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1 Korean Journal of Pediatric Urology ol, No. : 4-45, 9 ORGNAL ARTCLE 방광요관역류환아에서요관점막하 Dextranomer/Hyaluronic Acid Copolymer (Deflux R ) 주입치료의경험 Experience of Subureteral Dextranomer/Hyaluronic Acid Copolymer (Deflux R ) njection Treatment in Children with esicoureteral Reflux Jong Jin Oh, Sang Hyun Jee, Young Kwon Hong From the Department of Urology, College of Medicine, CHA University, Seongnam, Korea 오종진ㆍ지상현ㆍ홍영권 포천중문의과대학교비뇨기과학교실 교신저자홍영권분당차병원비뇨기과경기도성남시분당구야탑동 35, Tel: Fax: urohong@yahoo.co.kr Purpose: We assessed the results of endoscopic subureteral Dextranomer/Hyaluronic acid copolymer (Deflux R ) injection treatment in children with vesicoureteral reflux. Patients and Methods: Between September 6 and December 7, a total of 3 (5 renal units) UR patients underwent subureteral Deflux R injection treatment. All the patients were postoperatively assessed by ultrasound and voiding cystourethrography (CUG) to evaluate any complication and the result of treatment. Results: The mean follow-up period was 5.9 months (range 3-7). Of the 5 refluxing ureters, 4 were cured (7.5%) and 6 were improved (5.9%) after treatment. Cure rates by ascending grade were %, %, 36%, 8%, % after st trial with Deflux R. All of two grade URs were cured. Of two grade URs, one was improved (5.%) and the other was persistent (5.%). Of grade URs, eight were cured (36.4%), improved (54.5%), and two were persistent (9.%). Of grade URs, four were cured (8.%), improved (5.%), and seven were persistent (3.8%). Of three grade URs, none was cured, two improved (66.7%), and one was persistent (33.3%). There was no significant complication associated with this procedure. All of the cured patients had sterile urine even without prophylactic antibiotics, and none of the patients with bacteriuria after the procedure proved to be cured. Conclusions: An endoscopic subureteral Deflux R injection can be used as the st line of therapy for UR because it is a safe procedure without causing any significant complication. Downgrading was encountered in more than half of the cases. However, the cure rate was not so high probably due in some part to the fact that this study was our initial experience. Additional injection trial after failed initial injection is worthy of consideration. Postoperative bacteriuria is thought to be a significant factor to predict the result of the operation. Key Words: Deflux, njection, esico-ureteral reflux (Received: February 8, 9, Accepted: March 6, 9) 4

