Iv Group Research Articles

Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal

AimsThe aim of the study is to evaluate the clinical and biochemical response of inflammatory bowel disease patients treated with vedolizumab, 16 weeks after transitioning from intravenous (iv) to subcutaneous (sc). MethodsAn observational, prospective, single-center cohort study was performed. Patients with inflammatory bowel disease and maintenance treatment with vedolizumab, stable for at least 4 months, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin. ResultsForty-three patients were included, 12 of them (27.9%) chose to transition to sc formulation. All included patients remained in remission during follow-up. At week 16 no significant differences were found in terms of calprotectin levels in patients on iv treatment (mean 146.6±SD 45.9) vs. sc (159.26±53.9) (p=0.9). Vedolizumab serum levels at week 16 were higher in the sc group (22,364.3±5141.6) vs. iv (11,425.9±1514.2) (p=0.009). At week 16, 9 (75%) of the patients in the sc group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. Four patients (12.9%) in the iv group and 2 (16.6%) in the sc group presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site. ConclusionIn our experience, vedolizumab sc is a convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.

Effect of single dose preemptive intravenous paracetamol, dexamethasone, and magnesium sulfate on perioperative hemodynamic variables and post-operative nausea, vomiting, and pain in open cholecystectomy done under general anesthesia: A prospective, randomized, and single-blind study

Background: Pain due to open cholecystectomy can result in delayed recovery and poor operative outcomes. Multimodal approaches to pain control cause functional improvement. We compared the efficacy of paracetamol 1 g, dexamethasone 8 mg, and magnesium sulfate 2 g with normal saline in control over perioperative hemodynamics and post-operative pain in patients undergoing open cholecystectomy under general anesthesia. Aims and Objectives: This study conducted to assess the effect of preemptive intravenous paracetamol, dexamethasone, and magnesium sulfate on perioperative hemodynamic variables (primary outcome) and post-operative nausea, vomiting, and pain (secondary outcome) in open cholecystectomy. Materials and Methods: Sixty patients of ASA Grade I/II were randomized into two groups to receive either normal saline 100 ml iv (Group C, n=30) or infusion containing inj. paracetamol 1 g, inj. dexamethasone 8 mg and inj. magnesium sulfate 2 g iv (group PDM, n=30), 20 min before induction. Intraoperative and post-operative hemodynamic data, post-operative pain scores, and incidence of nausea vomiting were recorded. Results: Intraoperative pulse rate was significantly higher at intubation and 15 min after intubation in the control group and intraoperative systolic, diastolic, and mean arterial blood pressure were significantly higher in control group at intubation and until 60 min. Post-operative pulse rate was significantly higher in the control groups at 180 min and incidence of PONV reduced in PDM group until 90 min. Conclusion: Preemptive intravenous infusion of paracetamol, dexamethasone, and magnesium sulfate provided better stability over perioperative hemodynamics, reduced the incidence of post-operative nausea vomiting, and provided better post-operative pain control.

449 - Phenotypic and genotypic changes over time in serotype iv group b streptococcus strains

449 - Phenotypic and genotypic changes over time in serotype iv group b streptococcus strains

P-028 POSTOPERATIVE ASSESSMENT OF PAIN AFTER LICHTENSTEIN TENSION-FREE MESH INGUINAL HERNIA REPAIR

Abstract Background-Aim Effective postoperative pain management is vital for the well being of the patients after inguinal hernia repair. The aim of this study was to assess the analgesic efficacy and safety of parecoxib sodium versus diclofenac sodium following inguinal hernia repair. Material & Methods Patients that underwent from 1/1/2019 to 31/12/2020 an Lichtenstein tension free inguinal hernia repair at General Hospital of Amfissa were included in this study, They were randomly assigned to receive postoperatively parecoxib 40mg twice daily iv (group A), or diclofenac 75mg twice daily im (Group B). Tramadol 50mg iv was used as “rescue” treatment. Pain Rating System (PRS) was utilized for pain assessment. Results 214 patients (162 males, 52 females) with a mean age of 72 (26–93) years were included in this study. Patients receiving parecoxib sodium experienced significantly lower PRS scores at 6 hours postoperatively (2.2 vs 3.1) and 24hrs postoperatively (1.2 vs 2.0). Fifty-nine patients (27.8%) needed a “rescue” analgesic treatment with the majority of them (43 patients) belonging to the Group B. 96.7% of total patients left the hospital on 1st postoperative day without needing any additional analgesic treatment. Conclusions Administration of parecoxib sodium 40mg twice daily is more effective than diclofenac for pain management after inguinal hernia repair.

