Tag: pubmed

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2982. Online ahead of print.

ABSTRACT

Oral azacitidine (Oral-AZA) maintenance is approved for adults with acute myeloid leukemia (AML) in remission post-intensive chemotherapy, not proceeding to hematopoietic stem cell transplantation. This study aimed to develop a population pharmacokinetic (PopPK) model to characterize Oral-AZA concentration-time profiles in patients with AML, myelodysplastic syndrome, or chronic myelomonocytic leukemia. PopPK-estimated exposure parameters were used to evaluate exposure-response relationships in the phase 3 QUAZAR AML-001 study. The PopPK dataset comprised 286 patients with 1933 evaluable Oral-AZA concentration records. The final PopPK model was a one-compartment model with first-order absorption incorporating an absorption lag time and first-order elimination. Regression analyses identified two Oral-AZA exposure parameters (area under the plasma concentration-time curve at steady state [AUC_ss ]; maximum plasma concentration [C_max ]) as statistically significant predictors for relapse-free survival (HR=0.521, p<0.001; HR=0.630, p=0.013; respectively), and AUC_ss as a significant predictor for overall survival (HR=0.673, p=0.042). The probability of Grade ≥3 neutropenia was significantly increased with increases in AUC_ss (OR=5.71, 95% CI=2.73-12.62, p<0.001), cumulative AUC through cycles 1 to 6 (OR=2.71, 95% CI=1.76-4.44, p<0.001), and C_max at steady state (OR=2.38, 95% CI=1.23-4.76, p=0.012). A decreasing trend was identified between AUC_ss and relapse-related schedule extensions, versus an increasing trend between AUC_ss and event-related dose reductions. As the majority (56.8%) of patients required no dose modifications, and the proportions requiring schedule extension (19.4%) or dose reduction (22.9%) were almost equal, Oral-AZA 300 mg once daily for 14 days is the optimal dosing schedule balancing survival benefit and safety risk.

PMID:37422689 | DOI:10.1002/cpt.2982

Ital J Pediatr. 2023 Jul 8;49(1):80. doi: 10.1186/s13052-023-01491-y.

ABSTRACT

BACKGROUND: To examine the clinical impact of bronchoscope alveolar lavage (BAL) combination with budesonide, ambroxol + budesonide, or acetylcysteine + budesonide in the treatment of refractory Mycoplasma pneumoniae pneumonia (RMPP).

METHODS: Eighty-two RMPP patients admitted to Pediatrics at The First People’s Hospital of Zhengzhou were retrospectively evaluated between August 2016 and August 2019. All patients were administered BAL in addition to intravenous Azithromycin, expectoration, and nebulizer inhalation. The medications added to the BLA separated the patients into the Budesonide group, Ambroxol + budesonide group, and acetylcysteine + budesonide group. Analyzed were the variations in laboratory examination indices, improvement in lung imaging, overall effective rate, and adverse responses in the three groups.

RESULTS: The laboratory test indices of patients in all three groups improved significantly relative to pre-treatment levels, and the results were statistically significant. After therapy, there were no significant differences between the three groups in terms of white blood cell (WBC), C-reactive protein (CRP), or erythrocyte sedimentation rate (ESR). Serum lactate dehydrogenase (LDH) and serum ferritin (SF) varied significantly across the three groups (P < 0.05). In the acetylcysteine + budesonide group, the absorption rate of lung imaging lesions and clinical efficacy were superior to those of the other two groups. There were no significant differences between the three groups in the occurrence of adverse events (P > 0.05).

CONCLUSIONS: BLA-coupled acetylcysteine + budesonide was superior to the other two groups in enhancing the effectiveness of RMPP in children, which might increase lung opacity absorption and minimize lung inflammation.

PMID:37422684 | DOI:10.1186/s13052-023-01491-y

BMC Health Serv Res. 2023 Jul 8;23(1):737. doi: 10.1186/s12913-023-09758-0.

ABSTRACT

OBJECTIVES: Vaccination is an important part of public health services. We aim to assess the efficiency of vaccination services in Beijing, the capital of China, and to further study the influencing factors of efficiency.

METHODS: Using the immunization service data of Beijing, China in 2020, we firstly developed a data envelopment analysis (DEA) model to calculate the score of vaccination efficiency. Secondly, we used DEA model scenario simulations with different combinations of input-output factors to derive the magnitude of the effect of each input factor on the efficiency. Finally, combined with the data from the Beijing Regional Statistical Yearbook 2021, we developed the Tobit model to examine the effect of external social environmental factors on efficiency.

