西维来司他钠治疗成人急性呼吸窘迫综合征效果的meta分析  

Efficacy of sivelestat sodium in acute respiratory distress syndrome in adults:a systematic review and meta-analysis

作　　者：王之舟[1] 花一鸣 董宪喆 姜丹 宋再伟 王可[1] 邢晓璇[1] 赵荣生[2,3] 张兰 WANG Zhi-zhou;HUA Yi-ming;DONG Xian-zhe;JIANG Dan;SONG Zai-wei;WANG Ke;XING Xiao-xuan;ZHAO Rong-sheng;ZHANG Lan(Department of Pharmacy,Xuanwu Hospital Capital Medical University,Beijing 100053,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]北京大学第三医院药剂科,北京100191 [3]北京大学医学部药物评价中心,北京100191

出　　处：《临床药物治疗杂志》2024年第2期18-25,共8页Clinical Medication Journal

基　　金：北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022079);北京市医院管理中心“登峰”人才培养计划(DFL20190803);科技智库青年人才计划(20220615ZZ07110070)。

摘　　要：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。Objective To systematically evaluate the clinical efficacy of sivelestat sodium in the treatment of adult patients with acute respiratory distress syndrome(ARDS).Methods A comprehensive search of PubMed,Embase,the Cochrane Library,CNKI,SinoMed,and Wanfang Databases were conducted to gather RCTs and cohort studies of sivelestat sodium in the treatment of adult ARDS from the inception of the databases to May 31,2023.Data were extracted from the literature that met the inclusion and exclusion criteria.The risk of bias in RCTs(RoB 2.0) and risk of bias in non-randomized studies of intervention(ROBINS-I) were employed to assess the quality of the studies.RevMan 5.4 and Stata 17.0 software were utilized for meta-analysis.Results A total of 16 studies involving 9202 patients were included,including 7 RCTs and 9 cohort studies.Meta-analysis revealed that sivelestat sodium had no impact on 28-day or 30-days mortality of ARDS patients in RCTs study(RR=0.95,95%CI:0.74 to 1.21,P=0.68),but in the cohort study,sivelestat sodium treatment could decrease the 28~30 d mortality of ARDS patients(RR=0.86,95%CI:0.81 to 0.92,P<0.0001).Sivelestat sodium treatment could significantly enhance the oxygenation index in ARDS patients(in RCTs study,MD=33.08,95%CI:15.43 to 50.74,P<0.000 01;in cohort study,MD=39.74,95%CI:29.81 to 49.68,P<0.000 01).Sivelestat sodium treatment could abbreviate the duration of mechanical ventilation in patients with mild to moderate ARDS(MD=-2.48,95%CI:-2.91 to-2.05,P<0.000 01).Egger′s test showed that there was no publication bias in the included studies(P<0.05).Conclusion Sivelestat sodium can improve oxygenation index and shorten the duration of mechanical ventilation in patients with mild-to-moderate ARDS.The effect of sivelestat sodium on 28-day or 30-day mortality needs further study to verify.

关 键 词：西维来司他钠 急性呼吸窘迫综合征 疗效 META分析 

分 类 号：R974[医药卫生—药品]