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Nevin Manimala Statistics

Bioinformatics-guided Disproportionality Analysis of Sevoflurane-Induced Nephrogenic Diabetes Insipidus using the FDA Adverse Event Reporting System (FAERS) Database

Br J Clin Pharmacol. 2023 Aug 3. doi: 10.1111/bcp.15869. Online ahead of print.

ABSTRACT

AIM: Sevoflurane is an ether-based inhalational anesthetic that induces and maintains general anesthesia. Our study aimed to detect sevoflurane-induced nephrogenic diabetes insipidus using Data Mining Algorithms (DMAs) and molecular docking. The FAERS database was analyzed using OpenVigil 2.1 for disproportionality analysis.

METHODS: We analyzed FAERS data from 2004 to 2022 to determine the incidence of nephrogenic diabetes insipidus associated with sevoflurane. Reporting Odds Ratios (RORs) and Proportional Odds Ratios (PRRs) with 95% confidence intervals were calculated. We also used molecular docking with AutoDock Vina to examine sevoflurane’s binding affinity to relevant receptors.

RESULTS: A total of 554 nephrogenic diabetes insipidus cases were reported in FAERS, of which 2.5% (14 cases) were associated with sevoflurane. Positive signals were observed for sevoflurane with reporting odds ratios (ROR) of 76.012 (95% CI: 44.67-129.35) and proportional odds ratios (PRR) of 75.72 (Chi-sq: 934.688). Of the 14 cases, 50% required hospitalization, 14% resulted in death, and the remaining cases were categorized as other outcomes. Molecular docking analysis showed that sevoflurane exhibited high binding affinity towards AQP2 (4NEF) and AVPR2 (6U1N) with docking scores of -4.9 and -5.3, respectively.

CONCLUSION: Sevoflurane use is significantly associated with the incidence of nephrogenic diabetes insipidus. Healthcare professionals should be cautious when using this medication and report any adverse events to regulatory agencies. Further research is needed to validate these findings and identify risk factors while performing statistical adjustments to prevent false-positives. Clinical monitoring is crucial to validate potential adverse effects of Sevoflurane.

PMID:37536932 | DOI:10.1111/bcp.15869

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Phenox HPC and Phenox flow modulation devices for the endovascular treatment of intracranial aneurysms: a systematic review and meta-analysis

J Neurointerv Surg. 2023 Aug 3:jnis-2023-020514. doi: 10.1136/jnis-2023-020514. Online ahead of print.

ABSTRACT

BACKGROUND: Surface-modified flow diverters are increasingly used in clinical settings. However, their safety profiles and additional benefits over non-coated devices still need to be explored. In this meta-analysis, we aimed to investigate and compare the clinical outcomes of the uncoated Phenox and coated Phenox HPC flow diverters.

METHODS: A systematic literature review was performed using PubMed, Scopus, Embase, and Web of Science databases. Collected data were pooled and corresponding 95% confidence intervals (CI) were calculated. Outcomes of interest included aneurysm occlusion (>6 months) and complication rates. Additionally, the safety outcomes of prophylactic single (SAPT) and dual antiplatelet treatment (DAPT) approaches were compared for patients treated with coated Phenox HPC flow diverters.

RESULTS: We included 17 studies with 1238 patients. The overall complete occlusion rates were 80% (95% CI 74.01% to 86.56%) for Phenox HPC and 71.3% (95% CI 59.71% to 85.20%) for non-coated Phenox flow diverters (p=0.24). Ischemic complication rates were 7.3% (95% CI 4.6% to 11.39%) with the Phenox HPC and 5.3% (95% CI 4.07% to 6.91%) with the Phenox (p=0.24). For patients treated with Phenox HPC, the SAPT (5.5%; 95% CI 2.83% to 10.85%) and DAPT (7.1%; 95% CI 1.23% to 41.45%) approaches resulted in comparable ischemic complication rates (p=0.79). The DAPT group (4.8%; 95% CI 1.46% to 16.24%) had higher hemorrhagic complication rates than the SAPT group (1.7%; 95% CI 0.52% to 6.09%), but the difference was not statistically significant for patients treated with Phenox HPC (p=0.25).

