摘要信息：【摘要】目的 探讨中性粒细胞弹性蛋白酶(NE)抑制剂西维来司他钠在重症监护室(ICU)急性肺损伤(ALI)患者中应用的有效性和安全性。方法回顾性分析2020年6月至2021年6月郑州大学第一附属医院 ICU 171 例 ALI患者，其中西维来司他钠组 77 例，常规治疗组 94例。收集患者的临床资料，包括急性生理和慢性健康评分Ⅱ(APACHE Ⅱ)、Mumray 肺损伤评分、氧合指数(PaO,FiO,)、炎症因子(I-6、IL-10、TNF-α )，并统计无呼吸机天数(VED)、ICU 住院天数及 28 d病死率等，来评估西维来司他钠对 ICU 中 ALI治疗的有效性。同时，记录西维来司他钠使用后 30d内患者不良反应及化验指标来评估其应用的安全性。结果与常规治疗相比，西维来司他钠治疗7d后氧合指数、Mumray 肺损伤评分、I-6、IL-10、TNF-a 均明显改善，差异有统计学意义。与常规治疗组相比，西维来司他钠组 VFD 更长(P=0.0119 )，ICU 住院天数更少(P0.0269 )，差异具有统计学意义。西维来司他钠组病死率为 14.29%，常规治疗组病死率为 22.34%,两组间病死率差异无统计学意义。西维来司他钠使用后 30 d内未增加患者不良反应，安全性良好,结论 重症监护室急性肺损伤患者使用西维来司他钠治疗安全性良好，较常规治疗更有效。

摘要信息：【摘 要】 目的 探讨西维来司他钠联合乌司他丁治疗急性肺损伤(ALI)/急性呼吸窘迫综合征(ARDS)患者的疗效及安全性。方法回顾性选取2020年5月一2022年5月福建医科大学附属闽东医院收治的 60 例 ALV/ARDS患者作为研究对象,根据治疗方法分为对照组和观察组,各30例。患者人院后均进行原发病的对症处理,在此基础上,对照组患者予以乌司他丁单药治疗,观察组患者在对照组基础上予以西维来司他钠治疗,2组均用药7d。比较2 组治疗前及治疗7d后呼吸功能指标[动脉血氧分压(Pa0,)/吸入氧浓度( Fi0,),血管外肺水指数(ELWI)1、实验室指标[白介素6(Ⅱ-6)、肿瘤坏死因子 α(TNF-a)、C反应蛋白(CRP)、降钙素原(PCT)、白细胞计数( WBC)、血肌酐(SCr)、丙氨酸氨基转移酶(ALT)、尿素氮(BUN)1,住院指标[ICU 住院时间,机械通气时间及急性生理学和慢性健康状况Ⅱ(APACEI)评分1、不良反应及28 d存活率。结果 治疗7d后,2组 Pa0,/Fi0,较治疗前升高,ELWI较治疗前降低,且观察组 PaO,/Fi0,较对照组更高,ELWI较对照组更低(P<0.01)。治疗7d后,2组血清 Ⅱ-6、TNF-aCRP、PCT、SCr、ALT、BUN 水平及 WBC 较治疗前降低,且观察组血清 IL-6、TNF-α、CRP、PCT、ALT 水平及 WBC 较对照组更低(P<0.01)。与对照组相比,观察组ICU 住院时间、机械通气时间更短,APACEI评分更低(P<0.01)。2组不良反应总发生率比较,差异无统计学意义(P=1.000)。随访28 d,观察组存活率为90.00%(27/30),高于对照组的66.67%(20/30)(x =4.812,P=0.028)。结论 西维来司他钠联合乌司他丁治疗 AL/ARDS 可有效减轻机体炎性反应,改善肺通气功能,促进疾病快速康复,且可保护主要脏器功能,提高 28 d存活率,且安全性较高。

