Clinical Utility of the Sivelestat for the Treatment of ALI/ARDS: Moving on in the Controversy?

Ding, Qiongli; Wang, Yi; Yang, Chunbo; Li, Xiang; Yu, Xin

doi:10.1007/s44231-022-00012-5

Cited by 13 publications

(6 citation statements)

References 31 publications

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“…Neutrophil elastase plays a crucial role in the development of ARDS, and sivelestat sodium, as a neutrophil elastase inhibitor, can effectively inhibit its activity. By inhibiting neutrophil aggregation, adhesion, and infiltration, [ 15 ] sivelestat sodium can reduce pulmonary hemorrhage, exudation, and attenuate pulmonary edema [ 27 ]. Sivelestat sodium was marketed in Japan in 2002 and is now widely used in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…For example, a large-sample study involving 4276 patients showed that sivelestat sodium treatment within seven days of hospital admission may improve the prognosis of patients with ALI/ARDS [ 11 ]. However, other studies have concluded that sivelestat sodium does not significantly affect the risk of death in ARDS patients [ 10 , 15 , 19 ]. Instead, these studies have shown that sivelestat sodium can lead to a reduced length of hospital stay and improvements in inflammatory markers and oxygenation indices in patients.…”

Section: Discussionmentioning

confidence: 99%

“…Mechanical ventilation is often used to assist with breathing [ 13 , 14 ]. However, it has been argued that developing therapeutic strategies such as protective mechanical ventilation techniques may increase mortality in ARDS patients [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy Analysis and Prognostic Impact of Sivelestat Sodium in Coronavirus Disease 2019-Related Acute Respiratory Distress Syndrome

Che,

Hu,

Zhang

et al. 2024

Pharmaceuticals

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Purpose: This study aimed to evaluate the efficacy of sivelestat sodium on mortality, oxygenation index, and serum markers in patients with acute respiratory distress syndrome (ARDS) associated with Coronavirus Disease 2019 (COVID-19). Methods: A retrospective analysis was conducted on adult inpatients admitted to the Intensive Care Unit (ICU). The study compared clinical characteristics, laboratory indices, and mortality rates between patients treated with and without sivelestat sodium. Cox regression analysis was employed to assess the effect of sivelestat sodium on the risk of death, oxygenation index, and improvement of serum markers in patients with COVID-19-associated ARDS. Results: A total of 110 patients with COVID-19-associated ARDS were included, with 45 patients in the sivelestat group and 65 patients in the control group. The overall patient mortality rate was 69.1%, with 62.2% in the sivelestat group and 73.8% in the control group. After five days of treatment, the median change from baseline in the oxygenation index was 21 mmHg in the medicated group and −31 mmHg in the control group (p < 0.05). Analysis of the oxygenation index as a clinical endpoint event showed a significantly higher rate of improvement in the sivelestat group compared to the control group (57.8% vs. 38.5%, p < 0.05), and the odds of raising the oxygenation index after treatment were 2.05 times higher in the sivelestat group than in the control group (HR = 2.05, 95%CI: 1.02–4.15, p < 0.05). Among patients with a baseline oxygenation index < 200 mmHg, patients in the sivelestat group had an 86% lower risk of death compared to the control group (HR = 0.14, 95%CI: 0.02–0.81, p < 0.05). Conclusions: Sivelestat sodium demonstrated a significant improvement in the oxygenation index of patients with COVID-19-associated ARDS and was found to considerably reduce the risk of death in patients with a baseline oxygenation index of <200 mmHg.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Efficacy Analysis and Prognostic Impact of Sivelestat Sodium in Coronavirus Disease 2019-Related Acute Respiratory Distress Syndrome

Che,

Hu,

Zhang

et al. 2024

Pharmaceuticals

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“…In addition, sivelestat sodium appears to reduce clinical neutrophil stiffness, improve postoperative lung permeability and reduce alveolar damage, which happens in the onset phase of ARDS [9,10]. Despite sivelestat sodium has been demonstrated effective in animal models, there is still controversy over its clinical e cacy of improving the oxygenation status of patients, especially those at high-risk of progressing to severe ARDS [11,12].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Sivelestat Sodium in the Therapy of Critically ill Patients at high risk of developing ARDS due to SIRS: A Multicenter Prospective Study

