[The efficacy and safety of eculizumab biosimilar in patients with paroxysmal nocturnal hemoglobinuria. Results of a phase III randomized open-label comparative clinical trial].

AIM: To establish the equivalent efficacy and comparable safety profile of biosimilar Acveris and referent eculizumab product Soliris used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). MATERIALS AND METHODS: Were included in the phase III multicenter 28 PNH patients, open-label clinical trial. Participants were randomized (1:1) into 2 treatment groups: investigational product (Acveris, n=14) and referent product (Soliris, n=14). Patients received eculizumab as the intravenous infusion 600 mg once a week during the first 4 weeks, 900 mg at week 5 and then 900 mg every 14 days (2 days) up to week 27 of the study. The efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of the compared products were analyzed after the end of 27 weeks of the study. The primary efficacy endpoint was the area under the curve LDH concentrationtime (AUCLDH) throughout the study period weeks 527. RESULTS: The difference between the mean AUCLDH values between the Acveris and Soliris groups was 5380.0 [-38 773.87; 49 533.87] U/ldays. The 95% CI limits for the difference in mean AUCLDH values between the groups fit the preset 95% CI [-146 500.9146 500.9] U/ldays and establish the equivalent efficacy of the biosimilar and referent product according to the primary efficacy endpoint. The safety profile of both Acveris and Soliris was expected and comparable according to the proportion of patients with adverse events. The formation of binding antibodies to eculizumab was not detected in both the groups. CONCLUSION: The study established the equivalent efficacy of biosimilar product Acveris and referent eculizumab product with the evidence of effective suppression of intravascular hemolysis in PNH patients along with a comparable favorable safety profile.

Labor analgesia in Czech Republic and Slovakia: a 2015 national survey.

BACKGROUND: The purpose of this international survey was to describe the current practices and techniques of labor analgesia in the Czech Republic (CZE) and Slovakia (SVK). METHODS: All Czech and Slovak departments that provide obstetric anesthesia were invited to participate in a one-month (November 2015) prospective study that monitored in detail all peripartum anesthetic procedures delivered by anesthesiologists. Participating centers recorded all data on-line in the CLADE-IS database (Masaryk University, CZE). RESULTS: The response rate was 71% (70 of 95 departments in CZE, 35 of 54 centers in SVK). Participating centers represented 87.7% of all births in CZE and 66.4% of all births in SVK during the study period. Analgesia for labor, administered by anesthesiologists, was recorded in 12.5% of deliveries (CZE 12.1%, SVK 13.4%). Epidural analgesia was used in most of the cases (CZE 97.2%, SVK 99.1%) whereas spinal (CZE 1.4%, SVK 0.9%) or combined spinal-epidural (CZE 0.5%, SVK 0.0%) and intravenous remifentanil analgesia (CZE 2.4%, SVK 0.0%) were used infrequently. One fifth of the labors with analgesia administered by anesthesiologists (CZE 20.2%, SVK 20.5%) terminated in cesarean section. CONCLUSIONS: Although labor analgesia was available in all Czech and Slovak obstetric centers, only a small proportion of parturients received an effective method of labor pain relief (regional or intravenous analgesia).

Rocuronium versus suxamethonium for rapid sequence induction of general anaesthesia for caesarean section: influence on neonatal outcomes.

BACKGROUND: In a previous study we compared rocuronium and suxamethonium for rapid-sequence induction of general anaesthesia for caesarean section and found no difference in maternal outcome. There was however, a significant difference in Apgar scores. As this was a secondary outcome, we extended the study to explore this finding on a larger sample. METHODS: We included 488 parturients of whom 240 were women from the original study. Women were randomly assigned to receive either rocuronium 1mg/kg (ROC n=245) or suxamethonium 1mg/kg (SUX n=243) after propofol 2mg/kg. Anaesthesia was maintained with up to 50% nitrous oxide and up to one minimum alveolar concentration of sevoflurane until the umbilical cord was clamped. We compared neonatal outcome using Apgar scores and umbilical cord blood gases. RESULTS: Data were analysed for 525 newborns (ROC n=263vs. SUX n=262). There was a statistically significant difference in the proportion of Apgar scores <7 at 1min (ROC 17.5% vs. SUX 10.3%, P=0.023) but no difference at 5min (ROC 8% vs. SUX 4.2%, P=0.1) or 10min (ROC 3.0% vs. SUX 1.9%, P=0.58). There was no difference between groups in other measured outcomes. CONCLUSION: The use of rocuronium was associated with lower Apgar scores at 1min compared with suxamethonium. The clinical significance of this is unclear and warrants further investigation.