Effects of oral administration and intravenous injection of polygalacturonic acid on the immunomodulation and gut microbiota in UC mice

This study aimed to compare the differences between oral administration and intravenous injection of polygalacturonic acid (PGA) in the regulation of immune and intestinal microflora in ulcerative colitis (UC) mice. PGA was administered orally or intravenously. PGA in the high-dose ig group was the most effective in treating UC by increasing colon length and downregulating disease activity index, histopathological score and proinflammatory cytokine levels. In spleen, the efficacy of PGA on restoring Th17/Treg balance in the high-dose iv group was better than that in the high-dose ig group, the opposite was observed in the lamina propria. The level of colonic IL-17A in the high-dose ig group was lower than that in the high-dose iv group, the opposite was observed for that of colonic IL-10. Western blot and immunohistochemistry analysis revealed that PGA in the high-dose ig group decreased the protein expression of RORγt, and increased that of FOXP3. Furthermore, PGA in the high-dose ig group was more effective than that in the high-dose iv group in improving the intestinal microflora structure. Our results suggest that in immune regulation, oral PGA is more effective in the lamina propria and gut microbiota while intravenous PGA is more effective in the spleen.

Effect of the Inverted V-Shaped Osteotomy on Patellofemoral Joint and Tibial Morphometry as Compared With the Medial Opening Wedge High Tibial Osteotomy

Background: Recent studies have reported that medial opening wedge (OW) high tibial osteotomy (HTO) induces patella baja, resulting in degenerative changes in the patellofemoral joint. We have developed an inverted V-shaped (iV) HTO, which is classified as a neutral wedge osteotomy. Hypotheses: The study hypotheses were as follows: (1) patellar height, posterior tibial slope, and tibial length will not change between pre- and postoperative evaluations after iV-HTO; (2) the lateral shift ratio of the patella and the distance between the tibial tubercle and the trochlear groove may be significantly decreased after iV-HTO. Study Design: Cohort study; Level of evidence, 3. Methods: A total of 191 patients (220 knees) who underwent HTO for medial osteoarthritis were enrolled retrospectively in this study: 107 knees underwent OW-HTO and 113 knees underwent iV-HTO. Clinical and radiological evaluations were performed before and at least 3 years after surgery. Results: Postoperatively, the mean Caton-Deschamps ratio was significantly decreased (P < .0001) from 0.95 to 0.79 in the OW group, while there were no significant changes in the iV group. The mean posterior tibial slope was significantly increased (P < .0001) from 8.5° to 10.5° in the OW group, while there were no significant differences in the iV group. Although the entire leg length was significantly increased (P < .0003) in both groups after HTO, there were no significant differences in tibial length between the pre- and postoperative periods in the iV group. Regarding the congruity of the patellofemoral joint, the mean lateral shift ratio did not significantly change in the OW group, whereas it was significantly decreased (P = .0012) from 11.5% to 8.8% in the iV group. The mean tibial tubercle–trochlear groove distance was significantly decreased (P < .0001) from 12.8 to 9.7 mm in the iV group, while it was significantly increased in the OW group (P < .0001). Concerning the clinical outcome, the Japanese Orthopaedic Association (JOA) and Lysholm knee scores at final follow-up (OW vs iV: JOA, 91.2 vs 90.1; Lysholm, 92.5 vs 89.0) were significantly increased (P < .0001) as compared with the preoperative values (OW vs iV: JOA, 68.3 vs 66.8; Lysholm, 67.9 vs 61.0). Conclusion: Patellar height, posterior tibial slope, and tibial length did not change after the iV-HTO, while they were significantly changed after the OW-HTO. Although the preoperative degrees of varus knee and patellofemoral osteoarthritis were more severe in the iV group than the OW group, the iV-HTO led to altered patellofemoral joint congruity.

