, 순천향대학교의과대학내과학교실 4, 가톨릭대학교의과대학외과학교실 5 Efficacy of Feeding Pump for Patients on Enteral Tube Feeding: A Systematic Literature Review and Analysis Jin A Mo 1,2, Seon Heui Lee 1, Mi Hye Jeon 1, Kyung Sik Kim 3, Hwa Soon Kim 2, Jae Young Jang 4 and Myung Duk Lee 5 National Evidence-based Health Care Collaborating Agency, Seoul 1, Department of Nursing, Inha University College of Medicine, Incheon 2, Department of Surgery, Yonsei University College of Medicine, Seoul 3, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul 4, Department of Surgery, The Catholic University of Korea College of Medicine, Seoul 5, Korea Background/Aims: This study was conducted to establish a guideline on the utilizing of feeding pump in patients requiring enteral tube feeding. Methods: As a first step, textbooks on nutrition and guidelines from regional clinical nutrition societies were analyzed. Afterwards, data on the efficacy, safety, and practicality of feeding pump application were collected and evaluated by systematically reviewing the related literature. As data sources, 8 domestic databases including KoreaMed and global databases such as Ovid-MEDLINE, Ovid-EMBASE, and Cochrane Library were utilized. A total of 2,016 related articles was selected by applying the keyword (enteral feeding.mp AND pump.mp). Results: Textbooks and guidelines were not able to draw conclusions on the effects of the feeding pump because the injection speed, tube size, and etcetera were different for enteral feeding. Feeding pump assisted enteral tube feeding was an efficient, safe, and practical procedure for reducing maladjustment-related complications of enteral tube feeding, which are obvious obstacles for maintaining nutritional balances in patients requiring tube feeding. Conclusions: Feeding pump application can be considered an efficient and safe measure that is acceptable in patients on small intestinal tube feeding, critically-ill patients on gastro-intestinal tube feeding, premature babies, and critically-ill or severely malnourished children (recommendation grade D). (Korean J Gastroenterol 2014;63:99-106) Key Words: Enteral nutrition; Feeding methods; Review 서론 미숙아, 흉복부수술, 화상, 주요외상, 심한패혈증, 폐쇄두부외상, 심한췌장염등영양섭취가불량하나구강을통한정상적인급식이불가능한경우또는부족한환자에서경관급식 (tube feeding) 을통한적절한영양공급은치유와회복을빠 르게할뿐만아니라, 사망률을 50% 까지줄일수있다고알려져있다. 