RESULTS: The average scores of efficiency of POVs (Point of Vaccination) in different areas of Beijing vary greatly. Different input factors had different degrees of positive effects on the efficiency score. In addition, the number of populations served by POV was positively associated with efficiency, the GDP and financial allocation of the POVs’ district was also positively associated with efficiency score, while the total dependency ratio of the POVs’ district was negatively associated with efficiency score.

CONCLUSION: The efficiency of vaccination services varied considerably across POVs. Constrained by limited resources, efficiency scores can be increased by increasing input factors that have a larger impact on efficiency score and reducing those that have a smaller impact on efficiency. In addition, the social environment should be considered in allocating vaccination resources, and more resources should be invested in areas with low levels of economic development, low financial allocation, and high population.

PMID:37422663 | DOI:10.1186/s12913-023-09758-0

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2994. Online ahead of print.

ABSTRACT

Hybrid designs with both randomised arms and an external control cohort preserve key features of randomisation and utilise external information to augment clinical trials. In this study, we propose to leverage high-quality, patient-level concurrent registries to enhance clinical trials and illustrate the impact on trial design for amyotrophic lateral sclerosis (ALS). The proposed methodology was evaluated in a randomised, placebo-controlled clinical trial. We used patient-level information from a well-defined, population-based registry, that was running parallel to the randomised clinical trial, to identify concurrently non-participating, eligible patients who could be matched with trial participants, and integrate them into the statistical analysis. We assessed the impact of the addition of the external controls on the treatment effect estimate, precision, and time to reach a conclusion. During the runtime of the trial, a total of 1,141 registry patients were alive; 473 (41.5%) of them fulfilled the eligibility criteria and 133 (11.7%) were enrolled in the study. A matched control population could be identified among the non-participating patients. Augmenting the randomised controls with matched external controls could have avoided unnecessary randomisation of 17 patients (-12.8%) as well as reducing the study duration from 30.1 months to 22.6 months (-25.0%). Matching eligible external controls from a different calendar period led to bias in the treatment effect estimate. Hybrid trial designs utilising a concurrent registry with rigorous matching can minimise bias due to a mismatch in calendar time and differences in standard of care, and may accelerate the development of new treatments.

PMID:37422655 | DOI:10.1002/cpt.2994

BMC Musculoskelet Disord. 2023 Jul 8;24(1):557. doi: 10.1186/s12891-023-06681-7.

ABSTRACT

PURPOSE: To investigate the safety and accuracy of applying a new self-guided pedicle tap to assist pedicle screw placement.

METHODS: A new self-guided pedicle tap was developed based on the anatomical and biomechanical characteristics of the pedicle. Eight adult spine specimens, four males and four females, were selected and tapped on the left and right sides of each pair of T1-L5 segments using conventional taps (control group) and new self-guided pedicle taps (experimental group), respectively, and pedicle screws were inserted. The screw placement time of the two groups were recorded and compared using a stopwatch. The safety and accuracy of screw placement were observed by CT scanning of the spine specimens and their imaging results were graded according to the Heary grading criteria.

RESULTS: Screw placement time of the experimental group were (5. 73 ± 1. 18) min in thoracic vertebrae and (5. 09 ± 1. 31) min in lumbar vertebrae respectively. Screw placement time of the control group were respectively (6. 02 ± 1. 54) min in thoracic vertebrae and (5.51 ± 1.42) min in lumbar vertebrae. The difference between the two groups was not statistically significant (P > 0. 05). The Heary grading of pedicle screws showed 112 (82.35%) Heary grade I screws and 126 (92.65%) Heary grade I + II screws in the experimental group, while 96 (70.59%) Heary grade I screws and 112 (82.35%) Heary grade I + II screws in the control group.The difference between the two groups was statistically significant (P < 0.05).

CONCLUSION: The new self-guided pedicle tap can safely and accurately place thoracic and lumbar pedicle screws with low-cost and convenient procedure,which indicates a good clinical application value.

PMID:37422653 | DOI:10.1186/s12891-023-06681-7

BMC Womens Health. 2023 Jul 8;23(1):364. doi: 10.1186/s12905-023-02510-0.

ABSTRACT

BACKGROUND: To explore the pathogen distribution in Chinese females with vaginitis.

METHODS: This retrospective study included Chinese females with vaginitis admitted at the outpatient department of the Gynecology Clinic of the Second Affiliated Hospital of Kunming Medical University between January 2013 and June 2013. Data on the vaginal pathogens and inflammation were analyzed.

