Category: Statistics

J Clin Oncol. 2023 Jun 14:JCO2201895. doi: 10.1200/JCO.22.01895. Online ahead of print.

ABSTRACT

PURPOSE: Given the increasing incidence of early-onset colorectal cancer (CRC; diagnosed before age 50 years) worldwide, it is important to identify modifiable risk factors. We investigated whether alcohol consumption in the young population correlated with an increased early-onset CRC risk that differed by tumor location and sex.

PATIENTS AND METHODS: We investigated the association between average daily alcohol consumption and the risk of early-onset CRC among 5,666,576 individuals age 20-49 years using data from the Korean National Health Insurance Service (2009-2019). Alcohol consumption levels of nondrinker, light (reference), moderate, and heavy drinker were defined as 0, <10, 10 to <30, and ≥30 g/d for men and 0, <10, 10 to <20, and ≥20 g/d for women, respectively. Multivariate Cox proportional hazards models were used to estimate adjusted hazard ratios (aHRs) with 95% CIs.

RESULTS: We identified 8,314 incident early-onset CRC cases during the follow-up period. Moderate and heavy drinkers showed an increased risk of early-onset CRC compared with light drinkers (aHR, 1.09; 95% CI, 1.02 to 1.16 and aHR, 1.20; 95% CI, 1.11 to 1.29, respectively). Subgroup analysis by tumor location showed positive dose-response significance for early-onset distal colon and rectal cancers, but not for proximal colon cancer. The dose-response association between drinking frequency and risk of early-onset CRC was significant, with a 7%, 14%, and 27% increased risk for 1-2, 3-4, and ≥5 d/wk compared with nondrinkers, respectively.

CONCLUSION: Excessive alcohol consumption increases the risk of CRC onset before age 50 years. Thus, effective interventions are required to discourage alcohol consumption among young people and to tailor CRC screening approaches for high-risk individuals.

PMID:37315287 | DOI:10.1200/JCO.22.01895

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):153-159. doi: 10.17116/jnevro2023123051153.

ABSTRACT

OBJECTIVE: To identify risk factors and predictors of the development of psychotic disorders in patients who used synthetic cathinones (SKat).

MATERIAL AND METHODS: The study included 176 patients who used SKat, which was toxicologically confirmed. One hundred and eleven (63.1%) were male and 65 (36.9%) were female. The median age was 27 years (22-32 (Q1-Q3)). Patients were divided into main and control groups depending on the presence of a psychotic disorder. The main group (those who developed psychosis) consisted of 98 patients, the control groupincluded 78 participants. Clinical-psychopathological, parametric and statistical methods were performed to study predictors and risk factors for the development of psychotic disorders associated with the use of SKat.

RESULTS: The study established factors influencing the incidence of psychosis. Older patients were more likely to develop psychosis (p=0.002). Patients who used SKat for more than 21 consecutive days developed psychoses more often (p=0.048). The use of α-pvp (α-pyrrolidinovalerophenone, alpha-pvp) more often led to the development of psychosis (p<0.001). Patients undergoing rehabilitation were less likely to experience the development of psychosis (p=0.009). The resulting regression model is statistically significant (p<0.001). Based on the value of the Nigelkirk coefficient of determination, the model explains 30.9% of the observed group variance. It has been established that the combination of the following factors increases the chances of developing psychosis: female gender, age, duration of daily use, the presence of signs of mental infantilism, fear of the dark in childhood. In turn, the experience of undergoing rehabilitation and any pathology of the mother’s pregnancy reduces the risk of psychosis.

CONCLUSION: The results are consistent with other studies of substance-induced psychoses. The observed patterns demonstrate that this is a special group of disorders that requires the attention of specialists. The results allow us to outline the field for further study, and may also be useful in the development of therapeutic and preventive recommendations.

PMID:37315255 | DOI:10.17116/jnevro2023123051153

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):139-144. doi: 10.17116/jnevro2023123051139.

ABSTRACT

OBJECTIVE: To study the impairment of cognitive functions in patients with different stages of the burnout syndrome (BS).

MATERIAL AND METHODS: 78 patients aged 25-45 years (average age 36.9±9.5 years) were examined, which at the BS stage were divided into two subgroups: Residence (51.3%, n=40) and Exhaustion (48.7%, n=38). The control group consisted of 106 practically healthy (average age 36.3±7.2 years) The following methods were used: Russian-language version of the MBI questionnaire, questionnaire to diagnose the level of emotional burnout by V.V. Boyko, questionnaire CFQ, method «Learning 10 words» by A.R. Luria, registration of cognitive evoked potentials (EP) in the psychophysiological visual test VCPT.

