• Surgery today · Jan 2006

    Randomized Controlled Trial Clinical Trial

    Effect of a polymorphonuclear elastase inhibitor (sivelestat sodium) on acute lung injury after cardiopulmonary bypass: findings of a double-blind randomized study.

    • Masahiro Ryugo, Yoshiki Sawa, Hiroshi Takano, Goro Matsumiya, Shigemitsu Iwai, Masamichi Ono, Hiroki Hata, Takashi Yamauchi, Masaji Nishimura, Yuji Fujino, and Hikaru Matsuda.
    • Division of Cardiovascular Surgery, Department of Surgery, Osaka University Graduate School of Medicine, Suita, Japan.
    • Surg. Today. 2006 Jan 1; 36 (4): 321-6.

    PurposeWe evaluated the effect of sivelestat sodium (SiV), a novel synthesized polymorphonuclear (PMN) elastase inhibitor, on acute lung injury (ALI) caused by cardiopulmonary bypass (CPB).MethodsFourteen patients who underwent cardiopulmonary surgery using CPB, followed by the development of both systemic inflammatory response syndrome (SIRS) and ALI, were treated with either 0.2 mg/kg per hour SiV (SiV group, n = 7) or saline (control group, n = 7) for 4 days from the time of arrival in the intensive care unit.ResultsThe SiV group had a significantly lower ratio of serum PMN elastase and interleukin (IL)-8, a significantly lower ratio of the respiratory index, and a significantly higher ratio of PaO(2)/FiO(2) after 24 h of treatment than the control group.ConclusionSivelestat sodium suppressed the production of PMN elastase and IL-8, resulting in improved respiratory function in patients with ALI caused by CPB.

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