2 4 Korean Journal of Pediatric Urology ol., 4-45, 9 서 방광요관역류는소아에서 -% 의유병률을보이며, 특히소아요로감염환자의 3-4% 에서발견된다. 국제소아역류연구회분류법에따라 - 등급의방광요관역류는자연적으로호전이되는경우가많지만, - 등급의방관요관역류는 5년이내에 6% 만이자연적으로호전된다고한다.,3 치료는내과적치료로예방적항생제사용과외과적치료로서개복항역류수술및내시경요법으로크게나눌수있다. 내시경요법은 98년 Matouschek 4 이보고하고, 984년 O Donell 등 5,6 이 polytetra-fluoroethylene (PTFE, Teflon R ) 를시도한이후에현재널리사용되고있다. 특히, Deflux R 는여러연구를통해효과와안정성이입증되어최근역류교정의 차치료로인정되고있다. 7 이에저자들은소아역류에대한내시경적요관점막하 Deflux R 주입치료의효과와안전성에대해알아보고자하였다. 론 대상및방법 6년 9월부터 8년 월까지방광요관역류로요관점막하 Deflux R 주입치료를시행한환자 3명 (5 신단위 ) 을대상으로후향적으로자료를분석하였다. 모든환아에서술전신장초음파, 배뇨중방광요도조영술, 신주사 (99mTc-DMSA) 를시행하였으며, 방광요관역류의등급은 985년국제소아역류연구회에서소개한분류법을사용하여 -단계로분류하였다. 요관점막하 Deflux R 주입치료의적응증은 ) 발열성요로감염이발생한병력이있거나신주사에서신반흔이있는 UR, ) 등급이상의 UR로하였으며, ) 과 ) 모두보호자가예방적항생제복용을원하지않는경우에시행하였다. 시술당시환자의평균나이는 5.76±3.세로, 3명중남아가 3명, 여아가 7명이었다. 수술은한명의술자 (operator) 에의해이루어졌다. 대상환아를전신마취후쇄석위자세에서소아용방광내시경 (8/9.5 Fr, Richard Wolf, Germany) 을이용하여요도및방광내를관찰한후, 3 gauge의주사용바늘에생리식염수를통과한뒤 Deflux가들어있는주사기와연결하여시술하였다. 수술후도뇨관은삽입하지않았고, 다음날아침환아가소변을잘보고발열이없으면 주간의 경구용항생제를처방받고퇴원하였다. 수술이후 - 주사이에신장초음파, 요검사, 요배양검사를시행하였으며, 이후 개월간격으로요검사와요배양검사를시행하여세균뇨가있는경우에만예방적항생제를사용하였다. 수술후 3개월에는배뇨중방광요도조영술을시행하여방광요관역류의소실여부를확인하였다. 역류가소실되지않았을경우에는잔존역류의등급에따라 - 등급은추적관찰을, - 등급은 Deflux 차시도를, 등급은개복수술을시행하는것을원칙으로하였으나보호자의선택을고려하여결정하였다. 결과에대한판단은역류가완전히소실되었을경우를완치 (cured), 수술전등급에비해낮아진경우호전, 수술전과동일한경우지속으로판단하였다. 결과. 대상환자특성전체 5요관중, 양측성이 4요관, 단측성이 3요관이었다. 수술전요로감염횟수는평균.±.3회 (-8) 였으며, DMSA 신주사에서환측의상대신기능은평균 36.6±8.% 였다. 수술전역류의등급은신단위기준으로 등급이 례, 등급이 례, 등급이 례, 등급이 례, 등급이 3례였다 (Table ).. Deflux R 주입치료의성적추적관찰기간은 3개월에서 7개월사이로평균 5.9개월이며, 수술후 3개월에시행한배뇨중방광요도조영술시행결과완치는 4례 (7.5%), 호전은 6례 (5.9%) 로총 4 신단위에서역류의완치및호전을보였으며, 례 (.6%) 에서는변화가없었다 (Table ). 차시술후에도 등급이상의역류가있었던 례 ( 등급이 4례, 등급이 7례, 등급이 례 ) 의경우, 차시술을시행한후완치가 례 (6.7%), 호전은 7례 (58.3%), 지속은 3례 (5.%) 로 차시술결과와비교하여완치율은더낮았다 (Table 3). 3. 수술후경과수술후임상적으로유의한요관폐색의증상은발견되지않았으며, 육안적혈뇨를보인경우라도 -3일이내에호전되었다. 수술후 -주사이에시행한신장초음파에서수술전에관찰되지않았던수신증의발생및악화는없었으며, 수술후 -주사이에시행

3 오종진외 : 방광요관역류환아에서요관점막하 Deflux R 주입치료의경험 43 Table. Patients characteristics Table. Treatment results after initial injection of Deflux grade of reflux ariables No. of renal unit Bilateral Unilateral Age (year) Laterality (right:left) Number of febrile UT UR grade Cured mproved Persistent ±3. :3.±.3 3 UT: urinary tract infection, UR: vesicoureteral reflux 한요배양검사에서 5 개이상의 CFU (colony-forming unit) 가배양되는유의한세균뇨가있었던환아는 8명 (3 신단위 ), 없었던환아는 명 (38 신단위 ) 이었다. 발열성요로감염으로입원치료가필요했던환아는 명으로한명은 Deflux 차시술로역류가소실되었으며나머지한명은요관방광재문합술을시행받았다. 세균뇨가없었던경우에는완치 4례 (36.8%), 호전 례 (55.3%), 지속 3례 (7.9%) 로, 세균뇨가있던경우완치 례 (.%), 호전 5례 (38.5%), 지속 8례 (6.5%) 의결과에비해유의하게높은성공율을보였다 (p<.5) (Table 4). 고 방광요관역류의교정수술은방광점막아래요관의길이를충분히확보하고요관말단부가방광근육 찰 Table 3. Treatment results of second trial after failed initial injection of Deflux grade of reflux Table 4. Treatment results according to postoperative bacteriuria bacteriuria (+) ( ) Cured* (.) 4 (36.8) mproved 5 (38.5) (55.3) Persistent* 8 (6.5) 3 (7.9) *: p<.5 Cured mproved Persistent 층의충분한지지를받게하여배뇨중요관구가폐쇄상태를유지하도록하는것을목표로한다. 같은원리로비교적시술방법이간단한요관점막하이물질주입치료가고안되었는데, 관혈적수술을피할수있는장점이있다. 984년 O'Donnell과 Puri가 polytetrafluoroethylene (Teflon) 을이용한주입요법을보고한이후 Teflon을포함하여 collagen, polydimethylsiloxane (Macroplastique), Deflux 등을이용한연구들이보고되었다. 방광점막아래에주입되는이물질은타장기로전이가없어야하고, 전이가되더라도안전해야하며, 이상반응을보이지않고장기간효과를유지하여야이상적이지만, 실제로는이물질입자의이동, 염증및육아종성반응등으로안전성에문제가대두되어왔다. 8- 인체에무해하면서시술부위에염증또는면역반응, 이동, 전이가없이쉽게주입할수있는물질로 년미국식약청 (Food and Drug Administration) 의승인을받은 Deflux R 는 995년 Stenberg와 Lackgren 이보고한이후현재가장많이사용되는방광요관역류치료물질중하나로인식되고있다. 4 7

