エンドトキシン吸着カラム（PMX-DHP）は有用か
Polymyxin B（PLB）はエンドトキシンを吸着する作用があり，PLBを結合させたカラム（PMX-DHP）が日本で開発された。日本では PMX-DHPが早い段階で保険適応となったこともあり，有用性を評価するための質の高い研究が行われてこなかった。海外では現在まで敗血症性ショック患者を対象とし死亡率をアウトカムとする比較的大規模な RCTが 3件行われたが，1件は有意な有用性を示したものの，1件は差がなかった。1件の RCTはプレスリリースでの結果公表の段階であるが，primary outcomeでは有意差がないものの，post-hocの subgroup解析では有意に死亡率を減少した。敗...
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| Published in | 日本外科感染症学会雑誌 Vol. 15; no. 3; pp. 242 - 247 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本外科感染症学会
30.06.2018
Japan Society for Surgical Infection |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1349-5755 2434-0103 |
| DOI | 10.24679/gekakansen.15.3_242 |
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| Abstract | Polymyxin B（PLB）はエンドトキシンを吸着する作用があり，PLBを結合させたカラム（PMX-DHP）が日本で開発された。日本では PMX-DHPが早い段階で保険適応となったこともあり，有用性を評価するための質の高い研究が行われてこなかった。海外では現在まで敗血症性ショック患者を対象とし死亡率をアウトカムとする比較的大規模な RCTが 3件行われたが，1件は有意な有用性を示したものの，1件は差がなかった。1件の RCTはプレスリリースでの結果公表の段階であるが，primary outcomeでは有意差がないものの，post-hocの subgroup解析では有意に死亡率を減少した。敗血症の標準診療が普及し，死亡率が低下しつつある現在において，死亡率を outcomeとして有意差を得ることはますます困難になりつつあるが，これはすなわち，PMX-DHPを始め多くの治療法は，ある限られた患者群でのみ有用である治療法であることを示唆し，適応をよく考慮して使用すべきと言えよう。 |
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| AbstractList | Polymyxin B, an antibiotic with high affinity for endotoxin, has been bound and immobilized to polystyrene fibers (PMX-DHP) in a medical device for hemoperfusion that was developed in Japan. Since PMX-DHP has become the insurance adaptation in Japan at an early stage, high quality clinical study had not been performed. Relatively large-scale 3 randomized controlled trials (RCTs) were performed abroad to date for the patients with septic shock to evaluate the reduction of mortality. Although one RCT showed significant difference in mortality compared with standard care, one RCT did not have significant difference. The result of last RCT was press-released that reported no significant difference in mortality of primary outcome in all cases, but significant difference in mortality in post-hoc, subgroup analysis. Nowadays, since standard management of sepsis has been distributed, and the mortality of sepsis has been decreased, it has been getting more difficult to prove significant difference in mortality. That indicates many therapies such as PMX-DHP, are effective in only very limited septic patients, therefore, indications of these therapies should be considered very carefully.
