Nevin Manimala

Eur J Pharm Sci. 2023 Sep 30:106601. doi: 10.1016/j.ejps.2023.106601. Online ahead of print.

ABSTRACT

The aim of this work is to develop a novel simultaneous in vitro dissolution – in situ perfusion system (SDPS) as a potential tool to evaluate the in vivo performance of solid oral formulation in rat. The innovative nitrendipine (NTD) tablet of Bayotensin mite® made in Germany was used as reference listed drug (RLD), and five generic products from Chinese market were compared with RLD using the in vitro dissolution test method specified by the orange book and the SDPS method developed in this study. Four self-prepared NTD tablets with different proportions of microcrystalline cellulose/starch were employed to investigate the discriminatory ability of the SDPS for formulation. In addition, the predictivity of the SDPS in relation to data from in vivo pharmaceutics studies was evaluated. The 45-min dissolution test and multiple-pH dissolution profiles of generic product 1 and 2 have no difference compared with the RLD, but their dissolution profiles from the SDPS showed statistically significant differences. A biexponential formula successfully described the concentration profiles of self-prepared formulations in SDPS experiments. The k_dis (0.08 ± 0.01 ∼ 0.2 ± 0.03 min^-1) and k_a (about 2.30 × 10^-3 min^-1) values calculated by the formulas of F1-F3 suggested that the used excipients had no effect on the intestinal absorption of NTD, and it might be the property of active pharmaceutical ingredient that led to the difference among the generics. Furthermore, the in vivo rat pharmacokinetics study results of F1-F3 showed a good correlation (R² = 0.99) with the SDPS data. In summary, the SDPS is a promising tool to detect the unexpected quality changes of pharmaceutical products in weakly regulated markets, facilitate formulation screening, and potentially reduce animal testing for estimating the in vivo absorption behavior of solid oral formulations. The absorption performance of generic drugs in vivo should be further investigated.

PMID:37783379 | DOI:10.1016/j.ejps.2023.106601

J Oral Maxillofac Surg. 2023 Sep 14:S0278-2391(23)01118-7. doi: 10.1016/j.joms.2023.09.008. Online ahead of print.

ABSTRACT

BACKGROUND: The use of cannabis in the general population has steadily increased over recent years and there is limited literature regarding the anesthetic implications of chronic cannabis use, particularly in the setting of outpatient anesthesia.

PURPOSE: To determine whether chronic cannabis users undergoing deep sedation or general anesthesia during ambulatory procedures require more anesthetic agents than nonusers.

STUDY DESIGN, SETTING, AND SAMPLE: A retrospective cohort study of subjects undergoing deep sedation or general anesthesia at the Oklahoma University Oral and Maxillofacial Surgery Clinic from January to December 2022 was performed. The inclusion criteria were duration of anesthetic procedure between 15 to 40 minutes, use of propofol, fentanyl, ketamine, and midazolam, and extraction of at least 2 teeth. The exclusion criterion was patients undergoing adjunctive procedures other than extractions during sedation.

PREDICTOR VARIABLE: Cannabis use status was grouped as users and nonusers. A user was defined as a subject who self-reported any regular use of cannabis.

OUTCOME VARIABLE: The primary outcome variable was the amount of intravenous anesthetic agents administered. Secondary outcome variables included the length of the procedure and the number of teeth extracted.

COVARIATES: Age, sex, and the senior-most resident involved in the sedation.

ANALYSES: IBM SPSS was utilized to perform descriptive statistics, paired t-tests, ANOVA, and multivariate linear regression. A level of significance of 5% (P < .05) was used for all analyses.

RESULTS: Four hundred and ninety nine subjects were identified, 189 met the inclusion criteria, and 57 reported using cannabis. The mean age of nonusers was 28.2 ± 7.8 years and that of users was 26.6 ± 6.4 years (P = .09). Females represented 71.9% of nonusers and 72.7% of users. Cannabis users received significantly more propofol (117.5 mg ± 71.3 vs 152.5 mg ± 101.8; P = .004), midazolam (4.7 mg ± 1.0 vs 5.1 mg ± 1.5; P = .01), ketamine (40.2 mg ± 15.7 vs 46.1 mg ± 16.9; P = .01), and fentanyl (75.2 μg ± 26.3 vs 88.6 μg ± 32.8; P = .002) than nonusers, despite extracting a similar number of teeth (4.5 ± 3.1 vs 4.4 ± 3.5; P = .37) in a similar amount of time (25.5 ± 7.3 vs 27.3 ± 7.8; P = .06).