4 44 Korean Journal of Pediatric Urology ol., 4-45, 9 지금까지여러연구에서방광요관역류에대한 Deflux R 주입술의치료성공률은 65-9% 로보고되고있으며, 성공률은등급이높을수록낮아진다고보고되었다. 3-5 본원에서의치료성공률은완치율이 7.5%, 호전이 5.9% 로이전의보고들에비해낮은성공률을보였다. 이러한차이의가장큰원인은 Kirsch 등 5 이보고한학습곡선효과에서기인한것으로판단된다. 그들의결과에따르면, 례까지는성공률이 6%, 례까지는 7% 의성공률을보였으며, 례이후에 8% 까지성공률의상승을보고하여학습곡선과성공률간의연관요소가크다고하였다. 또한환아의역류등급구성에있어 등급이 43% 를차지하고있는점도낮은성공률을초래한원인으로생각한다. Elmore 등 6 은 차 Deflux R 주입시술을받고역류가소실되지않은환아를대상으로 차주입술을시행하였을때, 39례의환아 (53 신단위 ) 에서 84-9% 의높은성공률을보여 차 Deflux R 주입술후, 특히낮은등급의방광요관역류가남아있을경우, 차주입술로만족할만한결과를얻을수있다고보고하였다. 소규모의연구이긴하지만 Lee 등 7 이 7례 ( 신단위 ) 의환아를대상으로 차주입술을시행한국내연구에서는추적검사가가능한 3례 (4 신단위 ) 중 례 ( 신단위 ) 에서 차주입술로역류가소실되었으며, 례 (3 신단위 ) 에서는역류가잔존하여요관방광재문합술을시행하였다고보고하였다. 본연구에서 차시술한환아는 신단위 (7명) 였으며, 결과는완치가 신단위 (6.7%), 호전은 7 신단위 (58.3%), 지속은 3 신단위 (5.%) 로 차시술과큰차이는없었다. 차시술후잔존하였던역류등급이 등급이 4 례, 등급이 7례, 등급이 례로구성에있어높은등급의역류가많아성공률이다소낮게나온것으로판단된다. 방광요관역류에대한내시경적 Deflux 주입술후요로감염이발생하는경우가드물지않은데, Elder 등 8 은약 6% 에서요로감염이발생하였다고하였고, Chi 등 9 은 % 에서열성요로감염이발생하였다고하였다. Kang 등 의보고에서는 차 Deflux 시술후역류가잔존한 49명중 6.% (8/49) 는수술후예방적항생제를복용했음에도불구하고열성요로감염이발생하였다고한다. 본연구에서세균뇨는 6.7% (8/3 명 ) 에서발생하였으나열성요로감염으로발현된경우는 6.7% (/3명) 로기존의보고와큰차이는없었 다. 다만본연구에서는추적검사에서세균뇨가증명된경우에만예방적항생제를사용하였다는점을고려하여결과를해석해야할것이다. Deflux 주입술의성공여부를바로확인하기의해 Purlmutter 등 은수술종료직전방광압박에의한 CUG 촬영을시행하였는데수술전에발견되지않았던대측의역류를발견하는경우는있었지만환측의 Deflux 수술의성공여부를예측할수는없다고하였다. Deflux 주입술의성공여부를판단하는인자로서 수술후세균뇨 가유용한지에대해서는잘알려져있지않지만본연구에서는수술후세균뇨가없는경우더높은성공률을보여향후이에대한추가연구가필요할것으로생각한다. 결 내시경을이용한 Deflux 주사는안전한방법으로방광요관역류의치료에일차적으로사용될수있으며, 많은경우역류등급의하향변화를기대할수있으나본연구에서의역류의소실률은기대에미치지못하였다. 따라서초기경험술자는학습곡선을고려하여역류에대한치료계획을세워야할것으로생각한다. 시술후에도지속되는세균뇨는방광요관역류의존속을의미하는지표가될수있을것으로판단된다. 론 REFERENCES. Perez-Brayfield M, Kirsch AJ, Hensle TW, Koyle MA, Furness P, Scherz HC. Endoscopic treatment with dextranomer/hyaluronic acid for complex cases of vesicoureteral reflux. J Urol 4;7:64-6. Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol ;: Tamminen-Mobius T, Brunier E, Ebel KD, Lebowitz R, Olbing H, Seppanen U, et al. Cessation of vesicoureteral reflux for 5 years in infants and children allocated to medical treatment. The nternational Reflux Study in Children. J Urol 99;48: Matouschek E. Treatment of vesicorenal reflux by transurethral teflon-injection. Urologe A 98;: O'Donnell B, Puri P. Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 984;89: Puri P, O'Donnell B. Correction of experimentally produced vesicoureteric reflux in the piglet by intravesical injection of teflon. Br Med J 984;89: Lackgren G, Wahlin N, Skoldenberg E, Stenberg A.