1 또한, 조기경관급식을통한적절한영양공급제공은중환자실재원기간단축, 감염률감소및의료비용지출감소에긍정적인효과가있다. 2 질병치료를위하여환자의일일영양요구량에맞추어일정시간내또는일정시간간격으로정확히공급하는것이필수 Received November 14, 2013. Revised January 2, 2014. Accepted January 15, 2014. CC This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/ by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 교신저자 : 이명덕, 137-701, 서울시서초구반포대로 222, 가톨릭대학교서울성모병원소아외과 Correspondence to: Myung Duk Lee, Department of Pediatric Surgery, The Catholic University of Korea, Seoul St. Mary s Hospital, 222 Banpo-daero, Seocho-gu, Seoul 137-701, Korea. Tel: +82-2-2258-6092, Fax: +82-2-596-2944, E-mail: myungdlee@gmail.com Financial support: This study was supported by research funds of the Ministry of Health and Welfare. Conflict of interest: None. Korean J Gastroenterol, Vol. 63 No. 2, February 2014 www.kjg.or.kr
100 모진아등. 경장영양펌프의효과 적이지만, 중력을이용한점적방법이나주사기를이용한영양액주입은일정시간내정확한양을공급하기어렵다. 특히장운동이감소한중환자에서는단시간내에많은양이위에주입되어위식도역류에의한흡인성폐렴, 고삼투성설사등이자주발생하는등중대한위험을초래할수있고, 합병증이발생한경우에는경관급식이중단됨으로써충분한영양공급이이루어지지않는문제점이있다. 3 미숙아의경우에는투여된영양제에대한적응력이떨어지거나괴사성장염혹은영양소의독성효과를나타낼위험성이존재한다. 4 따라서간헐주입부적응시나혈당조절문제가있는경우, 또는공장내로직접투입시에는시간당주입용량을일정하게유지하고자펌프를이용한지속주입방법이개발되었다. 5 2009년한국정맥경장영양학회에서실시한국내실태조사결과에따르면, 경관급식은 1일 3회가 74.3% 로가장많았으나주된공급방법중펌프를이용한경장영양액주입은 0% 로조사되었고, 대부분볼루스 (bolus) 주입법 (28.6%) 과간헐적주입법 (60%) 으로영양액을공급하였다. 그러나, 응답자중약 68.8% 와중환자실경장영양 (enteral tube feeding) 을시행받는환자중 50% 정도가주입용펌프가필요하다고하였으며, 경장영양펌프사용지침및현실에맞는경장영양펌프개발, 이에따른의료행위별수가책정이필요하다는의견이있었다. 6 경장영양펌프 (feeding pump) 를이용한경장영양공급은환자에게적절한 1일영양요구량을정확히공급하고, 영양상태를유지또는호전시켜치료와회복에기여할뿐만아니라, 의료사고방지, 합병증감소등의목적이있음에도불구하고, 아직그효과에대해객관적으로입증되어있지않아의료진각자의판단에따라임의로사용되고있는것이현실이다. 따라서이번연구에서는체계적문헌고찰을통해경장영양펌프적용의효과, 안전성및유효성을총괄적으로조사하고정리함으로써향후이에대한국내실정에맞는기준을제시하고자한다. 문헌고찰을시행하였다. 체계적문헌고찰을통해도출된자료는대한의사협회에서추천한소아외과전문의 1인, 보건복지부산하신의료기술평가위원회에서추천한소화기내과전문의 1인, 한국정맥경장영양학회에서추천한외과전문의 2인, 대한간호협회에서추천한간호학과교수 1인과함께총 8회의연구회의 ( 서면회의 4회, 대면회의 4회 ) 를하였고임상현장을고려하여종합적으로재평가하고정리하였다. 체계적문헌고찰의문헌검색은 KoreaMed를포함한 8개국내데이터베이스와 Ovid-MEDLINE, EMBASE 및 Cochrane Library의국외데이터베이스를이용하여 2012년 7월 9 일최종검색을완료하였다. 