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1 Original Articles Journal of Korean Epilepsy Society Journal of Korean Epilepsy Society 13(2):47-51, 2009 ISSN Received October 19, 2009 Accepted November 27, 2009 소아난치성간질중첩증에서미다졸람지속적주입치료와토피라메이트추가치료의임상적효과및안정성 경북대학교의과대학소아과학교실 1, 신경과학교실 2 황수경 1 서혜은 1 박성파 2 권순학 1 Clinical Effectiveness and Safety of Midazolam Infusion and Topiramate Add-on Therapy against Refractory Status Epilepticus in Children Su Kyeong Hwang, MD 1, Hye-Eun Seo, MD 1, Sung-Pa Park, MD 2, and Soonhak Kwon, MD 1 Departments of 1 Pediatrics, 2 Neurology, Kyungpook National University Hospital, School of Medicine, Daegu, Korea Purpose: This study was aimed to evaluate the effectiveness and safety of midazolam infusion and topiramate add-on therapy for refractory status epilepticus (RSE) in children. Methods: Nineteen children were involved in the study and their clinical data were retrospectively analyzed. After failure of initial conventional treatment, all of the children were given midazolam (MDZ) infusion, titrated until a response is achieved or maximum dose of 20 mcg/kg/min. Eleven children were given additional topiramate (TPM) at 1-2mg/kg/day by nasogastric and titrated to the favorable response every 1-3 days. We subdivided the children into 2 groups by whether TPM added (TPM group) or not (MDZ group) and compared them each other. Results: The age of subjects ranged from 2 to 175 months (54.9±53.3 months; male 10, female 9). Seizure duration of initial presentation ranged from 30 to 1,440 minutes (218.4±432.9 minutes). Seizure types were convulsive in 16 children (84%) and 3 were non-convulsive (16%). In the MDZ group (4.0±2.9 mcg/kg/minutes), time to seizure control ranged from 1 day to 2 days (1.1±0.4 days), but seizures recurred in 50 %. In the TPM group (6.3±1.5 mg/kg/day), time to seizure control ranged from 1 day to 5 days (1.9±1.5 days), but seizures recurred in 36%. 1 child () died of sepsis and 7 children (36.8%) experienced cardio-respiratoty compromise. 7 children (63.6%) in the TPM group recovered completely to baseline neurological function. Conclusions: The results indicate that midazolam infusion is still the mainstay of treatment, but TPM add-on therapy seems to be a useful option in RSE. However, further studies are needed to establish its precise role and safety. Keywords: Status epilepticus; Refractory epilepsy; Children; Midazolam; Topiramate 서론 소아의간질중첩증은생명을위협하는신경학적응급상황으로즉각적인치료가수반되어야만한다. 1 고전적인정의는경련이 30분이상지속되거나두번이상의경련사이에서기저의식으로회복이되지않는경우를말하였으나, 최근에는 5분정의즉경련이 5분이상지속되거나두번이상의 경련사이에서기저의식으로회복이되지않는경우로바뀌고있는추세이다. 