A hospital-based assessment of the efficacy of prophylactic antibiotic usage to that of regular antibiotics usage in patients undergoing elective caesarean section: A comparative study

Aim: This study was planned to assess the efficacy of prophylactic antibiotic usage to that of regular antibiotics usage in patients undergoing elective surgeries. Material and Methods: A comparative Prospective study was conducted in the Department of obstetrics and gynaecology, Mamata Academy of Medical Sciences, Bachupally, Hyderabad, India for the period of 2 years. Total 200 Patients for elective LSCS and BMI < 30 were include in this study. Group A - patients received injection Ceftriaxone 1gm. intravenous stat at the time of induction of anesthesia. Group B - patients received intravenous ampicillin and metronidazole for 1 day followed by oral for next 5 days. Temperature monitoring, vital signs, abdominal, perineal examinations were performed daily till 5-7 days. Results: Patients were randomly divided on alternate number basis, in 2 groups (Group A Ceftriaxone 1gm iv stat and Group B ampicillin and metronidazole for 5 days) each consisted of 100 patients. Mean age was 24.5±4.2 years in group A & 23.4±3.8 years in group B. BMI at the time of admission was 27.9±7.8 kg/m² & 28.8± 6.2 kg/m² in group A & B respectively. Mean duration of surgery was 45.8±6.8 min in group A & 46.1±5.4 in group B. Average blood loss was in groups A 645±70 & 670±75 in group B was comparable. Mean days of hospitalisation was 4.6±4.1 days & 5.4±3.1 days in group A & B respectively. History of previous laparotomy like LSCS, ectopic surgery, etc. was present in 42 & 36 patients from group A & B respectively. Fever was most common morbidity noted (Group A – 7& Group B -5) followed by urinary tract infection (Group A – 5 & Group B -7), wound infection, endometritis & early neonatal sepsis. Statistical difference between group A & B was non-significant for all morbidities. Conclusion: We conclude that the single dose antibiotic prophylaxis is as effective as conventional multi dose antibiotic therapy.

A comparison of four different models of acute respiratory distress syndrome in sheep

BackgroundAcute respiratory distress syndrome (ARDS) can have various causes. The study objective was to investigate whether different pathophysiologic models of ARDS would show different respiratory, cardiovascular and inflammatory outcomes.MethodsWe performed a prospective, randomized study in 27 ventilated ewes inducing ARDS using three different techniques to mimic the pulmonary causes of ARDS (ARDSp): warm saline lavage (n = 6), intratracheal hydrochloric acid (HCl; n = 6), intratracheal albumin (n = 10), and one technique to mimic an extrapulmonary cause of ARDS (ARDSexp): intravenous lipopolysaccharide (LPS iv; n = 5). ARDS was defined when PaO2 was < 15 kPa (112 mmHg) when ventilated with PEEP 10 cm H2O and FiO2 = 1.0. The effects on gas exchange were investigated by calculating the oxygenation index (OI) and the ventilation efficacy index (VEI) every 30 min for a period of 4 h. Post mortem lung lavage was performed to obtain broncho-alveolar lavage fluid (BALF) to assess lung injury and inflammation. Lung injury and inflammation were assessed by measuring the total number and differentiation of leukocytes, the concentration of protein and disaturated phospholipids, and interleukine-6 and -8 in the BALF. Histology of the lung was evaluated by measuring the mean alveolar size, alveolar wall thickness and the lung injury score system by Matute-Bello et al., as markers of lung injury. The concentration of interleukin-6 was determined in plasma, as a marker of systematic inflammation.ResultsThe OI and VEI were most affected in the LPS iv group and thereafter the HCl group, after meeting the ARDS criteria. Diastolic blood pressure was lowest in the LPS iv group. There were no significant differences found in the total number and differentiation of leukocytes, the concentration of protein and disaturated phospholipids, or interleukin-8 in the BALF, histology of the lung and the lung injury score. IL-6 in BALF and plasma was highest in the LPS iv group, but no significant differences were found between the other groups. It took a significantly longer period of time to meet the ARDS criteria in the LPS iv group.ConclusionsThe LPS model caused the most severe pulmonary and cardiovascular insufficiency. Surprisingly, there were limited significant differences in lung injury and inflammatory markers, despite the different pathophysiological models, when the clinical definition of ARDS was applied.

Dose-dense early postoperative intraperitoneal chemotherapy in ovarian cancer: Randomized, phase II trial.

