文章来源：中国知网

摘要信息：推荐意见 1 ：对于 ARDS 患者，应当在诊断的同时评估氧合状况用以指导抗炎药物使用，推荐标准治疗基础上早期（至少 48 h 内）联合应用西维来司他钠。（证据级别 ：中等质量 ；推荐级别 ：强推荐） 推荐意见 2 ：推荐 ARDS 患者同步检测 IL-6 等炎症因子以评估炎症水平，高炎症表型 ARDS 患者中使用西维来司他钠等抗炎药物可能有效。（证据级别 ：低质量 ；推荐级别 ：弱推荐） 推荐意见 3 ：对于存在 ARDS 高危因素的低氧血症患者应用西维来司他钠可早期改善氧合。（证据级别：低质量；推荐级别 ：弱推荐） 推荐意见 4 ：ARDS 患者中可尝试西维来司他钠与其他抗炎药物联合治疗，可能通过多途径抑制炎症带来获益。（证据级别 ：低质量 ；推荐级别 ：弱推荐） 推荐意见 5 ：对于脓毒症并发 ARDS 的患者，可参考西维来司他钠在 ARDS 患者中的应用。（证据级别 ：中等质量 ；推荐级别 ：强推荐） 推荐意见 6 ：脓毒症患者即使未并发 ARDS，应用西维来司他钠可能有潜在心、肺及肠道等器官功能保护作用。（证据级别 ：低质量 ；推荐级别 ：弱推荐） 推荐意见 7 ：急性中毒患者应尽量明确中毒机制，对于靶器官为肺或合并其他 ARDS 高危因素的患者可以在常规治疗基础上联合应用西维来司他钠等抗炎药物。（证据级别 极低质量 ；推荐级别 ：弱推荐） 推荐意见 8 ：创伤合并高炎症状态患者可继发 ARDS及其他多器官功能障碍，对于此类患者或创伤性湿肺患者应用西维来司他钠可能有潜在获益。（证据级别 ：低质量 ；推荐级别 ：弱推荐）

文章来源：PubMed

摘要信息：Objective: Neutrophil elastase (NE) plays an important role in the development of acute respiratory distress syndrome (ARDS). Sivelestat sodium, as a selective NE inhibitor, may improve the outcomes of patients with sepsis-induced ARDS in previous studies, but there is a lack of solid evidence. This trial aimed to evaluate the effect of sivelestat sodium on oxygenation in patients with sepsisinduced ARDS. Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial enrolling patients diagnosed with sepsisinduced ARDS admitted within 48 hours of the advent of symptoms. Patients were randomized in a 1:1 fashion to sivelestat or placebo. Trial drugs were administered as a 24-hour continuous intravenous infusion, for a minimum duration of 5 days and a maximum duration of 14 days. The primary outcome was the proportion of PaO2/FiO2 ratio improvement on Day 5 after randomization, deffned by a greater than 50% improvement in PaO2/FiO2 compared with that on ICU admission or PaO2/FiO2 reached over 300 mmHg on Day 5. Results: The study was stopped midway due to a potential between-group difference in mortality observed during the interim analysis. Overall, a total of 70 patients were randomized, of whom 34 were assigned to receive sivelestat sodium and 36 placebo. On day 5, 19/ 34 (55.9%) patients in the sivelestat group had PaO2/FiO2 ratio improvement compared with 7/36 (19.4%) patients in the placebo group (risk difference, 0.36; 95% CI, 0.14 to 0.56, p<0.001). The Kaplan–Meier curves showed a signiffcantly improved 28-day survival rate in patients receiving sivelestat than those not (hazard ratio, 0.32; 95% CI, 0.11 to 0.95; p=0.041). Conclusion: In patients with sepsis-induced ARDS, sivelestat sodium could improve oxygenation within the ffrst ffve days and may be associated with decreased 28-day mortality. Keywords: sepsis, acute respiratory distress syndrome, neutrophil elastase, sivelestat, oxygenation

文章来源：中国知网

摘要信息：目的 探析西维来司他钠联合俯卧位通气在急性肺损伤（ALI）/急性呼吸窘迫综合征（ARDS）中的疗效。方法 确认研究样本为50例ALI/ARDS患者，来源潍坊市第二人民医院，研究起止时间2023年10月至2024年9月，以随机数字法设计分组，分成对照组（25例，常规治疗）和试验组（25例，在对照组的基础上增加静脉泵入西维来司他钠联合俯卧位通气治疗）。评价组间血气指标[动脉血氧饱和度（SaO2）、动脉血氧分压（PaO2）、动脉血二氧化碳分压（PaCO2）]、临床指标、病死率及并发症发生情况。结果 试验组血气指标高于对照组（P<0.05）；试验组症状缓解时间及住院时间均短于对照组（P<0.05）；试验组并发症总发生率低于对照组（P<0.05）。结论 西维来司他钠与俯卧位通气联合使用，有助于改善ALI/ARDS患者的血气水平，加速症状缓解，缩短住院时间，并降低并发症的发生率。

