Tag: statistics

Int Immunopharmacol. 2021 Sep 24;101(Pt A):108192. doi: 10.1016/j.intimp.2021.108192. Online ahead of print.

ABSTRACT

The mounting evidence regarding the pathogenesis of COVID-19 indicated that the cytokine storm has an axial role in the severity of this disease, which may lead to thrombotic complications, acute respiratory distress syndrome (ARDS), and myocardial damage, among other consequences. It has recently been demonstrated that statins are known to have anti-viral, anti-inflammatory, anti-thrombotic, and immunomodulatory features; however, their advantage has not been evaluated in COVID-19. This study aimed to investigate the protective effects of lovastatin in intensive care unit (ICU) patients with COVID-19. The case-control study consists of 284 ICU patients, which classified into three groups as follows: 1) the patients who no received lovastatin as a control (92 patients), 2) patients received 20 mg per day lovastatin (99 patients), and 3) patients received 40 mg per day lovastatin (93 patients). Each group’s demographic and clinical parameters, along with CRP, interleukin (IL)-6, IL-8 levels, and mortality rate, were studied in three-time points. The results showed that there was no statistically significant difference between our study groups in terms of age and sex. (P > 0.05). Besides, in patients, receiving lovastatin the CRP, IL-6, IL-8 levels were significantly decreased from T1 to T3 than to the control group. Our results also showed that the use of lovastatin in COVID-19 patients significantly reduced the length of hospitalization in the ICU compared with the control group. In addition, our results showed that the mortality rate in patients receiving lovastatin was lower when compared to the control group; however, this difference was not statistically significant. Since the cytokine storm is a significant factor in the pathology of SARS-CoV-2, our findings highlighted the potential use of lovastatin to mitigate the inflammatory response induced by SARS-CoV-2 infection.

PMID:34607230 | DOI:10.1016/j.intimp.2021.108192

Psychoneuroendocrinology. 2021 Aug 14;133:105391. doi: 10.1016/j.psyneuen.2021.105391. Online ahead of print.

ABSTRACT

Salivary cortisol has been the central marker in psychoneuroendocrinological stress research for three decades. Given the technological possibilities to assess data in ecologically valid circumstances, many studies have implemented longitudinal assessments of salivary cortisol in study participants’ everyday life. Such studies bear the potential to understand real-life associations of cortisol with psychological traits, states, and health variables. Furthermore, changes in the neuroendocrine regulation and in cortisol reactivity can be used to evaluate the effects of behavioral interventions in real-life circumstances. While standardized paradigms have been developed to measure cortisol in laboratory settings, there is high heterogeneity in the assessment, statistical processing, and interpretation of everyday life cortisol measures. This methodological tutorial aims at summarizing important knowledge which had been accumulated during the past two decades and which could be used to set up an ambulatory assessment study focusing on salivary cortisol in everyday life. Practical advice for possible strategies at all stages of the research process is outlined in detail. Additionally, an example on how to statistically process cortisol data in a multilevel framework (including syntax) is provided. In these analyses, we investigate within- and between-person research questions regarding the association between stress and cortisol in daily life. Thus, the present work (a) can be used as tutorial for setting up everyday life studies focusing on the assessment of salivary cortisol, and (b) can be useful to avoid inconsistencies in study planning, data assessment and data processing in future studies.

PMID:34607270 | DOI:10.1016/j.psyneuen.2021.105391

J Pharm Biomed Anal. 2021 Sep 21;206:114384. doi: 10.1016/j.jpba.2021.114384. Online ahead of print.

ABSTRACT

The genus Uncaria belongs to the family of Rubiaceae, which contains approximately 34 species. It has been widely used as a traditional Chinese medicine (TCM) in China to treat hypertension, fevers, headaches, gastrointestinal illness, epilepsy, wounds, and ulcers. Uncaria rhynchophylla. (Miq.) Miq. ex Hvail.(URM) and Uncaria hirsuta Havil.(UHH) are mainly used as remedies for hypertension, which both belong to the resource of “Gou-teng” in the Chinese Pharmacopoeia. However, the authentic antihypertensive components of Uncaria still have not been fully elucidated until now. In this work, we firstly explored and compared the vasorelaxation effect of URM and UHH on the isolated rat mesenteric artery ring. Then, the variations of metabolite profiles between URM and UHH samples were investigated by UHPLC/Q-Orbitrap-MS, and 16 different metabolites have been found through multivariate statistical analysis. Further, the potential vasodilative compounds which include corynoxeine, isocorynoxeine, isorhynchophylline, rhynchophylline, hirsuteine and hirsutine were screened through the correlation analysis between metabolites and anti-hypertension activities. And the relaxation effects of the six compounds on the mesenteric artery have verified. The results indicated that metabolomics combined with correlation analysis could be effective strategies to rapid explore the active compounds from TCM.

