Tag: pubmed

BMJ Open. 2021 Jun 28;11(6):e047543. doi: 10.1136/bmjopen-2020-047543.

ABSTRACT

INTRODUCTION: Ulcerative colitis (UC) is a type of inflammatory bowel disease, and 62% of patients with UC felt that it is difficult for them to live a normal life. Furthermore, some researches have shown that about 15% of patients with UC undergo at least one extreme clinical course in their lifetime, and 10%-30% of patients with UC oblige colectomy. Although many investigations have demonstrated that HBO₂ has a beneficial impact on UC treatment, a systematic review and meta-analysis are unavailable. Therefore, a meta-analysis is essential to assess the efficacy and safety of HBO₂ in treating UC.

METHODS AND ANALYSIS: A systematic search plan will be performed in the following seven databases with a restriction of time from inception to September 2020 to filter the eligible studies: PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journal Database (VIP) and Chinese Biomedical Database WanFang. Other related resources will be also searched. Two independent reviewers will choose eligible researches and extract data. The risk of bias will be evaluated based on Cochrane Collaboration’s Risk of Bias tool and Newcastle-Ottawa Scale. Eventually, a systematic review and meta-analysis will be performed via the Review Manager V.5.3 statistical software and STATA V.14.0 software.

ETHICS AND DISSEMINATION: This study will not involve the individual patient and any ethical problems since its outcomes are based on published data. Therefore, no ethical review and approval are required. We plan to publish the study in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42020210244.

PMID:34183344 | DOI:10.1136/bmjopen-2020-047543

Br J Clin Pharmacol. 2021 Jun 28. doi: 10.1111/bcp.14956. Online ahead of print.

ABSTRACT

AIM: This three-part, randomised, phase 1 first-in-human study (NCT03436316) investigated the safety, tolerability and pharmacokinetics (PK) of AZD8154, a dual phosphoinositide 3-kinase (PI3K γδ) inhibitor developed as a novel inhaled anti-inflammatory treatment for respiratory disease.

METHODS: Healthy men, and women of non-childbearing potential, were enrolled to receive single and multiple ascending inhaled doses of AZD8154 in parts 1 and 3 of the study, respectively, while part 2 characterised the systemic PK after a single intravenous (IV) dose. In part 1, participants received 0.1 mg to 7.7 mg AZD8154 in six cohorts. In part 2, participants were given 0.15 mg AZD8154 as an IV infusion. In part 3, AZD8154 was given in three cohorts of 0.6, 1.8 and 3.1 mg, with a single dose on Day 1 followed by repeated once-daily doses on Days 4-12.

RESULTS: In total, 78 volunteers were randomised. All single inhaled, single IV and multiple inhaled doses were shown to be well tolerated without any safety concerns. A population PK model, using non-linear mixed-effect modelling, was developed to describe the PK of AZD8154. The terminal mean half-life of AZD8154 was 18.0-32.0 hours. The geometric mean of the absolute pulmonary bioavailability of AZD8154 via the inhaled route was 94.1%.

CONCLUSION: AZD8154 demonstrated an acceptable safety profile, with no reports of serious adverse events and no clinically significant drug-associated safety concerns reported in healthy volunteers. AZD8154 demonstrated prolonged lung retention and a half-life supporting once-daily dosing.

PMID:34182611 | DOI:10.1111/bcp.14956

Rom J Intern Med. 2021 Jun 28. doi: 10.2478/rjim-2021-0025. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the ability of severity scoring systems to predict 30-day mortality in patients with severe community-acquired pneumonia.

METHODS: The study included 98 patients aged ≥18 years with community acquired pneumonia hospitalized at the Intensive Care Unit of the University Clinic for Infectious Diseases in Skopje, Republic of North Macedonia, during a 3-year period. We recorded demographic, clinical and common biochemical parameters. Five severity scores were calculated at admission: CURB 65 (Confusion, Urea, Respiratory Rate, Blood pressure, Age ≥65 years), SCAP (Severe Community Acquired Pneumonia score), SAPS II (Simplified Acute Physiology Score), SOFA (Sequential Organ Failure Assessment Score) and MPM (Mortality Prediction Model). Primary outcome variable was 30-day in-hospital mortality.