CONCLUSIONS: Our findings indicate that Phenox HPC is equally as safe and effective as non-coated Phenox devices. Additionally, our results suggest that prasugrel monotherapy might effectively prevent ischemic complications in patients treated with Phenox HPC flow diverters.

PMID:37536930 | DOI:10.1136/jnis-2023-020514

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Nevin Manimala Statistics

Early postpartum treatment strategies and early postpartum relapses in women with active multiple sclerosis

J Neurol Neurosurg Psychiatry. 2023 Aug 3:jnnp-2023-331525. doi: 10.1136/jnnp-2023-331525. Online ahead of print.

ABSTRACT

BACKGROUND: Relapse risk after delivery is increased in women with active multiple sclerosis (MS), the best strategy to reduce it is unknown. We aimed to assess the association of four different postpartum strategies with relapses during the first 6 months post partum.

METHODS: This cohort study includes data prospectively collected through structured telephone interviews from the German Multiple Sclerosis and Pregnancy Registry. Pregnancies with active MS (fingolimod or natalizumab treatment OR relapse within 1 year before pregnancy) and postpartum follow-up of ≥6 months were included. We compared four strategies: (1) intention to breastfeed exclusively without disease-modifying therapy (DMT) (exclusive breast feeding ≥2 months or switching to non-exclusive/weaning within 2 weeks after a relapse during the first 2 months), (2) early treatment with natalizumab/fingolimod and (3) other DMT initiated within 6 weeks post partum before a relapse. If women did not or only partially breastfed, or started DMT≤6 weeks after delivery after a relapse or later, we assumed (4) no-DMT-no-exclusive- breastfeeding-strategy. Main outcome was time to postpartum MS relapses.

RESULTS: In 867 women with 911 pregnancies, most (n=416) intended to breastfeed exclusively or had no-DMT-no-exclusive-breastfeeding-strategy (n=290); fewer started fingolimod (n=38), natalizumab (n=74) or another DMT (n=93) early. Recurrent time-to-event analysis showed a statistically significant reduction in relapse hazard only with the natalizumab/fingolimod-strategy as of months 3-4 post partum compared with intention-to-breastfeed-exclusively-strategy. The very early relapse risk was highest in no-DMT-no-exclusive-breastfeeding-strategy.

CONCLUSION: In active MS, an early postpartum treatment strategy should be determined well before delivery. Natalizumab/fingolimod-strategy reduced postpartum relapse hazard from month 3, but none diminished the early postpartum relapse hazard.

PMID:37536925 | DOI:10.1136/jnnp-2023-331525

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Nevin Manimala Statistics

Physiotherapy treatments for the care of patients with chronic pain

Soins. 2023 Jul;68(877):48-51. doi: 10.1016/j.soin.2023.06.016. Epub 2023 Jul 21.

ABSTRACT

In recent years, numerous studies have highlighted the advances made possible by kinesitherapy treatments. These can be used to reduce the frequency, intensity and duration of pain, as well as the functional repercussions of chronic pain. The neurophysiological mechanism involved in primary chronic pain and the pathology producing secondary chronic pain must be taken into account in determining the nature of the treatments to be implemented. This article presents the main physiotherapy interventions recommended for the management of patients with chronic pain, according to the type of pain experienced (nociceptive, neuropathic or nociplastic).

PMID:37536906 | DOI:10.1016/j.soin.2023.06.016

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Development, calibration and validation of a comprehensive customizable lumbar spine FE model for simulating fusion constructs

Med Eng Phys. 2023 Aug;118:104016. doi: 10.1016/j.medengphy.2023.104016. Epub 2023 Jun 28.

