Analysis of covariance models were used to compute within-group and between-group change in average symptom scores including treatment arm and geographic region as factors and baseline values as a ...covariate. Results: Of the 1,992 patients (994 LIN, 998 PBO) included in this study, similar demographic and baseline characteristics were identified between groups (Table 1). Baseline demographics, characteristics, and disease severity Placebo N = 1998 Linaclotide 145 μg N = 994 Total N = 1992 Patient Demographics Age, mean (SD) 46.7 (14.2) 47.5 (13.5) 47.1 (13.9) Female, n (%) 853 (85.5) 838 (84.3) 1691 (84.9) Race, n (%) White 724 (72.5) 723 (72.7) 1447 (72.6) Black or African American 237 (23.7) 235 (23.6) 472 (23.7) Asian 24 (2.4) 20 (2) 44 (2.2) American Indian or Alaska Native 1 (0.1) 5 (0.5) 6 (0.3) Native Hawaiian or Other Pacific Islander 1 (0.1) 0 1 (0.1) Multiple 3 (0.3) 4 (0.4) 7 (0.4) Other 8 (0.8) 7 (0.7) 15 (0.8) Hispanic or Latino, n (%) 237 (23.7) 236 (23.7) 473 (23.7) Baseline Characteristics Weight, kg, mean (SD) 78.46 (19.0) 78.11 (18.1) 78.28 (18.6) BMI, kg/m2, mean (SD) 28.74 (6.4) 28.64 (6.1) 28.69 (6.2) Disease Severity at Baseline Abdominal pain score, mean (SD) 2.51 (1.0) 2.48 (1.0) 2.50 (1.0) Abdominal discomfort score, mean (SD) 2.86 (1.0) 2.79 (1.0) 2.82 (1.0) Bloating score, mean (SD) 3.08 (0.9) 3.05 (0.9) 3.07 (0.9) SD, standard deviation.
Abstract Purpose The purpose of this study is to test the hypothesis that procollagen type III aminoterminal propeptide (PIIINP) is early elevated in septic episodes and can indicate the acute organ ...dysfunction/failure characterizing severe sepsis. Materials and Methods This prospective study included 107 consecutive septic patients (44 with sepsis, 13 with severe sepsis, and 50 with septic shock) and 45 controls. After blood sampling (within 48 hours after onset of septic episodes), serum was assayed. Patients were followed up, and their disease severity was daily evaluated. Results Procollagen type III aminoterminal propeptide (median range) increased in patients with sepsis (9.4 2.2-42.4 ng/mL) compared with controls (3.6 1.9-4.9 ng/mL; P < .001), exhibiting further significant increase in patients with severe sepsis and septic shock (19.5 6.0-52.4 and 20.2 1.8-89.2 ng/mL, respectively; P < .01-.001 vs sepsis). Among biomarkers of host response severity, PIIINP was the sole that was independently associated with severe sepsis/septic shock ( P = .01). The area under the receiver operating characteristic curve for PIIINP to predict which patients with sepsis would eventually develop severe sepsis/septic shock was 0.87; the cutoff of 12 ng/mL had sensitivity 82% and specificity 89%. Conclusions Increased serum PIIINP can signify severe sepsis/septic shock and predict which patients with sepsis will eventually develop severe sepsis/septic shock, thus representing a biomarker of risk stratification of patients with sepsis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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