Tag: statistics

Pharm Dev Technol. 2024 Mar 18:1-17. doi: 10.1080/10837450.2024.2331243. Online ahead of print.

ABSTRACT

In this work we exploit Computational Fluid Dynamics (CFD) to evaluate Stirred Tank Reactor (STR) Process Engineer Parameters (PEP) and design a scale down system (SDS) to be representative of the formulation and filling process steps for an Aluminum adjuvanted vaccine Drug Product (DP). To study the shear history in the SDS we used the concept of number of passages, combined with an appropriate stirring speed down scale strategy comprising of either i) Tip speed equivalence, widely used as scale-up criterion for shear-sensitive product, or ii) Rotating shear, a shear metric introduced by Metz and Otto in 1957 but never used as scaling criterion. The outcome of the CFD simulations shows that the tip equivalence generates a worst case SDS in terms of shear, whereas the rotating shear scaling approach could be used to design more representative SDS. We monitored the trend over time for “In Vitro Relative Potency” as DP Critical Quality Attribute for both scaling approaches, which highlighted the crucial role of choosing the appropriate scaling down approach to be representative of the manufacturing scale during process characterization studies.

PMID:38497925 | DOI:10.1080/10837450.2024.2331243

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):2107-2116. doi: 10.26355/eurrev_202403_35623.

ABSTRACT

OBJECTIVE: This study aimed to determine the effect of tocilizumab use on mortality and the potential side effects in COVID-19 patients.

PATIENTS AND METHODS: The intensive care patients were divided into the tocilizumab group and the control group. Hemogram, biochemistry, acute phase reactant values, age, gender, comorbidity, and culture results were recorded on the 0th, 3rd, 7th, and 14th days. Factors affecting mortality between and within the groups and side effects were examined.

RESULTS: 32.14% of the patients were female, and 67.85% were male. The tocilizumab group had high alanine aminotransferase and potassium on day 3. On day 7, low levels of platelet, glucose, international normalized ratio, prothrombin time, and active partial thromboplastin time levels were observed. Procalcitonin, C-reactive protein, and fibrinogen levels were low on days 3 and 7. The relationship between the tocilizumab treatment and mortality was statistically not significant, although the APACHE score was low. In the tocilizumab group, the presence of additional disease and reproduction in culture significantly increased mortality.

CONCLUSIONS: Despite the risks of side effects, tocilizumab was used in COVID-19 treatment since it is an interleukin-6 blocker. Although the first publications stated that the treatment could decrease the mortality rate, later meta-analyses did not support these results. Our study also found that using tocilizumab did not make a difference in long-term mortality. We also observed that the known side effects were seen in short-term use.

PMID:38497892 | DOI:10.26355/eurrev_202403_35623

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):2005-2013. doi: 10.26355/eurrev_202403_35615.

ABSTRACT

OBJECTIVE: Uncarboxylated osteocalcin is an important osteocalcin enzyme found in the bloodstream and is a crucial protein for maintaining calcium binding in bones, controlling blood sugar levels, and balancing body minerals.

PATIENTS AND METHODS: Due to the lack of data, the current study intends to investigate the relationship between uncarboxylated osteocalcin levels and DM-II in Saudi patients. For 138 patients, case-control research was conducted in 2021-2023, with 69 type II diabetes mellitus patients and 69 matching healthy control participants. An enzyme immunoassay kit was used to quantify the levels of uncarboxylated osteocalcin in fasting blood samples, and an automated analyzer evaluated Hb1Ac, fasting blood glucose, enzymes, electrolytes, lipid, and kidney profiles. Data processing and analysis were carried out using GraphPad Prism statistical software.

RESULTS: According to our study, patients with type II diabetes mellitus had considerably lower levels of uncarboxylated osteocalcin than healthy controls. According to the correlation analysis, uncarboxylated osteocalcin and fasting blood sugar had a negative relationship. In the overweight BMI group, uncarboxylated osteocalcin was considerably higher in control subjects.