5514 Background: Dose-dense early postoperative intraperitoneal chemo (DD-EPIC) had been carried out in advanced ovarian cancer (OC) pts in China over the past three decades but it was not proved by a prospective study. This trial was designed to confirm the benefit of DD-EPIC in delaying progression and improving survival. Methods: In a multicenter, phase 2 trial, pts with FIGO IIIC-IV OC and optimal debulking surgery (residual disease ≤1cm) were randomly allocated to receive 4 doses of weekly DD-EPIC with cisplatin (50mg/m2) and etoposide (100mg/m2) followed by 6 cycles of intravenous (iv) chemo with carboplatin and taxane every 3 weeks (DD-EPIC group), or standard iv chemo alone (iv group). (ClinicalTrials.gov, NCT01669226). Results: Between 2009 and 2015, 218 pts were randomized, of whom 215 initiated treatment (106 to DD-EPIC and 109 to iv; for efficacy analyses). Totally, 36 pts (16·7%) were received neoadjuvant chemo. With a median of 61·9 mos follow-up, 122 pts died (54 in DD-EPIC and 68 in iv group). Remarkable OS benefit of DD-EPIC was recorded (67·5 mos for DD-EPIC vs. 46·3 mos for iv; HR 0·70, 95% CI 0·49-1·00, P=0·047). Pts in DD-EPIC had a significantly increased median PFS compared with those in iv group (21·7 vs. 16·8 mos; HR 0·64, 95% CI 0·47-0·86, P=0·003). Median TFST was 25·1 vs. 18·0 mos in favor of DD-EPIC (HR 0·62, 95%CI 0·46-0·83, P=0·002). Similar findings were detected in TSST (42·2 vs. 29·3 mos; HR 0·66, 95%CI 0·47-0·94, P=0·019). Grade 3 and 4 Leucopenia (53·8% vs. 35·2%), anemia (23·6% vs. 5·6%) and gastrointestinal events (10·4% vs. 1·9%) were more common in DD-EPIC ( P=0·006, P&lt;0·001 and P=0·010, respectively). Ninety-one pts were detected by gBRCA testing, with 25·3% of cases carrying deleterious BRCAm, but PFS and OS benefit were observed in patients with BRCA-wild type (HR 0·46 and 0·55, 95%CI 0·27-0·81 and 0·27-1·11, respectively). Conclusions: DD-EPIC with a higher completion rate and acceptable treatment burden was associated with longer OS than standard iv alone. Owing to the benefit of relatively long-term OS, DD-EPIC may be considered as a valuable option for OC, particularly in developing countries and BRCA-wild type pts. Clinical trial information: NCT01669226. [Table: see text]

Effect of sulfur dioxide on arterial baroreflex in rat with sepsis

Objective The present work was designed to investigate the potential role and mechanism of sulfur dioxide (SO2) in regulating Arterial baroreflex (ABR) in septic rats. Methods The rat model of cecal ligation and puncture (CLP) induced sepsis was established. Sixty six male Spargue-Dawley rats were randomly divided into 11 groups, involved three parts, with random table method. Part1: (1) Sham operation (SO)+ Saline+ intravenous injection (iv) group; (2) CLP+ Saline+ iv group; (3) SO+ SO2+ iv group; (4) CLP+ SO2+ iv group; Part2; (5) SO+ artificial cerebrospinal fluid (aCSF)+ nucleus tractus solitarii (NTS) group; (6) CLP+ aCSF+ NTS group; (7) SO+ SO2+ NTS group; (8) CLP+ SO2+ NTS group; Part3: (9) CLP+ kynurenic acid (KYN)+ NTS group; (10) SO+ aCSF+ SO2+ NTS group; (11) SO+ KYN+ SO2+ NTS group. The ABR value was measured 5 min and 30 min after treatment, which unit denoted by ms/mmHg. Statisticalanalysis of data using the statistical product and service solutions 24.0 software. Results In the same groups: The ABR value in CLP+ SO2+ iv group (5 min: 0.230±0.058, 30 min: 0.171±0.045 vs. baseline: 0.406±0.070, F=132.373, P<0.05) and CLP+ SO2+ NTS group (5 min: 0.180±0.049, 30 min: 0.259±0.089 vs. baseline: 0.413±0.097, F=84.101, P<0.05) were significantly decreased, but the CLP+ kynurenic acid (KYN)+ NTS group (5 min: 0.639±0.071, 30 min: 0.630±0.054 vs. baseline: 0.407±0.058, F=84.101, P<0.05) was Increased. Comparison between the two groups: SO+ KYN+ SO2+ NTS group was significantly higher than that in the SO+ aCSF+ SO2+ NTS group (5 min: 0.831±0.108 vs. 0.351±0.026, F=73.318, P<0.05; 30 min: (0.854±0.122 vs. 0.471±0.040, F=35.184, P<0.05). Conclusion Sulfur dioxide plays an adverse role in septic ABR value, and activating glutamate inotropic non-selective receptor at the pathway of ABR, may be the mechanism involved in the down-regulation of ABR function in septic rat. Key words: Sulfur dioxide; Sepsis; Arterial baroreflex

