TABLE 2.
CHANGE IN CLINICAL CHARACTERISTICS AFTER ENDOTOXIN ADMINISTRATION
| Placebo (n = 6) | Lovastatin (n = 6) | rhAPC (n = 6) | P Value | |||||
|---|---|---|---|---|---|---|---|---|
| Change in vital signs* | ||||||||
| Temperature, °C | 0.4 ± 0.4 | 0.7 ± 0.4 | 0.6 ± 0.3 | 0.51 | ||||
| Systolic blood pressure, mm Hg | −18 ± 5 | −16 ± 16 | −15 ± 4 | 0.88 | ||||
| Diastolic blood pressure, mm Hg | −13 ± 6 | −11 ± 13 | −10 ± 8 | 0.86 | ||||
| Mean arterial pressure, mm Hg | −14 ± 5 | −13 ± 14 | −12 ± 9 | 0.86 | ||||
| Heart rate, beats/min | 30 ± 10 | 20 ± 6 | 30 ± 12 | 0.15 | ||||
| Respiratory rate, breaths/min | 4 ± 4 | 2 ± 3 | 2 ± 3 | 0.58 | ||||
| Change in pulmonary function tests | ||||||||
| FVC, L | −0.23 ± 0.29 | −0.15 ± 0.36 | −0.22 ± 0.40 | 0.93 | ||||
| FVC, % predicted | −4.8 ± 6.7 | −4.3 ± 9.8 | −5.3 ± 8.87 | 0.98 | ||||
| FEV1, L | −0.32 ± 0.29 | −0.05 ± 0.36 | −0.18 ± 0.29 | 0.37 | ||||
| FEV1, % predicted | −7.8 ± 6.9 | −3.8 ± 11.0 | −5.3 ± 9.2 | 0.75 | ||||
| SaO2,* % | −2 ± 1 | −3 ± 2 | −4 ± 3 | 0.42 | ||||
| Change in hematologic parameters | ||||||||
| White blood cells, × 103/μl | 1.5 ± 1.8 | 4.3 ± 2.4 | 3.0 ± 1.8 | 0.10 | ||||
| Neutrophils, % | 5.3 ± 7.8 | 17.2 ± 6.9† | 8.5 ± 8.0 | 0.04 | ||||
| Lymphocytes, % | −5.3 ± 3.2 | −15.0 ± 2.2† | −7.3 ± 2.8 | 0.03 | ||||
| Monocytes, % | 0.7 ± 1.4 | −2.1 ± 0.7 | −1.7 ± 0.6 | 0.12 | ||||
| Eosinophils, % | −0.4 ± 0.5 | −0.2 ± 0.3 | 0.7 ± 0.3 | 0.13 | ||||
| Hematocrit, % | −0.8 ± 2.0 | −1.4 ± 2.2 | −2.4 ± 2.4 | 0.47 | ||||
| Platelets, × 103/μl | −30 ± 24 | −26 ± 10 | −49 ± 31 | 0.24 | ||||
| International normalized ratio | 0.003 ± 0.06 | 0.02 ± 0.04 | 0.12 ± 0.05‡ | 0.002 | ||||
| Change in serum chemistry values | ||||||||
| Creatinine, mg/dl | 0.03 ± 0.1 | −0.03 ± 0.08 | −0.05 ± 0.05 | 0.21 | ||||
| Bilirubin, mg/dl | −0.07 ± 0.2 | −0.11 ± 0.26 | −0.07 ± 0.08 | 0.89 | ||||
| AST, IU/L | −5 ± 7 | 3 ± 16 | −5 ± 2 | 0.36 | ||||
| ALT, IU/L | −5 ± 5 | −3 ± 5 | −6 ± 4 | 0.49 | ||||
| Glucose, mg/dl | 2.4 ± 5.9 | 5.9 ± 6.4 | 2.7 ± 5.5 | 0.55 | ||||
Values represent means ± SD for postendotoxin measurement minus preendotoxin measurement.
Represents maximal change from baseline.
Significant difference compared with placebo.
Significant difference compared with both placebo and lovastatin cohorts.