먼저, 2012년 5월 3일 Ovid- EMBASE에서 (enteral feeding.mp AND pump.mp), Ovid-MEDLINE에서 (enteral nutrition.mp AND pump. mp) 의검색어로조합하여검색된문헌 183개의초록을검토하여 Patients-Intervention-Comparators-Outcomes (PICO) 및검색전략초안을작성하였다. 대상환자는경관급식이필요한환자였으며, 중재시술은펌프를이용한경장영양액주입이었고, 비교시술은펌프를사용하지않은경장영양액주입이었다. 임상의료결과는안전성과유효성으로나누어평가하였다. 안전성은정량조절상태, 영양공급부작용관련혈액지표 (alkaline phosphatase, inorganic phosphate, glutamic oxaloacetate transaminase/ glutamic pyruvate transaminase), 합병증정도로평가하였고, 유효성은의료결과향상 ( 경장영양적응도, 혈액영양지표, 체중변화 ), 환자만족도, 의료진의편의성으로하였다. 국내문헌은 enteral feeding pump, feeding pump, 경장영양펌프 등과같은관련검색어를위주로한검색전략을통해 8개의인터넷검색데이터베이스를이용하여검색하였으나, 관련문헌은검색되지않았다. 국외문헌은 MEDLINE 과 EMBASE를이용하여 Table 1과같은검색전략을도출하 대상및방법 1. 문헌고찰을통한도출과정경장영양펌프를이용한경관급식요법의평가는첫째, 동시술의임상적유용성에대해임상영양관리지침서 (2008), 7 미국정맥경장영양학회 (2009), 8 미국중환자의학회 (2008), 9 유럽정맥경장영양학회 (2006), 10 캐나다중환자회 (2009) 11 에서발표한가이드라인을검토하였고, 둘째, 코크란연합 (Cochrane collaboration) 의중재법에대한체계적문헌고찰핸드북 12 및 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 그룹이제시한체계적문헌고찰보고지침 13 에따라동시술의안전성과유효성에대해체계적 Table 1. Ovid-MEDLINE and EMBASE Search Strategy PICO No Search term Searched literature (n) MEDLINE EMBASE Intervention 1 (continuous* or enter*).mp 569,028 808,196 2 (nutrition* or feed*).mp 479,194 637,210 3 1 AND 2 40,241 57,349 Comparators 4 (intermittent or bolus).mp 95,752 129,443 5 3 AND 4 978 1,398 Human 6 animal/ 4,996,634 1,787,973 7 human/ 12,410,338 13,549,870 8 6 not (6 and 7) 3,659,357 1,339,269 9 5 not 8 720 1,296 Total 720 1,296 PICO, Patients-Intervention-Comparators-Outcomes. The Korean Journal of Gastroenterology
Mo JA, et al. Efficacy of Feeding Pump 101 Fig. 1. Flow diagram of the article selection process. 였으며, 그외 Cochrane Library 및국외데이터베이스에서 feeding pump 로검색하여, 1편의문헌 14 이확인되었다. 2. 문헌선택및배제기준 1) 선택기준 (inclusion criteria) ㆍ경장영양이필요한환자를대상으로한연구ㆍ영양액주입방법으로펌프또는주사기장착형펌프 (syringe pump) 를이용한연구ㆍ적절한의료결과를보고한연구 2) 배제기준 (exclusion criteria) ㆍ동물치료및전임상시험연구ㆍ한국어, 영어및일본어로출판되지않은연구ㆍ원저가아닌연구 (non-systematic reviews, editorial, letter, comment, opinion pieces, review, congress or conference material, guideline, note, news article, abstract, etc.) ㆍ다른치료법과결과가혼합되어경장영양펌프의결과만을구별하기어려운경우ㆍ적절한비교시술과비교되지않은연구 ( 펌프사용유무를기술하지않은연구 ) 총 2,016개의문헌을검색하였고, 그후위와같은문헌 배제기준에해당하는 1,319개문헌과중복검색자료 686편을포함하여총 2,005개문헌이제외되어총 11편 ( 무작위임상시험연구 9편, 15-23 코호트연구 2편 24,25 ) 의연구가최종평가의대상에포함되었다 (Fig. 1). 