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Physiologically-based pharmacokinetic modeling of nafamostat to support dose selection for treatment of pediatric patients with COVID-19 基于生理学的奈法莫司他药代动力学模型支持新冠肺炎儿科患者的剂量选择
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2022-03-01 DOI: 10.12793/tcp.2022.30.e4
Yong-Soon Cho, Jae-Gook Shin
{"title":"Physiologically-based pharmacokinetic modeling of nafamostat to support dose selection for treatment of pediatric patients with COVID-19","authors":"Yong-Soon Cho, Jae-Gook Shin","doi":"10.12793/tcp.2022.30.e4","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e4","url":null,"abstract":"Pediatric patients with coronavirus disease 2019 (COVID-19) are increasing, and severe cases such as multisystem inflammatory syndrome are being reported. Nafamostat, a repurposing drug, is currently being explored for the treatment of COVID-19 in adults. However, the data supporting its exposure in pediatrics remains scarce. Physiologically-based pharmacokinetic (PBPK) modeling enables the prediction of drug exposure in pediatrics based on ontogeny of metabolic enzymes and age dependent anatomical and physiological changes. The study aimed to establish a PBPK model of nafamostat in adults, then scale the adult PBPK model to children for predicting pediatric exposures of nafamostat and an optimal weight-based nafamostat dose in pediatric population. The developed model adequately described adult exposure data in healthy volunteers following i.v. administration with three doses (10, 20, and 40 mg). Scaling adult PBPK models to five pediatric groups predicted that as age advances from neonate to adult, the exposure of nafamostat slightly increased from neonate to infant, steadily decreased from infant to child, and then increased from child to adult after the administration of 0.2 mg/kg/h for 14 days, a dosing regimen being conducted in a clinical trial for COVID-19. Based on the fold change of predicted area under the curve for the respective pediatric group over those of adults, weight-based dosages for each pediatric group may be suggested. The novel PBPK model described in this study may be useful to investigate nafamostat pharmacokinetics in a pediatric subgroup further.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43668467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products. 细胞和基因治疗产品早期临床试验国际指南的比较
IF 1.1
Translational and Clinical Pharmacology Pub Date : 2022-03-01 Epub Date: 2022-03-07 DOI: 10.12793/tcp.2022.30.e2
Wonsuk Shin, Min-Gul Kim, Anhye Kim
{"title":"Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products.","authors":"Wonsuk Shin, Min-Gul Kim, Anhye Kim","doi":"10.12793/tcp.2022.30.e2","DOIUrl":"10.12793/tcp.2022.30.e2","url":null,"abstract":"<p><p>Cellular and gene therapies (CGT) are promising fields that are bringing significant clinical benefits to patients by directly targeting the underlying cause of disease. In line with this trend, regulatory agencies in every country have been making efforts to accelerate CGT product development. For acceleration, it is necessary to increase the efficiency of clinical trials, thus the early-phase clinical trials for CGT products should be elaborate and productive. The guidelines of international regulatory agencies were compared and analyzed to examine the considerations for the design of early-phase CGT products. The guidelines described a safety evaluation, preliminary evidence of effectiveness gathering, dose exploration, and a feasibility assessment as common objectives of early-phase clinical trials for CGT products. In addition, the considerations for the design of early-phase CGT products included pretreatment effects and problems in the manufacturing and administration process. The guidelines also covered selection of a study population, control group/blinding, and dose/regimen planning. There were differences in the degree of detail, description, and the scope of the content covered by each guideline. The guideline published by FDA was the most specific. However, when compared with the previous guidelines for designing early-phase clinical trials for small molecules and biologics, the current guidelines need to be revised to suggest more detailed and practical principles and rules.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8979759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48245953","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}
引用次数: 0
Prediction of metabolizing enzyme-mediated clinical drug interactions using in vitro information 利用体外信息预测代谢酶介导的临床药物相互作用
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2022-03-01 DOI: 10.12793/tcp.2022.30.e6
Suein Choi, D. Yim, S. Bae
{"title":"Prediction of metabolizing enzyme-mediated clinical drug interactions using in vitro information","authors":"Suein Choi, D. Yim, S. Bae","doi":"10.12793/tcp.2022.30.e6","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e6","url":null,"abstract":"Evaluation of drug interactions is an essential step in the new drug development process. Regulatory agencies, including U.S. Food and Drug Administrations and European Medicines Agency, have been published documents containing guidelines to evaluate potential drug interactions. Here, we have streamlined in vitro experiments to assess metabolizing enzyme-mediated drug interactions and provided an overview of the overall process to evaluate potential clinical drug interactions using in vitro data. An experimental approach is presented when an investigational drug (ID) is either a victim or a perpetrator, respectively, and the general procedure to obtain in vitro drug interaction parameters is also described. With the in vitro inhibitory and/or inductive parameters of the ID, basic, static, and/or dynamic models were used to evaluate potential clinical drug interactions. In addition to basic and static models which assume the most conservative conditions, such as the concentration of perpetrators as Cmax, dynamic models including physiologically-based pharmacokinetic models take into account changes in in vivo concentrations and metabolizing enzyme levels over time.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41566557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Ultrafast liquid chromatography-tandem mass spectrometry determination of donepezil in human plasma: application to a bioequivalence study 超快速液相色谱-串联质谱法测定人血浆中多奈哌齐的生物等效性研究
