乌司他丁治疗中国急性呼吸窘迫综合征的随机对照试验的荟萃分析。
Ulinastatin treatment for acute respiratory distress syndrome in China: a meta-analysis of randomized controlled trials.
机构信息
Department of Pharmacy, Peking University Third Hospital, 49 North Garden Road, Beijing, 100191, China.
Department of Pharmacy, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, Henan Province, China.
出版信息
BMC Pulm Med. 2019 Nov 4;19(1):196. doi: 10.1186/s12890-019-0968-6.
BACKGROUND
Epidemiologic studies have shown inconsistent conclusions about the effect of ulinastain treatment for acute respiratory distress syndrome (ARDS). It is necessary to perform a meta-analysis of ulinastatin's randomized controlled trials (RCTS) to evaluate its efficacy for treating ARDS.
METHODS
We searched the published RCTs of ulinastatin treatment for ARDS from nine databases (the latest search on April 30th, 2017). Two authors independently screened citations and extracted data. The meta-analysis was performed using Rev. Man 5.3 software.
RESULTS
A total of 33 RCTs involving 2344 patients satisfied the selection criteria and were included in meta-analysis. The meta-analysis showed that, compared to conventional therapy, ulinastatin has a significant benefit for ARDS patients by reducing mortality (RR = 0.51, 95% CI:0.430.61) and ventilator associated pneumonia rate (RR = 0.50, 95% CI: 0.360.69), and shortening duration of mechanical ventilation (SMD = -1.29, 95% CI: -1.76-0.83), length of intensive care unit stay (SMD = -1.38, 95% CI: -1.95-0.80), and hospital stay (SMD = -1.70, 95% CI:-2.63-0.77). Meanwhile, ulinastatin significantly increased the patients' oxygenation index (SMD = 2.04, 95% CI: 1.622.46) and decreased respiratory rate (SMD = -1.08, 95% CI: -1.29-0.88) and serum inflammatory factors (tumor necrosis factor-α: SMD = -3.06, 95% CI:-4.34-1.78; interleukin-1β: SMD = -3.49, 95% CI: -4.64-2.34; interleukin-6: SMD = -2.39, 95% CI: -3.34-1.45; interleukin-8: SMD = -2.43, 95% CI: -3.86~-1.00).
CONCLUSIONS
Ulinastatin seemly showed a beneficial effect for ARDS patients treatment and larger sample sized RCTs are needed to confirm our findings.
背景
流行病学研究对乌司他丁治疗急性呼吸窘迫综合征（ARDS）的效果得出的结论并不一致。有必要对乌司他丁的随机对照试验（RCT）进行荟萃分析，以评估其治疗 ARDS 的疗效。
方法
我们从 9 个数据库（最后一次检索日期为 2017 年 4 月 30 日）中检索了乌司他丁治疗 ARDS 的已发表 RCT。两位作者独立筛选引文并提取数据。使用 Rev. Man 5.3 软件进行荟萃分析。
结果
共有 33 项符合纳入标准的 RCT 被纳入荟萃分析，共纳入 2344 例患者。荟萃分析显示，与常规治疗相比，乌司他丁可显著降低 ARDS 患者的死亡率（RR=0.51，95%CI：0.430.61）和呼吸机相关性肺炎发生率（RR=0.50，95%CI：0.360.69），缩短机械通气时间（SMD=-1.29，95%CI：-1.76-0.83）、重症监护病房住院时间（SMD=-1.38，95%CI：-1.95-0.80）和住院时间（SMD=-1.70，95%CI：-2.63-0.77）。同时，乌司他丁显著增加了患者的氧合指数（SMD=2.04，95%CI：1.622.46），降低了呼吸频率（SMD=-1.08，95%CI：-1.29-0.88）和血清炎症因子（肿瘤坏死因子-α：SMD=-3.06，95%CI：-4.34-1.78；白细胞介素-1β：SMD=-3.49，95%CI：-4.64-2.34；白细胞介素-6：SMD=-2.39，95%CI：-3.34-1.45；白细胞介素-8：SMD=-2.43，95%CI：-3.86~-1.00）。
结论
乌司他丁治疗 ARDS 患者可能具有一定的疗效，但需要更大样本量的 RCT 来证实我们的研究结果。
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