3. 문헌의질평가선택된문헌의질평가도구는영국 Scottish Intercollegiate Guidelines (SIGN) 의 methodology checklist (2004 년 3월 ) 26 를채택하였다. SIGN의질평가도구는원래체계적문헌고찰, 무작위임상시험, 코호트연구, 환자-대조군연구, 진단법평가및경제성평가연구로구분되어있으나, 의료기술평가에서대부분의문헌이비무작위임상시험과비교관찰연구가많아 SIGN과협의하에일부도구를수정하였고, 연구유형별질평가도구는 Table 2와같다. 문헌검색부터선택기준적용및자료추출까지각단계는 2명의평가자가각과정을독립적으로수행하였으며이에따라근거의수준과권고의등급을선정하였다 (Table 3). 27 4. 자료추출평가에포함된문헌이한유형으로만한정되지않아자료의추출은여러차례반복되었다. 자료추출은 2명의평가자 Vol. 63 No. 2, February 2014
102 모진아등. 경장영양펌프의효과 Table 2. Levels of Evidence 26 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g., case reports, case series 4 Expert opinion RCT, randomized controlled trial. 가각각중복하여분석하였으며, 연구를진행하면서나타난문제점을토의하는과정을여러차례반복하였다. 동과정에서문헌에기술된내용과결과에영향을주는연구대상의특성및필수적으로기술되어야하는유효성에대한자료를구분하였다. 1차자료추출은 2명의평가자가각각중복하여분석하였고, 이후관련전문가 5인과함께연구회의를통해나타난문제점을토의하고자료추출과정을재차수행하였다. 5. 통계 본연구에사용된문헌들의출판편향정도를확인하기위하여 funnel plot 및고정효과모형에기초한메타분석을실시하고자하였으나, 임상의료결과가매우다양하고같은변수라하더라도결과의측정이나결과의기술방식이매우상이하여, 체계적문헌고찰의형식에따라중재에대한효과를하나의효과크기로종합하거나메타분석을실시하여제시할수없었다. 결 과 최근에발표된가이드라인중미국정맥경장영양학회 7 에서만경장영양펌프사용에대한권고안을제시하였다. 교과서및가이드라인검토결과, 경장영양펌프는지속적관급식요법에서만사용되었고, 경장영양펌프를이용한관급식요법에대해연구한각문헌에서사용한영양액종류, 주입속도, 튜브의크기가모두달라경장영양펌프만의효과에대한결론을낼수는없었으나, 소장급식관으로영양액을관급식받는환자, 위장급식관을통하여영양액을관급식해야하는중증환자, 미숙아, 중증및영양공급불량아동에게사용할 Table 3. Grades of Recommendations 27 A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+ RCT, randomized controlled trial. 수있다고하였다. 시간당주입량은성인의경우하루에제공해야하는총경장영양액의 10% 이내 ( 권고사항 B), 아동은공급해야하는하루총경장영양액의 5% 이내로한시간단위로주입되어야하며 ( 권고사항 C), 경장영양펌프기기의상태를주기적으로점검해야한다 ( 권고사항 B) 는권고사항이있었다. Cochrane Library 및국외데이터베이스에서검색된문헌은 1편 14 이었으며, 캐나다의 Cochrane Neonatal Group에서 1,500 g 이하미숙아아동의경장영양방법에따른효과를비교하고자수행한연구로, 1966년 1월부터 2011년 7월까지 MEDLINE, EMBASE, Cochrane Central Register of Controlled Clinical Trials에서 (infant OR newborn) AND (continuous OR intermittent) AND (nutrition OR feeding OR nursing OR enteroinsular OR metabolism OR gastric) 검색어로검색하였다. 대상환자는 1,500 g 이하미숙아, 중재시술은지속적경장영양, 비교시술은간헐적경장영양또는주입식경장영양이었고, 일차결과변수는경장영양을중지한날, 출생체중으로의회복, 경장영양목표량을달성한일수, 퇴원한날, 체중및키, 머리둘레증가정도, 괴사성장염발생정도였으며, 이차결과변수는무호흡과질식정도였다. 총 7편의연구에서미숙아 411명의자료를분석하여경장영양을공급하는방법 ( 지속적경장영양, 간헐적경장영양 ) 과출생체중 (<1,000 g, 1,000-1,249 g, 1,250-1,499 g) 으로구분하여결과를제시하였는데, 경장영양공급방법에따라경장영양공급목표량을달성한일수, 신체성장률이나괴사성장염발생률에는유의한차이가없었다. 또한, 체중변화를비교한한편의연구에서 1,000 g 이하와 1,000-1,250 g은지속적경장영양을제공받았을때에더빠른체중증가를나타낸다고하였으며, 1,000 g 이하의미숙아에서지속적경장영양을제공받았을때에더빨리퇴원하는경향을나타낸다고 The Korean Journal of Gastroenterology