RESULTS: The mean age of the patients was 59.08 ± 15.76 years, predominantly males (68%). The overall 30-day mortality was 52%. Charlson Comorbidity index was increased in non-survivors (3.72 ± 2.33) and was associated with the outcome. All severity indexes had higher values in patients who died, that showed statistical significance between the analysed groups. The areas under curve (AUC) values of the five scores for 30-day mortality were 0.670, 0.732, 0,726, 0.785 and 0.777, respectively.

CONCLUSION: Widely used severity scores accurately detected patients with pneumonia that had increased risk for poor outcome, but none of them individually demonstrated any advantage over the others.

PMID:34182618 | DOI:10.2478/rjim-2021-0025

Health Serv Res. 2021 Jun 28. doi: 10.1111/1475-6773.13688. Online ahead of print.

ABSTRACT

OBJECTIVE: Countries have adopted different approaches, at different times, to reduce the transmission of coronavirus disease 2019 (COVID-19). Cross-country comparison could indicate the relative efficacy of these approaches. We assess various nonpharmaceutical interventions (NPIs), comparing the effects of voluntary behavior change and of changes enforced via official regulations, by examining their impacts on subsequent death rates.

DATA SOURCES: Secondary data on COVID-19 deaths from 13 European countries, over March-May 2020.

STUDY DESIGN: We examine two types of NPI: the introduction of government-enforced closure policies and self-imposed alteration of individual behaviors in the period prior to regulations. Our proxy for the latter is Google mobility data, which captures voluntary behavior change when disease salience is sufficiently high. The primary outcome variable is the rate of change in COVID-19 fatalities per day, 16-20 days after interventions take place. Linear multivariate regression analysis is used to evaluate impacts.

DATA COLLECTION/EXTRACTION METHODS: publicly available.

PRINCIPAL FINDINGS: Voluntarily reduced mobility, occurring prior to government policies, decreases the percent change in deaths per day by 9.2 percentage points (pp) (95% confidence interval [CI] 4.5-14.0 pp). Government closure policies decrease the percent change in deaths per day by 14.0 pp (95% CI 10.8-17.2 pp). Disaggregating government policies, the most beneficial for reducing fatality, are intercity travel restrictions, canceling public events, requiring face masks in some situations, and closing nonessential workplaces. Other sub-components, such as closing schools and imposing stay-at-home rules, show smaller and statistically insignificant impacts.

CONCLUSIONS: NPIs have substantially reduced fatalities arising from COVID-19. Importantly, the effect of voluntary behavior change is of the same order of magnitude as government-mandated regulations. These findings, including the substantial variation across dimensions of closure, have implications for the optimal targeted mix of government policies as the pandemic waxes and wanes, especially given the economic and human welfare consequences of strict regulations.

PMID:34182593 | DOI:10.1111/1475-6773.13688

Anaesthesia. 2021 Jun 28. doi: 10.1111/anae.15527. Online ahead of print.

ABSTRACT

Whether high-flow vs. low-flow nasal oxygen reduces hypoxaemia for sedation during endoscopic retrograde cholangiopancreatography is currently unknown. In this multicentre trial, 132 patients ASA physical status 3 or higher, BMI > 30 kg.m^-2 or with known or suspected obstructive sleep apnoea were randomly allocated to high-flow nasal oxygen up to 60 l.min^-1 at 100% F_I O₂ or low-flow nasal oxygen at 4 l.min^-1 . The low-flow nasal oxygen group also received oxygen at 4 l.min^-1 through an oxygenating mouthguard, totalling 8 l.min^-1 . Primary outcome was hypoxaemia, defined as S_p O₂ < 90% regardless of duration. Hypoxaemia occurred in 7.7% (5/65) of patients with high-flow and 9.1% (6/66) with low-flow nasal oxygen (percentage point difference -1.4%, 95%CI -10.9 to 8.0; p = 0.77). Between the groups, there were no significant differences in frequency of hypoxaemic episodes; lowest S_p O₂ ; peak transcutaneous carbon dioxide; hypercarbia (transcutaneous carbon dioxide > 2.66 kPa from baseline); requirement of chin lift/jaw thrust; nasopharyngeal airway insertion; bag-mask ventilation; or tracheal intubation. Following adjustment for duration of the procedure, the primary outcome remained non-significant. In high-risk patients undergoing endoscopic retrograde cholangiopancreatography, oxygen therapy with high-flow nasal oxygen did not reduce the rate of hypoxaemia, hypercarbia or the need for airway interventions, compared with combined oral and nasal low-flow oxygen.