摘要信息：Background:The efficacy of neutrophil elastase inhibitor sivelestat in the treatment of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) remains controversial. A systematic review and meta-analysis were performed in accordance with the PRISMA guidelines assess the effect of sivelestat on ALI/ARDS patients, different studies were included. Methods:Electronic databases, National Knowledge Infrastructure (CNKI), Wan fang data, VIP, PubMed, Embase, Springer, Ovid and the Cochrane Library were searched using the following key words: ("Sivelestat" OR "Elaspol") AND ("ARDS" OR "adult respiratory distress syndrome" OR "acute lung injury"). All databases published from January 2000 to August 2022. The treatment group was treated with sivelestat and the control group was given normal saline. The outcome measurements include the mortality of 28-30 days, mechanical ventilation time, ventilation free days, intensive care unit (ICU) stays, oxygenation index (PaO2/FiO2) on day 3, the incidence of adverse events. The literature search was conducted independently by 2 researchers using standardized methods. We used the Cochrane risk-of-bias tool to assess the quality of the included studies. Mean difference (MD), Standardized mean difference (SMD) and relative risk (RR) were calculated using random effects model or fixed effects model. All statistical analyses were performed using RevMan software 5.4. Results:A total of 2050 patients were enrolled in 15 studies, including 1069 patients in treatment group and 981 patients in the control group. The results of the meta-analysis showed that: compared with the control group, sivelestat can reduce the mortality of 28-30 days (RR = 0.81, 95% CI = 0.66-0.98, p = 0.03) and the incidence of adverse events (RR = 0.91, 95% CI = 0.85-0.98, p = 0.01), shortened mechanical ventilation time (SMD = - 0.32, 95% CI = - 0.60 to - 0.04, p = 0.02) and ICU stays (SMD = - 0.72, 95% CI = - 0.92 to - 0.52, p < 0.00001), increased the ventilation free days (MD = 3.57, 95% CI = 3.42-3.73, p < 0.00001) and improve oxygenation index (PaO2/FiO2) on day 3 (SMD = 0.88, 95% CI = 0.39-1.36, p = 0.0004). Conclusions:Sivelestat can not only reduce the mortality of ALI/ARDS patients within 28-30 days and the incidence of adverse events, shorten the mechanical ventilation time and ICU stays, increase ventilation free days, but also improve the oxygenation index of patients on days 3, which has a good effect on the treatment of ALI/ARDS. These findings need to be verified in large-scale trials.

摘要信息：【摘 要】 目的 观察西维来司他钠联合小潮气量肺保护性通气对急性呼吸窘迫综合征(ARDS)患者氧合水平及机体炎性反应的影响。方法 选取2021年1月-2022年3月海南省肿瘤医院重症医学科收治 ARDS 患者 96 例按照随机数字表法分为对照组、观察组,各48 例。对照组采用小潮气量肺保护性通气治疗,观察组采用西维来司他钠联合小潮气量肺保护性通气治疗。比较2组机械通气时间、人住ICU 时间、住院时间,治疗前后血气指标[血氧分压(Pa0,)、二氧化碳分压(PaC0,)、氧合指数(Pa0,/Fi0,)]、血流动力学指标[心率(HR)、平均动脉压(MAP)、中心静脉压(CVP)1、肺功能指标[用力肺活量(FVC)、第1秒用力呼气容积(FEV,)FEV,/FVC7、炎性因子[白介素6(I6)、C反应蛋白(CRP)、白细胞计数( WBC)1,以及不良反应发生率。结果 观察组机械通气时间、人住 ICU 时间、住院时间短于对照组(t/P=6.414/<0.001、3.881/<0.001、5.290/<0.001);治疗后 24 h、72 h 观察组 Pa0,、Pa0,/FiO,较对照组高,PaC0,较对照组低(F/P=8.451/<0.001、9.785/<0.001、10.265/<0.001):治疗后24 h、72 h2组 HR呈降低趋势,MAP、CVP 均呈升高趋势,且同时间点观察组降低/升高较对照组更显著(F/P=18.621/<0.00125.786/<0.001、26.105/<0.001);治疗后72 h观察组 FVC、FEV,、FEV,/FVC 高于对照组(t/P =5.971/<0.0018.649/<0.001、10.404/<0.001);治疗后 72h观察组血清Ⅱ6、CRP、WBC 水平低于对照组(t/P=7.887/<0.0016.168/<0.001、2.879/0.005):2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 西维来司他钠联合小潮气量肺保护性通气可改善 ARDS 患者血气指标,稳定血流动力学,减轻肺损伤及机体炎性反应,从而改善肺功能缩短机械通气时间、入住 ICU 时间及住院时间,安全性高。