CONCLUSION AND RELEVANCE: Cannabis users required more propofol, midazolam, ketamine, and fentanyl than non-cannabis users during outpatient oral and maxillofacial surgery procedures.

PMID:37783364 | DOI:10.1016/j.joms.2023.09.008

Transplant Cell Ther. 2023 Sep 30:S2666-6367(23)01573-7. doi: 10.1016/j.jtct.2023.09.019. Online ahead of print.

ABSTRACT

Outcomes following allogeneic hematopoietic cell transplant (allo-HCT) for Chronic Myeloid Leukemia (CML) with post-transplant cyclophosphamide (PTCy) utilising an unrelated donor (UD) or mismatched related donor (MMRD) remain unknown. We report on a retrospective comparison of PTCy based allo-HCT from an UD, non-PTCy allo-HCT from an UD and PTCy allo-HCT from a MMRD. Inclusion criteria were adult patients with CML undergoing first allo-HCT between 2012 to 2019 from an UD with either PTCy or non-PTCy GvHD prophylaxis and MMRD using PTCy. Primary endpoint was GvHD relapse-free survival (GRFS). A total of 1341 patients were included (82% in the non-PTCy UD cohort). With a median follow-up of 34.9 months, the 3-year GRFS was 43%, 37% and 39% in the non-PTCy UD, PTCy-UD and PTCy MMRD cohorts, respectively (p=0.15). In multivariable analyses, there were no significant differences between the three cohorts regarding OS, PFS, RI and NRM. Factors independently associated with worse OS in the overall cohort were KPS<90 (HR 1.86, 95%CI, 1.41-2.45; p<0.001), older age (HR 1.24, 95%CI, 1.11-1.38; p<0.001) and disease stage (compared to CP1) blast phase HR 2.25, 95% CI, 1.60-3.16; p<0.001, accelerated phase HR 1.63, 95% CI, 1.05-2.54; p=0.03 and CP>2 HR 1.58, 95% CI, 1.15-2.17; p=0.005. These results suggest that allo-HCT in CML utilizing either an UD or MMRD with a PTCy GvHD-based prophylaxis are feasible transplant platforms and that the disease stage at allo-HCT remains a major prognostic factor, highlighting the importance to closely monitor CML patients and propose transplantation when indicated, when still in CP1.

PMID:37783337 | DOI:10.1016/j.jtct.2023.09.019

Am J Prev Med. 2023 Sep 30:S0749-3797(23)00385-9. doi: 10.1016/j.amepre.2023.09.024. Online ahead of print.

ABSTRACT

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic has disproportionately impacted workers in certain industries and occupations. The infection risk for SARS-CoV-2 and future respiratory viruses in the workplace is a significant concern for workers, employers, and policymakers. The current study describes the differences in COVID-19 mortality by sex and industry/occupation among working-age U.S. residents in 49 states and New York City.

METHODS: The 2021 National Vital Statistics System (NVSS) public use multiple-cause-of-death data for U.S. decedents aged 15‒64 years (working-age) with information on usual industry and occupation were analyzed in 2022. Age-standardized COVID-19 death rates for selected demographic characteristics and adjusted proportional mortality ratios (PMRs) were estimated by sex and by usual industry and occupation.

RESULTS: In 2021, 133,596 (14.3%) U.S. decedents aged 15‒64 years had COVID-19 listed as the underlying cause of death; the highest COVID-19 death rate was among persons aged 55‒64 years (172.4/100,000 population) and males (65.5/100,000 population). Among males, American Indian or Alaskan Native and among females, Black or African American had the highest death rates. Hispanic males had higher age-adjusted death rates than Hispanic females. Working-age male decedents in the public administration (PMR=1.39) and management of companies & enterprises industries (PMR=1.39) and community and social services occupations (PMR=1.68) and female decedents in the utilities industry (PMR=1.20) and protective services occupation (PMR=1.18) had the highest PMRs.

CONCLUSIONS: COVID-19 death rates and PMRs varied by sex, industry, and occupation groups. These findings underscore the importance of workplace public health interventions, which could protect workers and their communities.

PMID:37783282 | DOI:10.1016/j.amepre.2023.09.024

Am J Obstet Gynecol MFM. 2023 Sep 30:101170. doi: 10.1016/j.ajogmf.2023.101170. Online ahead of print.

ABSTRACT

BACKGROUND: Prenatal screening of congenital anomalies is an important component of maternity care with continual advances in screening technology. However, few recent studies have investigated the overall effectiveness of a systematic policy of prenatal screening for congenital anomalies, such as in France where an ultrasound per trimester is recommended for all pregnant individuals.