Pharmacokinetics of Nimodipine after Intraocular Administration in Rats

Objective To explore the pharmacokinetics of nimodipine in plasma of rats after intraocular administration.Methods Totally 135 SD rats were randomly divided into three groups according to drug administration routes:intraocular(io group),intravenous (iv group),and intragastric (ig group). The doses were 5.0 mg/kg for IO and IV groups and 10.0 mg/kg for IG group. The serum nimodipine level was analyzed by high performance liquid chromatography. The main pharmacokinetic parameters were calculated and compared.Results The pharmacokinetic parameters in io group were as follows:Cmax:0.52 mg/ml;tmax:5.0 min;and AUC0-t:21.10 mg/(ml·min). The main pharmacokinetic parameters in iv group were as follows:Cmax:3.62 mg/ml;and AUC0-t:52.58 mg/(ml·min). The main pharmacokinetic parameters in ig group were as follows:Cmax:0.20 mg/ml;tmax:5.0 min;and AUC0-t:5.98 mg/(ml·min).Conclusions Nimodipine is rapidly absorbed after io administration,and the ophthalmic formulation has a higher bioavailability than the oral solution. Therefore,the io route may help to improve the treatment effectiveness of cardiovascular diseases.

Effect of Kisspeptin-10 on plasma luteinizing hormone concentrations and follicular dynamics during the luteal phase in cattle

Two experiments were carried out to determine the effect of Kisspeptin-10 on plasma LH concentrations and follicular dynamics during the luteal phase in cattle. We tested the hypothesis that a single treatment of Kisspeptin-10 will increase plasma LH concentration and the diameter of the dominant follicle, and induce ovulation during the luteal phase of the estrous cycle in cattle. In the Experiment 1, Hereford-cross heifers (n = 28, 14–16 mo) were given PGF2α im to induce luteolysis and ovulation. On Day 5 (Day 0 = ovulation), a new follicular wave was induced by ultrasound-guided follicular ablation. Heifers were treated on Day 10 (4 days after wave emergence) with 100 μg GnRH im (n = 9), 2 mL saline im (n = 7), 1 mg Kisspeptin-10 im (Kp im, n = 6) or 1 mg Kisspeptin-10 iv (Kp iv; n = 6). Blood samples were collected at −60, −15, 0, 5, 15min (0 min = time of injection) and every 15 min thereafter until 3 h. Transrectal ovarian ultrasonography was performed at 12 h intervals from Day 10–14. In Experiment 2, non-lactating beef cows on Day 5 were treated with 100 μg GnRH im (n = 9), saline im (n = 5), 10 mg of Kisspeptin-10 iv (Kp 10 mg; n = 5) or 15 mg of Kisspeptin-10 iv (Kp 15 mg; n = 5). Blood samples were collected at −15, 0, 15, 30, 60, 120, 180 min and twice daily ovarian ultrasonography was done from Day 5–10. In Expt 1, plasma LH concentrations increased for 1 h following Kp iv administration. The peak concentration occurred at 15 min and was higher in the Kp iv group than in the Kp im group (P = 0.01). The LH peak was 3.5-folds higher in the GnRH group than the Kp iv group (P < 0.0001). In Expt 2, GnRH induced higher (P < 0.001) plasma LH concentrations for all time-points than other groups. Kp 15 mg at peak (15min), 30 and 60 min induced higher (P < 0.0001) plasma LH concentrations than Kp 10 mg and saline. Kisspeptin-treated animals did not ovulate in either experiment while GnRH induced ovulation (n = 5/9 in Expt 1; 9/9 in Expt 2). The diameter of the dominant follicle was greater (P = 0.02) at 12–48 h after kisspeptin treatment (Kp groups combined) than the Saline group in Expt 2. In conclusion, Kisspeptin-10 increased plasma LH concentrations and follicle size, and although plasma LH concentrations were higher after iv than im administration, but at the doses used, Kisspeptin-10 did not induce ovulation during the luteal phase in cattle.

A Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Acetaminophen on Hospital Length of Stay in Obese Individuals Undergoing Sleeve Gastrectomy.

Retrospective studies indicate that acetaminophen iv administration reduces hospital length of stay (LoS) and opiate consumption in patients undergoing bariatric surgery. This study sought to determine whether using acetaminophen iv in morbidly obese subjects undergoing sleeve gastrectomy decreased LoS and total hospital charges as compared to patients receiving saline placebo. Single-center university hospital METHODS: Using a randomized, double-blind, placebo-controlled design, subjects were assigned to receive either acetaminophen iv (group A) or saline placebo iv (group P). Data were collected between Jan 1 and Dec 31, 2016. Group A received acetaminophen every 6h for a total of four doses. The first dose was administered following the induction of general anesthesia; group P received saline iv on the same schedule. Anesthetic management and prophylactic antiemetic regimen were standardized in all subjects. Postoperative pain management consisted of hydromorphone via patient-controlled infusion pump. Primary outcomes include hospital LoS and associated hospital costs. Secondary outcomes include patient satisfaction and postoperative nausea and pain scores. Subject demographics (n = 127) and intraoperative management were similar in the two groups. Across all subjects, median hospital LoS in group A (n = 63) was 1.87 vs. 1.97days in group P (n = 64) (p = 0.03, Wilcoxon rank-sum test). Postoperatively, daily quality-of-recovery (QoR-15) scores, narcotic consumption, and the use of rescue antiemetics were not significantly different between groups. Median hospital costs were as follows: group A, $12,885 vs. group P, $12,977 (n = 64). Acetaminophen iv may reduce hospital LoS in subjects undergoing sleeve gastrectomy.

STUDY OF KEEPING PROBIOTIC PROPERTIES OF SOUR-CREAM BUTTER AT STORAGE

The aim of the work was the study of keeping probiotic properties of sour-milk butter with inclusion of Lactobacillus acidophilus La-5 (La-5) monoculture. Flora Danica mesophile culture independently (FD); in combination with La-5 and La-5 independently were used for fermenting cream. The output consistence of culture in cream was 1×106 CFU/cm3. In autumn-winter and spring-summer period of the year four butter groups were prepared, they differed by temperature of cream fermentation: I group – (30±1) ºС; II – (37±1) ºС; III – stage regimes of combination of fermentation and physical maturing; IV group – introduction of cultures into oil kernel; the output concentration – 1·108 CFU/cm3. As to the features of summer and winter periods, in summer one cream fermentation is more active that is indicated by more number of cells of both microbial cultures. The best parameters of viable cells keeping were typical to the samples at FD+La-5 use and temperature of cream fermentation (30±1) ºС. Storage life of sour-cream butter with probiotic properties is 35 days at temperature 0…-5 ºС.

Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia).

Although bariatric surgery is actually mainly performed laparoscopically, analgesic optimization continues being essential to reduce complications and to improve the patients' comfort. The aim of this study is to evaluate the postoperative pain after analgesia iv exclusively, or associated with epidural analgesia or port-sites infiltration with bupivacaine. A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2014 was performed. Patients were divided into three groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain was quantified by means of a Visual Analogic Scale, and morphine rescue needs were determined 24h after surgery. A total of 147 were included. Groups were comparable in age, gender and BMI. There were no differences in operation time, complications, mortality or hospital stay between groups. Median pain 24h after surgery was 5 in Group 1, 2.5 in Group 2 and 2 in Group 3 (P=0.01), without statistically significant differences between Groups 2 and 3. In Group 1, morphine rescue was necessary in 16.3% of the cases, 2% in Group 2 and 2% in Group 3 (P=0.014), without statistically significant differences between Groups 2 and 3. Epidural analgesia and port-sites infiltration with bupivacaine, associated with analgesia iv, reduce the postoperative pain, when compared with analgesia iv exclusively. ClinicalTrials.gov Identifier: NCT02662660.