RESULTS: Subjective symptoms of memory loss were in 47 patients (60.3% of the total number of patients with EBS): 17 patients (42.5%) from the subgroup Resistance and 30 patients (78.9%) from the subgroup Exhaustion. The quantitative evaluation of the subjective symptoms in the CFQ test showed a reliable increase in all patient groups (p<0.05) and especially in the subgroup Exhaustion. There was statistically reliable decrease of the P200 component in subgroup Resistence and control group in the alloys Cz (p<0.001) and Fz (p<0.001), as well as statistically reliable reduction of the P300 component in the indicated leads (Cz (p<0.001) and Pz (p<0.001)) in patients in the subgroup Resistance. Most BS patients had cognitive complaints that were more common at the Exhaustion stage. At the same time, objective cognitive impairments were detected only in patients at the stage of Exhaustion. Only the long-term memory is affected. Psychophysiological research has shown a decrease in the level of attention in both subgroups, which demonstrated an increased impairment of mental processes.

CONCLUSION: Cognitive impairment in patients with BS manifests in various forms of attention, memory impairment, and performance degradation in the resistance and exhaustion phases, and can result from high asthenization.

PMID:37315253 | DOI:10.17116/jnevro2023123051139

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):117-122. doi: 10.17116/jnevro2023123051117.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of sequential therapy with Mexidol and Mexidol FORTE 250 in the correction of postcovoid syndrome (PKS) in patients with chronic cerebrovascular diseases (CVD).

MATERIAL AND METHODS: The analysis of the results of examination and treatment of 110 patients with CVD who underwent COVID-19 was carried out. Patients of the main group (OH, n=55) received Mexidol (5 ml IV drip for 14 days, followed by the transition to the tablet form of Mexidol FORTE 250 1 table 3 times/day for 2 months); 55 patients of the comparison group (GS) did not receive antioxidants. All patients included in the study were conducted MRI examination and extensive neuropsychological testing.

RESULTS: There was a significant improvement in the state of cognitive functions, regression of symptoms of asthenia, improvement of night sleep in patients with OG. The differences were statistically significant both in comparison with the baseline level and the HS.

CONCLUSION: The administration of the drug does not require age-related dose adjustment and is well combined with basic therapy. The recommended regimen for the use of Mexidol: 14 days of 5 ml i/v or i/m, then taking the drug Mexidol FORTE 250 at a dose of 1 table 3 times/day for 2 months.

PMID:37315250 | DOI:10.17116/jnevro2023123051117

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):108-116. doi: 10.17116/jnevro2023123051108.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of using Cellex for the treatment of cognitive impairment as part of the complex therapy of patients with chronic cerebral ischemia (CCI) compared with placebo.

MATERIAL AND METHODS: The study randomized 300 patients with a reliable diagnosis of CCI stage 1-2, all participants were divided into two groups, 150 participants in each – main and control. The study drug Cellex or placebo was administered as two 10-day treatment courses, 1 ml once a day. The duration of the study was 90±5 days for each participant. The primary end point for evaluating the effectiveness of the therapy was the degree of improvement in the state of cognitive functions relative to the initial state according to the Montreal Cognitive Dysfunction Scale (MoCA) on the 31st and 60th days from the start of therapy in the compared groups. Secondary endpoints were the assessment of the degree of improvement in the state of cognitive functions according to psychometric testing scales (MoCA, Correction Test, Frontal Dysfunction Test Battery) relative to the initial state on the 31^st, 60^th and 90^th days from the start of therapy. Also, a dynamic assessment of the systemic concentration of markers of brain damage – S100β, GFAP, MMP9 and neurotrophins – BDNF and GDNF was carried out.

RESULTS: The primary endpoint of the study was achieved-the MoCA score in each group increased uniformly after baseline. However, in the main group, this indicator was significantly higher starting from visit 3 – 23.4±2.8 points in the main group, in the placebo group 22.7±2.3 (p<0.001), a statistically significant difference also remained at visit 5 (p<0.001). When analyzing the secondary endpoints according to the battery of frontal dysfunction tests and the correction test, a more pronounced positive trend was also noted in the main group. Changes in the emotional sphere in both groups remained within the normal range. The dynamics of the systemic concentration of markers of brain damage and neurotrophins was multidirectional, the assessment of which was possible only at the trend level.

CONCLUSION: Based on the statistical analysis of the results of the study, Cellex was confirmed to be superior to Placebo in the degree of improvement in cognitive functions measured by the MoCA scale after the 1st and 2nd treatment courses.

PMID:37315249 | DOI:10.17116/jnevro2023123051108

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):89-99. doi: 10.17116/jnevro202312305189.