Polymyxin B（PLB）はエンドトキシンを吸着する作用があり，PLBを結合させたカラム（PMX-DHP）が日本で開発された。日本では PMX-DHPが早い段階で保険適応となったこともあり，有用性を評価するための質の高い研究が行われてこなかった。海外では現在まで敗血症性ショック患者を対象とし死亡率をアウトカムとする比較的大規模な RCTが 3件行われたが，1件は有意な有用性を示したものの，1件は差がなかった。1件の RCTはプレスリリースでの結果公表の段階であるが，primary outcomeでは有意差がないものの，post-hocの subgroup解析では有意に死亡率を減少した。敗血症の標準診療が普及し，死亡率が低下しつつある現在において，死亡率を outcomeとして有意差を得ることはますます困難になりつつあるが，これはすなわち，PMX-DHPを始め多くの治療法は，ある限られた患者群でのみ有用である治療法であることを示唆し，適応をよく考慮して使用すべきと言えよう。 Polymyxin B（PLB）はエンドトキシンを吸着する作用があり，PLBを結合させたカラム（PMX-DHP）が日本で開発された。日本では PMX-DHPが早い段階で保険適応となったこともあり，有用性を評価するための質の高い研究が行われてこなかった。海外では現在まで敗血症性ショック患者を対象とし死亡率をアウトカムとする比較的大規模な RCTが 3件行われたが，1件は有意な有用性を示したものの，1件は差がなかった。1件の RCTはプレスリリースでの結果公表の段階であるが，primary outcomeでは有意差がないものの，post-hocの subgroup解析では有意に死亡率を減少した。敗血症の標準診療が普及し，死亡率が低下しつつある現在において，死亡率を outcomeとして有意差を得ることはますます困難になりつつあるが，これはすなわち，PMX-DHPを始め多くの治療法は，ある限られた患者群でのみ有用である治療法であることを示唆し，適応をよく考慮して使用すべきと言えよう。 |
| Author | 大坪, 広樹 宮川, 一平 佐藤, 直人 舛本, 直哉 草永, 真志 椎野, 明日実 手嶋, 悠人 秋本, 倫太郎 花石, 源太郎 首藤, 瑠里 弓指, 恵一 岡本, 直通 真弓, 俊彦 |
| Author_FL | Okamoto Naomiti Akimoto Rintaro Teshima Yuto Mayumi Toshihiko Hanaishi Gentaro Yumisashi Keichi Shuto Ruri Sato Naohito Masumoto Naoya Kusanaga Masashi Shiino Asumi Otsubo Hiroki Miyagawa Ippei |
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| Author_xml | – sequence: 1 fullname: 宮川, 一平 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 秋本, 倫太郎 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 大坪, 広樹 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 首藤, 瑠里 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 舛本, 直哉 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 椎野, 明日実 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 草永, 真志 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 佐藤, 直人 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 手嶋, 悠人 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 真弓, 俊彦 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 花石, 源太郎 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 岡本, 直通 organization: 産業医科大学医学部救急医学 – sequence: 1 fullname: 弓指, 恵一 organization: 産業医科大学医学部救急医学 |
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| References | 22) Payen DM, Guilhot J, Launey Y, et al: Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med 2015; 41: 975-984 10) EARLの医学ノート論文の読み方，統計（6），https://drmagician.exblog.jp/i14/（2018年 5月 21日アクセス） 21) Cruz DN, Antonelli M, Fumagalli R, et al: Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA 2009; 301: 2445-2452 3) 西田 修，小倉裕司，井上茂亮，ほか：日本版敗血症診療ガイドライン2016．日集中医会誌2017；28：S1-S232 4) 西田 修，小倉裕司，井上茂亮，ほか：日本版敗血症診療ガイドライン2016．日救医会誌2017；28： S1-S232 11) Zhang Z, Ni H, Xu X: Do the observational studies using propensity score analysis agree with randomized controlled trials in the area of sepsis? J Crit Care 2014; 29: 886.e9-15 7) Iwagami M, Yasunaga H, Doi K, et al: Postoperative polymyxin B hemoperfusion and mortality in patients with abdominal septic shock: a propensity-matched analysis. Crit Care Med 2014; 42: 1187-1193 18) Fujii T, Ganeko R, Kataoka Y, et al: Correction to: Polymyxin B-immobilized hemoperfusion and mortality in critically ill adult patients with sepsis/ septic shock: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med 2018; 44: 279-280 14) Zhou F, Peng Z, Murugan R, et al: Blood purification and mortality in sepsis: a meta-analysis of randomized trials. Crit Care Med 2013; 41: 2209-2220 5) 谷 徹，荒木 浩，小玉正智：エンドトキシン吸着療法を用いた SIRSの病態の調節と MOFの予防．