Mo JA, et al. Efficacy of Feeding Pump 103 Table 4. Documents Selected for Evaluation of Feeding Pump First author Research type Publication year Research location Subject (n, duration) Intervention Comparator Level of evidence Horn 15 RCT 2003 Australia Ill child (45, 6 mo) Continuous+pump Intermittent 1++ Dollberg 16 RCT 2000 Israel 501-1,250 g premature infants (28, 26.8±0.4 wk) Continuous+pump Bolus feeding 1++ Akintorin 17 RCT 1997 USA 1,250 g premature infants (80, 28.8±1.9 wk) Continuous+pump Intermittent 1++ Shimoni 18 RCT 2007 Israel 80 yr patients (148, 81.0±10 yr) Continuous+pump Intermittent 1+ Chen 19 RCT 2006 Taiwan Adult patients in ICU (107, no mention) Continuous+pump Intermittent 1+ Horn 20 RCT 2004 Australia Ill paediatric patients (45, 6 mo) Continuous+pump Intermittent 1+ Lee 21 RCT 2003 China 80 yr patients in neurology ICU (74, 81.3±1.5 yr) Continuous+pump Intermittent 1+ Tamowicz 22 RCT 2007 Poland 18-75 yr patients with respirator (40, no mention) Continuous+pump Intermittent 1 Ciocon 23 RCT 1992 USA 60 yr patients with swallowing disorders Continuous+pump Intermittent 2 (60, 72±9 yr) Rojahn 24 NRCT 2001 Norway <1,250 g premature infants (49, 27 wk) Continuous+pump Bolus feeding 2 Toce 25 NRCT 1987 USA 1,500 g premature infants (53, 30.7±0.3 wk) Continuous+pump Bolus feeding 2 RCT, randomized controlled trial; NRCT, non-randomized controlled trial; ICU, intensive care unit. Table 5. Studies on Safety of the Feeding Pump for Enteral Tube Feeding Category First author (year) Subject Intervention Comparator p-value Level of evidence NEC Dollberg (2000) 16 Premature infants 2/12 (16.6) 3/16 (18.7) NS 1++ Akintorin (1997) 17 Premature infants 4/39 (10.2) 1/41 (2.4) - 1++ Rojahn (2001) 24 Premature infants 0/25 (0) 2/24 (8.3) 0.45 2 Toce (1987) 25 Premature infants 2/30 (7) 0/23 (0) NS 2 Pneumonia Shimoni (2007) 18 80 yr patients 0 0-1+ Chen (2006) 19 Adult patients in ICU 26/51 (50.9) 8/56 (14.3) 0.000 1+ Tamowicz (2007) 22 18-75 yr patients