2 이러한간질중첩증환자중적절한초기치료에도불구하고경련이지속되는경우를난치성간질중첩증이라하며이환율과치사율이높으므로집중적인치료및중환자관리를요한다. 난치성간질중첩증에대해서도아직까지명확한정의는없으나많은연구에서경련지속시간, 치료에대한무반응의횟수, 치료약제의종류및가짓수 Address for correspondence: Soonhak Kwon, MD Department of Pediatrics, Kyungpook National University Hospital 200 Dongduk-ro, Jung-gu, Daegu , Korea Tel: , Fax: , E mail: shkwon@knu.ac.kr Journal of Korean Epilepsy Society Vol. 13 No. 2,

2 황수경 서혜은 박성파 권순학 Table 1. Demographic features and baseline clinical characteristics MDZ group (n=8) TPM group (n=11) Total (n=19) M:F 5:3 5:6 10:9 Age, month Mean±SD (range) 27.5±31.7 (2~97) 74.9±58.0 (3~175) 54.9±53.3 (2~175) Seizure duration Minutes 78.8±60.8 (30~210) 320.0±554.7 (30~1440) 218.4±432.9 (30~1440) Mean±SD (range) Seizure type,% C NC 87.5% 12.5% 81.8% 84% 16% Etiology,% AS RS RSAP PE I F 62.5% % 36.3% 47.3% % MDZ group, topiramate not added group; TPM group, topiramate added group; C, convlusive; NC, non-convulsive; AS, acute symptomatic; RS, remote symptomatic; RSAP, remote symptomatic with acute precipitant; PE, progressive encephalopathy; I, Idiopathic; F, Febrile. 등으로다양한정의를내리고있다. 일반적으로는일차항경련제인벤조다이아제핀 (benzodiazepines) 에이어이차항경련제인페니토인 (phenytoin), 페노바비탈 (Phenobarbital), 발프로익산 (valproic acid) 등을적절하게사용했음에도반응을보이지않고경련이지속되는경우난치성간질중첩증으로정의된다. 3 간질중첩증환자가난치성간질중첩증으로되는빈도는 31~43% 이며치사율은 16~22% 에이른다. 3,4 본연구는난치성간질중첩증환자에서미다졸람 (midazolam) 지속적주입과토피라메이트 (topiramate) 추가치료를시행하여임상적효과및안정성, 치료후의결과에대해평가하고자하였다. 대상과방법 1. 연구대상 2005년 1월 1일부터 2008년 12월 31일까지경북대학교병원소아청소년과에간질중첩증으로입원한환자중일차항경련제인벤조다이아제핀에대한무반응에이어이차항경련제인페니토인, 페노바비탈등을적절하게투여했음에도경련이지속되어미다졸람지속적정맥주입을시작한환자를대상으로하였다. 그중일부의환자들에게는토피라메이트경구투여를추가하여경련조절여부를관찰하였다. 2. 연구방법 (1) 내원당시의특성 환자의내원당시특성을성별, 나이, 발작지속시간, 발작양상, 유발원인의측면에서파악하였다. 발작지속시간은환자가병원에내원하여치료를받기전까지발작의총지속시간으로정하였으며발작사이에의식이회복되지않은시간도포함하였다. 발작양상은경련성 (convulsive), 비경련성 (non-convulsive) 으로나누었다. 난치성간질중첩증을유발시킨원인에대한분류는 acute symptomatic, remote symptomatic, remote symptomatic with acute precipitant, progressive encephalopathy, idiopathic, febrile의 6가지로나누었다. 모든환자는미다졸람지속적주입치료를받았으며그중일부의환자는토피라메이트추가치료를받았는데, 토피라메이트추가치료를받지않은환자들을 MDZ 군, 토피라메이트추가치료를받은환자들을 TPM 군으로명명하여두그룹의특성을비교하였다. (2) 치료방법우선기도를확보하고호흡및순환에대한적절한조치를비롯하여정맥을확보하고혈당을확인한후, 로라제팜 (lorazepam, 0.1 mg/kg IV, 최대용량 5 mg) 을투여하여 5분동안발작종료여부를관찰하였다. 경련지속시로라제팜재투여또는페니토인 (20~30 mg/kg IV) 을투여하고 5~10분간관찰하였다. 이후에도경련지속시바로미다졸람지속적정맥주입 (0.1 mg/kg/hr로시작하여반응을보일때까지증량, 최대속도 2 mg/kg/hr), 혹은일부에서는페노바비탈 (20~30 mg/kg IV) 을투여하여 5-10분간반응을관찰하여반응이없는경우미다졸람지속적정맥주입을시작하였다. 미다졸람지속적주입치료를시작한후일부의환자들에게토피라메이트추가치료를시행하였으며, 비위관을통해토피라메이트를 1~2 mg/kg/day로시작하여반응을보일때까지 1~3일간격을두고 1~2 mg/kg/day로증량하였다. (3) 치료효과두그룹의발작조절까지의시간, 발작재발률, 부작용, 치명률의측면에서살펴보았다. 발작이조절된상태는발작이종료되어 24시간동안재발이없는상태로정하였고, 재발은발작조절이후다시발작을보인경우로정하였다. (4) 토피라메이트추가치료받은환자들의예후에대한평가토피라메이트추가치료를받았던환자들의예후에대한평가는치명률, 2차적으로생긴 epilepsy 유무, 인지기능손상여부, 행동장애유무, 기타로나누어살펴보고이를종합하여전반적인예후를 good, fair, poor로나누어살펴보았다. good은간질중첩증으로인한신경학적후유증이전혀없이기저상태로완전히회복된경우, fair는중등도의신경 48 대한간질학회지제 13 권제 2 호, 2009