PMID:34182603 | DOI:10.1111/anae.15527

ORL J Otorhinolaryngol Relat Spec. 2021 Jun 28:1-20. doi: 10.1159/000516345. Online ahead of print.

ABSTRACT

INTRODUCTION: Biofilm formation on voice prostheses is the primary reason for their premature implant dysfunction. Multiple strategies have been proposed over the last decades to achieve inhibition of biofilm formation on these devices. The purpose of this study was to assess the results of the available in vitro biofilm inhibition modalities on silicone rubber voice prostheses.

METHODS: We conducted a systematic search in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases up to February 29, 2020. A total of 33 in vitro laboratory studies investigating the efficacy of different coating methods against Candida, Staphylococcus, Streptococcus, Lactobacilli, and Rothia biofilm growth on silicone rubber medical devices were included. Subgroup analysis linked to the type of prevention modality was carried out, and quality assessment was performed with the use of the modified CONSORT tool.

RESULTS: Data from 33 studies were included in qualitative analysis, of which 12 qualified for quantitative analysis. For yeast biofilm formation assessment, there was a statistically significant difference in favor of the intervention group (standardized mean difference [SMD] = -1.20; 95% confidence interval [CI] [-1.73, -0.66]; p < 0.0001). Subgroup analysis showed that combined methods (active and passive surface modification) are the most effective for biofilm inhibition in yeast (SMD = -2.53; 95% CI [-4.02, -1.03]; p = 0.00001). No statistically significant differences between intervention and control groups were shown for bacterial biofilm inhibition (SMD = -0.09; 95% CI [-0.68, 0.46]; p = 0.65), and the results from the subgroup analysis found no notable differences between the surface modification methods. After analyzing data on polymicrobial biofilms, a statistically significant difference in favor of prevention methods in comparison with the control group was detected (SMD = -2.59; 95% CI [-7.48, 2.31]; p = 0.30).

CONCLUSIONS: The meta-analysis on biofilm inhibition demonstrated significant differences in favor of yeast biofilm inhibition compared to bacteria. A stronger inhibition with the application of passive or combined active and passive surface modification techniques was reported.

PMID:34182551 | DOI:10.1159/000516345

Am J Perinatol. 2021 Jun 28. doi: 10.1055/s-0041-1731452. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to assess whether there was any difference in the transition time to full oral feedings between parent-administered and professional-administered premature infant oral motor intervention (PIOMI). The study also evaluated parental satisfaction with performing the intervention through an open-ended questionnaire.

STUDY DESIGN: A single-center, randomized, controlled, open-label pilot study was carried on between March 2017 and May 2019. A total of 39 infants born ≤32 weeks’ gestation were randomly assigned to either parent-performed or professionally performed oral stimulation. The oral stimulation was performed once a day for seven consecutive days between 31 and 32 weeks’ postmenstrual age.

RESULTS: There was no statistically significant difference in transition time, weight gain, or length of hospital stay between the two groups. No adverse events were observed. Parents’ satisfaction was high, and their active involvement enhanced their perception of adequacy to care for their infant.

CONCLUSION: Following adequate training, a parent-administered PIOMI may be considered in preterm infants to reduce the transition time to full oral feeding and enhance the direct involvement of parents in neonatal care.

KEY POINTS: · No difference in transition time between parent-performed and professional-performed PIOMI.. · PIOMI may be delivered by parents following appropriate training.. · Active involvement of parents may improve the parent-infant bonding..

PMID:34182577 | DOI:10.1055/s-0041-1731452

Aging (Albany NY). 2021 Jun 28;13. doi: 10.18632/aging.203179. Online ahead of print.