ABSTRACT

OBJECTIVE: To access the efficacy and safety of the first Russian botulinum toxin type A (Relatox) as a headache prophylaxis in adult with chronic migraine (CM).

MATERIAL AND METHODS: The randomized, one-blind, multicenter, active-controlled, parallel-group trial study involved 209 patients with CM aged from 19 to 65 years. The patients were randomized to injections of the Russian botulinum toxin type A – Relatox (n=101) or onabotulinumtoxinA injections – Botox (n=108). The duration of the study was 16 weeks, which included five visits of patients every 4 weeks. Relatox and Botox were injected once into seven muscle groups of the head and neck at a dose of 155-195 units. Primary efficacy variable was mean change from baseline in frequency of headache days after 12 weeks. Secondary efficacy variables were mean changes from the baseline to week 12 in frequency of migraine days, acute headache pain medication intakes days; headache intensity; proportion of patients achieving ≥50% reduction from baseline in headache days, the proportion of the patients with medication overuse, the proportion of the patients with severe (≥60) Headache Impact Test-6 score and with a severe (≥21) MIDAS score.

RESULTS: Analyses demonstrated a large mean decrease from baseline in frequency of headache days, without statistically significant between-group differences Relatox vs Botox at week 12 (-10.89 vs -10.06; p=0.365) and at other time points. Significant differences from baseline were also observed for all secondary efficacy variables at all time points without differences between the groups. The proportion of patients achieving ≥50% reduction from baseline in headache days was 75.0% and 70% in the Relatox and Botox groups, respectively (OR, CI 95% 1.58 [0.84; 3.02], p=0.155). Adverse events (AE) occurred in 15.8% of Relatox patients and 15.7% of Botox patients (p=1.000). No unexpected AE were identified.

CONCLUSION: The results demonstrate that the first Russian botulinum toxin type A (Relatox) is an effective prophylactic treatment for CM in adult patients. Relatox led to significant improvements from baseline in multiple measures of headache symptoms, headache-related disability and quality of life. For the first time, a comparative analysis of two botulinum toxin type A products in parallel groups showed no less (not inferior) efficacy and safety of Relatox relative to Botox in the treatment of CM in adults.

PMID:37315247 | DOI:10.17116/jnevro202312305189

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(5):74-82. doi: 10.17116/jnevro202312305174.

ABSTRACT

OBJECTIVE: To analyze the causes of violations of expressive speech in children 4-5 years old, to assess changes in neurological status in children with motor alalia without and during treatment with Cellex.

MATERIAL AND METHODS: Two groups of patients were recruited: the main group (n=30; treatment; Cellex) and the control group (n=12; without Cellex). The drug was administered in the first half of the day by 1.0 ml subcutaneously, 10 days, daily. The patient’s visit card was analyzed 4 times: before treatment, 10 days later, 1 and 2 months after the start of treatment. Statistical hypotheses were tested using the χ² and Fisher criterions, the odds ratio (OR) and the 95% confidence interval (CI) OR were determined.

RESULTS: In more than half of the cases, violations of the neurological status, the burden of the perinatal period, a decrease in cognitive tests, and a lack of fine motor skills were revealed. Left-handedness or two-handedness, overload of viewing or listening to gadgets from the age of up to a year, violations of opercular praxis were almost always noted. The effect of the drug Cellex on the «launch of speech» in children with motor alalia has been shown. It has been established that the drug is well tolerated, has no adverse side effects and has a positive effect on the «launch of speech». The progress of the dynamics of speech development, progress in play and cognitive activity was observed in all children of the main group.

CONCLUSION: The use of the drug Cellex can be effective in the treatment of children with motor alalia.

PMID:37315245 | DOI:10.17116/jnevro202312305174

Adv Mind Body Med. 2023 Spring;37(2):5-8.

ABSTRACT

CONTEXT: Diabetes is a metabolic disorder characterized by high blood sugar levels. Yoga has been shown to have positive effects on blood sugar levels in diabetes patients. However, there is limited research on the effects of specific yoga poses on blood sugar levels in patients with type 2 diabetes (T2DM).

OBJECTIVE: This study aimed to evaluate the effect of a single yoga asana, Ardha Matsyendrasana, on random blood glucose (RBG) levels in patients with T2DM. Specifically, we aimed to investigate whether a 15-minute practice of Ardha Matsyendrasana could reduce RBG levels in patients with T2DM.

DESIGN: This study employed a self-controlled design to evaluate the effect of Ardha Matsyendrasana on blood glucose levels in patients with type 2 diabetes mellitus.

PARTICIPANTS: 100 patients with type 2 diabetes mellitus (T2DM) were recruited for this study.

