Translational and Clinical Pharmacology最新文献

{"title":"Efficacy and safety assessment of protein supplement - micronutrient fortification in promoting health and wellbeing in healthy adults - a randomized placebo-controlled trial.","authors":"Pranit Ambulkar,&nbsp;Prashant Hande,&nbsp;Bhagwat Tambe,&nbsp;Vidyadhar G Vaidya,&nbsp;Ninad Naik,&nbsp;Ramshyam Agarwal,&nbsp;Gayatri Ganu","doi":"10.12793/tcp.2023.31.e1","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e1","url":null,"abstract":"<p><p>Protein supplements are extensively used for muscle building, weight loss, recovery from exercise, improving endurance & cardio-performance. Major challenge with protein supplement is undigested protein and impaired gut health which results in nausea, dehydration, diarrhea, constipation, indigestion, stomach pain, and decreased appetite. Several studies have linked plant protein with reduced metabolic syndrome incidence. Probiotics can improve gut health as well. The objective of the study is to assess the efficacy and safety of protein supplement in promoting health and wellbeing in healthy adults. The present trial is a double blind, multi-center, randomized, placebo controlled, clinical trial involving 60 healthy individuals. The treatment duration was of 90 days. The subjects were randomized to receive either protein supplement treatment or placebo control. Protein supplement significantly improved quality-of-life score by 85.76%, VO₂ max by 42.92%, distance covered in 6 minutes, 100% individuals with at least 25% reduction in low energy events as compared to the control group. Protein supplement treatment reduced body weight (1.94 kg), waist circumference (2.46 cm), body mass index, waist circumference, hip circumference and body fat. Remarkable and significant improvement in digestive and sleep quality score, percent skeletal muscle was observed among protein supplement treated group. There were no clinically significant changes in hematological, biochemical and vital parameters; indicating safety of protein supplement. Present study concluded that protein supplement is safe and efficacious in weight management, improving high energy events, aerobic capacity, quality of life, digestive behavior score and sleep quality. This study ensures consumers about safety and effectiveness of protein supplement.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"13-27"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/07/tcp-31-13.PMC10079511.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9278462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of antioxidants in improving semen parameters like count, motility and DNA fragmentation in sub-fertile males: a randomized, double-blind, placebo-controlled clinical trial.","authors":"Ameet Patki,&nbsp;Rohit Shelatkar,&nbsp;Monica Singh,&nbsp;Sweta Agarwal,&nbsp;Venugopal M,&nbsp;Shashikant Umbardand,&nbsp;Apoorva Reddy,&nbsp;Priya Kannan,&nbsp;Srilatha Gorthi,&nbsp;Gautam Khastgir,&nbsp;Anita Kulshreshtha,&nbsp;Gayatri Ganu","doi":"10.12793/tcp.2023.31.e6","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e6","url":null,"abstract":"<p><p>Male infertility is solely responsible for 20-30% of infertility cases. Oxidative damage of sperm DNA is positively linked with oligoasthenoteratozoospermia (OAT), and male infertility. The antioxidants are being explored worldwide to combat OAT, sperm DNA fragmentation and reactive oxygen species. The objective of the study was to assess the effectiveness of an antioxidant blend in improving sperm count, semen parameters and reducing DNA fragmentation index (DFI) in sub-fertile males. A prospective, double-blind, randomized, placebo-controlled trial was conducted in 300 sub-fertile males (25-45 years) from ten study sites in India. Subjects were randomized in either the antioxidant blend treatment group or placebo group. We assessed changes in sperm count, motility, normal morphology, semen volume, and percent DFI before and after treatment (90 days). To further stratify data on different criteria <i>post hoc</i> analysis was performed. Statistical analysis was performed using SPSS 10.0 software. There were improvements in sperm count, semen volume, sperm motility, and sperm normal morphology in the treatment group. There was improvement in sperm count in severe oligospermia subjects (sperm count < 5 million/mL, 5-10 million/mL, 10.1-15 million/mL), and high-extremely higher baseline DFI (20-30%, 31-40% and above 40%), as per <i>post hoc</i> analysis. There was no premature discontinuation and adverse events were reported during the study, indicating safety and well-tolerability of treatment. Study results confirmed the well-researched fact of antioxidants being effective to reduce oxidative stress and thus improve sperm DNA integrity and also improved semen parameters in males aged 40 and above.