3 소아난치성간질중첩증에서미다졸람지속적주입치료와토피라메이트추가치료의임상적효과및안정성 Table 2. Clinical efficacy and safety of the treatment MDZ group TPM group Maximal dose of MDZ, mean±sd (range) 4.0±2.9 mcg/kg/min (1.0~10.0) 10.8±6.8 mcg/kg/min (3.0~20.0) Maximal dose of TPM, mean±sd (range) 6.3±1.5 mg/kg/day (5.0~10.0) Time to seizure control, day (range) 1.1±0.4 (1~2) 1.9±1.5 (1~5) Sezure recurrence rate, % Side effect, % 12.5% 54.5% (during MDZ Tx) Mortality, % MDZ, midazolam; TPM, topiramate. Table 3. Treatment outcome of TPM group Outcome % Good 63.6% Fair 27.3% Poor 학적후유증이남아어느정도의도움이나보조장치를필요로하는정도로경우, poor는심각한신경학적후유증이남아타인의도움없이생존할수없는상태또는사망한경우로정하였다. (5) 내원당시발작지속시간에따른발작조절시간과의관계내원당시발작지속시간을 1시간이내, 1-2시간, 2시간초과한경우로나누어두그룹의발작조절시간을비교해보았다. 3. 통계학적분석 모든자료의통계는평균 ± 표준편차및 % 로표시하였으며통계학적분석은 SPSS, version 14.0, Mann-Whitney의 U-test 를이용하였고유의수준은 p<0.05 로설정하였다. 결과 1. 내원당시의특성 총 19명으로남아가 10명, 여아가 9명이었고평균나이는 54.9개월 (2~175 개월 ) 이었다. 치료전발작지속시간은평균 218.4분 (30~1440분) 이었다. 발작양상을경련성과비경련성으로나누었을때 84% 가경련성, 16% 가비경련성이었다. 유발원인은 acute symptomatic이, remote symptomatic이 47.3%, remote symptomatic with acute precipitant 가 21., progressive encephalopathy가, idiopathic이 15.8%, febrile 이 를차지하였다. 두그룹을비교하여보면 MDZ group 환자의평균나이는 27.5개월 (2~97 개월 ) 이었으며치료전발작지속시간은평균 78.8분 (30~210 분 ) 이었다. TPM 군의경우 환자의평균나이가 74.9개월 (3~175개월) 이었으며치료전발작지속시간은평균 320분 (30~1,440분) 으로, MDZ 군에비해평균나이가많고평균발작지속시간이길었다 (Table 1). 2. 치료효과에대한평가 MDZ 군의경우평균미다졸람주입용량은 4.0±2.9 mcg/ kg/minutes (1.0~10.0 mcg/kg/minutes) 였으며평균발작조절시간은 1.1±0.4일 (1~2일 ), 발작조절까지의시간이 1일이내였던경우가 8명중 7명 (87.5%) 이었으며나머지 1명 (12.5%) 은미다졸람주입 2일째에발작이조절되었다. 발작의조절후재발된경우는 8명중 4명 (5) 에서있었다. 부작용은 8 명중 1명 (12.5%) 에서호흡부전이있었으나미다졸람을감량하면서회복되었다. 치료중사망한경우는없었다. TPM 군의경우평균미다졸람주입용량은 10.8±6.8 mcg/ kg/minutes ( mcg/kg/minutes) 였으며평균토피라메이트투여용량은 6.3±1.5 mg/kg/day (5.0~10.0 mg/kg/day) 였다. 이들의평균발작조절시간은 1.9±1.5일 (1-5일) 이었으며발작조절까지의시간이 1일이내였던경우가 11명중 5명 (46%) 이었으며 2일이상 5일이내였던경우가 11명중 6명 (54%) 이었다. 발작의조절후재발은 11명중 4명 (36%) 에서있었다. 부작용은 11명중 6명 (54.5%) 에서있었는데모두미다졸람지속적주입치료를하는동안발생하였고 5명에서호흡부전, 1명에서저혈압이있었다. 미다졸람을감량하면서회복되었으며토피라메이트에대한심각한부작용은관찰되지않았다. 치료중사망한경우는 1명 (9%) 이었으며사인은패혈증이었다 (Table 2). 3. 토피라메이트추가치료받은환자들의퇴원후경과퇴원이후간질중첩증으로인한신경학적후유증이전혀없이기저상태로완전히회복된경우가 63.6% 로가장많았고중등도의신경학적후유증이남은경우가 27.3%, 심각한신경학적후유증이남았거나사망한경우가 였다 (Table 3). Journal of Korean Epilepsy Society Vol. 13 No. 2,