ABSTRACT

Evidence suggests that abnormal DNA methylation patterns play a crucial role in the etiology and pathogenesis of colon adenocarcinoma (COAD). In this study, we identified a total of 97 methylation-driven genes (MDGs) through a comprehensive analysis of the Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO) databases. Univariate Cox regression analysis identified four MDGs (CBLN2, RBM47, SLCO4C1, and TMEM220) associated with overall survival (OS) in COAD patients. A risk prediction model was then developed based on these four MDGs to predict the prognosis of COAD patients. We also created a nomogram that incorporated risk scores, age, and TNM stage to promote a personalized prediction of OS in COAD patients. Compared with the traditional TNM staging system, our new nomogram was better at predicting the OS of COAD patients. In cell experiments, we confirmed that the mRNA expression levels of CLBN2 and TMEM220 were regulated by the methylation of their promoter regions. Moreover, immunohistochemistry showed that CBLN2 and TMEM220 were potential prognostic biomarkers for COAD patients. In summary, we have established a risk prediction model and nomogram that might be effectively utilized to promote the prediction of OS in COAD patients.

PMID:34182539 | DOI:10.18632/aging.203179

Eur Neurol. 2021 Jun 28:1-7. doi: 10.1159/000508185. Online ahead of print.

ABSTRACT

BACKGROUND: Insomnia is a highly common sleep disorder in patients with Parkinson’s disease (PD). Yet, no screening questionnaires following the Diagnostic and Statistical Manual-5 (DSM-5) criteria have been validated in PD patients.

OBJECTIVES: We assessed the validity and reliability of the French version of the sleep condition indicator (SCI), in patients with PD.

METHODS: In a sample of 65 patients (46% women, mean age 63.8 ± 7.9 years) with PD, but without dementia, insomnia was assessed with a clinical interview and the SCI. Statistical analyses were performed to determine the reliability, construct validity, and divergent validity of the SCI. In addition, an explanatory factor analysis was performed to assess the underlying structure of the SCI.

RESULTS: Of the 65 patients (mean duration PD 9.7 ± 6.9 years), 51% met the criteria for insomnia disorder when measured with a clinical interview. The mean SCI score was 18.05 ± 8.3. The internal consistency (α = 0.89) of the SCI was high. Using the previously defined cutoff value of ≤16, the area under the receiver operating characteristic curve was 0.86 with a sensitivity of 86% and a specificity of 87%. Exploratory factor analysis showed a 2-factor structure with a focus on sleep and daytime effects. Additionally, good construct and divergent validity were demonstrated.

CONCLUSION: The SCI can be used as a valid and reliable screener for DSM-5 insomnia disorder in PD patients. Due to its short length, it is useful in both clinical practice and scientific research.

PMID:34182546 | DOI:10.1159/000508185

Urol Int. 2021 Jun 28:1-9. doi: 10.1159/000516941. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to evaluate long-term safety and efficacy of the suprapubic arc (SPARC) procedure for the surgical treatment of stress urinary incontinence (SUI).

MATERIALS AND METHODS: 139 female patients treated by SPARC were included in this retrospective analysis, whereby 126 patients were available for follow-up after 1 year, 70 after 6 years, and 41 after 9 years. The cough test, pad test, uroflowmetry, and post-void residual volume measurements were performed. Severity of bother (visual analogous scale [VAS] 0-10), continence, and the satisfaction rate were assessed. Objective cure was defined as a negative cough test and pad weight ≤1 g, subjective cure as no urine loss during daily activities and no usage of pads. The VAS, pad weight, number of pads per day, and maximal flow rate were compared preoperatively and postoperatively.

RESULTS: Objective cure rates at 1, 6, and 9 years were 78.6, 71.4, and 70.7% and subjective cure rates were 72.2, 55.7, and 65.8%, respectively. The VAS, pad weight, number of pads, and maximal flow rate decreased significantly. Study limitations include a relatively small sample size and the retrospective fashion of the analysis.

CONCLUSIONS: In the long-term context, SPARC showed to represent an efficient and safe procedure for treatment of female SUI.

PMID:34182548 | DOI:10.1159/000516941