with respirator 7/20 (35) 4/20 (20) >0.05 1 Diarrhea Horn (2003) 15 Ill child 6/22 (27) 4/23 (18) 0.30 1++ Shimoni (2007) 18 80 yr patients 4/70 (10.8) 11/78 (26.8) <0.001 1+ Lee (2003) 21 80 yr patients in neurology ICU 28/37 (75.7) 20/37 (54.1) 0.833 1+ Ciocon (1992) 23 60 yr patients with swallowing disorders 20/no mention 29/no mention 0.008 1 Values are presented as n/total n (%). NEC, necrotizing enterocolitis; ICU, intensive care unit; NS, not significant. 하였다. 그러나대상자수가적고결과에영향을미치는요인들이다양하며복합적인인자들의영향에대한통제가어려워, 1,500 g 이하미숙아에게경장영양제공방법에대해추천할만한결정적인근거를제시하기에는한계가있었으며, 이에대한연구가더많이필요하다고기술하였다. Cochrane Library에서검색한체계적문헌고찰의포함여부를관련전문가집단과논의한결과, 첫째로는대상이미숙아로한정적이고, 둘째로자료추출시경장영양을제공하는방법과출생체중으로만구분하여결과를제시하였으므로이번연구에서평가하고자하는경장영양펌프사용여부에대한결과를구분하기어려워이번연구의목적과맞지않았으며, 셋째로는선택된문헌중에는이번연구과정에서선택된문헌과일부중복되어평가결과가과대혹은과소평가될우려가있어, 이번연구에는포함시키지않기로하였다. 체계적문헌고찰결과, 총 11편의문헌적근거로평가하였으며, 이번평가에포함된문헌의주요자료추출목록은 Table 4 15-25 와같다. 경장영양펌프를이용한경관급식요법의안전성은논의결과를바탕으로, 정량조절상태인혈당조절상태, 영양공급부작용관련혈액지표 (akaline phosphatase, inorganic phosphate, glutamin oxaloacetate transaminase/glutamic pyruvate transaminase), 그리고관급식요법의합병증감소를무작위임상시험연구 9편 15-23 과코호트연구 2편 24,25 을근거로평가하였다. 경장영양펌프를이용한경관급식요법의안전성은합병증중괴사성장염을보고한 4편의연구모두펌프사용여부에따른차이가없었으며, 설사는총 4편의연구중 2편에서유의하게펌프사용군에서설사환자가적은것으로보고하였고, 2편의연구에서는비교군과차이가없는것으로보고하였다. 폐렴의경우총 3편의무작위임상시험연구에서보고하였으며, 이중 2편은펌프사용군에서폐렴발생률이낮았으나통계적으로유의한차이는없는것으로보고되었고, 구토에서도치료군과비교군에차이가없었다 (Table 5 15-19, 21-25 ). 경장영양펌프를이용한경관급식요법의유효성은, 첫째, 경장영양적응도 ( 잔여량, 목표량에도달한일수, 목표량도달 Vol. 63 No. 2, February 2014
104 모진아등. 경장영양펌프의효과 Table 6. Studies on Effectiveness of the Feeding Pump for Enteral Tube Feeding Category Sub category First author (year) Subject Intervention Comparator p-value Level of evidence Amount Feeding fitness Residual volume Chen (2006) 19 Adult patients in ICU 42/51 (82.3%) 52/56 (92.8%) 0.097 1+ 60 ml Horn (2004) 20 Premature infants 6/22 (27%) 6/23 (26%) - 1+ 5 ml/kg Lee (2003) 21 80 yr patients in Neurology ICU 2/37 (5.4%) 4/52 (10.8%) 0.674 1+ 100 ml Dollberg (2000) 16 Premature infants 9.0 days 12.0 days 0.03 1++ Time to attain full enteral feeds Akintorin (1997) 17 Premature infants 19.7 days 18.0 days NS 1++ 700-1,000 g 21.0 days 13.0 days - 1,001-1,250 g Volume of formula Horn (2003) 