</p><p><strong>Trial registration: </strong>Clinical Trials Registry-India Identifier: CTRI/2020/12/029590.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"28-39"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/86/98/tcp-31-28.PMC10079508.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9278457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation.","authors":"A-Young Yang,&nbsp;Hyounggyoon Yoo,&nbsp;Wonsuk Shin,&nbsp;Yil-Seob Lee,&nbsp;Hyejung Lee,&nbsp;Sung-Eun Kim,&nbsp;Anhye Kim","doi":"10.12793/tcp.2023.31.e3","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e3","url":null,"abstract":"<p><p>Fexuprazan (DWP14012), a potassium-competitive acid blocker, is a medical formulation prescribed to inhibit the secretion of gastric acid. The present study encompasses a comparative evaluation of pharmacokinetic (PK) analysis between the previous (reference) and size-reduced (test) formulation of fexuprazan 20 mg in healthy subjects. The study employed a randomized, open-label, single-dose, 2-sequence, 2-period, crossover design with a 7-day wash-out between periods. A total of 24 subjects were enrolled in this randomized study. During each period, the 21 subjects received either the test or reference formulation. Blood samples were collected at multiple time point ranging from 0 (pre-dose) to 48 hours post-dosing for PK analysis. The calculated PK parameters were considered bioequivalent when the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) were within the bioequivalence limit of 0.8-1.25. Safety and tolerability were included in the evaluation. A total of 20 subjects completed the study. Point estimates (90% CIs) of the GMRs were 1.1014 (0.9892-1.2265) for the maximum plasma concentration and 1.0530 (0.9611-1.1536) for the area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration, between the test and reference formulations. The reference and size-reduced test formulations of fexuprazan were well tolerated with no reports of serious adverse events. In conclusion, size-reduced and previous formulations of fexuprazan 20 mg were bioequivalent with regard to PKs, safety and tolerability.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"40-48"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ec/64/tcp-31-40.PMC10079506.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9278458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of pharmacokinetic interactions between lobeglitazone, empagliflozin, and metformin in healthy subjects.","authors":"Heeyoung Kim,&nbsp;Choon Ok Kim,&nbsp;Hyeonsoo Park,&nbsp;Min Soo Park,&nbsp;Dasohm Kim,&nbsp;Taegon Hong,&nbsp;Yesong Shin,&nbsp;Byung Hak Jin","doi":"10.12793/tcp.2023.31.e4","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e4","url":null,"abstract":"<p><p>Concomitant administration of lobeglitazone, empagliflozin, and metformin is expected to enhance blood glucose-lowering effects and improve medication compliance in patients with diabetes mellitus. In this study, we investigated the pharmacokinetic (PK) interactions and safety of lobeglitazone and co-administered empagliflozin and metformin, which are approved agents used in clinical settings. Two randomized, open-label, multiple-dose, 2-treatment, 2-period, 2-sequence crossover clinical trials (parts 1 and 2) were conducted independently. In part 1, lobeglitazone monotherapy or lobeglitazone, empagliflozin, and metformin triple therapy was administered for 5 days. In part 2, empagliflozin and metformin dual therapy or the abovementioned triple therapy were administered for 5 days. Serial blood samples were collected up to 24 hours after the last dose in each period for PK evaluation. The primary PK parameters (AUC_tau,ss, C_max,ss) of treatment regimens in each study part were calculated and compared. For lobeglitazone, the geometric mean ratios (GMRs) with 90% confidence intervals (CI) for triple therapy over monotherapy were 1.08 (1.03-1.14) for C_max,ss and 0.98 (0.90-1.07) for AUC_tau,ss. For empagliflozin, the GMRs and 90% CIs for triple therapy over dual therapy were 0.87 (0.78-0.97) for C_max,ss and 0.97 (0.93-1.00) for AUC_tau,ss. For metformin, the GMRs and 90% CIs for triple therapy over dual therapy were 1.06 (0.95-1.17) for C_max,ss and 1.04 (0.97-1.12) for AUC_tau,ss. All reported adverse events were mild. The triple therapy consisting of lobeglitazone, empagliflozin, and metformin did not show any clinically relevant drug interactions in relation to the PKs and safety of each drug substance.