RESULTS: The vaginal secretions from 15,601 gynecologic outpatients were abnormal, including 8547 (54.78%) with vaginal infection and 7054 (45.22%) without. In patients with vaginal infections, a single infection was observed in 69.72% (5959/8547) of them, and mixed infection was observed in 30.28% (2588/8547). The differences in age and inflammation grade between the infection and no-infection groups were statistically significant (all P < 0.001). In addition, multiple types of vaginitis could be diagnosed in patients with mixed infections.

CONCLUSIONS: About half of the Chinese women with abnormal vaginal secretions are positive for pathogens in the study period. Patients’ age and inflammation grade are associated with co-infection. From the public health perspective, this study suggests that the importance of vaginal hygiene should be enforced in Chinese women.

PMID:37422650 | DOI:10.1186/s12905-023-02510-0

BMC Oral Health. 2023 Jul 8;23(1):466. doi: 10.1186/s12903-023-03124-6.

ABSTRACT

BACKGROUND: Maxillary sinus septa increase perforation risk of Schneiderian membrane during the sinus floor elevation (SFE). Cone Beam Computed Tomography (CBCT) allows for a more precise assessment of the septal position; thus, preoperative CBCT analysis is substantial to avoid possible complications. This study aims to investigate the 3D characteristics of the maxillary sinus septa based on CBCT images. To our knowledge, no study reported the CBCT-based investigation for the sinus septa among Yemeni population.

MATERIALS AND METHODS: This is a retrospective cross-sectional analysis of 880 sinus CBCT images 440 patients. The septa prevalence, locations, orientations, morphology, and associated factors were analyzed. The effect of age, gender, and dental status on the sinus septa and the relationship between sinus membrane pathology and sinus septa were also analyzed. Anatomage (Invivo version 6) was used for CBCT images analysis. Descriptive and analytical statistics were performed, and a P-value < 0.05 was significantly considered.

RESULTS: The maxillary sinus septa were found among 63.9% of patients and 47% of sinuses. The average septa height was 5.2 mm. 15.7% of patients had septa in the right maxilla, 18% in the left, and 30.2% in both. Gender, age, and dental condition had no influence on the presence of septa, and septa presence did not influence sinus membrane pathology. Many septa originated from the floor (54.5%), located in the middle (43%), with coronal orientation (66%) and complete configuration (58.2%).

CONCLUSION: Based on our findings, the septa prevalence, locations, orientations, and morphology were significant and equivalent to the highest recorded in the literature yet. Thus, when sinus floor elevation is planned, CBCT imaging of the maxillary sinus is recommended for safe dental implantation.

PMID:37422645 | DOI:10.1186/s12903-023-03124-6

BMC Health Serv Res. 2023 Jul 8;23(1):741. doi: 10.1186/s12913-023-09779-9.

ABSTRACT

BACKGROUND: Infection, prevention, and control (IPC) practices are essential to protect patients and staff within healthcare facilities. Radiology departments cater to both inpatients and outpatients, and breaches of IPC practice have led to outbreaks of disease within healthcare facilities. This study aims to examine the knowledge, attitudes and practice (KAP) of computed tomography (CT) radiographers and nurses in their infection, prevention, and control (IPC) practice. The KAP components focuses on the CT environment, contrast injector use, and workplace factors that impact IPC practice.

METHODS: A cross-sectional KAP survey was distributed online to Australian CT radiographers and radiology nurses across different institutions. The survey covered demographics, each KAP component, and workplace culture. Spearman’s correlation was used to compare KAP scores. Kruskal-Wallis test was used to compare the KAP scores between demographic categories, and Chi Square was used to compare demographic data with workplace culture.

RESULTS: There were 147 respondents, 127 of which were radiographers and 20 were nurses. There was a moderate positive correlation between knowledge and attitude for radiographers (rho = 0.394, p < 0.001). Radiographers also had a moderate positive relationship between attitudes and practice (rho = 0.466, p < 0.001). Both radiographers and nurses scored high in the knowledge section of the survey, but nurses had statistically significant higher practice scores than radiographers (p = 0.014). CT radiographers who had an IPC team in their workplace or worked in public hospitals, had statistically significant higher attitudes and practice scores. Age, education, and years of experience did not impact on KAP scores.

CONCLUSION: The study found that radiographers and nurses had a good baseline knowledge of standard precautions. IPC teams and continued training is important to positively influence knowledge and attitudes of health professionals towards IPC practice. The KAP survey was a useful tool to assess the knowledge, attitudes, and practice on IPC of CT radiographers and nurses and identified areas for education, interventions, and leadership.