15 Ill child 66.2 ml/kg/d 72.8 ml/kg/d 0.39 1++ Horn (2004) 20 Premature infants 66.2 ml/kg/d 72.8 ml/kg/d 0.39 1+ Chen (2006) 19 Adult patients in ICU 783±29 kcal/d 795±25 kcal/d 0.1 1+ Ciocon (1992) 23 60 yr patients with swallowing disorders 21/51 (41.2%) 4/56 (7.1%) <0.00 1 1,000 ml Toce (1987) 25 Premature infants 93.6 kcal/d 104.0 kcal/d NS 2 Dollberg (2000) 16 Premature infants 12.0 days 12.0 days 0.81 1++ Weight change Time to regain birth weight Akintorin (1997) 17 Premature infants 12.8 days 12.9 days NS 1++ 700-1,000 g 12.5 days 12.0 days NS 1,001-1,250 g Rojahn (2001) 24 Premature infants 12.0 days 12.0 days 0.81 2 Reach discharge weight Akintorin (1997) 17 Premature infants 68 days 49 days NS 1++ 700-1,000 g 68 days 48 days NS 1,001-1,250 g Weight gain Toce (1987) 25 Premature infants 13.4 g/kg/d 12.2 g/kg/d NS 2 ICU, intensive care unit; NS, not significant. 에걸린시간, 주입된영양액의양등 ), 둘째, 혈액영양지표 (prealbumin 등 ), 셋째, 체중변화, 넷째, 환자만족도와다섯째로의료진의편의성등에대해보고한무작위임상시험연구 7편 15-17,19-21,23 과코호트연구 2편 24,25 의문헌적근거를평가하고자하였다. 첫번째잔여량에대해보고한 3편 19-21 의문헌에서는펌프를사용한치료군과사용치않은비교군에유의한차이가없는것으로보고되었으며, 목표량에도달한일수를보고한 2편 16,17 에서치료군에서목표량을공급할수있었던일수가많았으나, 이중 1편 16 에서는유의하게높았고 1편 17 에서는차이가없었다. 주입된영양액의양은 5편 15,16,20,23,25 의문헌에서치료군과비교군간에유의한차이가없는것으로나타났다 (Table 6). 두번째혈액영양지표인총단백질변화와알부민을살펴본결과, 총단백질변화에대해서펌프사용여부에따른유의한차이가없었다. 세번째체중변화중출생체중으로의회복날짜 16,17,24 가치료군은 12.0-12.8일, 비교군은 12.0-12.9일로통계적으로유의한차이가없었으며, 목표체중에도달한일수 17 는펌프사용군이 68일, 사용치않은군이 48-49일로치료군이목표체중에도달한일수가많았지만, 통계적으로유의하지않았다. 체중변화 25 는펌프사용군이 13.4 g/kg/day로비교군의 12.2 g/kg/day보다더많았지만, 통계적으로유의한차이가없었다 (Table 6). 네번째환자만족도에대한보고는관련문헌이없어평가하지못하였다. 다섯번째의료진의편의성은 1편의연구 23 에서기술되었으며, 경장영양에필요한간호시간이치료군은 46.46±11.19시간, 비교군은 48.45±11.54시간으로치료군에서간호시간이단축되었지만, 통계적으로유의한차이가없었다. 고찰 경장영양공급시경장영양펌프이용에대한임상현장에서의요구도가높고, 경장영양공급을부작용없이원활히하기위해일정한주입속도와주입시간을유지ㆍ조정할수있는펌프의사용이아주중요하고필요하지만, 체계적문헌고찰을통해확인해본결과, 펌프를사용한치료군이펌프를사용하지않은비교군과비교하여통계적으로유의한차이가없었으며, 일부결과에서는일관된결과를나타내지않았다. 또한, 살펴본가이드라인에서는일부에서만펌프사용이필요한적응증이소개되고있을뿐펌프의효과에대해서는아직의문시되고있었다. 그러나, 체계적문헌고찰결과에대해서이번연구과정에구성된경장영양전문가자문그룹은펌프를사용한치료군이펌프를사용하지않은비교군과비교하여통계적으로유의한차이가없다하더라도신뢰도가높은전문학술단체의가이드라인에서제시하고있는소장급식관이용환자, 중증환자및 The Korean Journal of Gastroenterology