CONCLUSIONS: We concluded that, in Saudi type II diabetes mellitus patients, the compromised glucose level is associated with diminished serum uncarboxylated osteocalcin. This study has limitations, such as a small sample size and only measuring the uncarboxylated form of plasma osteocalcin. Future research is needed to understand how anti-diabetic drugs affect undercarboxylated osteocalcin’s effect on metabolic control and provide more efficient techniques and resources in diabetes and osteoporosis prevention and care.

PMID:38497883 | DOI:10.26355/eurrev_202403_35615

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1937-1946. doi: 10.26355/eurrev_202403_35608.

ABSTRACT

OBJECTIVE: Cerebral ischemia (CI) is a condition in which metabolic stress increases when blood flow is interrupted in a part of the brain, resulting in oxygen and glucose deprivation. It is known that asprosin (Asp), secreted from adipose tissue during fasting, has an effect on some metabolic processes such as apoptosis, autophagy, and glucose metabolism. This study aimed to explain which of the cell death/survival Asp induces in the CI/reperfusion model.

MATERIALS AND METHODS: In the study, 48 male Wistar Albino rats were divided into 6 groups: Sham, CI, Asp+CI, CI+Asp, CI+Asp+3-MA, and Asp+CI+3-MA (n=48). CI was created using the intraluminal filament technique for 60 minutes, autophagy inhibitor 3-MA (15 mg/kg/day) and Asp (1 µg/kg/day) injections were administered 3 days before or 3 days during reperfusion. Beclin-1, ATG5, ATG7, p62, Bcl-2, Bax, active-caspase-3, and active-caspase-9 protein levels from brain tissues were determined by the Western-Blot method. The infarct area was determined by triphenyl tetrazolium chloride (TTC) staining. The Kruskal-Wallis’ test was used to compare differences between groups. p<0.05 was considered statistically significant.

RESULTS: Compared to the Sham group, the increase in ischemic area and the decrease in Beclin-1, ATG-5, ATG-7, Bcl-2, Bax, active-caspase-3 and active-caspase-9 levels in the CI groups are statistically significant (p<0.05). The increase of Beclin-1, ATG-7, Bcl-2, and Bax levels in the Asp groups is statistically significant compared to the CI group (p<0.05). When Asp+CI groups and CI+Asp groups are compared, an increase in Beclin-1 levels in the Asp+CI group and the increase in Bcl-2, Bax, active-caspase-3/9 and ATG-5 levels in the CI+Asp groups are statistically significant (p<0.05).

CONCLUSIONS: Asp has protective and therapeutic effects against CI/R damage. While applying Asp before ischemia activates the autophagy pathway more, applying it after ischemia protects the neuronal death/survival balance by activating the apoptosis pathway more.

PMID:38497877 | DOI:10.26355/eurrev_202403_35608

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1931-1936. doi: 10.26355/eurrev_202403_35607.

ABSTRACT

OBJECTIVE: The autonomic nervous system (ANS) plays an important role in maintaining physiological regulation. It regulates the body’s response to many variable situations. Orthostatic intolerance (OI) is one of the most important signs of autonomic dysfunction. Autonomic dysfunction is known to cause premature ejaculation (PE) by disturbing the balance in erection and ejaculation cycles. Considering that OI may develop due to autonomic dysfunction in patients with PE, we hypothesized that OI symptoms would increase in these patients. The aim of our study was to investigate the relationship between orthostatic intolerance and PE.

PATIENTS AND METHODS: This case-control study included a total of 39 patients with PE and 47 volunteers without PE. All subjects were assessed using the self-reported Orthostatic Grading Scale (OGS). In addition, the validated five-item Turkish version of the Premature Ejaculation Diagnostic Tool (PEDT) was used to evaluate PE. The PE group included patients with a PEDT score ≥ 11.

RESULTS: The mean ages of the PE and control groups were 38.2 ± 7.8 and 40.5 ± 9.1 years, respectively (p = 0.137). The mean PEDT scores of the PE and control groups were 13.9 ± 3.6 and 6.6 ± 2.9, respectively (p < 0.0001), and their mean OGS scores were 5.6 ± 2.4 and 1.6 ± 1.3, respectively (p < 0.0001). A statistically significant correlation was found between the PEDT and OGS scores (r: 0.686, p < 0.0001).