文章来源：PubMed

摘要信息：Background. Since the 2012 Berlin Definition of the Acute Respiratory Distress Syndrome (ARDS), several developments have supported the need for an expansion of the definition, including the use of high flow nasal oxygen (HFNO), expanding use of pulse oximetry in place of arterial blood gases, use of ultrasound for chest imaging, and the need for applicability in resource-limited settings. Methods. A Consensus Conference of 32 critical care ARDS experts was convened, had six virtual meetings (June 2021-March 2022), and subsequently obtained input from members of several critical care societies. The goal was to develop a definition that would: (1) identify patients with the currently accepted conceptual framework for ARDS; (2) facilitate rapid ARDS diagnosis for clinical care and research; (3) be applicable in resource-limited settings; (4) be useful for testing specific therapies; and (5) be practical for communication to patients and caregivers. Results. The committee made four main recommendations: (1) Include HFNO with a minimum flow rate of  30 liters/min; (2) Use arterial oxygen tension (PaO2)/FiO2  300 mmHg or SpO2/FiO2 < 315 (if SpO2  97%) to identify hypoxemia; (3) Retain bilateral opacities for imaging criteria but add ultrasound as an imaging modality, especially in resource-limited areas; and (4) In resource-limited settings, do not require PEEP, oxygen flow rate, or specific respiratory support devices. Conclusions. We propose a New Global Definition of ARDS that builds on the Berlin Definition. The recommendations also identify areas for future research, including the need for prospective assessments of feasibility, reliability, and prognostic validity of the proposed Global Definition.

文章来源：PubMed

摘要信息：Objective:We aimed to evaluate the protective effects of sivelestat sodium on the basis of corticosteroid therapy in patients with moderate-to-severe acute respiratory distress syndrome (ARDS).Methods:We retrospectively investigated 127 patients with confirmed moderate-to-severe ARDS treated in the intensive care unit (ICU) at Dazhou Central Hospital. Patients were divided into the control group (corticosteroids alone) and the combination therapy of steroids and sivelestat sodium (CTSSS) group according to the therapeutic interventions. The primary outcome was in-hospital mortality. And the baseline characteristics and laboratory findings of patients were collected for analysis.Results:The overall mortality rate in 127 patients was 48.8%. There was no statistically significant difference in in-hospital mortality between the CTSSS group and the control group (45.3% vs. 56.1%). In the subgroup of patients aged < 80 years or with an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 30, CTSSS could reduce the risk of mortality (odds ratio [OR] = 0.41, 95% confidence interval [CI], 0.17-0.96, p=0.041; OR = 0.31, 95% CI, 0.13-0.77, p=0.012; respectively). Among patients aged 80 years or older, those with CTSSS exhibited a significantly elevated risk of mortality (OR = 13; 95% CI, 1.20-140.73; p=0.035).Conclusion:Compared with corticosteroids alone, CTSSS could improve oxygenation index, increase lymphocyte count, protect extrapulmonary organs and reduce in-hospital mortality rate in patients with moderate-to-severe ARDS in specific subgroups (age < 80 years or APACHE II score < 30). It might be advisable to avoid CTSSS in moderate-to-severe ARDS patients aged 80 years or older. Prospective studies involving larger sample sizes are needed to verify these findings.

文章来源：中国知网

摘要信息：目的 探讨西维来司他钠治疗急性呼吸窘迫综合征（ARDS）的临床疗效及其应用价值。方法 回顾性分析2022年10月至2023年10月平顶山市第一人民医院诊治的80例ARDS患者分为对照组（40例）、观察组（40例）。对照组接受常规治疗，观察组接受西维来司他钠治疗。统计对比两组临床疗效及治疗前后生理生化指标[动脉血氧饱和度（SaO2）、动脉血氧分压（PaO2）]、Murray肺损伤评分、急性生理功能和慢性健康状况评分系统Ⅱ（APACHEⅡ）、炎症因子[超敏C反应蛋白（hs-CRP）、白细胞介素-6（IL-6）、降钙素原（PCT）]、血管内皮功能[血管生成素-2（Ang-2）、可溶性晚期糖基化终产物受体（sRAGE）、内皮素-1（ET-1）、一氧化氮（NO）]。比较两组不良反应发生率与病死率。结果 观察组总有效率（90.00%）较对照组（72.50%）升高（P<0.05）;与对照组比较，观察组治疗后SaO2、PaO2升高，Murray评分、APACHEⅡ评分降低（P<0.05）;与对照组比较，观察组治疗后血清hs-CRP、IL-6、PCT、Ang-2、sRAGE、ET-1水平降低，血清NO水平升高（P<0.05）;两组不良反应发生率比较差异无统计学意义（P>0.05）;观察组病死率低于对照组（P<0.05）。结论 西维来司他钠治疗ARDS的效果确切，可改善血气指标，抑制炎症反应，减轻肺损伤，改善血管内皮功能，降低病死率，具有一定安全性。

文章来源：PubMed

摘要信息：患者平均年龄65岁（35 ~ 87岁），女性2例，男性13例。这些数据最好的描述是一个具有比例残差的单室模型。西维来司他钠表观分布体积和表观清除率分别为20.88 L和1.79 L/h。西维来司他钠清除率受协变量总胆红素（TBIL）的影响，提示建议在TBIL水平升高的患者减少剂量。