Mo JA, et al. Efficacy of Feeding Pump 105 미숙아, 영양공급이불량한아동등에대하여는경장영양액을주입할때에펌프를사용하지않는것은주입영양액의장내수용가능용적에한계와주입속도가잘통제되지않음으로인해단시간내과량투여가될위험이있으며, 이로인해경장영양부적응관련합병증 ( 장괴사, 역류등 ) 이발생할가능성이높기때문에경장영양펌프사용이필요하다는데에의견이일치하였다. 아울러, 문헌검색데이터베이스를국내외를제한하지않았음에도불구하고펌프를사용하지않은지속적경관급식과비교한연구가없는이유에대해정량적인경관급식주입과단시간내영양액과량투여를예방하는차원에서경장영양펌프를사용하는것은, 이미기본적인의료행위로보기때문에임상연구주제로서타당성이결여되어이번연구의목적에맞는연구가부족할수밖에없다는의견이었다. 따라서이번연구에서는교과서, 가이드라인및문헌적근거를토대로종합분석한결과경장영양펌프를이용한경관급식요법은소장급식관으로영양액을제공받는환자, 위장급식관을통하여영양액을경관급식해야하는환자중중증환자, 미숙아, 중증및영양공급불량아동에서경장영양부적응관련합병증발생가능성을줄이기위해사용할경우, 안전성및유효성의근거가있는기술이라고평가하였다 ( 권고등급 D). 이번연구는체계적문헌고찰을바탕으로경장영양펌프의효과를평가해보고자하였으나, 체계적문헌고찰만으로는경장영양펌프의효과를입증하지못하였다. 다만, 기존 Cochrane의평가 14 와동일하게경장영양을제공하는데에있어서공급방법에따른차이는없는것으로생각되는정도의수준으로생각되며, 경장영양펌프는기존경장영양공급방법들과동일한하나의방법으로판단하였다. 경장영양을공급할때가장큰문제는급식부적응으로인한부적절한영양공급이며, 이에대한해결방식은주입방법을조정하는것이다. 일정한속도로일정한기간동안에일정한양의영양액을정확히주입할수있는경장영양펌프를경장영양을제공받는다양한환자들에게로적절하게적용하기위해서는다양한임상상황에서경장영양펌프의필요성과유효성을객관적으로입증받아야할것이다. 연구계획설정에서부터발표까지의학계의현실로는어려운일이겠지만, 이번연구와같은특정한목표를중심으로생각해볼때추후다양한환자들을대상으로한과학적이고실질적이면서도특정목표에집중한연구들이임상에서시행되고발표될수있기를기대해본다. 요약 목적 : 경장영양펌프사용의안전성및유효성에대한연구문헌을총괄정리함으로써현실에맞는경장영양펌프사용기준을마련해보고자하였다. 대상및방법 : 첫째, 임상적유용성을가인드라인을통해검토하였고, 둘째, 안전성과유효성을체계적문헌고찰을통해검토하였다. 경장영양펌프를이용한관급식요법은 8개국내데이터베이스와 Ovid-MEDLINE, Ovid-EMBASE 및 Cochrane Library 등의국외데이터베이스를이용하였다. 관련문헌은 (enteral feeding.mp AND pump.mp) 와관련된검색어를활용하여총 2,016편의문헌이검색되었고, 중복문헌 (686편) 배제후선택 / 배제기준을적용하여총 11편이최종평가에포함되었다. 문헌검색부터선택기준적용및자료추출까지각단계는모두소위원회와아울러 2명의평가자가각과정을독립적으로수행하였으며, 문헌의질평가는 SIGN의도구를이용하였고이에따라근거의수준과권고의등급을선정하였다. 결과 : 유용성검토결과, 경장영양펌프를이용한관급식요법에대해연구한각문헌에서사용한영양액종류, 주입속도, 튜브의크기가모두달라경장영양펌프의효과에대한결론을낼수는없었으나, 소장급식관을통하여경관급식을해야하는환자, 위장급식관을통하여영양액을경관급식해야하는중증환자, 미숙아, 중증및영양공급불량아동에게경장영양펌프사용이권고된것은타당하다는결론에전문가그룹은합의하였다. 체계적문헌고찰결과, 경장영양펌프를이용한경관급식요법의안전성은합병증발생률을주요지표로평가하였으며, 모두임상적으로허용할수있는수준이었고, 경장영양부적응관련합병증발생가능성을줄여주어안전하다고보고되었다. 유효성은경장영양적응도를보고한연구에서동일한결과로기술되지않았지만, 소장급식관을통하여경관급식받는환자, 위장급식관을통하여영양액을경관급식받는중증환자, 미숙아, 중증및영양공급이불량한아동의경우, 펌프를사용하지않고경장영양액주입시직접영양액이투여되는위장관내의특정부위의단위시간당수용가능한용적의한계성을넘게되는위험으로인해경장영양부적응관련합병증발생가능성이높기때문에경장영양펌프사용이필요하다는인식을함께하였다. 결론 : 경장영양펌프를이용한경관급식요법은소장급식관을통하여경관급식을받는환자, 위장급식관을통하여영양액을경관급식받는중증환자, 미숙아, 중증및영양공급이불량한아동을대상으로안전성및유효성의근거가있는기술로평가된다 ( 권고등급 D). 색인단어 : 경관급식 ; 영양액주입방법 ; 문헌고찰 감사의글 이번연구의결과도출을위해조언해주신울산대학교서울아산병원홍석경교수님께감사의말씀을전한다. Vol. 63 No. 2, February 2014
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