OBJECTIVE: To assess the proportion and the type of congenital anomalies that are not detected during pregnancy.

STUDY DESIGN: The study population included all singleton fetuses and newborns with congenital anomalies from the Paris Registry of Congenital Malformations (remaPAR) from 2001 to 2021. The Registry includes all live births and stillbirths ≥22 weeks of gestation, and terminations of pregnancy for fetal anomaly at any gestational age with congenital anomalies diagnosed prenatally until discharge home from hospital after birth. The prevalence of postnatally detected congenital anomalies was estimated overall and for five-year intervals within the study period. We also reported the proportion of postnatal detection by subgroups of congenital anomalies according to the EUROCAT classification.

RESULTS: Of the 16,602 malformed singleton fetuses and newborns, 32.7% were detected postnatally. This percentage was 11.9% for those with severe anomalies. The postnatal detection rate decreased from 34.3% in 2001-2005 to 27.8% in 2016-2021 (P<0.001). Anomalies most frequently detected postnatally were genital anomalies (n=969, 87.0%), followed by ear, neck and face anomalies (n=71, 78.0%), eye anomalies (n=154, 74.0%) and limb anomalies (n=1,802, 68.4%). Anomalies of the kidney and urinary tract (n=219, 7.1%) and the abdominal wall (n=37, 8.7%) were least likely to be detected after birth. Among the anomalies classified as severe, postnatal detection rates were highest for limb reduction defects (n=142, 40.6%), complete transposition of great arteries (n=31, 17.6%) and diaphragmatic hernia (n=26, 17.2%).

CONCLUSION: Despite improvement of prenatal screening over a 20-year period, our results show that there is still a margin for improvement in prenatal diagnosis of congenital anomalies.

PMID:37783275 | DOI:10.1016/j.ajogmf.2023.101170

Lancet Child Adolesc Health. 2023 Sep 29:S2352-4642(23)00224-9. doi: 10.1016/S2352-4642(23)00224-9. Online ahead of print.

NO ABSTRACT

PMID:37783222 | DOI:10.1016/S2352-4642(23)00224-9

Am J Audiol. 2023 Oct 2:1-11. doi: 10.1044/2023_AJA-23-00027. Online ahead of print.

ABSTRACT

PURPOSE: The primary purpose of this study was to determine which scope of practice roles and responsibilities are attributed to the profession of audiology (AUD) relative to other health care disciplines by a group of health and human services faculty and students.

METHOD: An online survey inquiring about participant knowledge of different health professions’ scopes of practice, and experience with and attitude toward the profession of AUD, was sent to faculty and students in the Western Michigan University College of Health and Human Services. Students also completed two subscales of the Interprofessional Attitudes Scale. Descriptive statistics and chi-square and Kruskal-Wallis analyses evaluating response differences between groups are presented.

RESULTS: Thirty-six faculty and 118 students (48 graduate and 70 undergraduate) completed the survey. AUD was the profession most often associated with all hearing-related scope of practice activities. Speech-language pathology was often associated with hearing-related scope of practice activities. Audiologists were less commonly associated with vestibular, balance, and mobility scope of practice activities. Group was significant for four scope of practice activities. About half of respondents indicated they knew nothing or a little about AUD, and a majority had no or rare interactions with audiologists in class or clinic. Only about half of participants responded they were likely or very likely to refer patients to an audiologist.

CONCLUSION: Increased knowledge of the scope of practice and exposure to the profession of AUD may benefit other health care professionals and patients, possibly leading to increased interprofessional practice and an increased number of appropriate referrals.

PMID:37783210 | DOI:10.1044/2023_AJA-23-00027

Ann Med. 2023;55(2):2263869. doi: 10.1080/07853890.2023.2263869. Epub 2023 Oct 2.

ABSTRACT

OBJECTIVES: To improve diagnostic accuracy of pulmonary mucoepidermoid carcinoma (PMEC) through multi-detector computed tomography (MSCT) findings.

METHODS: MSCT findings of 27 histopathologically confirmed PMEC cases were retrospectively analyzed, including the location, size, margin, density, enhancement of the lesion and accompanying signs.

RESULTS: Among the 27 PMEC cases, 6 (6/27, 22.2%) were the large airway pattern, 14 were (14/27, 51.9%) the pulmonary hilum pattern, and 7 (7/27, 26.9%) were the peripheral pattern. Among those 20 cases with central pattern(6 large airway and 14 pulmonary hilum patterns), 6 presented mild enhancement, 4 moderate enhancement, 5 severe enhancement, 5 heterogeneous enhancement, and 3 with calcification. 7 cases with peripheral patterns were presented as solid pulmonary nodules and masses, 3 with severe enhancement, 1 with moderate enhancement and 3 with mild enhancement. Four cases accompanied by lymph nodal metastasis, and 7 cases with distant organ metastasis. Age(t = -3.132, p = 0.005), enlarged lymph node (x² = 9.281, p = 0.005), and distant metastasis(x² = 7.816, p = 0.008) were statistically significant in the low-grade group and high-grade group.