INTERVENTIONS: All participants underwent two sessions: a control session (CS) and an asana session (AS), each lasting 15 minutes. During the CS, participants rested in a sitting pose, while during the AS, they practiced Ardha Matsyendrasana. The order of the sessions was randomized, with half the participants undergoing the CS on day 1, the AS on day 2, and the other half undergoing the sessions in reverse order.

OUTCOME MEASURES: We measured participants’ random blood glucose (RBG) levels immediately before and after each intervention.

STATISTICAL ANALYSIS: The statistical package for the social sciences, version 16, was used to perform a paired t-test to compare RBG levels before and after each intervention.

RESULTS: The study demonstrated a significant reduction in random blood glucose (RBG) levels in the Ardha Matsyendrasana session compared to the control session. This trend was observed in both males and females with T2DM.

CONCLUSIONS: A single session of Ardha Matsyendrasana for 15 minutes can effectively reduce blood glucose levels in patients with T2DM. However, further studies are required to determine the long-term effects of this asana on glycemic control.

PMID:37315227

Blood Adv. 2023 Jun 14:bloodadvances.2023010133. doi: 10.1182/bloodadvances.2023010133. Online ahead of print.

ABSTRACT

Given the paucity of data surrounding the prognostic relevance of monoclonal paraprotein (M-protein) in marginal zone lymphoma (MZL), we sought to evaluate the impact of M-protein at diagnosis on outcomes in MZL patients in a large retrospective cohort. The study included 547 patients receiving first-line therapy for MZL. M-protein was detectable at diagnosis in 173 (32%) patients. There was no significant difference in the time from diagnosis to initiation of any therapy (systemic and local) between the M-protein and no M-protein groups. Patients with M-protein at diagnosis had significantly inferior progression-free survival (PFS) compared to those without M-protein at diagnosis. After adjusting for factors associated with inferior PFS in univariate models, presence of M-protein remained significantly associated with inferior PFS (HR=1.74, 95%CI=1.20-2.54, p=0.004). We observed no significant difference in the PFS based on the type or quantity of M-protein at diagnosis. There were differential outcomes in PFS according to first-line therapy in patients with M-protein at diagnosis in that those receiving immunochemotherapy had better outcomes compared to rituximab monotherapy. The cumulative incidence of relapse in stage 1 disease among the recipients of local therapy was higher in the presence of M-protein, however, this did not reach statistical significance. We found that M-protein at diagnosis was associated with a higher risk of histologic transformation. Because the PFS difference related to presence of M-protein was not observed in patients receiving bendamustine and rituximab, immunochemotherapy may be a preferred approach over rituximab monotherapy in this group and needs to be explored further.

PMID:37315169 | DOI:10.1182/bloodadvances.2023010133

Eur J Prev Cardiol. 2023 Jun 14:zwad198. doi: 10.1093/eurjpc/zwad198. Online ahead of print.

ABSTRACT

AIMS: For patients with diabetes, the European guideline updated the cardiovascular disease (CVD) risk prediction recommendations using diabetes-specific models with age-specific cut-offs, whereas American guidelines still advise models derived from the general population. We aimed to compare the performance of four cardiovascular risk models in diabetes populations.

METHODS: Patients with diabetes from CHERRY study, an electronic health record-based cohort study in China, were identified. Five-year CVD risk was calculated using original and recalibrated diabetes-specific models (ADVANCE and HK) and general-population-based models (PCE and China-PAR).

RESULTS: During a median 5.8-year follow-up, 46,558 patients had 2605 CVD events. C-statistics were 0.711 (95% CI: 0.693-0.729) for ADVANCE and 0.701 (0.683-0.719) for HK in men, and 0.742 (0.725-0.759) and 0.732 (0.718-0.747) in women. C-statistics were worse in two general-population-based models. Recalibrated ADVANCE underestimated risk by 1.2% and 16.8% in men and women, whereas PCE underestimated risk by 41.9% and 24.2% in men and women. With the age-specific cut-offs, the overlap of the high-risk patients selected by every model-pair ranged from only 22.6% to 51.2%. When utilizing the fixed cut-off at 5%, the recalibrated ADVANCE selected similar high-risk patients in men (7400) as compared to the age-specific cut-offs (7102), whereas age-specific cut-offs exhibited a reduction in the selection of high-risk patients in women (2646 under age-specific cut-offs vs 3647 under fixed cut-off).

CONCLUSION: Diabetes-specific CVD risk prediction models showed better discrimination for patients with diabetes. High-risk patients selected by different models varied significantly. Age-specific cut-offs selected fewer patients at high CVD risk especially in women.

PMID:37315163 | DOI:10.1093/eurjpc/zwad198