ABSTRACT

Instrumentation alters the biomechanics of the spine, and therefore prediction of all output quantities that have critical influence post-surgically is significant for engineering models to aid in clinical predictions. Geometrical morphological finite element models can bring down the development time and cost of custom intact and instrumented models and thus aids in the better inference of biomechanics of surgical instrumentation on patient-specific diseased spine segments. A comprehensive hexahedral morphological lumbosacral finite element model is developed in this work to predict the range of motions, disc pressures, and facet contact forces of the intact and instrumented spine. Facet contact forces are needed to predict the impact of fusion surgeries on adjacent facet contacts in bending, axial rotation, and extension motions. Extensive validation in major physiological loading regimes of the pure moment, pure compression, and combined loading is undertaken. In vitro, experimental corridor results from six different studies reported in the literature are compared and the generated model had statistically significant comparable values with these studies. Flexion, extension and bending moment rotation curves of all segments of the developed model were favourable and within two separately established experimental corridor windows as well as recent simulation results. Axial torque moment rotation curves were comparable to in vitro results for four out of five lumbar functional units. The facet contact force results also agreed with in vitro experimental results. The current model is also computationally efficient with respect to contemporary models since it uses significantly smaller number of elements without losing the accuracy in terms of response prediction. This model can further be used for predicting the impact of different instrumentation techniques on the lumbar vertebral column.

PMID:37536837 | DOI:10.1016/j.medengphy.2023.104016

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Pain and sleep after open-heart surgery-inhalation peppermint essence: double-blind randomized clinical trial

BMJ Support Palliat Care. 2023 Aug 3:spcare-2023-004214. doi: 10.1136/spcare-2023-004214. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to determine the effect of inhaling peppermint essence on pain relief and sleep quality after open-heart surgery.

METHODS: In a double-blind randomised clinical trial carried out in Iran in 2020, 64 cardiac patients were selected by convenience sampling and randomly allocated to aromatherapy (n=32) and placebo (n=32) groups. The aromatherapy and control groups received inhaled aromatherapy using peppermint essence and distilled water, respectively. Data gathering tools were the Numeric Pain Rating Scale and St Mary’s Hospital Sleep Questionnaire. Data were analysed using an independent t-test, χ2 test, Mann-Whitney U test and generalised estimating equation analysis.

RESULTS: The mean severity of pain in the aromatherapy and placebo groups was 3.22±0.88 and 4.56±0.90, respectively, which was a statistically significant difference (p=0.0001). The mean sleep scores after the intervention on day 1 were 20.10±4.90 and 25.76±6.36 in the aromatherapy and placebo groups, respectively, and 18.63±5.56 and 22.62±5.69, respectively, on day 2. The difference between the two groups was statistically significantly different after the intervention in terms of sleep quality (p<0.05).

CONCLUSION: Aromatherapy attenuated pain and improved sleep quality after open-heart surgery. Peppermint essence aromatherapy is therefore recommended after surgery.

PMID:37536755 | DOI:10.1136/spcare-2023-004214

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Nevin Manimala Statistics

Unequal burdens of COVID-19 infection: a nationwide cohort study of COVID-19-related health inequalities in South Korea

Epidemiol Health. 2023 Jul 31:e2023068. doi: 10.4178/epih.e2023068. Online ahead of print.

ABSTRACT

OBJECTIVES: While the Korean government’s response to the coronavirus disease 2019 (COVID-19) pandemic is considered effective given the relatively low motality rate, issues of inequality have been insufficiently addressed. This study explored COVID-19-related health inequalities in South Korea.

METHODS: Age standardization for various health inequality indices was derived using data from the Korean National Health Insurance Service, the Korea Disease Control and Prevention Agency, and the Microdata Integrated Service of Statistics Korea. The slope index of inequality (SII) and relative index of inequality (RII) were calculated for socioeconomic variables, while absolute difference (AD) and relative difference (RD) were used for gender and disability inequalities.