CONCLUSIONS: MSCT images of PMEC patients demonstrated some characteristic findings, which would help improve the diagnostic accuracy of the disease.

PMID:37783202 | DOI:10.1080/07853890.2023.2263869

J Health Popul Nutr. 2023 Oct 2;42(1):105. doi: 10.1186/s41043-023-00429-8.

ABSTRACT

BACKGROUND: A virus infection may lead the body to produce more immune cells of particular types or stimulate the production of new ones, both of which may have anti-leukemic effects. There has been no research on whether immune cells stimulated by varicella-zoster virus (VZV) infection have anti-leukemic effects. The objective of this investigation is to assess the impact of VZV infection on patients’ long-term survival following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

METHODS: This retrospective study investigated the association between varicella-zoster virus (VZV) reactivation and outcomes in 219 individuals who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the Sun Yat-sen University’s First Affiliated Hospital. According to being diagnosed with VZV infection or not, these patients were grouped into two groups. The comparison of cumulative incidence of relapse, non-recurrent mortality, and overall survival (OS) was conducted between the two groups.

RESULTS: Analyzing multivariate data, VZV reactivation was linked to lower relapse incidence in the group containing all individuals (hazard ratio [HR] = 0.27; 95% confidence interval [CI], 0.12-0.64), patients suffering from acute myeloid leukaemia (HR = 0.10; 95% CI, 0.01-0.83), and patients suffering from acute lymphoblastic leukaemia (HR = 0.25; 95% CI, 0.08-0.77). Moreover, VZV reactivation was linked with decreased non-relapse mortality in all individuals (HR = 0.20; 95% CI, 0.05-0.79), but no statistical significance was found for any disease subgroup. Further, VZV reactivation was an independent predictor for improved OS in the group containing all individuals (HR = 0.10; 95% CI, 0.03-0.29), patients suffering from acute myeloid leukaemia (HR = 0.09; 95% CI, 0.01-0.66), and patients suffering from acute lymphoblastic leukaemia (HR = 0.16; 95% CI, 0.04-0.68).

CONCLUSION: This is the first study to show that VZV reactivation following allo-HSCT is an independent predictor for lower relapse rates and improved OS, providing novel therapeutic approaches to improve patients’ long-term survival following allo-HSCT.

PMID:37784192 | DOI:10.1186/s41043-023-00429-8

Acta Psychol (Amst). 2023 Sep 30;240:104042. doi: 10.1016/j.actpsy.2023.104042. Online ahead of print.

ABSTRACT

Given that there is limited evidence concerning the psychometric properties of DASS-21 when applied to primary school students, the present study undertook a comprehensive exploration of the psychometric evidence supporting the use of the DASS-21 within this demographic. The research comprised three studies. In Study 1, the basic psychometric properties of internal consistency and construct validity were examined. A total of 3138 primary school students from three provinces in mainland China participated. The internal reliability of the overall scale was 0.93, and for all the subscales, it was higher than 0.80. Construct validity was partially supported. Both exploratory and confirmatory factor analyses upheld the factorial validity of the original three-factor structure. While convergent validity was established, the results showed unsatisfactory discriminant validity. The bifactor model showed that DASS-21 raw scores predominantly indicated the general factor, evidenced by the high explained common variance and omega-hierarchical values. However, the contributions from the three specific factors were minimal, with their omega hierarchical values all below 0.15. In Study 2, a longitudinal design was adopted, tracking 1366 primary school students from Southwest China over a three-month interval. The results further confirmed that the DASS-21 exhibited scalar time-invariance. The latent mean analysis showed that there were no statistically significant differences in the latent means of depression, anxiety, and stress between Time 1 and Time 2. In Study 3, which included 364 college students and 483 enterprise workers, the results demonstrated that the DASS-21 had measurement invariance across different populations. The latent mean analysis further confirmed that, in terms of the latent mean of all three subscales, both college students and enterprise workers had significantly higher scores than primary school students. Overall, the findings indicated that the DASS-21 is a suitable tool for screening schoolchildren for general psychological distress, but it is not suitable for discerning distinct negative mood state disorders.

PMID:37783184 | DOI:10.1016/j.actpsy.2023.104042