{"title":"粒细胞和单核细胞吸附治疗脓毒症的可行性研究。","authors":"Osamu Nishida, Tomoyuki Nakamura, Takaaki Nakada, Gaku Takahashi, Yoshiki Masuda, Hiroki Tsubouchi, Yasuyuki Kakihana, Yuichiro Sakamoto, Osamu Takasu, Hiroyuki Suzuki, Koichi Nakazawa, Iwao Kobayashi, Kent Doi, Sohta Uchiyama, Nobuya Kitamura, Toru Kotani, Naohide Kuriyama, Noriyuki Hattori, Yasushi Suzuki, Hiroomi Tatsumi, Kazuhiro Moriyama","doi":"10.1111/aor.14943","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>The pathogenesis of sepsis is thought to be linked to a dysregulated immune response, particularly that involving neutrophils. We have developed a granulocyte adsorption column as a “decoy organ,” which relocates the massive inflammation in organs in the body to a blood purification column. This study was conducted to assess the safety and experimental effectiveness of granulocyte monocyte adsorption apheresis-direct hemoperfusion (G1-DHP) in the treatment of patients with sepsis, using a prospective, multicenter design.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>The study included patients diagnosed with sepsis and with an APACHE II score ranging from 17 to 34. A total of five G1-DHP were performed within 3 days of patient enrollment. The primary endpoint was the change in sequential organ failure assessment (SOFA) score from enrollment to 7 days, and the safety endpoints were adverse events and mortality at 28 days.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>G1-DHP was performed on 82 patients. The median (interquartile range) SOFA score decreased from 10 (8–11) to 4 (3–7) after 7 days (<i>n</i> = 70; <i>p</i> < 0.01). Granulocytes, mainly neutrophils, were adsorbed, and the neutrophil-to-lymphocyte ratio significantly improved (<i>p</i> < 0.01). Notable improvements were observed in the SOFA scores for circulation and renal function. The acute physiology and chronic health evaluation II score of the 77 patients evaluated for mortality was 27, and the 28-day mortality rate was 7.8%.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This study confirmed that G1-DHP can be safely used as an adjunct to standard sepsis treatment regimens. Although further investigations are required, G1-DHP is a promising supplemental therapy for sepsis.</p>\n \n <p><b>Trial Registration:</b> jRCT1080225183 (Japan Registry of Clinical Trials identifier)</p>\n </section>\n </div>","PeriodicalId":8450,"journal":{"name":"Artificial organs","volume":"49 5","pages":"852-863"},"PeriodicalIF":2.2000,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/aor.14943","citationCount":"0","resultStr":"{\"title\":\"Granulocyte and Monocyte Adsorption Therapy in Patients With Sepsis: A Feasibility Study\",\"authors\":\"Osamu Nishida, Tomoyuki Nakamura, Takaaki Nakada, Gaku Takahashi, Yoshiki Masuda, Hiroki Tsubouchi, Yasuyuki Kakihana, Yuichiro Sakamoto, Osamu Takasu, Hiroyuki Suzuki, Koichi Nakazawa, Iwao Kobayashi, Kent Doi, Sohta Uchiyama, Nobuya Kitamura, Toru Kotani, Naohide Kuriyama, Noriyuki Hattori, Yasushi Suzuki, Hiroomi Tatsumi, Kazuhiro Moriyama\",\"doi\":\"10.1111/aor.14943\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>The pathogenesis of sepsis is thought to be linked to a dysregulated immune response, particularly that involving neutrophils. We have developed a granulocyte adsorption column as a “decoy organ,” which relocates the massive inflammation in organs in the body to a blood purification column. This study was conducted to assess the safety and experimental effectiveness of granulocyte monocyte adsorption apheresis-direct hemoperfusion (G1-DHP) in the treatment of patients with sepsis, using a prospective, multicenter design.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>The study included patients diagnosed with sepsis and with an APACHE II score ranging from 17 to 34. A total of five G1-DHP were performed within 3 days of patient enrollment. The primary endpoint was the change in sequential organ failure assessment (SOFA) score from enrollment to 7 days, and the safety endpoints were adverse events and mortality at 28 days.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>G1-DHP was performed on 82 patients. The median (interquartile range) SOFA score decreased from 10 (8–11) to 4 (3–7) after 7 days (<i>n</i> = 70; <i>p</i> < 0.01). Granulocytes, mainly neutrophils, were adsorbed, and the neutrophil-to-lymphocyte ratio significantly improved (<i>p</i> < 0.01). Notable improvements were observed in the SOFA scores for circulation and renal function. The acute physiology and chronic health evaluation II score of the 77 patients evaluated for mortality was 27, and the 28-day mortality rate was 7.8%.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>This study confirmed that G1-DHP can be safely used as an adjunct to standard sepsis treatment regimens. Although further investigations are required, G1-DHP is a promising supplemental therapy for sepsis.</p>\\n \\n <p><b>Trial Registration:</b> jRCT1080225183 (Japan Registry of Clinical Trials identifier)</p>\\n </section>\\n </div>\",\"PeriodicalId\":8450,\"journal\":{\"name\":\"Artificial organs\",\"volume\":\"49 5\",\"pages\":\"852-863\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-01-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/aor.14943\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Artificial organs\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/aor.14943\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Artificial organs","FirstCategoryId":"5","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/aor.14943","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
Granulocyte and Monocyte Adsorption Therapy in Patients With Sepsis: A Feasibility Study
Background
The pathogenesis of sepsis is thought to be linked to a dysregulated immune response, particularly that involving neutrophils. We have developed a granulocyte adsorption column as a “decoy organ,” which relocates the massive inflammation in organs in the body to a blood purification column. This study was conducted to assess the safety and experimental effectiveness of granulocyte monocyte adsorption apheresis-direct hemoperfusion (G1-DHP) in the treatment of patients with sepsis, using a prospective, multicenter design.
Methods
The study included patients diagnosed with sepsis and with an APACHE II score ranging from 17 to 34. A total of five G1-DHP were performed within 3 days of patient enrollment. The primary endpoint was the change in sequential organ failure assessment (SOFA) score from enrollment to 7 days, and the safety endpoints were adverse events and mortality at 28 days.
Results
G1-DHP was performed on 82 patients. The median (interquartile range) SOFA score decreased from 10 (8–11) to 4 (3–7) after 7 days (n = 70; p < 0.01). Granulocytes, mainly neutrophils, were adsorbed, and the neutrophil-to-lymphocyte ratio significantly improved (p < 0.01). Notable improvements were observed in the SOFA scores for circulation and renal function. The acute physiology and chronic health evaluation II score of the 77 patients evaluated for mortality was 27, and the 28-day mortality rate was 7.8%.
Conclusions
This study confirmed that G1-DHP can be safely used as an adjunct to standard sepsis treatment regimens. Although further investigations are required, G1-DHP is a promising supplemental therapy for sepsis.
Trial Registration: jRCT1080225183 (Japan Registry of Clinical Trials identifier)
期刊介绍：
Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.
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