Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: a multivariate analysis of a randomized controlled trial

Background To compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) placement in young women. Methods In this randomized controlled trial, 100 women aged 15–24 years were block-randomized to receive either 6 mL 2%-lidocaine intracervical block 5 min before the LNG-IUS insertion or 550 mg naproxen 30 min before the procedure. Forty-nine women received 550 mg naproxen and 51 received intracervical block. The primary outcome was pain at LNG-IUS insertion. Secondary outcomes were ease of insertion, insertion failures, and correct IUS positioning. Neither participants nor doctors were blinded. Pain at insertion was assessed by using a Visual Analog Scale (VAS). Results Women randomized to lidocaine intracervical block presented lower mean pain score at insertion, when compared to women who received naproxen (5.4 vs. 7.3, respectively; p < 0.001). Parous women had a 90.1% lower chance of experiencing severe pain (p = 0.004). There was a 49.8% reduction in the chance of severe pain for every 1-cm increase in the hysterometry (p = 0.002). The only complication observed during insertion was vasovagal-like reactions (7%). The insertion was performed without difficulty in 82% of the women. Participants in the intracervical block group presented higher proportion of malpositioned IUS on transvaginal ultrasound examination compared to women in naproxen group. Nevertheless, all the malpositioned IUS were inserted by resident physicians. Conclusion Lidocaine intracervical block was found to be more effective than naproxen in reducing LNG-IUS insertion pain. Trial registration number: RBR-68mmbp, Brazilian Registry of Clinical Trials, Retrospectively registered (August 4, 2020), URL of trial registry record: https://ensaiosclinicos.gov.br/rg/RBR-68mmbp/.

Oxycodone versus morphine for analgesia after laparoscopic endometriosis resection

Background The objective of this study was to compare the analgesic potency of oxycodone versus morphine after laparoscopic deep infiltrating endometriosis resection. Methods Fifty patients undergoing laparoscopic deep infiltrating endometriosis resection were randomized to receive oxycodone or morphine intravenous-PCA after surgery. The primary outcome was opioid consumption during the 24 h after surgery. Secondary outcomes included time to first request for analgesia, the number of bolus, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia. The prominent pain that caused patients to press the analgesic device was also recorded. Results Oxycodone consumption (14.42 ± 2.83) was less than morphine consumption (20.14 ± 3.83). Compared with the morphine group, the total number of bolus (78 vs 123) was less and the average time to first request for analgesia (97.27 ± 59.79 vs 142.17 ± 51) was longer in the oxycodone group. The incidence of nausea was higher in the morphine group than in the oxycodone group at 0–2 h (45.45% vs 17.19%), 2–4 h (50% vs 17.19%),12–24 h (40.91% vs 13.04%) and 0–24 h (39.17% vs 19.13%). The overall incidence of vomiting was higher in the morphine group (27.27% vs 13.92%). There was no difference in visual analogue scale score, the incidence of respiratory depression, and bradycardia between groups. Of the three types of pain that prompted patients to request analgesia, the incidence of visceral pain was highest (59.9%, P < 0.01). Conclusion Oxycodone was more potent than morphine for analgesia after laparoscopic endometriosis resection, and oxycodone has fewer side effects than morphine. Name of the registry: Chinese Clinical Trial Registry Trial registration number: ChiCTR1900021870 URL of trial registry record:http://www.chictr.org.cn/edit.aspx?pid=35799&htm=4 Date of registration: 2019/3/13 0:00:00

Asma infantil: Efectos inmunomoduladores de los liofilizados bacterianos

Background: Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate’s action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma. Methods: This study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3−CD16+CD56+ were described. Results: At baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3−CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased. Conclusions: The EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes. Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.

Testament as a Source of Researching Urban Literacy in the Volynia Region of the 17th Century

Ukrainian historiography has not properly determined the problems of Volynian cities’ secretariats and development of burghers’ literacy in particular. The goal of the article is to research some aspects of these problems by the means of testaments; specifically, to highlight the role of city secretaries in the process of writing down citizens’ testaments and facts that testify about development of urban literacy in cities of Volynia of the 17th century.The municipal registry record analysis implies that executing posthumous inventories, settlement deeds, and especially testaments influenced the development of pragmatic urban literacy. Among the analyzed group of testators, several people wrote down their testaments by themselves. Then city clerks had no option but to accept prepared documents post factum for saving records in town council registers, which in some extent is evidence of the literacy culture development in the Volynian cities in the early modern times. However, the predominant majority of testators were illiterate and in order to approve their act of last will, they signed it with a criss-cross (“X”); the conclusion of the act required specialized assistance from municipal clerks.At those times, testaments were normally written down in the house of a dying person in the presence of municipal officers who provided the document according to an appropriate form and legal validity, and eye-witnesses; or it could be written down at the city hall before the court. City secretaries had a significant role in this procedure, but their level of proficiency was not always appropriate.As in the majority of Central-East European cities of that time, in Volynian cities substantial amounts of acts of last will were given by verbal directions and were not recorded in municipal registers. This fact explains such a small amount of saved documents in comparison with Western European cities. They were not set aside into a separate register series as in bigger crown cities, but the acts were recorded into the current municipal registers in response to citizens’ demand.