5 오종진외 : 방광요관역류환아에서요관점막하 Deflux R 주입치료의경험 45 Long-term followup of children treated with dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol ;66: Joyner BD, Atala A. Endoscopic substances for the treatment of vesicoureteral reflux. Urology 997;5: Bhatti HA, Khattak H, Boston E. Efficacy and causes of failure of endoscopic subureteric injection of Teflon in the treatment of primary vesicoureteric reflux. Br J Urol 993;7:-5. Smith DP, Kaplan WE, Oyasu R. Evaluation of polydimethylsiloxane as an alternative in the endoscopic treatment of vesicoureteral reflux. J Urol 994;5:-4. Cukier J, Beauchamp RA, Spindler JS, Spindler S, Lorenzo C, Trentham DE. Association between bovine collagen dermal implants and a dermatomyositis or a polymyositis-like syndrome. Ann ntern Med 993;8:9-8. Stenberg A, Lackgren G. A new bioimplant for the endoscopic treatment of vesicoureteral reflux: experimental and short-term clinical results. J Urol 995;54: Lorenzo AJ, Pippi Salle JL, Barroso U, Cook A, Grober E, Wallis MC, et al. What are the most powerful determinants of endoscopic vesicoureteral reflux correction? Multivariate analysis of a single institution experience during 6 years. J Urol 6;76: Méndez R, Somoza, Tellado MG, Liras J, Sanchez A, Paris E, et al. Predictive value of clinical factors for successful endoscopic correction of primary vesicoureteral reflux grades -. J Pediatr Urol 6;: Kirsch AJ, Perez-Brayfield MR, Scherz HC. Minimally invasive treatment of vesicoureteral reflux with endoscopic injection of dextranomer/hyaluronic acid copolymer: the Children's Hospitals of Atlanta experience. J Urol 3;7:-5 6. Elmore JM, Scherz HC, Kirsch AJ. Dextranomer/hyaluronic acid for vesicoureteral reflux: success rates after initial treatment failure. J Urol 6;75: Lee DW, Kang KM, Oh WS, Kim JS, Chung SK. Risk factors for treatment failure after endoscopic subureteral injection of dextranomer/hyaluronic acid copolymer (Deflux R ) for vesicoureteral reflux. Korean J Urol 9;5: Elder JS, Diaz M, Caldamone AA, Cendron M, Greenfield S, Hurwitz R, et al. Endoscopic therapy for vesicoureteral reflux: a meta-analysis.. Reflux resolution and urinary tract infection. J Urol 6;75:76-9. Chi A, Gupta A, Snodgrass W. Urinary tract infection following successful dextranomer/hyaluronic acid injection for vesicoureteral reflux. J Urol 8;79: Kang MY, Park DS, Park YH, Lee JW, Baek MK, Choi H. Overall outcomes and factors predicting the success of endoscopic dextranomer/hyaluronic acid copolymer injection for vesicoureteral reflux. Korean J Urol 9;5:5-6. Perlmutter AE, Talug C, Darbandi SS, Morabito R, Tarry WF. Utility of an intra-operative cystogram with a simulated voiding phase after endoscopic treatment of vesicoureteral reflux. W Med J 8;4:-4

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untitled 방광요관역류환아에서요관점막하 Dextranomer/Hyaluronic Copolymer (Deflux R ) 주입후역류재발의위험인자 Risk Factors for Treatment Failure after Endoscopic Subureteral Injection of Dextranomer/ Hyaluronic Acid Copolymer (Deflux R )