わが国におけるAntihypertensive Treatment of Acute Cerebral Hemorrhage（ATACH）-II試験の開始：デザインと国内研究体制の構築
ATACH-IIは，米国NIHの助成による脳出血急性期の適切な降圧目標確立のための第III相国際共同試験で，国内からも約400例の登録（全体で1,280例）を目指す．対象は収縮期血圧が180mmHgを超えるテント上脳出血患者である．積極降圧療法群（収縮期血圧110～140mmHg）または標準降圧療法群（140～180mmHg）のいずれかに無作為に割り付け，ニカルジピン静注を発症から4.5時間以内に開始し，24時間継続する．主要評価項目は90日後のmodified Rankin scaleスコア4～6の割合である．研究者主導国際共同試験を今後国内で継続的に遂行するための試金石と考えている．...
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| Published in | 臨床神経学 Vol. 52; no. 9; pp. 642 - 650 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
日本神経学会
2012
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0009-918X 1882-0654 |
| DOI | 10.5692/clinicalneurol.52.642 |
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| Abstract | ATACH-IIは，米国NIHの助成による脳出血急性期の適切な降圧目標確立のための第III相国際共同試験で，国内からも約400例の登録（全体で1,280例）を目指す．対象は収縮期血圧が180mmHgを超えるテント上脳出血患者である．積極降圧療法群（収縮期血圧110～140mmHg）または標準降圧療法群（140～180mmHg）のいずれかに無作為に割り付け，ニカルジピン静注を発症から4.5時間以内に開始し，24時間継続する．主要評価項目は90日後のmodified Rankin scaleスコア4～6の割合である．研究者主導国際共同試験を今後国内で継続的に遂行するための試金石と考えている． |
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| AbstractList | ATACH-IIは，米国NIHの助成による脳出血急性期の適切な降圧目標確立のための第III相国際共同試験で，国内からも約400例の登録（全体で1,280例）を目指す．対象は収縮期血圧が180mmHgを超えるテント上脳出血患者である．積極降圧療法群（収縮期血圧110～140mmHg）または標準降圧療法群（140～180mmHg）のいずれかに無作為に割り付け，ニカルジピン静注を発症から4.5時間以内に開始し，24時間継続する．主要評価項目は90日後のmodified Rankin scaleスコア4～6の割合である．研究者主導国際共同試験を今後国内で継続的に遂行するための試金石と考えている． |
| Author | 佐藤, 祥一郎 山本, 晴子 Y., Palesch Yuko I., Qureshi Adnan ATACH-II国内研究グループ 豊田, 一則 |
| Author_xml | – sequence: 1 fullname: 豊田, 一則 organization: 国立循環器病研究センター脳血管内科 – sequence: 1 fullname: I., Qureshi Adnan organization: ミネソタ大学神経内科 – sequence: 1 fullname: 山本, 晴子 organization: 国立循環器病研究センター先進医療・治験推進部 – sequence: 1 fullname: 佐藤, 祥一郎 organization: 国立循環器病研究センター脳血管内科 – sequence: 1 fullname: Y., Palesch Yuko organization: サウスカロライナ医科大学生物統計部門 – sequence: 1 fullname: ATACH-II国内研究グループ |
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| References | 25) Mayer SA, Brun NC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005;352:777-785. 13) Qureshi AI, Wilson DA, Hanley DF, et al. Pharmacologic reduction of mean arterial pressure does not adversely affect regional cerebral blood flow and intracranial pressure in experimental intracerebral hemorrhage. Crit Care Med 1999;27:965-971. 11) Maruishi M, Shima T, Okada Y, et al. Involvement of fluctuating high blood pressure in the enlargement of spontaneous intracerebral hematoma. Neurol Med Chir (Tokyo) 2001;41:300-304;discussion 304-305. 3) Qureshi AI, Ezzeddine MA, Nasar A, et al. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med 2007;25:32-38. 22) Anderson CS, Huang Y, Wang JG, et al. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol 2008;7:391-399. 17) Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003;289:2560-2572. 4) 篠原幸人, 小川 彰, 鈴木則宏ら, 編. 脳卒中治療ガイドライン2009. 東京: 協和企画; 2009. 10) Toyoda K, Okada Y, Minematsu K, et al. Antiplatelet therapy contributes to acute deterioration of intracerebral hemorrhage. Neurology 2005;65:1000-1004. 26) Koga M, Toyoda K, Naganuma M, et al. Nationwide survey of antihypertensive treatment for acute intracerebral hemorrhage in Japan. Hypertens Res 2009;32:759-764. 29) Delcourt C, Huang Y, Wang J, et al. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke 2010;5:110-116. 12) Powers WJ, Zazulia AR, Videen TO, et al. Autoregulation of cerebral blood flow surrounding acute (6 to 22 hours) intracerebral hemorrhage. Neurology 2001;57:18-24. 20) Willmot M, Leonardi-Bee J, Bath PM. High blood pressure in acute stroke and subsequent outcome: a systematic review. Hypertension 2004;43:18-24. 24) Davis SM, Broderick J, Hennerici M, et al. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology 2006;66:1175-1181. 8) Kazui S, Naritomi H, Yamamoto H, et al. Enlargement of spontaneous intracerebral hemorrhage. Incidence and time course. Stroke 1996;27:1783-1787. 15) Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care 2011;15:559-576. 5) Morgenstern LB, Hemphill JC 3rd, Anderson C, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2010;41:2108-2129. 9) Toyoda K, Yasaka M, Nagata K, et al. Antithrombotic therapy influences location, enlargement, and mortality from intracerebral hemorrhage. The Bleeding with Antithrombotic Therapy (BAT) Retrospective Study. Cerebrovasc Dis 2009;27:151-159. 23) Qureshi AI, Palesch YY, Martin R, et al. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol 2010;67:570-576. 30) 山本晴子, 峰松一夫. 神経疾患における公的研究費による大規模多施設共同試験実施システム構築の必要性：米国のcooperative groupの仕組みより. 臨床神経 2011;51:612-616. 27) Ohwaki K, Yano E, Nagashima H, et al. Blood pressure management in acute intracerebral hemorrhage: relationship between elevated blood pressure and hematoma enlargement. Stroke 2004;35:1364-1367. 1) 鈴木一夫, 坂本哲也. インターベンション時代の脳卒中学（改訂第2版）超急性期から再発予防まで 脳血管障害各論 脳内出血 脳内出血（高血圧性脳出血）総論 脳内出血の臨床疫学的研究. 日本臨床 2006;64:315-319. 14) Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care 2007;6:56-66. 2) 小林祥泰, 編著. 脳卒中データバンク2009. 東京: 中山書店; 2009. 21) Terayama Y, Tanahashi N, Fukuuchi Y, et al. Prognostic value of admission blood pressure in patients with intracerebral hemorrhage. Keio Cooperative Stroke Study. Stroke 1997;28:1185-1188. 6) Steiner T, Kaste M, Forsting M, et al. Recommendations for the management of intracranial haemorrhage-part I: spontaneous intracerebral haemorrhage. The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis 2006;22:294-316. 7) Brott T, Broderick J, Kothari R, et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 1997;28:1-5. 28) Itabashi R, Toyoda K, Yasaka M, et al. The impact of hyperacute blood pressure lowering on the early clinical outcome following intracerebral hemorrhage. J Hypertens 2008;26:2016-2021. 18) Qureshi AI, Tuhrim S, Broderick JP, et al. Spontaneous intracerebral hemorrhage. N Engl J Med 2001;344:1450-1460. 19) Carlberg B, Asplund K, Hagg E. The prognostic value of admission blood pressure in patients with acute stroke. Stroke 1993;24:1372-1375. 16) EuroQol -a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990;16:199-208. |
| References_xml | – reference: 2) 小林祥泰, 編著. 脳卒中データバンク2009. 東京: 中山書店; 2009. – reference: 18) Qureshi AI, Tuhrim S, Broderick JP, et al. Spontaneous intracerebral hemorrhage. N Engl J Med 2001;344:1450-1460. – reference: 21) Terayama Y, Tanahashi N, Fukuuchi Y, et al. Prognostic value of admission blood pressure in patients with intracerebral hemorrhage. Keio Cooperative Stroke Study. Stroke 1997;28:1185-1188. – reference: 30) 山本晴子, 峰松一夫. 神経疾患における公的研究費による大規模多施設共同試験実施システム構築の必要性：米国のcooperative groupの仕組みより. 臨床神経 2011;51:612-616. – reference: 20) Willmot M, Leonardi-Bee J, Bath PM. High blood pressure in acute stroke and subsequent outcome: a systematic review. Hypertension 2004;43:18-24. – reference: 14) Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care 2007;6:56-66. – reference: 10) Toyoda K, Okada Y, Minematsu K, et al. Antiplatelet therapy contributes to acute deterioration of intracerebral hemorrhage. Neurology 2005;65:1000-1004. – reference: 3) Qureshi AI, Ezzeddine MA, Nasar A, et al. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med 2007;25:32-38. – reference: 9) Toyoda K, Yasaka M, Nagata K, et al. Antithrombotic therapy influences location, enlargement, and mortality from intracerebral hemorrhage. The Bleeding with Antithrombotic Therapy (BAT) Retrospective Study. Cerebrovasc Dis 2009;27:151-159. – reference: 28) Itabashi R, Toyoda K, Yasaka M, et al. The impact of hyperacute blood pressure lowering on the early clinical outcome following intracerebral hemorrhage. J Hypertens 2008;26:2016-2021. – reference: 4) 篠原幸人, 小川 彰, 鈴木則宏ら, 編. 脳卒中治療ガイドライン2009. 東京: 協和企画; 2009. – reference: 6) Steiner T, Kaste M, Forsting M, et al. Recommendations for the management of intracranial haemorrhage-part I: spontaneous intracerebral haemorrhage. The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis 2006;22:294-316. – reference: 8) Kazui S, Naritomi H, Yamamoto H, et al. Enlargement of spontaneous intracerebral hemorrhage. Incidence and time course. Stroke 1996;27:1783-1787. – reference: 27) Ohwaki K, Yano E, Nagashima H, et al. Blood pressure management in acute intracerebral hemorrhage: relationship between elevated blood pressure and hematoma enlargement. Stroke 2004;35:1364-1367. – reference: 19) Carlberg B, Asplund K, Hagg E. The prognostic value of admission blood pressure in patients with acute stroke. Stroke 1993;24:1372-1375. – reference: 24) Davis SM, Broderick J, Hennerici M, et al. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology 2006;66:1175-1181. – reference: 17) Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003;289:2560-2572. – reference: 23) Qureshi AI, Palesch YY, Martin R, et al. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol 2010;67:570-576. – reference: 16) EuroQol -a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990;16:199-208. – reference: 12) Powers WJ, Zazulia AR, Videen TO, et al. Autoregulation of cerebral blood flow surrounding acute (6 to 22 hours) intracerebral hemorrhage. Neurology 2001;57:18-24. – reference: 25) Mayer SA, Brun NC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005;352:777-785. – reference: 1) 鈴木一夫, 坂本哲也. インターベンション時代の脳卒中学（改訂第2版）超急性期から再発予防まで 脳血管障害各論 脳内出血 脳内出血（高血圧性脳出血）総論 脳内出血の臨床疫学的研究. 日本臨床 2006;64:315-319. – reference: 5) Morgenstern LB, Hemphill JC 3rd, Anderson C, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2010;41:2108-2129. – reference: 26) Koga M, Toyoda K, Naganuma M, et al. Nationwide survey of antihypertensive treatment for acute intracerebral hemorrhage in Japan. Hypertens Res 2009;32:759-764. – reference: 7) Brott T, Broderick J, Kothari R, et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 1997;28:1-5. – reference: 22) Anderson CS, Huang Y, Wang JG, et al. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol 2008;7:391-399. – reference: 15) Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care 2011;15:559-576. – reference: 29) Delcourt C, Huang Y, Wang J, et al. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke 2010;5:110-116. – reference: 13) Qureshi AI, Wilson DA, Hanley DF, et al. Pharmacologic reduction of mean arterial pressure does not adversely affect regional cerebral blood flow and intracranial pressure in experimental intracerebral hemorrhage. Crit Care Med 1999;27:965-971. – reference: 11) Maruishi M, Shima T, Okada Y, et al. Involvement of fluctuating high blood pressure in the enlargement of spontaneous intracerebral hematoma. Neurol Med Chir (Tokyo) 2001;41:300-304;discussion 304-305. |
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| Snippet | ATACH-IIは，米国NIHの助成による脳出血急性期の適切な降圧目標確立のための第III相国際共同試験で，国内からも約400例の登録（全体で1,280例）を目指す．対象は収縮期血... |
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| SubjectTerms | ニカルジピン 脳出血 臨床試験 降圧療法 高血圧 |
| Title | わが国におけるAntihypertensive Treatment of Acute Cerebral Hemorrhage（ATACH）-II試験の開始：デザインと国内研究体制の構築 |
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