PMID:34607203 | DOI:10.1016/j.jpba.2021.114384

Lung Cancer. 2021 Sep 17;161:180-188. doi: 10.1016/j.lungcan.2021.09.004. Online ahead of print.

ABSTRACT

OBJECTIVES: Both combinations of the PARP inhibitor veliparib plus platinum doublet chemotherapy (CT), and the programmed death receptor-1 (PD-1) inhibitor nivolumab plus CT have demonstrated encouraging efficacy for treatment of non-small cell lung cancer (NSCLC). This phase 1 dose-escalation study (NCT02944396) evaluated the quadruple combination of veliparib with nivolumab and doublet CT in patients with unresectable advanced/metastatic NSCLC.

MATERIALS AND METHODS: Patients were enrolled into five dosing cohorts: patients received veliparib 120 mg twice daily (BID) combined with nivolumab 360 mg, carboplatin AUC 6 mg/mL∙min, and paclitaxel 200 mg/m² (C/PAC) or veliparib 80/120/200/240 mg BID in combination with nivolumab 360 mg, carboplatin AUC 6 mg/mL∙min, and pemetrexed 500 mg/m² (C/PEM). Primary objective was to identify the recommended phase 2 dose (RP2D) of veliparib + nivolumab + CT. Safety, tolerability, and efficacy of this combination were also assessed.

RESULTS: Twenty-five patients were enrolled: 6 patients received veliparib 120 mg BID + nivolumab + C/PAC and 19 received veliparib (80-240 mg BID) + nivolumab + C/PEM. No dose-limiting toxicities were reported, and the RP2Ds were veliparib 120 mg BID + nivolumab + C/PAC, and veliparib 240 mg BID + nivolumab + C/PEM. The most common any-grade adverse events (AEs) were fatigue (56%), nausea (52%), and anemia (48%). Grade 3/4 AEs included anemia (32%) and neutropenia (24%), and the most frequent serious AE was malignant neoplasm progression (12%). Veliparib exhibited approximately dose proportional kinetics in the dose range 80-240 mg BID combined with nivolumab and C/PEM, with no effects on pemetrexed pharmacokinetics. Overall, the confirmed objective response rate was 40%, and best overall response was 64%.

CONCLUSION: Veliparib combined with nivolumab and platinum doublet CT was tolerated in patients with advanced/metastatic NSCLC, and no evidence of drug-drug interaction was observed. Although preliminary, this quadruple therapy may have promising antitumor activity.

PMID:34607210 | DOI:10.1016/j.lungcan.2021.09.004

J Pharm Biomed Anal. 2021 Sep 25;207:114379. doi: 10.1016/j.jpba.2021.114379. Online ahead of print.

ABSTRACT

Process Analytical Technology (PAT) instruments include analyzers capable of measuring physical and chemical process parameters and key attributes with the goal of optimizing process controls. PAT in the form of a probe or sensor is designed to integrate within the pharmaceutical manufacturing line and is coupled with computing equipment to perform chemometric modeling for result interpretation and multilayer statistical control of processes. PAT solutions are intended for understanding bioprocesses with a goal to control quality at all stages of product manufacturing and achieve quality by design (QbD). The goal of PAT implementation is to promote real-time release of products to decrease the cycle time and cost of production. This review focuses on the applications of PAT solutions at different stages of the manufacturing process for vaccine production, the advantages, challenges at present state, and the vision of the future development of biopharmaceutical industries.

PMID:34607168 | DOI:10.1016/j.jpba.2021.114379

Clin Neurol Neurosurg. 2021 Sep 17;210:106954. doi: 10.1016/j.clineuro.2021.106954. Online ahead of print.

ABSTRACT

In the present study, we investigated whether Neuroaspis PLP10™, a well-designed intervention, rich in omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) with specific antioxidant vitamins, may exert positive action in the improvement of Parkinson’s disease symptoms and perhaps delay the progression of the disease when used as an adjuvant to the conventional treatment. Forty patients were randomized 1:1 to receive either 20 ml dose, once daily, of control (pure virgin olive oil) or Neuroaspis PLP 10™, a formula containing a mixture of omega-3 (810 mg Eicosapentaenoic acid and 4140 mg Docosahexaenoic acid) and omega-6 fatty acids (1800 mg gamma-Linolenic acid and 3150 mg Linoleic acid) (1:1 w/w), with 0.6 mg vitamin A, vitamin E (22 mg) plus pure gamma (γ)-tocopherol (760 mg), for a total of 30 months in a randomized double-blind, placebo-controlled trial. Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson’s Disease (HY scale) and the Unified Parkinson’s Disease Rating Scale (UPDRS) III. Overall, for this small sample size clinical trial, Neuroaspis PLP10™ supplementation as an adjuvant treatment for 30 months in PD patients significantly delayed disease progression according to UPDRS (p ≤ 0.05) Vs placebo.