Establishment and evaluation of a post caesarean acute pain service in a perinatological center:retrospective observational study.

OBJECTIVE: The aim of this study was to determine the efficacy of establishing a Post Caesarean Acute Pain Service. DESIGN: Retrospective observational study. SETTING: University Hospital Brno. METHODS: We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the periods 10/2009 - 9/2010 and 11/2010 - 10/2011. During the postoperative period at predefined times, we measured the Visual Analogue Scale, Additional Analgesic Requests, blood pressure, pulse rate and recorded any complications. We compared the Visual Analogue Scale Score and number of Additional Analgesic Requests in two groups of women, 212 patients before and 195 patients after the establishment of an Acute Pain Service in the first 72 hours after Caesarean Section. RESULTS: There was a statistically significant difference in Visual Analogue Scale Score between the groups (p<0.05). The number of Additional Analgesic Requests 24-72 hours after Caesarean Section decreased below one requirement per 24 hours. The most effective analgesic method after Caesarean Section during the first 24 hours postoperatively was epidural analgesia. There was no statistically significant difference 24-72 hours after Caesarean Section between the methods of analgesia used. CONCLUSION: In conclusion, implementation of a Post Caesarean Acute Pain Service led to decrease in Visual Analogue Scale Score postoperatively. KEYWORDS: Acute Pain Service, postoperative analgesia, Caesarean Section, non-opioid analgesia, opioid analgesia, epidural analgesia.

Chemical interactions in the layered system BCxNy/Ni(Cu)/Si, produced by CVD at high temperature.

Layered samples Si(100)/C/Ni/BC(x)N(y) and Si(100)/C/Cu/BC(x)N(y) were produced by physical vapor deposition of a metal (Ni, Cu, resp.) and low-pressure chemical vapor deposition of the boron carbonitride on a Si(100) substrate. Between the Si and the Ni (Cu) and on the surface of the Ni (Cu) layer, thin carbon layers were deposited, as a diffusion barrier or as a protection against oxidation, respectively. Afterwards, the surface carbon layer was removed. As precursor, trimethylamine borane and, as an auxiliary gas, H(2) and NH(3) were used, respectively. The chemical compositions of the layers and of the interfaces in between were characterized by total-reflection X-ray fluorescence spectrometry combined with near-edge X-ray absorption fine-structure spectroscopy, X-ray photoelectron spectroscopy, and secondary ion mass spectrometry. The application of H(2) yielded the BC(x)N(y) compound whereas the use of NH(3) led to a mixture of h-BN and graphitic carbon. At the BC(x)N(y)/metal interface, metal borides could be identified. At the relatively high synthesis temperature of 700 °C, broad regions of Cu or Ni and Si were observed between the metal layer and the substrate Si.

[Prognostic significance of the determination of carcinoembryonic antigen in the blood of patients with lung cancer]. / Prognosticheskoe znachenie opredeleniia rakovo-embrional'nogo antigena v krovi bol'nykh rakom legkogo.

Correlation analysis of the results of examination of 86 lung cancer patients treated by surgery and methods other than surgery established an inverse relationship between life-span and carcinoembryonic antigen (CEA) level. An analysis using reagents supplied by CEA-IRE-Sorin Company showed that a CEA level in blood in excess of 10 micrograms/l is associated with the most unfavorable prognosis. The degree and rate of CEA excretion are in direct correlation with life-span and provide the most reliable criterion in evaluating the effectiveness of lung cancer treatment.