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04334213.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"59-68"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a7/37/tcp-31-59.PMC10079507.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9273564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of the distribution of trial sites in South Korea using social network analysis.","authors":"Ki Young Huh,&nbsp;Kyung-Sang Yu,&nbsp;Ildae Song","doi":"10.12793/tcp.2023.31.e2","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e2","url":null,"abstract":"<p><p>Location of trial sites can be a potential source of study bias. Considering that clinical trials have been mostly conducted in urban areas, the distribution of trial sites need to be evaluated. We analyzed clinical trial approval data using social network analysis to quantitatively assess the site-by-site connections. The approval list of clinical trials from the Ministry of Food and Drug Safety database between 2014 and 2021 was analyzed. The number of clinical trials per trial site was counted according to the approval year and study phase and evaluated for distribution using empirical cumulative distribution function plots. Trial sites and conducts of a clinical trial were mapped into nodes and edges in the social network analysis, and basic network parameters were obtained. The clinical trials were concentrated at several trial sites. Forty-nine to 60.6% of phase 1 and up to 30% of the other study phases of clinical trials were at the top 5 trial sites. The annual distribution of the number of clinical trials per site was comparable across the study period. Connections among the trial sites in the metropolitan area were prominent. Graph size and density were higher in phase 3 trials than in the other phases. We demonstrated that the conduct of clinical trials was concentrated in the Seoul Metropolitan Area in both number of trials and connections using social network analysis.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"1-12"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ba/d7/tcp-31-1.PMC10079509.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9278461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of three-dimensional image based insole for healthy volunteers: a pilot clinical trial.","authors":"Bi O Jeong,&nbsp;Su Jin Jeong,&nbsp;Kyungwon Park,&nbsp;Bo-Hyung Kim,&nbsp;Sung-Vin Yim,&nbsp;Sehyun Kim","doi":"10.12793/tcp.2023.31.e5","DOIUrl":"https://doi.org/10.12793/tcp.2023.31.e5","url":null,"abstract":"<p><p>Insoles are used to treat various foot diseases, including plantar foot, diabetic foot ulcers, and refractory plantar fasciitis. In this study, we investigated the effects of 3-dimensional image-based (3-D) insole in healthy volunteers with no foot diseases. Additionally, the comfort of the 3-D insole was compared with that of a custom-molded insole. A single-center, randomized, open clinical trial was conducted to address the effectiveness of insole use in a healthy population with no foot or knee disease. Two types of arch support insoles were evaluated for their effectiveness: a 3-D insole and a custom-molded insole. Fifty Korean volunteers participated in the study and were randomly allocated into the \"3-D insole\" (n = 40) or \"custom-molding insole\" (n = 10) groups. All subjects wore 3-D insoles or custom-molded insoles for 2 weeks. The sense of wearing shoes (Visual Analog Scale [VAS] and score) and fatigue of the foot were used to assess the insole effects at the end of the 2-week study period. The 3-D insole groups showed significantly improved sense of wearing shoes (VAS, <i>p</i> = 0.0001; score, <i>p</i> = 0.0002) and foot fatigue (<i>p</i> = 0.0005) throughout the study period. Although the number of subjects was different, the custom-molding insole group showed no significant changes in the sense of wearing shoes (VAS, 0.1188; score, <i>p</i> = 0.1483). Foot fatigue in the 3-D insole group improved significantly (<i>p</i> = 0.0005), which shows that a 3-D insole might have favorable effects on foot health in a healthy population.