Background <p>Granulocyte and monocyte adsorption therapy has been explored as an adjunctive treatment for sepsis due to its potential to modulate excessive systemic inflammation. However, clinical evidence characterizing its real-world use for sepsis remains limited. This study aimed to conduct an exploratory comparative assessment of granulocyte and monocyte adsorption apheresis-direct hemoperfusion (G1-DHP) in patients with sepsis.</p> Methods <p>We conducted a retrospective comparative study using a prospective multicenter dataset of patients treated with G1-DHP (G-1 trial) and three independent sepsis datasets (Japan Septic Disseminated Intravascular Coagulation [JSEPTIC-DIC], Focused Outcomes Research in Emergency Care in Acute Respiratory Distress Syndrome, Sepsis, and Trauma [FORECAST], and Japan Medical Data Center [JMDC]) as controls. Propensity score matching was performed using one-to-one nearest-neighbor matching. The primary outcome was 28-day mortality. Secondary outcomes included ventilator-free period, intensive care unit (ICU)-free period, and improvements in organ dysfunction scores. Ordinal logistic regression and linear regression were used based on outcome characteristics.</p> Results <p>After matching, the cohorts included 71, 72, and 68 patient pairs for comparisons with JSEPTIC-DIC, FORECAST, and JMDC, respectively. 28-day mortality was significantly lower in the G-1 trial across all matched datasets (G-1 trial vs. JSEPTIC-DIC: 5.6% vs. 23%; G-1 trial vs. FORECAST: 5.6% vs. 28%; G-1 trial vs. JMDC: 5.9% vs. 38%, all <i>P</i> &lt; 0.01). The G-1 trial had a significantly longer ventilator-free period and a trend toward a longer ICU-free period. G1-DHP was also associated with greater observed improvement in Sequential Organ Failure Assessment (SOFA) score by day 7 in comparison to controls. Improvements in liver and coagulation SOFA subscores were particularly notable.</p> Conclusions <p>In this multi-dataset analysis, patients treated with G1-DHP showed lower mortality and more favorable clinical outcomes in comparison to external controls. These exploratory findings provide preliminary insights into the potential role of G1-DHP as an immunomodulatory approach in sepsis and warrant further evaluation in prospective studies.</p>

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Granulocyte and monocyte adsorption therapy in sepsis: a propensity score-matched analysis

  • Ryo Hisamune,
  • Kazuma Yamakawa,
  • Tomoyuki Nakamura,
  • Kent Doi,
  • Gaku Takahashi,
  • Kazuhiro Moriyama,
  • Takuma Ishihara,
  • Osamu Nishida

摘要

Background

Granulocyte and monocyte adsorption therapy has been explored as an adjunctive treatment for sepsis due to its potential to modulate excessive systemic inflammation. However, clinical evidence characterizing its real-world use for sepsis remains limited. This study aimed to conduct an exploratory comparative assessment of granulocyte and monocyte adsorption apheresis-direct hemoperfusion (G1-DHP) in patients with sepsis.

Methods

We conducted a retrospective comparative study using a prospective multicenter dataset of patients treated with G1-DHP (G-1 trial) and three independent sepsis datasets (Japan Septic Disseminated Intravascular Coagulation [JSEPTIC-DIC], Focused Outcomes Research in Emergency Care in Acute Respiratory Distress Syndrome, Sepsis, and Trauma [FORECAST], and Japan Medical Data Center [JMDC]) as controls. Propensity score matching was performed using one-to-one nearest-neighbor matching. The primary outcome was 28-day mortality. Secondary outcomes included ventilator-free period, intensive care unit (ICU)-free period, and improvements in organ dysfunction scores. Ordinal logistic regression and linear regression were used based on outcome characteristics.

Results

After matching, the cohorts included 71, 72, and 68 patient pairs for comparisons with JSEPTIC-DIC, FORECAST, and JMDC, respectively. 28-day mortality was significantly lower in the G-1 trial across all matched datasets (G-1 trial vs. JSEPTIC-DIC: 5.6% vs. 23%; G-1 trial vs. FORECAST: 5.6% vs. 28%; G-1 trial vs. JMDC: 5.9% vs. 38%, all P < 0.01). The G-1 trial had a significantly longer ventilator-free period and a trend toward a longer ICU-free period. G1-DHP was also associated with greater observed improvement in Sequential Organ Failure Assessment (SOFA) score by day 7 in comparison to controls. Improvements in liver and coagulation SOFA subscores were particularly notable.

Conclusions

In this multi-dataset analysis, patients treated with G1-DHP showed lower mortality and more favorable clinical outcomes in comparison to external controls. These exploratory findings provide preliminary insights into the potential role of G1-DHP as an immunomodulatory approach in sepsis and warrant further evaluation in prospective studies.