METHODS: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs).
RESULTS: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval [CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p
METHODS: In 20 patients undergoing cardiac surgery in sevoflurane-remifentanil anesthesia, we analyzed intraoperative S' values which were determined after 10 min exposure to sevoflurane at 1.0, 2.0, and 3.0 inspired-vol% (T1, T2, and T3, respectively) with a fixed remifentanil dose (1.0 μg/kg/min) using transesophageal echocardiography.
RESULTS: Linear mixed-effect modeling demonstrated dose-dependent declines in S' according to the end-tidal sevoflurane concentration increments (C(ET)-sevoflurane, p < 0.001): the mean value of S' reduction for each 1.0 vol%-increment of C(ET)-sevoflurane was 1.7 cm/s (95 % confidence interval 1.4-2.1 cm/s). Medians of S' at T1, T2, and T3 (9.6, 8.9, and 7.5 cm/s, respectively) also exhibited significant declines (by 6.6, 15.6, and 21.2 % for T1 vs. T2, T2 vs. T3, and T1 vs. T3, p < 0.001, =0.002, and <0.001 in Friedman pairwise comparisons, respectively).
CONCLUSIONS: Administering sevoflurane as a part of a sevoflurane-remifentanil anesthesia regimen appears to dose-dependently reduce S', indicating LV systolic performance, in patients undergoing cardiac surgery. Further studies may be required to evaluate the clinical implications of these findings.
MATERIALS AND METHODS: A total of 30 CF-1 albino mice obtained from the animal house of faculty of Medicine, Benghazi University, Benghazi, Libya were included in the study. These mice were fed with high cholesterol diet and divided into 2 groups. Twenty mice were administered piperine at a dose of 5mg/kg body weight. Piperine was isolated in Department of Pharmacognosy, Faculty of Pharmacy, Benghazi University, Benghazi and 10 mice were not administered piperine but fed with high fat diet. These mice were anesthetized with ketamine and halothane and blood was drawn from each mouse before the study and after three weeks by cardiocentesis. Serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase and total protein were measured by authenticated methods.
RESULTS: Serum alanine amino transferase was significantly elevated (p=0.0002) in group A mice after the administration of Piperine extract for three weeks compared to those of group B mice. Serum aspartate amino transferase was elevated significantly (p=0.046) and alkaline phosphatase (p= 0.0001) also was significantly increased after the administration of piperine. Serum total protein (p= 0.011) values were significantly decreased after the use of piperine for three weeks in group A mice.
CONCLUSION: This study showed that there might have been a considerable damage to liver with piperine extract. Further research may be required to prove this damage to liver function.