</p><p><strong>Trial registration: </strong>Clinical Research Information Service Identifier: KCT0008100.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"31 1","pages":"49-58"},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/01/fe/tcp-31-49.PMC10079510.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9278459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Common <i>ABCB1</i> SNP, C3435T could affect systemic exposure of dapagliflozin in healthy subject.","authors":"Jun Gi Hwang,&nbsp;Sae Im Jeong,&nbsp;Yu Kyong Kim,&nbsp;Yujin Lee,&nbsp;Sang Chun Ji,&nbsp;SeungHwan Lee,&nbsp;Min Kyu Park","doi":"10.12793/tcp.2022.30.e23","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e23","url":null,"abstract":"<p><p>P-glycoprotein (P-gp) is a transporter that plays an excretory role in epithelial cells. It is encoded by <i>ABCB1</i>, and single nucleotide polymorphisms (SNPs) in this gene can affect systemic drug exposure. Dapagliflozin and sitagliptin, used in type 2 diabetes treatment, are P-gp substrates. Here, we aimed to investigate whether <i>ABCB1</i> polymorphisms affect dapagliflozin and sitagliptin pharmacokinetics (PK) in healthy Korean subjects. The study population consisted of 100 healthy Korean subjects (94 men and 6 women) who participated in four different clinical trials and received dapagliflozin and sitagliptin doses of 10 and 100 mg, respectively. We determined <i>ABCB1</i> genotypes for the C3435T, C1236T, and G2677T/A SNPs. The relationship between the genotypes and dapagliflozin PKs was examined. Dapagliflozin and sitagliptin PK parameters were not statistically significantly affected by <i>ABCB1</i> SNP genotypes. However, homozygous 3435TT subjects showed higher dapagliflozin PK parameters than CT and CC subjects. In subjects with the 3435TT and those with 3435CC and 3435CT genotypes, mean C_max, AUC_inf, and AUC_0-1 values of dapagliflozin were 223.06 ng/mL and 194.81 ng /mL (<i>p</i> = 0.2767), 673.58 ng*h/mL and 573.96 ng*h/mL (<i>p</i> = 0.0492), and 128.53 ng*h/mL and 104.61 ng*h/mL (<i>p</i> = 0.2678), respectively. In summary, dapagliflozin and sitagliptin PK parameters were not significantly different between individuals with C1236T and C2677T/A ABCB1 genetic polymorphisms. Dapagliflozin exhibited higher systemic exposure in 3435TT subjects than in CC/CT subjects.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"30 4","pages":"212-225"},"PeriodicalIF":0.9,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1f/09/tcp-30-212.PMC9810488.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9088699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predicting the systemic exposure and lung concentration of nafamostat using physiologically-based pharmacokinetic modeling.","authors":"Hyeon-Cheol Jeong,&nbsp;Yoon-Jee Chae,&nbsp;Kwang-Hee Shin","doi":"10.12793/tcp.2022.30.e20","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e20","url":null,"abstract":"<p><p>Nafamostat has been actively studied for its neuroprotective activity and effect on various indications, such as coronavirus disease 2019 (COVID-19). Nafamostat has low water solubility at a specific pH and is rapidly metabolized in the blood. Therefore, it is administered only intravenously, and its distribution is not well known. The main purposes of this study are to predict and evaluate the pharmacokinetic (PK) profiles of nafamostat in a virtual healthy population under various dosing regimens. The most important parameters were assessed using a physiologically based pharmacokinetic (PBPK) approach and global sensitivity analysis with the Sobol sensitivity analysis. A PBPK model was constructed using the SimCYP^® simulator. Data regarding the <i>in vitro</i> metabolism and clinical studies were extracted from the literature to assess the predicted results. The model was verified using the arithmetic mean maximum concentration (C_max), the area under the curve from 0 to the last time point (AUC_0-t), and AUC from 0 to infinity (AUC_0-∞) ratio (predicted/observed), which were included in the 2-fold range. The simulation results suggested that the 2 dosing regimens for the treatment of COVID-19 used in the case reports could maintain the proposed effective concentration for inhibiting severe acute respiratory syndrome coronavirus 2 entry into the plasma and lung tissue. Global sensitivity analysis indicated that hematocrit, plasma half-life, and microsomal protein levels significantly influenced the systematic exposure prediction of nafamostat. Therefore, the PBPK modeling approach is valuable in predicting the PK profile and designing an appropriate dosage regimen.