CONCLUSIONS: The orthostatic intolerance symptoms of patients with PE were higher than those of the control group. There was a correlation between the severity of PE and the severity of orthostatic intolerance. This is the first study in the literature to reveal a relationship between orthostatic intolerance and PE.

PMID:38497876 | DOI:10.26355/eurrev_202403_35607

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1812-1820. doi: 10.26355/eurrev_202403_35595.

ABSTRACT

OBJECTIVE: The primary aim of the present study was to determine the success of single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in detecting critical coronary artery disease (CAD) as identified by invasive coronary angiography (ICA), as well as to compare the positive predictive values (PPV) of different stress methods. Our secondary aim was to investigate demographic, laboratory, electrocardiographic, and echocardiographic variables that could predict true positive results. PATIENTS AND METHODS: The study was conducted with 317 consecutive patients. Exercise, dipyridamole, adenosine, or dobutamine were used as stress methods. According to the results of ICA, patients with and without critical CAD were divided into two groups and compared statistically. The independent predictors of true positive results of positive SPECT-MPI were determined using univariate and multivariate logistic regression analysis (MLRA). RESULTS: Among the patients, 129 (40.7%) were found to have critical CAD (+) and 188 (50.3%) critical CAD (-). The PPVs of different stress methods were similar. Age, diabetes, and monocyte to HDL ratio (MHR) were found to be independent predictors of critical CAD in MLRA (p<0.005, p=0.002, and p<0.005, respectively). ROC curve analysis revealed 81.4% sensitivity and 47.3% specificity (AUC: 0.683) at a cut-off of 57 for age and 72.1% sensitivity and 54.3% specificity (AUC: 0.649) for MHR at a cut-off of 9.7. CONCLUSIONS: The true positivity rate of SPECT-MPI is low. Moreover, this rate is much lower for women. The PPVs of different stress methods are similar. Age, presence of diabetes, and MHR ratio are independent predictors for true positive results of SPECT-MPI.

GRAPHICAL ABSTRACT: https://www.europeanreview.org/wp/wp-content/uploads/Graphical-abstract-9.jpg.

PMID:38497864 | DOI:10.26355/eurrev_202403_35595

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1733-1740. doi: 10.26355/eurrev_202403_35586.

ABSTRACT

OBJECTIVE: Dental healthcare personnel face the potential danger of being exposed to infectious patients while administering local anesthesia injections during dental operations. This could lead to unintentional transfer of infectious diseases from patients to physicians. Although safety measures such as the One-hand-scoop technique and the use of safety syringes, plastic needle cap holders, and needles with safety caps are in place, there have been instances of needle stick injuries reported in clinics. This might be due to the lack of adherence to conventional safety measures or the impracticality of safety techniques and safety syringes. This article aims to demonstrate the utilization of dental tweezers, specifically London College tweezers or dental forceps, for the secure recapping of needles, eliminating the requirement for extra equipment or devices.

SUBJECTS AND METHODS: After obtaining ethical approval (Approval No.: 024-01-2024) from the College of Dentistry, Dar Al Uloom University, 67 dental professionals, with consent for participation in the study, were included. They were requested to use dental tweezers/London College tweezers and dental extraction forceps such as maxillary anterior, mandibular anterior, and maxillary bayonet root forceps individually to recap the local anesthetic needles. The efficacy of these techniques was evaluated against the one-hand scoop technique for its ease, convenience, and reliability in preventing needle stick injuries.

RESULTS: The evaluation of dental professionals regarding the ease of using dental tweezers to recap needles, compared to the one-hand scoop technique (p=0.592), maxillary bayonet root forceps (p=0.746), mandibular anterior forceps (p=0.380), and maxillary anterior forceps (p=0.808), did not yield statistically significant results. The assessment of the procedural simplicity of the one-hand scoop technique showed a satisfaction rate of over 40%, whereas the application of dental tweezers resulted in a satisfaction rate of 30%. However, the use of dental tweezers for needle recapping resulted in a satisfaction rate of over 50%, compared to a satisfaction rate of 30% for the one-handed scoop technique.