Serum Molecular Biomarkers in Neuromyelitis Optical and Multiple Sclerosis

ObjectiveThe aims of this study were to determine whether the expression levels of serological cytokines could distinguish 1) neuromyelitis optical spectrum disorders (NMOSD) from healthy controls (HCs); and 2) NMOSD patients with and without the aquaporin-4 (AQP-4) antibody biomarker from each other; and 3) NMOSD patients without antibody to AQP-4 from multiple sclerosis (MS). MethodsThe expression levels of 200 proteins in serum from 41 NMOSD (32 with antibodies to AQP-4, 9 without antibodies to AQP-4), 12 MS patients, and 34 HCs were measured using glass-based antibody arrays. In parallel, the correlation between protein expression in NMOSD/MS patients and clinical traits was analyzed with Weighted Gene Co-expression Network Analysis (WGCNA).ResultsThirty-nine serological proteins were differentially expressed in NMOSD patients compared to HCs. 29 differentially-expression proteins (DEPs) were specific to NMOSD whereas 10 of these were observed in NMOSD and MS samples. In addition, there were 15 DEPs between AQP-4-IgG seronegative and AQP-4-IgG seropositive NMOSD patients, and 9 DEPs between NMOSD and MS patients who did not have AQP-4-IgG. ConclusionsOur findings highlight that serological Interleukin-17B (IL-17B) may be key biomarker of NMOSD and MS. While epidermal growth factor (EGF) may be correlated with the breakdown of the blood-brain barrier in NMOSD patients, granulocyte chemotactic protein-2 (GCP-2) and monocyte differentiation antigen CD14 (CD14) may play different roles in the pathogenesis of AQP-4-IgG seronegative and seropositive NMOSD and MS. Novel biomarkers identified in our study could potentially be used in the diagnosis and treatment of NMOSD.Trial registrationPublic title: Multi-Center Clinical Study of GFAP AstrocytopathyRegistration number: ChiCTR2000041291Date of registration: 2020-12-23 (Retrospective registration)URL of trail registry record: http://www.chictr.org.cn/showproj.aspx?proj=65306

Publication Rate and Consistency of Registered Trials of Motor-Based Stroke Rehabilitation

ObjectiveTo determine the publication rate of motor-rehabilitation trials poststroke and the consistency between registry records and their corresponding main publications in trial design, primary objectives and outcomes, eligibility criteria, and sample size.MethodsWe searched 18 clinical trial registries to identify randomized controlled trials of motor-based stroke rehabilitation registered after July 2005 and completed before April 2017. Eligible trials included adults with stroke, with at least one outcome measure related to motor function. Information in the registry records was compared with that of their main publications, if any.ResultsThree hundred twenty-three trials met our eligibility criteria; we were unable to find a peer-reviewed publication reporting the main findings for 46% (150/323) of these. Of the 169 trials with peer-reviewed articles published in English, 141 (83%) were consistent with the registry record in trial design, 100 (59%) were consistent in primary objectives, 71 (42%) were consistent in primary outcomes, 28 (17%) were consistent in eligibility criteria, and 74 (44%) were consistent in sample size.ConclusionsApproximately half of motor-based stroke rehabilitation trials were not published, even more than 3 years after the end of the trial. When main publications were found, they substantially deviated from information in the registry record. These findings highlight the importance of trial registries for identifying unpublished stroke rehabilitation trials and of searching trial registries when conducting systematic reviews and meta-analysis to help ensure that reviews are unbiased.

Abstract 215: The Treatment Quality of Patients With Non-ST Elevation Acute Coronary Syndrome: Association With In-hospital Outcomes, Predictors of Nonconformity With Guidelines

Background: It is known that closer adherence to clinical guidelines for management of acute coronary syndrome (ACS) is associated with better outcomes. Despite financial and organizational efforts only a small reduction of ACS mortality has been achieved in Russia during recent years. Official statistic data does not allow to evaluate the association of outcomes with quality of ACS treatment. AIM of the analysis was to assess quality of treatment (determined as conformity with guidelines) in patients with non-ST elevation ACS (NSTEACS) in Russian hospitals based on the data of the RECORD-3 registry. Methods: The ACS registry RECORD-3 was prospective observational study in which consecutive patients with ACS admitted to 47 hospitals from 37 cities were included within 1 month (Mar-Apr 2015). Recommendations of IA and IB classes from 2015 European society of cardiology guidelines (n=15) were used for evaluation of quality of treatment. The number of applicable recommendations (from 8 to 15) and the rate of their implementation were calculated for each patient. The 3-rd-4-th quartiles of implementation were named “guideline conforming treatment” (GCT), and 1-st and 2-nd quartiles - “guideline non-conforming treatment” (GNT). Results: Among 2370 included patients, 1502 (63.4%) had NSTEACS. The median of implementation of recommendations was 63.6% (1-3 quartiles 54.5% - 72.7%). Portions of patients with 100%, >75% and <50% implementation of recommendations were 1.4%, 19.0%, and 14.6%, respectively. During hospitalization (median 10 days) 7 patients (1.0%) receiving “GCT” and 30 patients (3.7%) receiving “GNT” died (relative risk 3.65, 95% confidence interval 1.61-8.26; p=0.0015). At multifactorial regression analysis, independent predictors of “GNT” were: Killip class IV, hospitalization without an ambulance assistance and admission to “noninvasive” hospital, previous atrial fibrillation, absence of ST-depression on first ECG, normal troponin level, first glucose level ≤6.0 mmol/l, not using aspirin or ACE-inhibitor regularly before ACS. Conclusions: The analysis of Russian registry RECORD-3 data showed that in participating hospitals >75% of recommendations of IA and IB classes were implemented only in 19% of NSTEACS patients. Hospital mortality was significantly higher in patients with “GNT”. Independent predictors of “GNT” were Killip class IV, hospitalization without an ambulance assistance and admission to “noninvasive” hospital, previous atrial fibrillation, absence of ST-depression, normal troponin or glucose levels, lack of aspirin or ACE-inhibitor regular use before ACS.