Ding Qiongli, Wang Yi, Yang Chunbo, Tuerxun Dilireba, Yu Xiangyou
Critical Medicine Center, the First Afiliated Hospital of Xinjiang Medical University, Urumqi, 830054 Xinjiang Uygur Autonomous Region China.
Xinjiang Medical University, Urumqi, 830054 Xinjiang Uygur Autonomous Region China.
Intensive Care Res. 2023 Jun 1:1-10. doi: 10.1007/s44231-023-00032-9.
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.
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 (PaO/FiO) 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.
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, = 0.03) and the incidence of adverse events (RR = 0.91, 95% CI = 0.85-0.98, = 0.01), shortened mechanical ventilation time (SMD = - 0.32, 95% CI = - 0.60 to - 0.04, = 0.02) and ICU stays (SMD = - 0.72, 95% CI = - 0.92 to - 0.52, < 0.00001), increased the ventilation free days (MD = 3.57, 95% CI = 3.42-3.73, 0.00001) and improve oxygenation index (PaO/FiO) on day 3 (SMD = 0.88, 95% CI = 0.39-1.36, = 0.0004).
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.
中性粒细胞弹性蛋白酶抑制剂西维来司他在治疗急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）方面的疗效仍存在争议。按照PRISMA指南进行了一项系统评价和荟萃分析，以评估西维来司他对ALI/ARDS患者的影响，纳入了不同的研究。
使用以下关键词检索电子数据库、中国知网（CNKI）、万方数据、维普、PubMed、Embase、Springer、Ovid和Cochrane图书馆：（“西维来司他”或“依帕司他”）以及（“ARDS”或“成人呼吸窘迫综合征”或“急性肺损伤”）。所有数据库的发表时间为2000年1月至2022年8月。治疗组接受西维来司他治疗，对照组给予生理盐水。结局指标包括28至30天的死亡率、机械通气时间、无通气天数、重症监护病房（ICU）住院时间、第3天的氧合指数（PaO/FiO）、不良事件发生率。文献检索由2名研究人员使用标准化方法独立进行。我们使用Cochrane偏倚风险工具评估纳入研究的质量。使用随机效应模型或固定效应模型计算平均差（MD）、标准化平均差（SMD）和相对风险（RR）。所有统计分析均使用RevMan软件5.4进行。
15项研究共纳入2050例患者，其中治疗组1069例，对照组981例。荟萃分析结果显示：与对照组相比，西维来司他可降低28至30天的死亡率（RR = 0.81，95%CI = 0.66 - 0.98，P = 0.03）和不良事件发生率（RR = 0.91，95%CI = 0.85 - 0.98，P = 0.01），缩短机械通气时间（SMD = - 0.32，95%CI = - 0.60至 - 0.04，P = 0.02）和ICU住院时间（SMD = - 0.72，95%CI = - 0.92至 - 0.52，P < 0.00001），增加无通气天数（MD = 3.57，95%CI = 3.42 - 3.73，P = 0.00001），并改善第3天的氧合指数（PaO/FiO）（SMD = 0.88，95%CI = 0.39 - 1.36，P = 0.0004）。
西维来司他不仅可以降低ALI/ARDS患者28至30天内的死亡率和不良事件发生率，缩短机械通气时间和ICU住院时间，增加无通气天数，还可以改善患者第3天的氧合指数，对ALI/ARDS的治疗有良好效果。这些结果需要在大规模试验中得到验证。