摘要信息：目的 探讨西维来司他钠治疗对COVID-19相关急性呼吸窘迫综合征（ARDS）重症患者的生存率、氧合指数和感染血清标志物的影响。方法 回顾性纳入南方医科大学南方医院重症医学科中诊断为COVID-19相关ARDS患者，从医疗系统收集其入ICU 24 h内以及出院当天的数据，并收集入ICU后第1、3、7天的CRP、PCT、IL-6和氧合指数值。采用倾向性评分匹配将接受西维来司他钠治疗的患者与未接受治疗的患者进行匹配。采用Cox回归分析与线性回归分析探讨西维来司他钠给药与院内死亡率以及住院时间之间的相关性。结果 研究纳入199名COVID-19相关ARDS重症患者。经过倾向性评分匹配，接受西维来司他钠治疗的35名患者和没有接受西维来司他钠治疗的70名患者进行了匹配。西维来司他钠治疗与院内死亡率的降低（P=0.36）、ICU住院时间的延长（P=0.39）、住院时间（P=0.68）以及氧合指数的改善（P>0.05）无关。C反应蛋白和降钙素原没有发现明显的差异，但在西维来司他钠治疗组发现IL-6水平明显降低（P=0.016）。结论 西维来司他钠与COVID-19相关ARDS重症患者的死亡率和住院时间的减少没有相关性，但与血清IL-6水平的降低有关。

摘要信息：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.

摘要信息：目的：系统评价西维来司他钠治疗成人急性呼吸窘迫综合征（ARDS）患者的临床疗效。方法：检索PubMed、Embase、the Cochrane Library、中国知网、中国生物医学文献服务系统、万方数据知识服务平台，检索时间自数据库建库至2023年5月31日，收集西维来司他钠治疗成人ARDS的RCTs和队列研究，提取符合纳入和排除标准的文献资料。采用 RCTs 偏倚风险评估工具 RoB 2. 0 和非随机干预研究偏倚风险评估工具ROBINS-I进行文献质量评价。采用RevMan 5. 4和Stata 17. 0软件进行meta分析。结果　共纳入16篇文献，包括7篇RCTs和9篇队列研究，共9202例患者。meta分析结果显示，RCTs研究中，西维来司他钠治疗对ARDS患者 28~30 d 死亡率无影响（RR=0. 95，95%CI：0. 74~1. 21，P=0. 68）；但队列研究中，西维来司他钠治疗可降低 ARDS 患者 28~30 d 死亡率（RR=0. 86，95%CI：0. 81~0. 92，P<0. 0001）。西维来司他钠治疗可显著改善ARDS 患者的氧合指数（RCTs 中，MD=33. 08，95%CI：15. 43~50. 74，P<0. 000 01；队列研究中，RR=39. 74，95%CI：29. 81~49. 68，P<0. 000 01），缩短了轻中度 ARDS 患者的机械通气时间（RR=-2. 48，95%CI：-2. 91~-2. 05，P<0. 000 01）。Egger′s检验结果显示，纳入文献均不存在发表偏倚（P>0. 05）。结论：西维来司他钠治疗可改善轻中度ARDS患者的氧合指数，缩短机械通气时间，对28~30 d死亡率的影响有待进一步研究验证。