日本未熟児新生児学会雑誌 25(1):35-42;2013 印刷する
日本未熟児新生児学会雑誌 第25巻第1号 35~42頁(2013年)
受付日:平成23.01.31
受理日:平成24.07.11
新生児低酸素性虚血性脳症における脳低温療法とエダラボン併用療法の有効性と安全性に関する検討
A Study of the Efficacy and Safety of a Combination Therapy of Brain Hypothermia and Edaravone in Neonatal Hypoxic Ischemic Encephalopathy
埼玉県立小児医療センター 未熟児新生児科
Department of Neonatology, Saitama Children’s Medical Center
川畑 建・清水正樹・菅野啓一・宮林 寛
Ken KAWABATA,Masaki SHIMIZU,Keiichi KANNO,Hiroshi MIYABAYASHI
Key Words:hypoxic ischemic encephalopathy,brain hypothermia,free radical scavenger,edaravon
 新生児低酸素性虚血性脳症(hypoxic ischemic encephalopathy:HIE)に対する脳低温療法(brain hypothermia:BHT)に,フリーラジカル除去剤であるエダラボンを使用した併用療法における有効性と安全性を検討した。22例のHIE 児を対象とし,神経学的予後および有害事象の発生の有無を診療録から後方視的に検討した。22 例中,BHT単独使用群が15 例,BHT にエダラボンを併用した群が7 例であった。両群の比較検討では,頭部MRI 検査所見および3 歳時予後に関して統計学的有意差を認めなかったが,入院期間はエダラボン併用群がBHT 単独使用群と比較して有意に短い傾向にあった。エダラボン併用群では7 例中6 例でMRI 所見が正常,残る1 例は多嚢胞性脳軟化症の状態であった。3 歳時の発達は7 例中5 例が正常,1 例で重度の脳性麻痺,1 例で軽度発達遅滞を認めた。エダラボン投与中に一過性の肝逸脱酵素の上昇を認めた症例も存在したが,その他に重篤な副作用はなく,安全に施行できた。エダラボン併用群では基底核壊死の症例が少なく,退院指導に多くの時間を要しなかったことが,入院期間の短縮に結びついたと考えられた。本療法は重症HIE に対しても有効な予後を期待でき,一つの治療戦略として有用であると考えられた。
 We examined the efficacy and safety of a combination therapy of brain hypothermia(BHT)and edaravone in neonatal hypoxic ischemic encephalopathy(HIE).
 BHT was achieved in 22 term infants suffering from moderate-to-severe HIE by head cooling within 6h of birth with the nasopharyngeal temperature being at 34℃.
 Fifteen babies were treated with BHT alone(C group)and 7 babies were administered a combination therapy of BHT and edaravone(E group).
 Magnetic resonance imaging(MRI)was performed at the time of hospital discharge. Sixty-two percent of infants in the C group showed abnormal MRI findings, whereas 6 infants in the E group demonstrated normal findings, and only 1 infant exhibited injury to the gray and white matter with cystic changes in the basal ganglia.
 The developmental quotient at 3 years of age demonstrated that the C group had an average of 50, whereas the E group had an average of 84.1. The E group demonstrated better prognosis than the C group, however no significant differences between the two groups were observed. In addition, the duration of hospital stays was significantly shorter in the E group(p=0.006).A transient increase in serum glutamic oxaloacetic transuminase(SGOT)levels was detected in some cases in the E group, but no apparent adverse effects of edaravone usage were noted. Because the number of cases in this study was small, no statistically significant differences between the two groups were observed with regard to developmental prognosis. However, future studies with larger number of cases may reveal more significant findings with regard to developmental prognosis in patients treated with a combination therapy of BHT and edaravone. Therefore, more detailed studies investigating the developmental prognosis need to be conducted.
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