Protective effect of a recombinant VHSV-G vaccine using poly(I:C) loaded nanoparticles as an adjuvant in zebrafish (Danio rerio) infection model

There is a constant need to increase the efficiency of vaccines in the aquaculture industry. Although several nano-based vaccine formulations have been reported, to the best of our knowledge so far only one of them have been implemented in the industry. Here we report on chitosan-poly(I:C) nanoparticles (NPs) that could be used as a non-specific adjuvant in antiviral vaccines in aquaculture. We have characterized the physical parameters of the NPs, studied the in vivo and in vitro bio-distribution of fluorescent NPs and verified NP uptake by zebrafish leucocytes. We used the zebrafish model to test the protective efficiency of the recombinant glycoprotein G (rgpG) of VHSV compared to inactivated whole virus (iV) against VHSV using NPs as an adjuvant in both formulations. In parallel we tested free poly(I:C) and rgpG (pICrgpG), and free chitosan and rgpG (CSrgpG) vaccine formulations. While the iV group (with NP adjuvant) provided the highest overall survival, all vaccine formulations with poly(I:C) provided a significant protection against VHSV; possibly through an early induction of an anti-viral state. Our results suggest that chitosan-poly(I:C) NPs are a promising adjuvant candidate for future vaccine formulations.

Pharmacokinetics of Inhaled Rifampicin Porous Particles for Tuberculosis Treatment: Insight into Rifampicin Absorption from the Lungs of Guinea Pigs.

Tuberculosis (TB) is a life-threatening infection that requires a lengthy treatment process that is often associated with adverse effects. Pulmonary delivery of anti-TB drugs has the potential to increase efficacy of treatment by increasing drug concentrations at the lungs, the primary site of infection. The aim of the present study is to evaluate the disposition of rifampicin (RIF) after its pulmonary administration as porous particles (PPs) to guinea pigs and contrast it to that after oral administration. RIF microparticles were prepared by spray drying a solution of RIF and L-leucine (9:1), and the resulting particles were characterized for their physicochemical properties. Animals received RIF either as intravenous solution (iv), as oral suspension of micronized RIF (ORS) and RIF-PPs (ORPP), or by insufflation of the PPs (IRPP). Plasma samples were collected at preselected time points, and bronchoalveolar lavage (BAL) was performed at the end of the study. RIF concentrations in biological samples were analyzed by HPLC. Plasma concentration versus time data was analyzed by compartmental and noncompartmental methods. RIF PPs were thin walled porous particles with mass median aerodynamic diameter (MMAD) of 4.8±0.1 μm, GSD=1.29±0.03, and fine particle fraction below 5.8 μm of 52.9±2.0%. RIF content in the resulting particles was 91.8±0.1%. Plasma concentration vs time profiles revealed that the terminal slope of the iv group was different from that of the oral or pulmonary groups, indicating the possibility of flip-flop kinetics. RIF from IRPP appeared to be absorbed faster than that of ORPP or ORS as evidenced by higher RIF plasma concentrations up until 2 h. Notably, similar AUC (when corrected by dose), similar CL, λ, and half-life were obtained after oral administration of RIF at 40 mg/kg and pulmonary administration of RIF at 20 mg/kg. However, RIF in the IRPP group had a shorter Tmax and higher bioavailability than orally dosed groups. In addition, RIF concentrations in the BAL of animals in the IRPP group were 3-4-fold larger than those in the orally dosed groups. The disposition in ORS and ORPP were best described by a model with two sequential compartments, whereas the disposition of IRPP was best described by a two parallel compartment model. The advantages of delivering RIF by the pulmonary route are demonstrated in the present study. These include achieving higher RIF concentrations in the lungs and similar systemic levels after pulmonary delivery of one-half of the oral nominal dose. This is expected to result in a more effective treatment of pulmonary TB, as shown previously in published efficacy studies.

Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial.

Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of a single dose of dexmedetomidine combined with a low-dose remifentanil infusion on cough suppression during emergence from general anesthesia. American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under sevoflurane anesthesia were recruited and randomly allocated to receive either dexmedetomidine 0.5μg·kg(-1) iv (Group D, n=70) or saline (Group S, n=71), each combined with a low-dose remifentanil infusion ten minutes before the end of surgery. Coughing was assessed using a four-point scale. The respiratory rate (RR), heart rate (HR), and mean arterial pressure were also recorded. The incidence of coughing was lower in Group D than in Group S (64% vs 91%, respectively; mean difference 27%; 95% confidence interval [CI] 13 to 41; P<0.001). The median cough grade at extubation was also lower in Group D. Mean arterial pressure and HR were elevated in Group S during tracheal extubation but were similar to baseline values in Group D. There was no difference in RR between the two groups throughout the study. A small delay in extubation was observed in Group D (3 minutes longer than Group S; 95% CI 2 to 4; P<0.001). Compared with an infusion of low-dose remifentanil alone, the addition of a single dose (0.5μg·kg(-1)) of dexmedetomidine during emergence from sevoflurane-remifentanil anesthesia was effective in attenuating coughing and hemodynamic changes and did not exacerbate respiratory depression after thyroid surgery. This trial was registered at Clinicaltrial.gov, identifier: NCT01774305.