PMID:37422620 | DOI:10.1186/s12913-023-09779-9

Ann Hematol. 2023 Jul 8. doi: 10.1007/s00277-023-05328-w. Online ahead of print.

ABSTRACT

Burkitt lymphoma (BL) is an extremely aggressive but curable subtype of non-Hodgkin lymphoma. While younger patients have excellent outcomes in response to aggressive chemoimmunotherapy, the rarity of this disease in older patients and limitations caused by age, comorbidities, and performance status may negate survival advantages. This analysis assessed outcomes of older adults with BL through data provided by the Texas Cancer Registry (TCR). Patients ≥65 years with BL were assessed. Patients were dichotomized into 1997-2007 and 2008-2018. Median overall survival (OS) and disease-specific survival (DSS) were assessed using Kaplan-Meier methodology, and covariates including age, race, sex, stage, primary site, and poverty index were analyzed using Pearson Chi-squared analysis. Odds ratio (OR) with 95% confidence intervals (CI) was used to assess factors contributing to patients not offered systemic therapy. P value <0.05 was considered statistically significant. Non-BL mortality events were also categorized. There were 325 adults, 167 in 1997-2007 and 158 in 2008-2018; 106 (63.5%) and 121 (76.6%) received systemic therapy, a trend that increased with time (p = 0.010). Median OS for 1997-2007 and 2008-2018 was 5 months (95% CI 2.469, 7.531) and 9 months (95% CI 0.000, 19.154) (p = 0.013), and DSS was 72 months (95% CI 56.397, 87.603) (p = 0.604) and not reached, respectively. For patients that received systemic therapy, median OS was 8 months (95% CI 1.278, 14.722) and 26 months (95% CI 5.824, 46.176) (p = 0.072), respectively, and DSS was 79 months (95% CI: 56.416, 101.584) and not reached, respectively (p = 0.607). Age ≥75 years (HR 1.39 [95% CI 1.078, 1.791], p = 0.011) and non-Hispanic whites (HR 1.407 [95% CI 1.024, 1.935], p = 0.035) had poorer outcomes, and patients at the 20-100% poverty index (OR 0.387 [95% CI 0.163, 0.921], p = 0.032) and increasing age at diagnosis (OR 0.947 [95% CI 0.913, 0.983], p = 0.004) were less likely to receive systemic therapy. Of 259 (79.7%) deaths, 62 (23.9%) were non-BL deaths, and 6 (9.6%) of these were from a second cancer. This two-decade analysis of older Texas patients with BL indicates a significant improvement in OS over time. Although patients were more likely to receive systemic therapy over time, treatment disparities existed in patients residing in poverty-stricken regions of Texas and in advancing age. These statewide findings reflect an unmet national need to find a systemic therapeutic strategy that can be tolerated by and augment outcomes in the growing elderly population.

PMID:37422592 | DOI:10.1007/s00277-023-05328-w

Sleep Breath. 2023 Jul 8. doi: 10.1007/s11325-023-02868-3. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to investigate the long-term mortality rates of patients with obstructive sleep apnea (OSA) who received an overnight polysomnogram (PSG) for obtaining the diagnosis and to determine the relationship between PSG parameters and overall mortality.

METHODS: Between 2007 and 2013, patients who had overnight PSG and were diagnosed with OSA were included in the study. Factors which are thought to influence mortality were assessed for 5-year and overall survival using the log rank test and Kaplan-Meier survival curves. Using multivariable Cox regression analysis, a model was constructed for factors influencing 5-year and overall survival.

RESULTS: A total of 762 patients with a mean age of 52.7 (±10.8) and a dominance of men (74.7%) were studied. Gender, OSA severity subgroups, and apnea hypopnea index (AHI) were not statistically significantly associated with either 5-year or overall mortality (p<0.05 for both). Age, having a cardiovascular comorbidity, proportion of rapid eye movement (%REM), and total sleep time with an oxyhemoglobin saturation of less than 90% (T90) all showed a significant correlation with overall all-cause mortality in the model. For 5-year mortality and overall mortality, the hazard ration (HR) for T90 was 3.6 (95% CI (1.6-8.0) p=0.001) and 3 (95% CI (1.6-5.7) p=0.001), respectively.

CONCLUSION: The study findings suggest that not AHI but PSG parameters of hypoxia, mainly T90, having cardiovascular comorbidity, and %REM sleep were significant risk factors for all-cause mortality in patients with OSA. The association of OSA, hypoxia, and mortality is an area that deserves further study.

PMID:37422579 | DOI:10.1007/s11325-023-02868-3