4 황수경 서혜은 박성파 권순학 Table 4. Time to seizure control by seizure duration of initial presentation Seizure duration of Time to seizure control, day, mean±sd initial presentation MDZ group TPM group <1 hr 1 1 1~2 hr 1 1 >2 hr 1.5± ±1.5* *p< 내원당시발작지속시간과발작조절시간과의관계 MDZ 군의경우초기발작지속시간이 1시간미만이었던환자와 1시간에서 2시간사이였던환자의경우평균발작조절시간은 1일이내였으나초기발작지속시간이 2시간이상이었던환자의경우는 1.5±0.7일이었다. TPM 군의경우도초기발작지속시간이 1시간미만이었던환자와 1시간에서 2시간사이였던환자의경우평균발작조절시간은 1일이내였으나초기발작지속시간이 2시간이상이었던환자의경우는 3.3±1.5일이었다 (Table 4). 고찰 본연구는난치성간질중첩증의치료에있어미다졸람지속적주입후토피라메이트추가치료를실시하여그효과및안정성을분석한국내의첫연구이다. 성인난치성간질중첩증을치료함에있어토피라메이트가효과적으로발작을조절한사례가보고되었으나 5,6 소아에서는아직까지연구가미미한상태이다. 미다졸람은혈액- 뇌장벽을빠르게통과하여짧은시간안에반응을보이는벤조다이아제핀계약제로서 GABA type A receptor의활성을증가시켜신경흥분을억제시키는역할을한다. 7 난치성간질중첩증의치료에있어미다졸람은다른혼수유도약물과마찬가지로효과적일뿐아니라낮은치명률을보인다. 8 그러나발작조절후재발률이 5 내외로비교적높은것으로몇몇연구에서보고가되고있으며 9,10 호흡억제나저혈압등의부작용도보고가되고있다. 10,11 토피라메이트는소디움채널및칼슘채널의차단작용을비롯하여 GABA 활성을증가시키는등다양한작용기전을가진약제로 7 소아의난치성간질중첩증의치료에있어효과적이며안전한약임이보고된바있다 용량및증량방법에대해서는여러가지연구가있으며천천히증량한경우 3~6일이내, 급속히증량한경우 1일이내큰부작용없이치료반응을보여효과적이고안전하게발작을조절할수있는것으로보고되었다 본연구에서 TPM 군이 MDZ 군에비해내원당시평균발 작지속시간이길었는데, 이로인해약물에대한치료반응이낮아져미다졸람의평균주입용량이 2.5배가량늘어나게되고이로인해호흡억제등의부작용의비율이높아진것으로생각된다 (Table 1, 2). 간질중첩증에서발작이오래지속되기전에치료가신속히시작되어야함에대한중요성은여러연구에서입증되어왔으며, 한연구에서는 30분내로치료를시작한경우초기치료에대한반응이환자의 8 에서있었으나 2시간이상경과된경우초기치료에대한반응이 4 로낮아지는결과를보였다. 15,16 본연구에서도치료전발작시간이 2시간이상경과한경우발작이조절되는시간이길어지는것을관찰할수있었으며특히 TPM 군환자들의경우통계적으로유의한결과를보여난치성간질중첩증치료에있어신속한치료의시작이치료반응을결정하는중요한요인이됨을확인할수있었다 (Table 4). MDZ 군에비해 TPM 군에서는 acute symptomatic 과 progressive encephalopathy 비율이높았는데, 한연구에서는이두가지원인으로인해난치성간질중첩증이발생한경우대부분의환자가신경학적후유증을가지게되며치명률이높아짐을보고하였다. 17 TPM 군의퇴원후결과를살펴보았을때 63.6% 의환자들이신경학적후유증이없이기저상태로회복되었으나 36.4% 의환자들은중등도내지중증의신경학적후유증또는사망에이르렀는데 acute symptomatic과 progressive encephalopathy 환자들이모두포함되어있었다 (Table 1, 3). 난치성간질중첩증환자의퇴원후결과에대한한연구에서는입원중사용한약제종류에관계없이난치성간질중첩증의유발요인에따라그결과가달라짐을보고하였다 18. 미다졸람지속적주입치료를받은환자들은평균 1.1일이내로발작이조절되었고약물로인해사망한경우는없었다. 발작조절후재발이 5 에서일어났으며 12.5% 에서일시적인호흡억제의부작용을보이기는했으나전반적인효과가좋고치명률이없으며부작용또한일시적이었던점으로미루어미다졸람의지속적주입이간질중첩증의치료에있어훌륭한주된치료로서의역할을할수있다고여겨진다. 미다졸람지속적주입후토피라메이트추가치료를받은환아들의경우토피라메이트투여후평균 1.9일이내로발작이조절되었고, 발작조절후재발은 36. 로 MDZ 군에비해낮은빈도를보였다. 토피라메이트가정신운동지연및집중력저하등의부작용을야기한보고들이있으나 19,20 본연구에서는토피라메이트투여중큰부작용은관찰되지않았다. TPM 군에서생긴부작용은모두미다졸람주입중일시적으로일어났으며 11명 6명 (54.5%) 에서있었는데그중 5 명은호흡억제, 1명은저혈압이었으며미다졸람감량후해소되었다. TPM 군의환아중 1명이사망하였으나사인이패 50 대한간질학회지제 13 권제 2 호, 2009

5 소아난치성간질중첩증에서미다졸람지속적주입치료와토피라메이트추가치료의임상적효과및안정성 혈증이었으며토피라메이트투여와는무관하였다 (Table 2). 소아난치성간질중첩증의치료에있어서여전히미다졸람지속적주입치료가주된치료로서역할을하고있으나, 토피라메이트추가치료역시효과적이고안전한선택적치료가될수있을것으로생각된다. 