Effect of Sivelestat Sodium Hydrate (Elaspol) for Lung Injury and Acute Respiratory Distress Syndrome After Cardiovascular Surgery

Background: Lung injury and acute respiratory distress syndrome after cardiopulmonary bypass were described as severe postoperative complication. Although the incidence of ARDS after cardiopulmonary bypass (CPB) is about 1%, the mortality of ARDS is extremely high. It has been well recognized that CPB is associated with systemic inflammation. This pulmonary dysfunction after CPB is one of those inflammatory responses, activated neutrophil and neurophil elastase play an important role in this injury. Method: ELASPOL (Sivelestat sodium hydrate: Ono Pharmaceutical Co., in Japan) is neutrophil elastase inhibitor that was introduced in 2002 for acute lung injury with SIRS. We hypothesized that this drug would reduce lung dysfunction after CPB especially in the patient who had total arch replacement or cardiac surgery with severe preoperative condition. We compared control group and group treated with ELASPOL® group retrospectively. The control group were cases of total arch replacement with severe lung dysfunction before 2002, therapeutic group were cases of total arch replacement with ELASPOL that included a case without operation. Arterial P02!FiOz as indication of lung injury (The P/F ratio is an index of acute lung injury and ARDS, it is defined as acute lung injury when the P/F ratio is under 300, and the P/F ratio of ARDS is under 200.), platelet count, WBC count, CRP, duration of intubation and ICU stay were evaluated. Results: As compared with the control group that had almost same operative procedure with ELASPOL, P/F ratio (arterial POz/FiOz) was increased over 200 at four postoperative days and well maintained after all in therapeutic group, On the other hand it dropped to below 150, and it did not recovered to 200 until 10 days after the operation in the control group (p<0.05). Platelet count in ELASPOL group was relatively higher than control, but there is no significance of differences between groups. The other factors such as WBC count, CRP level, duration of intubation and ICU stay were almost equal, Conclusions: We conclude that ELASPOL is expected to reduce lung injury after CPB in the case of total arch replacement or cardiac surgery with severe preoperative condition. Hirosaki Med. J. 57: 79-86, 2006 u -)v t:tt« 'L;%'J v)~{ffii:~~ G t-:iJi*1t§t,¥i'IJ t: ~J:ff;\~t~~~;g~t J:iJ)~ t-:. -'CO){t!!O)t~f~ ('f:{ltjp1Z~,ft f,f~{~t~~WJF~', ICUr*ttWJF~', s.rfnJ-*) ~J:jjIjj~ FCl'\:*fJJt~~J:~;g~tJ:iJ)~ tc, *a~g: ~~'H:m)jfE0)IL\*-(fiJ.~'f:{ij;j{7H:j;1 G'L1,fij{~ijili~!i!~~TIlJf9~J:l',I '7 /ZiF-)vO)ff~JJ'11iJi~ PJe~nt-:.