Jing,

Xu,

Dai

et al. 2024

Preprint

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Background Sivelestat sodium has been proposed as a therapeutic strategy to mitigate respiratory dysfunction and reduce the need for mechanical ventilation in critically ill patients. Its clinical usage remains controversial. This multicenter prospective study aimed to evaluate the efficacy of sivelestat sodium in patients presenting high-risk of developing acute respiratory distress syndrome (ARDS) due to systemic inflammatory response syndrome with an oxygenation index (PaO2/FIO2 ratio; P/F ratio) between 100–400 mmHg upon ICU administration. Methods Eighty-two patients were divided into two groups: sivelestat group and conventional group. Clinical information, including vital sign, etiology, scoring systems for illness severity, laboratory test data, P/F ratio and chronic comorbidities were collected at the time of administration. The primary end points were invasive mechanical ventilation ratio and ventilator-free days (VFDs). Besides, the severe ARDS ratio, changes of P/F ratio (∆P/F ratio), levels of inflammatory factors (procalcitonin (PCT), C-reactive protein (CRP) and Interleukin-6 (IL-6)) before and after 7 days therapy were also collected. Results Prescribe sivelestat sodium, as compared with conventional therapy, did not have a significant effect on mechanical ventilation ratio or severe ARDS ratio. Notably, sivelestat group exhibited significantly higher VFDs and an improved ∆P/F ratio in mild and moderate ARDS subgroup. Additionally, the ∆P/F ratio was significantly elevated on the fifth day following therapy initiation. Furthermore, there was a reduction in the levels of CRP and PCT, indicating a potential anti-inflammatory effect. Conclusion The results facilitate a randomized controlled trial to determine sivelestat sodium may be considered to alleviate inflammation response and protect patients with mild or moderate ARDS.

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“…Sivelestat Sodium Hydrate (SSH), known for inhibiting NE, shows significant promise for use in clinical settings [ 10 ]. Clinical trials indicate that SSH is effective in treating ARDS without compromising the host’s immune defense during infections [ 11 , 12 ], and nonclinical trials have addressed that SSH can improve pulmonary function in severe respiratory failure [ 13 ] and symptoms of acute lung injury (ALI) [ 14 ]. In combination, this trial applied UTI and SSH in the treatment of patients with sepsis and ARDS to determine their clinical efficacy.…”

Section: Introductionmentioning

confidence: 99%

A comparative analysis of sivelestat sodium hydrate and ulinastatin combination therapy in the treatment of sepsis with acute respiratory distress syndrome

Xu,

Zhang,

et al. 2024

BMC Pulm Med

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Objective This comparative analysis aimed to investigate the efficacy of Sivelestat Sodium Hydrate (SSH) combined with Ulinastatin (UTI) in the treatment of sepsis with acute respiratory distress syndrome (ARDS). Methods A control group and an observation group were formed with eighty-four cases of patients with sepsis with ARDS, with 42 cases in each group. The control group was intravenously injected with UTI based on conventional treatment, and the observation group was injected with SSH based on the control group. Both groups were treated continuously for 7 days, and the treatment outcomes and efficacy of both groups were observed. The Murray Lung Injury Score (MLIS), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II) were compared. Changes in respiratory function, inflammatory factors, and oxidative stress indicators were assessed. The occurrence of adverse drug reactions was recorded. Results The total effective rate in the observation group (95.24%) was higher than that in the control group (80.95%) (P < 0.05). The mechanical ventilation time, intensive care unit (ICU) hospitalization time, and duration of antimicrobial medication in the observation group were shorter and multiple organ dysfunction syndrome incidence was lower than those in the control group (P < 0.05). The mortality rate of patients in the observation group (35.71%) was lower than that in the control group (52.38%), but there was no statistically significant difference between the two groups (P > 0.05). MLIS, SOFA, and APACHE II scores in the observation group were lower than the control group (P < 0.05). After treatment, respiratory function, inflammation, and oxidative stress were improved in the observation group (P < 0.05). Adverse reactions were not significantly different between the two groups (P > 0.05). Conclusion The combination of SSH plus UTI improves lung injury and pulmonary ventilation function, and reduces inflammation and oxidative stress in patients with sepsis and ARDS.

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Clinical Utility of the Sivelestat for the Treatment of ALI/ARDS: Moving on in the Controversy?

Cited by 13 publications

References 31 publications

Efficacy Analysis and Prognostic Impact of Sivelestat Sodium in Coronavirus Disease 2019-Related Acute Respiratory Distress Syndrome

Efficacy Analysis and Prognostic Impact of Sivelestat Sodium in Coronavirus Disease 2019-Related Acute Respiratory Distress Syndrome

Efficacy of Sivelestat Sodium in the Therapy of Critically ill Patients at high risk of developing ARDS due to SIRS: A Multicenter Prospective Study

A comparative analysis of sivelestat sodium hydrate and ulinastatin combination therapy in the treatment of sepsis with acute respiratory distress syndrome

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