난치성간질중첩증의치료에있어토피라메이트투여의지침은아직까지없는상태로향후더많은연구가필요할것으로사료된다. REFERENCES 1. Scott RC, Surtees RA, Neville BG. Status epilepticus: pathophysiology, epidemiology, and outcomes. Arch Dis Child 1998;79(1): Sofou K, Kristjansdottir R, Papachatzakis NE, et al. Management of Prolonged Seizures and Status Epilepticus in Childhood: A Systematic Review. J Child Neurol Mayer SA, Claassen J, Lokin J, et al. Refractory status epilepticus: frequency, risk factors, and impact on outcome. Arch Neurol 2002; 59(2): Holtkamp M, Othman J, Buchheim K, Meierkord H. Predictors and prognosis of refractory status epilepticus treated in a neurological intensive care unit. J Neurol Neurosurg Psychiatry 2005;76(4): Reuber M, Evans J, Bamford JM. Topiramate in drug-resistant complex partial status epilepticus. Eur J Neurol 2002;9(1): Towne AR, Garnett LK, Waterhouse EJ, et al. The use of topiramate in refractory status epilepticus. Neurology 2003;60(2): Rogawski MA, Loscher W. The neurobiology of antiepileptic drugs. Nat Rev Neurosci 2004;5(7): Gilbert DL, Gartside PS, Glauser TA. Efficacy and mortality in treatment of refractory generalized convulsive status epilepticus in children: a meta-analysis. J Child Neurol 1999;14(9): Singhi S, Murthy A, Singhi P, Jayashree M. Continuous midazolam versus diazepam infusion for refractory convulsive status epilepticus. J Child Neurol 2002;17(2): Morrison G, Gibbons E, Whitehouse WP. High-dose midazolam therapy for refractory status epilepticus in children. Intensive Care Med 2006;32(12): Hayashi K, Osawa M, Aihara M, et al. Efficacy of intravenous midazolam for status epilepticus in childhood. Pediatr Neurol 2007; 36(6): Kahriman M, Minecan D, Kutluay E, et al. Efficacy of topiramate in children with refractory status epilepticus. Epilepsia 2003;44(10): Perry MS, Holt PJ, Sladky JT. Topiramate loading for refractory status epilepticus in children. Epilepsia 2006;47(6): Blumkin L, Lerman-Sagie T, Houri T, et al. Pediatric refractory partial status epilepticus responsive to topiramate. J Child Neurol 2005; 20(3): Lowenstein DH, Alldredge BK. Status epilepticus at an urban public hospital in the 1980s. Neurology 1993;43(3 Pt 1): Eriksson K, Metsaranta P, Huhtala H, et al. Treatment delay and the risk of prolonged status epilepticus. Neurology 2005;65(8): Sahin M, Menache CC, Holmes GL, Riviello JJ. Outcome of severe refractory status epilepticus in children. Epilepsia 2001;42(11): Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol 2007;22(10): Martin R, Kuzniecky R, Ho S, et al. Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults. Neurology 1999;52(2): Tatum WOt, French JA, Faught E, et al. Postmarketing experience with topiramate and cognition. Epilepsia 2001;42(9): Journal of Korean Epilepsy Society Vol. 13 No. 2,

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