Comparison of radioactive iodide uptake in the rat thyroid between oral and intravenous bolus administration

Radioiodide is commonly used to diagnose and treat hyperthyroidism and thyroid carcinoma. However, we could not find any experimental data that strictly compared the biodistribution and thyroid uptake of radioactive iodide between the oral and intravenous (iv) routes with time. This prompted us to compare (123)I biodistribution and thyroid uptake to clarify the differences between oral and iv bolus administration in rats. The rats were divided into two groups, A and B (n=5, each). In the first imaging experiment, Na(123)I solution (35MBq/200μL) was administered as a bolus to the rats orally in group A and intravenously in group B. Two weeks later, the second imaging experiment was performed as a crossover experiment. (123)I biodistribution was evaluated visually and quantitatively with a gamma camera at 10min, 3, 6, 12, 24, and 48h after (123)I administration. Thyroid uptake was compared between oral and iv groups. Correlation of (123)I thyroid uptake and whole-body excretion was evaluated. The area under the curve (AUC) of thyroid uptake was also calculated. (123)I biodistribution differed visually during 6h between the two groups. (123)I thyroid uptake was significantly higher in the iv group at 10min (P<0.05) and in the oral group at 6 or more hour time points (P<0.005-P<0.0001) and peaked at 12h in both groups (oral: 24.4±2.8%ID, iv: 15.2±2.8%ID). (123)I thyroid uptake showed significant inverse correlations with whole-body excretion from 6h (r=-0.799, P<0.0001), and thereafter [12h (r=-0.957, P<0.0001), 24h (r=-0.905, P<0.0001) and 48h (r=-0.893, P<0.0001)], respectively. (123)I whole-body excretion was significantly higher in the iv group at each time point (P<0.0001). The AUC of (123)I thyroid uptake was 1.6 times higher in the oral group than the iv group. These results suggest that radioiodide accumulates in the rat thyroid more effectively by oral than iv administration probably due to slower and lower (123)I clearance from the body in the oral administration when administered in a bolus fashion.

Efficacy of intravenous dexketoprofen trometamol compared to intravenous paracetamol for postoperative pain management after day-case operative hysteroscopy: randomized, double-blind, placebo-controlled study

Adequate pain management following day-case surgery allows early ambulation of patients. In this study, we aimed to compare postoperative analgesic efficacy of intravenous (iv) dexketoprofen vs. iv paracetamol following day-case operative hysteroscopy. One hundred and fourteen American Society of Anesthesiologists (ASA) I-II patients scheduled for day-case operative hysteroscopy were recruited and randomized to three groups in the study. Group D received 50 mg iv dexketoprofen trometamol, Group P 1000 mg iv paracetamol and Group C normal saline solution. Visual Analogue Scale (VAS) pain intensity, pain relief, sedation, nausea-vomiting, other side effects, and additional opioid analgesic requirement were noted at postoperative 15 minutes (min), 30 min, 1 hour (h), 2 h, and 3 h. Patients with VAS>=40 mm received meperidine 0.25 mg/kg as rescue analgesic medication. VAS scores at 15 min, 30 min, 1 h, and 2 h were significantly lower in Group D compared to Group C. VAS scores at 15 min and 30 min were significantly lower in Group D compared to Group P. The percentages of patients who required opioid treatment were 34%, 60%, and 63% in Groups D, P and C, respectively (p<0.05). Total delivered opioid dose was 0.10±0.16 mg/kg, 027±0.33 mg/kg and 0.28±0.25 mg/kg in Groups D, P and C, respectively (p<0.05). Pain relief score was significantly better in Group D at postoperative 15 min when compared with Group C (p<0.05). Our study demonstrated that iv dexketoprofen has superior efficacy for postoperative pain management following day-case operative hysteroscopy when compared with paracetamol and placebo.