医のあゆみ 1997; 181: 118-121 19) Cantaluppi V, Assenzio B, Pasero D, et al: Polymyxin-B hemoperfusion inactivates circulating proapoptotic factors. Intensive Care Med 2008; 34: 1638-1645 6) エンドトキシン除去向け吸着型血液浄化用浄化器70535000「トレミキシン」添付文書（http://www.info.pmda.go.jp/downfiles/md/PDF/480220/480220_20500BZZ00926000_A_01_04.pdf） 13) Cruz DN, Perazella MA, Bellomo R, et al: Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care 2007; 11: R47 17) Fujii T, Ganeko R, Kataoka Y, et al: Polymyxin B-immobilized hemoperfusion and mortality in critically ill adult patients with sepsis/septic shock: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med 2018; 44: 167-178 25) http ://www.spectraldx.com/assets/spectral-rls-05.30.17.pdf 27) http ://www.spectraldx.com/assets/spectral-rls-053018.pdf（2018. 6. 1アクセス） 2) Rhodes A, Evans LE, Alhazzani W, et al: Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 2017; 43: 304-377 24) Klein DJ, Foster D, Schorr CA, et al: The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials 2014; 15: 218 9) Nakamura Y, Kitamura T, Kiyomi F, et al: Potential survival benefit of polymyxin B hemoperfusion in patients with septic shock: a propensity-matched cohort study. Crit Care 2017; 21: 134 23) Coudroy R, Payen D, Launey Y, et al: Modulation by polymyxin-B hemoperfusion of inflammatory response related to severe peritonitis. Shock 2017; 47: 93-99 12) Dahabreh IJ, Sheldrick RC, Paulus JK, et al: Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur Heart J 2012; 33: 1893-1901 15) Terayama T, Yamakawa K, Umemura Y, et al: Polymyxin B Hemoperfusion for Sepsis and Septic Shock: A Systematic Review and Meta-Analysis. Surg Infect 2017; 18: 225-233 20) Vincent JL, Laterre PF, Cohen J, et al: A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection. Shock 2005; 23: 400-405 8) Iwagami M, Yasunaga H, Noiri E, et al: Potential Survival Benefit of Polymyxin B Hemoperfusion in Septic Shock Patients on Continuous Renal Replacement Therapy: A Propensity-Matched Analysis. Blood Purif 2016; 42: 9-17 16) Chang T, Tu YK, Lee CT, et al: Effects of Polymyxin B Hemoperfusion on Mortality in Patients With Severe Sepsis and Septic Shock: A Systemic Review, Meta-Analysis Update, and Disease Severity Subgroup Meta-Analysis. Crit Care Med 2017; 45: e858-e864 26) http ://www.spectraldx.com/assets/spectral-pwalker-cccf2017.pdf（2018. 5. 29アクセス） 1) Rhodes A, Evans LE, Alhazzani W, et al: Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med 2017; 45: 486-552 |
| References_xml | – reference: 21) Cruz DN, Antonelli M, Fumagalli R, et al: Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA 2009; 301: 2445-2452 – reference: 26) http ://www.spectraldx.com/assets/spectral-pwalker-cccf2017.pdf（2018. 5. 29アクセス） – reference: 9) Nakamura Y, Kitamura T, Kiyomi F, et al: Potential survival benefit of polymyxin B hemoperfusion in patients with septic shock: a propensity-matched cohort study. Crit Care 2017; 21: 134 – reference: 27) http ://www.spectraldx.com/assets/spectral-rls-053018.pdf（2018. 6. 1アクセス） – reference: 5) 谷 徹，荒木 浩，小玉正智：エンドトキシン吸着療法を用いた SIRSの病態の調節と MOFの予防．医のあゆみ 1997; 181: 118-121 – reference: 22) Payen DM, Guilhot J, Launey Y, et al: Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med 2015; 41: 975-984 – reference: 13) Cruz DN, Perazella MA, Bellomo R, et al: Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care 2007; 11: R47 – reference: 7) Iwagami M, Yasunaga H, Doi K, et al: Postoperative polymyxin B hemoperfusion and mortality in patients with abdominal septic shock: a propensity-matched analysis. Crit Care Med 2014; 42: 1187-1193 – reference: 24) Klein DJ, Foster D, Schorr CA, et al: The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials 2014; 15: 218 – reference: 15) Terayama T, Yamakawa K, Umemura Y, et al: Polymyxin B Hemoperfusion for Sepsis and Septic Shock: A Systematic Review and Meta-Analysis. Surg Infect 2017; 18: 225-233 – reference: 2) Rhodes A, Evans LE, Alhazzani W, et al: Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 2017; 43: 304-377 – reference: 3) 西田 修，小倉裕司，井上茂亮，ほか：日本版敗血症診療ガイドライン2016．