Effect of Neutrophil Elastase Inhibitor (Sivelestat Sodium) in the Treatment of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS): A Systematic Review and Meta-Analysis

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概要

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• Introduction Sivelestat is neutrophil elastase inhibitor, which is widely used in Japan for the treatment of acute lung injury. However, the clinical efficacy of the medication has not been convincingly demonstrated. Methods We conducted a systematic review and meta-analysis of randomized controlled trials on sivelestat for the treatment of acute lung injury and acute respiratory distress syndrome. Studies were identified using MEDLINE, EMBASE, Cochrane library, conference proceedings, and references of included studies. Authors were contacted if necessary. ICHUSHI, the Japanese database for medical literature and conference proceedings was also used for the search, since many studies on sivelestat were published in Japanese language and not registered in major databases such as MEDLINE. The primary outcome was mortality within 28-30 days after randomization. Relative risks were pooled with the random effect model. Results 8 trials were included in the analysis. There was no difference in mortality within 28-30 days after randomization (relative risk 0.95, 95% confidence interval 0.72 to 1.26). Subgroup analysis conducted only on studies conducted in Japan showed the same result (0.59, 0.28 to 1.28). There was no difference in mechanical ventilation days (standardized mean difference -0.43, -1.12 to 0.27), but sivelestat was associated with a better short term PaO2/FiO2 ratio (0.30, 0.05 to 0.56). Heterogeneity was not significant for the main analysis and funnel plot did not suggest publication bias. Conclusion Sivelestat was not associated with decreased mortality, even when including studies published in Japanese language.

著者

• SHIMADA Toshihiko

  Department of General Medicine & Clinical Epidemiology, Kyoto University Hospital, Kyoto University

• Iwata Kentaro

  Division of Health Risk Management, Research Center for Urban Safety and Security, Kobe University

• Doi Asako

  Department of General Medicine, Otowa Hospital

• Ohji Goh

  Division of Health Risk Management, Research Center for Urban Safety and Security, Kobe University

• Oka Hideaki

  Division of Infectious Diseases, Kobe University Hospital

• Oba Yuichiro

  Division of Infectious Diseases, Kobe University Hospital

• Takimoto Kohei

  Division of Infectious Diseases, Kobe University Hospital

• Igarashi Wataru

  Division of Infectious Diseases, Kobe University Hospital

• Gremillion David

  Department of General Medicine, Kameda Medical Center

• Shimada Toshihiko

  Department Of General Internal Medicine Rakuwakai Otowa Hospital

• Shimada Toshihiko

  Department of General Medicine, Otowa Hospital

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