Granulocyte and Monocyte Adsorption Therapy in Patients With Sepsis: A Feasibility Study

IF 2.2 3区医学 Q3 ENGINEERING, BIOMEDICAL

Artificial organs Pub Date : 2025-01-17 DOI:10.1111/aor.14943

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

{"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}

引用次数: 0

Abstract

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)

Abstract Image

查看原文本刊更多论文

粒细胞和单核细胞吸附治疗脓毒症的可行性研究。

背景：脓毒症的发病机制被认为与免疫反应失调有关，特别是涉及中性粒细胞的免疫反应失调。我们开发了粒细胞吸附柱作为“诱饵器官”，将体内器官的大量炎症转移到血液净化柱上。本研究采用前瞻性、多中心设计，评估粒细胞单核细胞吸附分离-直接血液灌流（G1-DHP）治疗脓毒症患者的安全性和实验有效性。方法：研究纳入了诊断为脓毒症且APACHE II评分在17 - 34之间的患者。患者入组后3天内共进行5次G1-DHP。主要终点是从入组到7天的顺序器官衰竭评估（SOFA）评分的变化，安全终点是28天的不良事件和死亡率。结果：82例患者行G1-DHP。7天后，SOFA评分中位数（四分位数间距）从10（8-11）降至4 (3-7)(n = 70；结论：本研究证实G1-DHP可以安全地作为标准脓毒症治疗方案的辅助药物。虽然需要进一步的研究，G1-DHP是一种很有希望的败血症补充治疗。试验注册：jRCT1080225183（日本临床试验注册标识）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Artificial organs 工程技术-工程：生物医学

CiteScore

4.30

自引率

12.50%

发文量

303

审稿时长

4-8 weeks

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.