RESULTS: We observed a number of COVID-19-related health outcome inequalities. Gender inequality was particularly noticeable in infection rates, with the rate of women 1.16 times higher than that of men. In contrast, socioeconomic inequality was evident in vaccination rates, with a 4.5-fold (SII, -4.519; 95% confidence interval, -7.403 to -1.634) difference between the highest and lowest household income groups. Regarding clinical progression post-infection, consistent findings indicated higher risk for men (RD for hospitalization, 0.90; severe cases, 0.54; and fatality, 0.65), individuals with disabilities (RD for hospitalization, 2.27; severe cases, 2.29; and fatality, 2.37), and those from lower socioeconomic groups (SII for hospitalization, 1.778; severe cases, 0.089; and fatality, 0.451).

CONCLUSION: While the infection risk was nearly ubiquitous, not everyone faced the same level of risk post-infection. To prevent further health inequalities, it is crucial to develop a thoughtful policy acknowledging individual health conditions and resources.

PMID:37536718 | DOI:10.4178/epih.e2023068

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Nevin Manimala Statistics

Longitudinal Changes in Smoking Behaviors and Cancer-Related Mortality Risk in Middle-aged Korean Women

Cancer Res Treat. 2023 Aug 2. doi: 10.4143/crt.2023.341. Online ahead of print.

ABSTRACT

PURPOSE: This study investigated association between smoking habit change and cancer-related mortality risk in Korean women.

MATERIALS AND METHODS: Study population were women aged ≥40 years who underwent two biennial cancer screenings during 2009-2012 and were followed up until 2020. Participants were grouped into sustained nonsmokers, sustained quitters, new quitters, relapsers/smoking initiators, and sustained smokers. Outcomes included all-cause and cancer-related deaths. Cox regression and competing risk analysis was used to assess association between smoking habit change and mortality risk.

RESULTS: Of 2,892,590 women, 54,443 death cases were recorded (median follow-up of 9.0 years). Compared with sustained non-smokers, mortality risk from all causes and cancer-related causes increased in all other smoking groups. Cancer-related risk increased 1.22-fold among sustained quitters (95% CI 1.10-1.36), 1.56-fold (95% CI 1.40-1.75) in new quitters, 1.40-fold (95% CI 1.21-1.62) in relapsers/smoking initiators, and 1.61-fold (95% CI 1.46-1.78) in sustained smokers compared with sustained non-smokers. Women who were sustained smokers with higher smoking intensity had a higher mortality risk in terms of HR compared to non-smokers (<5 pack-years 2.12-fold, 5-10 pack-years 2.15-fold, and >10 pack-years 2.27-fold).

CONCLUSION: Quitting smoking earlier is critical for preventing death from all causes and cancer among female smokers.

PMID:37536711 | DOI:10.4143/crt.2023.341

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Nevin Manimala Statistics

Predictors of Skin, Hair, and Nail Supplement Use: Analysis of National Health and Nutrition Examination Survey (NHANES) Cross-Sectional Data

South Med J. 2023 Aug;116(8):707-711. doi: 10.14423/SMJ.0000000000001589.

ABSTRACT

OBJECTIVES: Approximately half of US adults use dietary supplements, often for dermatologic purposes. When survey respondents in a nationally representative population were asked the reasons for their use of a specific supplement, 87% chose “for healthy skin, hair, and nails.” Despite widespread use, supplements have potential risks and lack regulatory safeguards. Because most supplement users choose to use them without the advice of a healthcare professional, it is important to identify factors predicting use. This study examined demographic predictors of skin, hair, and nail supplement use among 2015-2016 US National Health and Nutrition Examination Survey respondents, a nationally representative sample.

METHODS: Weighted descriptive analysis using χ2 tests examined group differences among respondents who took skin, hair, and nail supplements and those who did not take supplements in the past 30 days. Multivariable logistic regression models were performed to identify predictors of skin supplement use.

