ABSTRACT
Background@#and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset. @*Methods@#In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). @*Results@#Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group. @*Conclusion@#This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.
ABSTRACT
Dietary fiber (DF) obtained from wheat bran by microbial fermentation was used as a food additive to cookies. The cookies were evaluated sensorally through an orthogonal test to gain the optimized production conditions as follows: the suitable DF content 8%, leavening agent 1.5%, standing time 5 min, and baking time of the cookies is 8 min. A series of toxicological and physiological functions of the cookies were studied using KM mice as the experimental animal in this paper. No deaths or abnormal behaviors of mice occurred either in acute toxicity tests or in short-term feeding tests. Besides, the weight gains, food utilization ratios, blood and serum biochemical parameters, organ coefficients and the results of organ histopathology tests of all doses groups exhibited no significant differences with the control group. This reveals that the dietary fiber functional cookies made by this formula have no acute or sub-chronic toxicity. In terms of physiological function, compared with the control group, the total cholesterol (TC) and triglycerides (TG) were 17.0-21.7% and 18.7-35.0% lower in mice serum of all DF cookie doses groups, respectively, but this difference was not significant (P>0.05). Compared with positive control group, the Cd(2+) and Pb(2+) excretion ratios of DF group were 27.4% and 25.2% higher, respectively. Thus, a conclusion has been drawn that dietary fiber functional cookies made by this formula have no toxic or harmful actions on animals or humans, and the DF food was able to decrease TC and TG concentrations to some extent in serum and increase excretion of Cd(2+) and Pb(2+) in Feces.