文章来源：中国知网

摘要信息：目的 探讨儿童使用西维来司他钠治疗脓毒症和急性呼吸窘迫综合征的安全性和有效性。方法 回顾性收集空军军医大学第一附属医院儿科重症监护室2021年1月至2024年7月收治的使用西维来司他钠的重症患儿的资料，并以“西维来司他钠”、“脓毒症”、“急性呼吸窘迫综合征”和“儿童”为中文检索词检索知网、万方和维普等数据库，以“Sivelestat sodium”、“Sepsis”、“Respiratory distress syndrome”和“Child”为英文检索词检索PubMed、Embase、Web of Science数据库，检索日期截至2024年7月30日。结果 共收集到9例病例，其中我院6例，文献报道3例，年龄中位数为4岁5个月，男性5例（55.6%）。9例患儿中，5例在用药后白细胞计数（WBC）、降钙素原（PCT）和白介素-6（IL-6）较前明显好转，3例C反应蛋白（CRP）明显改善；4例患有脓毒症患儿用药后PCT均明显改善，其中3例IL-6明显改善，2例WBC明显下降。在7例患有急性呼吸窘迫综合征或呼吸衰竭的患儿中，有2例在用药后氧合指数（PaO2/FiO2）明显改善。结论 西维来司他钠有助于降低WBC、IL-6、PCT和CRP的水平，抑制重症患儿者体内炎症反应，有助于改善急性呼吸窘迫患儿PaO2/FiO2比值。

文章来源：PubMed

摘要信息：Background Recent studies suggest that neutrophil elastase inhibitor (Sivelestat) may improve pulmonary function and reduce mortality in patients with acute respiratory distress syndrome. We examined the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. Methods A large multicentre cohort study of patients with ARDS induced by COVID-19 who had been admitted to intensive care units (ICUs). We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. The diferences in continuous outcomes were assessed with the Wilcoxon signed-rank test. Kaplan–Meier method was used to show the 28-day survival curves in the matched cohorts. A log-rank P-test stratifed on the matched pairs was used to test the equality of the estimated survival curves. A Cox proportional hazards model that incorporated a robust sandwich-type variance estimator to account for the matched nature of the data was used to estimate hazard ratios (HR). All statistical analyses were performed with SPSS 26.0 and R 4.2.3. A two-sided p-value of < 0.05 was considered statistically signifcant. Results A total of 387 patients met inclusion criteria, including 259 patients (66.9%) who were treated with sivelestat. In 158 patients matched on the propensity for treatment, receipt of sivelestat was associated with improved oxygenation, decreased Murray lung injury score, increased non-mechanical ventilation time within 28 days, increased alive and ICU-free days within 28 days (HR, 1.85; 95% CI 1.29 to 2.64; log-rank p < 0.001), shortened ICU stay and ultimately improved survival (HR, 2.78; 95% CI 1.32 to 5.88; log-rank p = 0.0074). Conclusions Among patients with ARDS induce by COVID-19, sivelestat administration is associated with improved clinical outcomes.

文章来源：中国知网

摘要信息：目的：探讨西维来司他钠联合气道压力释放通气（APRV）治疗小儿重度急性呼吸窘迫综合征（ARDS）的临床效果。方法：前瞻性选取2021年5月至2023年5月该院收治的重度ARDS患儿102例，按照随机数字表法分为对照组和研究组，各51例。对照组患儿给予APRV+基础对症治疗，研究组患儿给予西维来司他钠+APRV+基础对症治疗。比较两组患儿的临床症状体征、临床疗效和并发症发生率，治疗前后的肺功能指标、动脉血气指标和炎症因子水平。结果：研究组患儿的总有效率为94.12%（48/51）,明显高于对照组的80.39%（41/51）,差异有统计学意义（P<0.05）。研究组患儿机械通气时间、气促消失时间、肺部啰音消失时间和住院时间较对照组缩短，差异均有统计学意义（P<0.05）。治疗3、7 d后，两组患儿的血氧分压（PaO2）、动脉血氧饱和度（SaO2）高于治疗前，血二氧化碳分压（PaCO2）低于治疗前；且研究组患儿PaO2、SaO2和PaCO2的变化幅度大于对照组，差异均有统计学意义（P<0.05）。治疗3、7 d后，两组患儿的最大呼气压、最大呼气流量、最大吸气压和最大呼气中段流量较治疗前升高，且研究组患儿高于对照组；治疗3、7 d后，两组患儿血清C反应蛋白、肿瘤坏死因子α、巨噬细胞移动抑制因子-1和白细胞介素6水平较治疗前降低，且研究组患儿低于对照组，差异均有统计学意义（P<0.05）。研究组患儿的并发症发生率为5.88%（3/51）,低于对照组的21.57%（11/51）,差异有统计学意义（P<0.05）。结论：西维来司他钠联合APRV治疗小儿重度ARDS的疗效显著，能有效抑制患儿血清炎症因子释放，改善患儿血气分析指标、临床症状和肺功能，且能减少并发症的发生。