Kido Takashi, Muramatsu Keiji, Yatera Kazuhiro, Asakawa Takeshi, Otsubo Hiroki, Kubo Tatsuhiko, Fujino Yoshihisa, Matsuda Shinya, Mayumi Toshihiko, Mukae Hiroshi
Department of Respiratory Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Department of Emergency Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Respirology. 2017 May;22(4):708-713. doi: 10.1111/resp.12969. Epub 2016 Dec 18.
The efficacy of sivelestat, a neutrophil elastase inhibitor, for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) remains controversial. We investigated the role of sivelestat in ALI/ARDS patients on mortality as an end point between the sivelestat group and the non-sivelestat group within 7 days of admission.
This study was performed using the Japanese nationwide administrative database (Diagnostic Procedure Combination; DPC) in 2012. We employed the propensity score weighting method with a Cox proportional hazards model to compare the mortality between the sivelestat group and the non-sivelestat group.
A total of 4276 patients were eligible for this study; 1997 patients were treated with sivelestat and 2279 patients did not receive sivelestat within 7 days of admission. After adjusting for confounds, the mortality within 3 months was significantly lower in the sivelestat group compared with the non-sivelestat group (weighted hazard ratio: 0.83; 95% CI: 0.75-0.93; P < 0.002). Multiple regression analysis revealed that younger age, absence of cancer, no need for haemodialysis and no use of high-dose methylprednisolone were significantly correlated with treatment success (survive).
These results of this retrospective and observational study suggest that administration of sivelestat within 7 days of admission may improve the prognosis of patients with ALI/ARDS. To our knowledge, this is the largest study to evaluate the efficacy of sivelestat on ALI/ARDS.
中性粒细胞弹性蛋白酶抑制剂西维来司他对急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）的疗效仍存在争议。我们以入院7天内的死亡率为终点，研究了西维来司他在ALI/ARDS患者中的作用，比较了西维来司他组和非西维来司他组的情况。
本研究使用了2012年日本全国行政数据库（诊断程序组合；DPC）。我们采用倾向评分加权法和Cox比例风险模型来比较西维来司他组和非西维来司他组的死亡率。
共有4276例患者符合本研究条件；1997例患者接受了西维来司他治疗，2279例患者在入院7天内未接受西维来司他治疗。在对混杂因素进行调整后，西维来司他组3个月内的死亡率显著低于非西维来司他组（加权风险比：0.83；95%可信区间：0.75-0.93；P＜0.002）。多元回归分析显示，年龄较小、无癌症、无需血液透析以及未使用大剂量甲泼尼龙与治疗成功（存活）显著相关。
这项回顾性观察性研究的结果表明，入院7天内给予西维来司他可能改善ALI/ARDS患者的预后。据我们所知，这是评估西维来司他对ALI/ARDS疗效的最大规模研究。