PMID:34607196 | DOI:10.1016/j.clineuro.2021.106954

Cir Pediatr. 2021 Oct 1;34(4):180-185.

ABSTRACT

INTRODUCTION: Neonatal airway examination through flexible/rigid bronchoscopy has proved to be useful in the presence of persistent stridor and extubation failure, as well as to assess complications following cardiac surgery. At our institution, these examinations are carried out by a pulmonologist, a neonatologist, an otorhinolaryngologist, and a pediatric surgeon from the pediatric airway committee, established in 2014.

OBJECTIVE: To analyze the airway examinations performed in neonates during their stay at the neonatology/neonatal intensive care unit since the airway committee was established.

MATERIAL AND METHODS: A retrospective study of the airway examinations conducted in neonates from 2015 to 2019 was carried out. Clinical and demographic data, number of examinations, indications, findings, and complications were collected. Results are presented as mean and standard deviation. Statistical significance was established at p < 0.05.

RESULTS: 92 airway examinations were analyzed in 51 patients (54.9% of whom were female). 51% of the patients were premature. Extubation failure and persistent respiratory symptoms following successful extubation were the most frequent indications for airway examination (35.3%). Stratification by gestational age or weight at birth was not associated with an increased risk of pathological findings at examination (p > 0.05). The most frequent finding was vocal cord paralysis (n = 14; 27.5%). In 10 patients (19.6%), no pathological findings were observed.

CONCLUSION: Airway examination is useful in patients with stridor to identify vocal cord paralysis following extubation failure. It also allows congenital airway pathologies to be diagnosed and treated. The number of examinations with no pathological findings was similar to that reported in international series.

PMID:34606697

Scand J Med Sci Sports. 2021 Oct 4. doi: 10.1111/sms.14071. Online ahead of print.

ABSTRACT

There is an urgent need for research on the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing corona virus disease 2019 (COVID-19), as the transmissibility differs between settings and populations. Here we report on a questionnaire-based retrospective cohort study of the prevalence and transmission of SARS-CoV-2 among participants in swimming activities in Denmark in the last five months of 2020 during the COVID-19 pandemic. Eight of 162 swimming activities with a SARS-CoV-2 positive participant led to transmission to 23 other participants. Overall, the percentage of episodes leading to transmission was 4.9% (competitive swimming 8.9%; recreational swimming 1.3%). Overall, the incidence rate of transmission was 19.5 participants per 100,000 pool activity hours (corresponding values: 43.5 and 4.7 for competitive and recreational swimming, respectively). Compliance with precautionary restrictions was highest regarding hand hygiene (98.1%) and lowest in distancing personal sports bags (69.9%). As a result of low statistical power, the study showed no significant effect of restrictions. Insight into the risk of transmission of SARS-CoV-2 during indoor swimming is needed to estimate the efficiency of restrictive measures on this and other sports and leisure activities. Only when we know how the virus spreads through various settings, optimal strategies to handle the COVID-19 pandemic can be developed.

PMID:34606662 | DOI:10.1111/sms.14071

J Cosmet Dermatol. 2021 Oct 4. doi: 10.1111/jocd.14503. Online ahead of print.

ABSTRACT

BACKGROUND: Platelet-rich plasma is a useful adjuvant therapy in the treatment of acne scars. Fat is as ideal soft tissue filler.

AIMS: To compare the efficacy and safety of subcision with autologous fat grafting versus subcision with intradermal Platelet-rich plasma for the treatment of acne scars.

METHODS: Twenty-four patients were divided into two groups with 12 patients each. One group subjected to single session of subcision with autologous fat grafting. Second group treated with subcision followed by intradermal Platelet-rich plasma monthly once for 3 months. High resolution digital photographs taken before and after every session. Single blinded physician assessment was also done.

RESULTS: In quantitative acne scar assessment scoring, both group of patients showed significant percentage of improvement in acne scars, 61.23 ± 9.48% in patients treated with subcision followed by autologous fat grafting and 44.16 ± 7.28% in patients treated with subcision followed by intradermal PRP. At the time of enrolment, 33.3% (n = 8) of patients had Grade A (milder) scarring, 50% (n = 12) had Grade B (moderate) scarring while 16.7% (n = 4) had Grade C (severe) scarring. After the completion of the treatment, it was found that 75% (n = 18) of patients were in Grade A while 20.8% (n = 5) of patients were in Grade B (p < 0.05; significant).

CONCLUSION: Both the treatment modalities, i.e., autologous fat grafting and intradermal PRP were effective and safe for the treatment of acne scars and results in each group was significant (p < 0.001). But there were no statistically significant differences between the two treatment groups (p = 0.23).

PMID:34606674 | DOI:10.1111/jocd.14503