日集中医会誌2017；28：S1-S232 – reference: 23) Coudroy R, Payen D, Launey Y, et al: Modulation by polymyxin-B hemoperfusion of inflammatory response related to severe peritonitis. Shock 2017; 47: 93-99 – reference: 19) Cantaluppi V, Assenzio B, Pasero D, et al: Polymyxin-B hemoperfusion inactivates circulating proapoptotic factors. Intensive Care Med 2008; 34: 1638-1645 – reference: 12) Dahabreh IJ, Sheldrick RC, Paulus JK, et al: Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur Heart J 2012; 33: 1893-1901 – reference: 20) Vincent JL, Laterre PF, Cohen J, et al: A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection. Shock 2005; 23: 400-405 – reference: 25) http ://www.spectraldx.com/assets/spectral-rls-05.30.17.pdf – reference: 16) Chang T, Tu YK, Lee CT, et al: Effects of Polymyxin B Hemoperfusion on Mortality in Patients With Severe Sepsis and Septic Shock: A Systemic Review, Meta-Analysis Update, and Disease Severity Subgroup Meta-Analysis. Crit Care Med 2017; 45: e858-e864 – reference: 14) Zhou F, Peng Z, Murugan R, et al: Blood purification and mortality in sepsis: a meta-analysis of randomized trials. Crit Care Med 2013; 41: 2209-2220 – reference: 18) Fujii T, Ganeko R, Kataoka Y, et al: Correction to: Polymyxin B-immobilized hemoperfusion and mortality in critically ill adult patients with sepsis/ septic shock: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med 2018; 44: 279-280 – reference: 1) Rhodes A, Evans LE, Alhazzani W, et al: Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med 2017; 45: 486-552 – reference: 4) 西田 修，小倉裕司，井上茂亮，ほか：日本版敗血症診療ガイドライン2016．日救医会誌2017；28： S1-S232 – reference: 8) Iwagami M, Yasunaga H, Noiri E, et al: Potential Survival Benefit of Polymyxin B Hemoperfusion in Septic Shock Patients on Continuous Renal Replacement Therapy: A Propensity-Matched Analysis. Blood Purif 2016; 42: 9-17 – reference: 17) Fujii T, Ganeko R, Kataoka Y, et al: Polymyxin B-immobilized hemoperfusion and mortality in critically ill adult patients with sepsis/septic shock: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med 2018; 44: 167-178 – reference: 6) エンドトキシン除去向け吸着型血液浄化用浄化器70535000「トレミキシン」添付文書（http://www.info.pmda.go.jp/downfiles/md/PDF/480220/480220_20500BZZ00926000_A_01_04.pdf） – reference: 10) EARLの医学ノート論文の読み方，統計（6），https://drmagician.exblog.jp/i14/（2018年 5月 21日アクセス） – reference: 11) Zhang Z, Ni H, Xu X: Do the observational studies using propensity score analysis agree with randomized controlled trials in the area of sepsis? J Crit Care 2014; 29: 886.e9-15 |
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| Snippet | Polymyxin B（PLB）はエンドトキシンを吸着する作用があり，PLBを結合させたカラム（PMX-DHP）が日本で開発された。日本では... Polymyxin B, an antibiotic with high affinity for endotoxin, has been bound and immobilized to polystyrene fibers (PMX-DHP) in a medical device for... |
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| SubjectTerms | RCT エンドトキシン吸着 システマティックレビュー 敗血症 |
| Title | エンドトキシン吸着カラム（PMX-DHP）は有用か |
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| ispartofPNX | 日本外科感染症学会雑誌, 2018/06/30, Vol.15(3), pp.242-247 |
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