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"30 4","pages":"201-211"},"PeriodicalIF":0.9,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/33/05/tcp-30-201.PMC9810492.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10529517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A case of sinus arrest in atrial fibrillation with pulmonary embolism after flecainide ingestion.","authors":"Hyung Ki Jeong,&nbsp;Sung Soo Kim,&nbsp;Hyun Kuk Kim,&nbsp;Young Jae Ki,&nbsp;Keun Ho Park,&nbsp;Dong Hyun Choi","doi":"10.12793/tcp.2022.30.e19","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e19","url":null,"abstract":"<p><p>A 76-year-old female visited the emergency department with complaining of dizziness and syncope. She had a history of paroxysmal atrial fibrillation (AF) and had been prescribed flecainide 50 mg and apixaban 5 mg 12-hourly in another hospital 1 day before the presentation. Upon admission, her electrocardiogram showed profound bradycardia and extremely long sinus arrest, which required temporary cardiac pacing. Within 24 hours, her intrinsic rhythm was restored, and the temporary pacemaker was removed. Transthoracic and transesophageal echocardiography revealed no structural heart disease or thrombus in the left atrial appendage. Cardiac computed tomography showed no coronary artery stenosis, but a pulmonary thrombus in the right pulmonary artery. She underwent an electrophysiology study, and four pulmonary vein (PV) isolations were attempted to treat the paroxysmal AF. A bidirectional PV conduction block was acquired in all PVs despite spontaneous dissociation of PV potential in the right PV. Programmed stimulation following ablation resulted in sinus node dysfunction. After the procedure, the patient did not complain of dizziness and syncope for 72 hours of telemetry monitoring. She was discharged with anticoagulant and did not show any further symptoms for 6 months. Flecainide acetate is a class Ic antiarrhythmics, and its clinical efficacy has been confirmed in several clinical trials. However, it can unmask sinus node dysfunction in asymptomatic patients with paroxysmal AF. Clinicians should screen candidates for sinus nodal diseases when prescribing flecainide.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"30 4","pages":"182-186"},"PeriodicalIF":0.9,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b3/21/tcp-30-182.PMC9810487.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10578212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors influencing decision making and antibiotic prescribing patterns for the treatment of carbapenem-resistant <i>Enterobacteriaceae</i> (CRE) among non-infectious physicians in Thailand: a qualitative study.","authors":"Suluck Soontaros,&nbsp;Nattawut Leelakanok,&nbsp;Yuttaphum Mepradis,&nbsp;Titinun Auamnoy","doi":"10.12793/tcp.2022.30.e18","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e18","url":null,"abstract":"<p><p>The treatment of carbapenem-resistant <i>Enterobacteriaceae</i> (CRE) is diverse in each region due to the difference in local resistant patterns of CRE. We aimed to explore how physicians in Thailand decide on selection options for treating CRE infections. In this study, 25 physicians who were not infectious disease (ID) specialists participated in this semi-structured in-depth interview. We found that they, in general, did not provide empiric antibiotics for the treatment of CRE. However, some patients, e.g., those with prior carbapenems exposure may have brought CRE to physicians' attention. ID specialists played critical roles in both empiric and specific CRE treatment. There were multiple scenarios when CRE management deviated from recommendations, especially when physicians perceived that the evidence that supported the recommendations was weak. Several supportive factors, challenges, and improvements were also suggested. In conclusion, ID specialists, adequate information, and consistent implementation of infectious control policy are crucial to the treatment and prevention of CRE infection.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"30 4","pages":"187-200"},"PeriodicalIF":0.9,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cf/42/tcp-30-187.PMC9810490.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10524377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}