CONCLUSIONS: There is no statistically significant difference in the assessment of the efficacy of dental tweezers and the one-hand scoop technique, bayonet root forceps, mandibular anterior forceps, maxillary anterior forceps, and dental tweezers for the needle capping technique. Therefore, dental forceps can be used instead of the one-handed scoop approach. The needle recapping procedure outlined in our study, aimed at preventing needle stick injuries, is simple to implement, and all dental specialties have convenient access to the required instruments.

PMID:38497855 | DOI:10.26355/eurrev_202403_35586

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1708-1732. doi: 10.26355/eurrev_202403_35585.

ABSTRACT

OBJECTIVE: The COVID-19 pandemic had a major impact on our lives all over the world. Changes have occurred in daily life as well as in all medical services. The aim of the present study was to evaluate the emergency accesses in four universities’ emergency services during the lockdown period from March to June 2020 during the COVID-19 pandemic.

SUBJECTS AND METHODS: A cross-sectional study was carried out on 44,787 patients to evaluate the emergency services of university centers. The medical data of Medical Emergency Service Data (MESD) were assessed by five independent operators considering the epidemiological findings for statistics methods.

RESULTS: A lower level of emergency access was reported in March-July compared to the pre-COVID period. The epidemiological data confirmed that female pathologies were more frequent compared to male patients. A fluctuation for almost all urgent healthcare centers was detected, showing one/two peaks per year during the years 2017-2019. The COVID-19 pandemic period did not influence the variety of pathology detected.

CONCLUSIONS: After the lockdown period, the emergency services slowly increased in cases. The pre-COVID period showed an overlapping of the most frequent pathologies compared to the post-COVID period: periodontitis (Bari and Tirana), dental fractures (Bari and Bucharest), odontogenic abscess (Bari, Cluj and Tirana).

PMID:38497854 | DOI:10.26355/eurrev_202403_35585

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1695-1707. doi: 10.26355/eurrev_202403_35584.

ABSTRACT

OBJECTIVE: This systematic review examines the effectiveness of Lactobacillus reuteri as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

MATERIALS AND METHODS: Scopus, PubMed, and Web of Science databases were searched according to specific inclusion and exclusion criteria in October 2022. Randomized control trials that evaluated the effects of Lactobacillus reuteri in patients with periodontitis were included. The primary outcome was pocket depth and clinical attachment levels, while the secondary outcome considered was bleeding on probing, microbial levels, and gingival index score. Study quality was assessed based on the Cochrane Handbook for Systematic Reviews of Interventions and the ROB2 tool.

RESULTS: A total of eleven studies that examined 369 subjects were included in the review. Adults in the age group of 18-70 years of age suffering from chronic periodontitis were evaluated. Eight out of the eleven studies reported statistically significant improvement in the intergroup pocket depths, whereas seven studies showed a statistically significant reduction in the clinical attachment levels in the probiotic group. Three studies showed no significant improvement in the pocket depth levels in the probiotic group as compared to the controls. Four studies showed no significant reduction in clinical attachment levels between the two groups. The overall risk of bias was high in four studies, while seven studies reported some concerns about the risk of bias.

CONCLUSIONS: Based on the limited evidence available, the adjunctive use of Lactobacillus reuteri to scaling and root planing may provide some additional benefit in improving periodontal parameters.

PMID:38497853 | DOI:10.26355/eurrev_202403_35584

Eur Rev Med Pharmacol Sci. 2024 Mar;28(5):1640. doi: 10.26355/eurrev_202403_35574.

ABSTRACT

Correction to: Eur Rev Med Pharmacol Sci 2020; 24 (12): 6605-6615-DOI: 10.26355/eurrev_202006_21646-published online on June 25, 2020. After publication, the authors have applied some corrections to the galley proof: – In Table II, data display in MMP14 expression between Low and high group was inverted. This correction does not involve any statistical data modification and does not affect the conclusion of the article. The correct table display should be as follows: – In Figure 4F, the cell invasion image of siRNA-2 group in T24 was misplaced. The authors have adjusted the brightness and contrast appropriately as well. The correct Figure 4F display should be as follows: There are amendments to this paper. The Publisher apologizes for any inconvenience this may cause. https://www.europeanreview.org/article/21646.

PMID:38497848 | DOI:10.26355/eurrev_202403_35574