RESULTS: Statistically significant differences in sex, education, income, and insurance status were observed between dermatologic supplement users and nonsupplement users (P < 0.0001). Factors significantly increasing the likelihood of skin supplement use included age between 30 and 60 years (odds ratio [OR] 1.788, 95% confidence interval [CI] 1.439-2.222), age older than 60 years (OR 4.983, 95% CI 3.838-6.469), having a college degree or above (OR 2.696, 95% CI 1.952-3.724), attending some college or above (OR 1.844, 95% CI 1.364-2.494), having an annual income of >$75,000 (OR 1.285, 95% CI 1.029-1.605), and having health insurance (OR 1.559, 95% CI 1.236-1.967). Male respondents were half as likely to use supplements, compared with females (OR 0.579, 95% CI 0.488-0.687).

CONCLUSIONS: Factors such as age, education, income, and sex predict supplement use. Knowledge of such trends may help practitioners counsel patients on potential supplement risks and the many unknowns related to their use. Any patient could be using skin, hair, and nail supplements over the counter, including pregnant and older adult populations, as well as generally healthy patients. This would help protect patients from the possible dangers of supplements, including laboratory test interference and teratogenicity.

PMID:37536702 | DOI:10.14423/SMJ.0000000000001589

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Nevin Manimala Statistics

Non-fatal overdose risk associated with prescribing opioid agonists concurrently with other medication: Cohort study conducted using linked primary care, secondary care and mortality records

Addiction. 2023 Aug 3. doi: 10.1111/add.16306. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: An apparently protective effect of opioid agonist treatment (OAT) on all-cause and cause-specific mortality risk has been widely reported. Non-fatal overdose (NFO) often precedes subsequent drug-poisoning deaths. We hypothesized that benzodiazepines, gabapentinoids, antipsychotics, antidepressants, Z-drugs or opioids increase the NFO risk when co-prescribed with OAT.

DESIGN: We conducted a cohort study using the Clinical Practice Research Datalink GOLD and Aurum databases. The cohort was linked to Hospital Episode Statistics admitted patient care data (HES-APC), neighbourhood- and practice-level Index of Multiple Deprivation quintiles and mortality records from the Office for National Statistics.

SETTING: Primary care in England.

PARTICIPANTS: We studied patients with opioid use disorder, aged 18-64 years, who were prescribed OAT (15155 methadone and 5743 buprenorphine recipients) between Jan 1, 1998, and Dec 31, 2017.

MEASUREMENTS: The main outcome examined was NFO risk during co-prescription of OAT with benzodiazepines, antipsychotics, gabapentinoids, antidepressants, Z-drugs or opioids. Overdose was defined according to International Classification of Diseases codes from the HES-APC data set. Negative binomial regression models were used to estimate weighted rate ratios (wRR) for NFO during co-prescription of OAT and benzodiazepines, antipsychotics, gabapentinoids, antidepressants, Z-drugs or opioids with periods of exclusive OAT usage.

FINDINGS: Among 20 898 patients observed over 83 856 person-years, we found an elevated overdose risk that resulted in hospital admission during co-prescription of OAT with benzodiazepines [wRR: 1.45; 95% confidence interval (CI) = 1.26-1.67], gabapentinoids (wRR = 2.22; 95% CI = 1.77-2.79), Z-drugs (wRR = 1.60; 95% CI = 1.31-1.96), antipsychotics (wRR = 1.85; 95% CI = 1.53-2.25) and opioids (wRR = 1.28; 95% CI = 1.02-1.60). The risk ratio for antidepressant co-prescriptions was below unity (wRR = 0.90; 95% CI = 0.79-1.02) but this result was not statistically significant.

CONCLUSION: Elevated risk of non-fatal overdose among opioid agonist treatment recipients is associated with concurrent use of medication prescribed for other reasons.

PMID:37536685 | DOI:10.1111/add.16306