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Objectives@#Insulin degludec (IDeg)/insulin aspart (IAsp; IDegAsp) is a co-formulation of 70% IDeg and 30% IAsp. According to several randomized controlled trials, IDegAsp is effective and safe for patients with type 2 diabetes mellitus (T2DM). A subgroup analysis of the ARISE study was conducted to explore the safety and efficacy of IDegAsp among Malaysian patients with T2DM in real-world settings.@*Methodology@#ARISE, an open-label, multicenter, non-interventional, prospective study was conducted between August 2019 and December 2020. Adult Malaysian patients with T2DM who were enrolled from 14 sites received IDegAsp as per the local label for 26 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c) levels from baseline to end of study (EOS).@*Results@#Of the 182 patients included in the full analysis set, 159 (87.4%) completed the study. From baseline to EOS, HbA1c (estimated difference [ED]: –1.3% [95% CI: –1.61 to –0.90]) and fasting plasma glucose levels (ED: –1.8 mmol/L [95% CI: –2.49 to –1.13]) were significantly reduced (p<0.0001). The patient-reported reduced hypoglycemic episodes (overall and nocturnal) during treatment. Overall, 37 adverse events were observed in 23 (12.6%) patients.@*Conclusion@#Switching or initiating IDegAsp treatment resulted in significant improvements in glycemic control and a reduction in hypoglycemic episodes.
ABSTRACT
This study is to establish and validation in vivo models of moxifloxacin based on the theory of physiologically based pharmacokinetics (PBPK), and then to predict the distribution of moxifloxacin in human venous return and organ such as lung, spleen and so on. The efficacy of moxifloxacin and its pharmaceutical preparations were quantified by comparing the pharmacokinetic parameters with the minimum inhibitory concentration of related pathogenic bacterium. The results showed that the anti-infection efficacy of pharmaceutical moxifloxacin preparation in the corresponding organs was basically the same. The PBPK model of moxifloxacin preparations can be more accurately described the pharmacokinetic of anti-infective drugs in human, it is suitable for the efficacy evaluation of anti-infective drugs and provides a strong basis for the corresponding scientific research and scientific supervision.
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Objective:To establish the prediction model of the ultimate risk of mechanical ventilation for patients undergoing nasal high-flow oxygen therapy in the intensive care unit (ICU), provide clinicians with a convenient and effective prediction method and accurate treatment timing, and improve the prognosis of ICU patients.Methods:Patients admitted to the ICU of our hospital from January 2019 to December 2021 were retrospectively enrolled. General clinical data of the patients were collected, including vital signs, biochemical indices of blood gas, inflammatory indices, acute comorbidities, APACHE Ⅱ score, length of stay in ICU and total length of stay, within 24 h after admission. Statistical analysis was performed on the above indicators and a chart was constructed.Results:Finally, 362 patients were enrolled in this study, and were divided into the transnasal high flow oxygen therapy group (HFNC group) and noninvasive positive pressure ventilation group (NIPPV group) according to whether mechanical ventilation was finally performed. The univariate and binary Logistic multivariate regression analysis showed that APACHE Ⅱ score ( OR=1.323, 95% CI: 1.818-1.483), ROX index ( OR=0.371, 95% CI: 0.226-0.609), total length of stay ( OR=1.097, 95% CI: 1.003-1.200) and complicating acute respiratory failure ( OR=2.456, 95% CI: 1.368-4.506) were independent influencing factors for determining whether patients underwent mechanical ventilation. Based on the above independent influencing factors, the lipopograms were constructed. The goodness of fit R2 and C-index of the model were 0.892 and 0.985, respectively through evaluation and verification model. The calibration curve of the model fitted well with the ideal curve, and the areas under the ROC curve of the rosettes and independent factors were 0.985, 0.959, 0.899, 0.656 and 0.576, respectively, indicating that the model was more effective than the independent index in predicting risk. Decision curve analysis also showed that the rosette had high clinical benefit. Conclusions:There are many related factors affecting whether patients undergo mechanical ventilation after nasal high-flow oxygen therapy. In this paper, after univariate and multivariate analysis, the most valuable indicators are combined to establish a line chart with better predictive performance to assess patients' risk, which can further provide clinicians with simple and effective prediction methods and improve the prognosis of patients.
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The critical attribute was analyzed in clavulanate potassium tablet of amoxicillin according to the principle QbD. By investigation of the drug impurity profile, the cycle-closed dimer and penicilloic acid of amoxicillin were considered to be the critical impurities, and the sources and the degradation pathways of these two impurities were discussed. The research confirmed that crystal form was the critical attribute of drug substance. The drying process in the tablet granulation was regarded as the critical process parameter. The tablet formulation was also another factor in the impurity generation. This study provides a new idea for the evaluation of drug quality.
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BAome III criteria. METHODS: After EAR3Q was developed by Asian experts by cCKGROUND/AIMS: The development-processes by regional socio-cultural adaptation of an Enhanced Asian Rome III questionnaire (EAR3Q), a cultural adaptation of the Rome III diagnostic questionnaire (R3DQ), and its translation-validation in Asian languages are presented. As English is not the first language for most Asians, translation-validation of EAR3Q is essential. Hence, we aimed to culturally adapt the R3DQ to develop EAR3Q and linguistically validate it to show that the EAR3Q is able to allocate diagnosis according to Ronsensus, it was translated into Chinese, Hindi-Telugu, Indonesian, Korean, and Thai, following Rome Foundation guidelines; these were then validated on native subjects (healthy [n = 60], and patients with irritable bowel syndrome [n = 59], functional dyspepsia [n = 53] and functional constipation [n = 61]) diagnosed by clinicians using Rome III criteria, negative alarm features and investigations. RESULTS: Experts noted words for constipation, bloating, fullness and heartburn, posed difficulty. The English back-translated questionnaires demonstrated concordance with the original EAR3Q. Sensitivity and specificity of the questionnaires were high enough to diagnose respective functional gastrointestinal disorders (gold standard: clinical diagnoses) in most except Korean and Indonesian languages. Questionnaires often uncovered overlapping functional gastrointestinal disorders. Test-retest agreement (kappa) values of the translated questionnaires were high (0.700-1.000) except in Korean (0.300-0.500) and Indonesian (0.100-0.400) languages at the initial and 2-week follow-up visit. CONCLUSIONS: Though Chinese, Hindi and Telugu translations were performed well, Korean and Indonesian versions were not. Questionnaires often uncovered overlapping FGIDs, which were quite common.