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2022-02-24 DOI: 10.12793/tcp.2022.30.e1
Yan-Wen Huang, L. Ding, Yuan-Ming Chen, Wei-Chen Lin, Fei Lin, Yunsheng Hsieh
{"title":"Ultrafast liquid chromatography-tandem mass spectrometry determination of donepezil in human plasma: application to a bioequivalence study","authors":"Yan-Wen Huang, L. Ding, Yuan-Ming Chen, Wei-Chen Lin, Fei Lin, Yunsheng Hsieh","doi":"10.12793/tcp.2022.30.e1","DOIUrl":"https://doi.org/10.12793/tcp.2022.30.e1","url":null,"abstract":"A liquid chromatography equipped with tandem mass spectrometric method using multi-stage flow rates was developed for the determination of donepezil in human plasma to support a randomized, crossover bioequivalence (BE) study in which healthy volunteers each received a single oral dose of the reference and test formulations of 10 mg donepezil hydrochloride. This integrated liquid chromatography with tandem mass spectrometry (LC-MS/MS) system with electrospray ionization and a deuterium-labeled internal standard (IS) were employed for the positive multiple-reaction-monitoring (MRM) analyses. The baseline separation using a high-resolution monolithic column under gradient and flexible flowrate conditions between donepezil and multiple interfering peaks from the extracted quality control, calibration standard and study plasma samples following simple protein precipitation extraction procedures was accomplished within 1.5 minutes. The ultrafast monolithic column performance in terms of chromatographic separation efficiency, peak asymmetry and resolution and retention time reproducibility was found to be sustainable. The linear dynamic range was detected over a concentration range of 0.2–50 ng/mL. The intra- and inter-day assay accuracy and precision were within 15% for the analyte in individual biological fluids. A positive correlation coefficient (r) greater than 0.995 for donepezil concentrations in study plasma samplers measured by the proposed and the other validated LC-MS/MS methods in support of a bioequivalence study was observed.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48894358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Clinical development and trial operations in COVID-19 era. 新冠肺炎时代的临床开发与试验运营。
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-12-21 DOI: 10.12793/tcp.2021.29.e23
Seong Choon Choe
{"title":"Clinical development and trial operations in COVID-19 era.","authors":"Seong Choon Choe","doi":"10.12793/tcp.2021.29.e23","DOIUrl":"https://doi.org/10.12793/tcp.2021.29.e23","url":null,"abstract":"Coronavirus disease 2019 (COVID-19) pandemic affects worldwide and various aspects of human life, including drug developments and clinical trials. Especially in trial operations, there are significant impacts from 2020 to 2021. According to the Arkivum report [1], ‘TMF futures 2021: good data within the age of digital transformation,’ 41% of latest clinical trials in 2020 were delayed or placed on hold indefinitely because of the COVID-19 pandemic, 41% of those delayed trials will now be run in 2021, 65% of the life sciences sector say they will still run clinical trials remotely after the pandemic, 57% of the sciences organizations say the price of running a trial has increased since the pandemic began and 49% of the sciences organizations say the time to finish a clinical trial has increased since the pandemic started. We need to review the trends and possible changes during and after the COVID-19 pandemic reviewing the various reports from biopharmaceutical consulting companies and contract research organizations (CROs).","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/e3/tcp-29-181.PMC8718356.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39816366","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}
引用次数: 1
Determination of candesartan or olmesartan in hypertensive patient plasma using UPLC-MS/MS. UPLC-MS/MS法测定高血压患者血浆中坎地沙坦或奥美沙坦的含量。
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-12-16 DOI: 10.12793/tcp.2021.29.e21
Hyeon-Cheol Jeong, Yo-Han Seo, Namyi Gu, Moo Yong Rhee, Kwang-Hee Shin
{"title":"Determination of candesartan or olmesartan in hypertensive patient plasma using UPLC-MS/MS.","authors":"Hyeon-Cheol Jeong,&nbsp;Yo-Han Seo,&nbsp;Namyi Gu,&nbsp;Moo Yong Rhee,&nbsp;Kwang-Hee Shin","doi":"10.12793/tcp.2021.29.e21","DOIUrl":"https://doi.org/10.12793/tcp.2021.29.e21","url":null,"abstract":"<p><p>Candesartan and olmesartan are angiotensin II receptor blockers (ARBs) used for the treatment of hypertension and heart failure. Quantitation methods for candesartan and olmesartan were developed using ultra-high performance liquid chromatography-tandem mass spectrometry following protein precipitation. Candesartan was separated using 5 mM ammonium formate (A) and 100% acetonitrile (B) and olmesartan was separated using 2 mM ammonium formate with 0.1% formic acid (A) and 100% acetonitrile (B). Separation was performed using an isocratic method with a Thermo hypersil GOLD C18 column. Electrospray ionization was used for analyte ionization and detection of candesartan, olmesartan, and the internal standards by multiple reaction monitoring. Developed method showed excellent linearity (<i>r</i> > 0.99) in the concentration range of 2-500 ng/mL for candesartan and 5-2,500 ng/mL for olmesartan. Accuracies were 86.70-108.8% for candesartan and 87.87-112.6% for olmesartan. These methods were able to successfully measure plasma candesartan or olmesartan concentrations in hypertensive patients. This study can be used for pharmacokinetic studies of candesartan or olmesartan in humans.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/17/3d/tcp-29-226.PMC8718358.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39818624","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}
引用次数: 3
Trends of clinical trials from 2017 to 2019 in Korea: an integrated analysis based on the Ministry of Food and Drug Safety (MFDS) and the Clinical Research Information Service (CRIS) registries. 2017 - 2019年韩国临床试验趋势:基于食品药品安全部(MFDS)和临床研究信息服务(CRIS)注册的综合分析
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-12-21 DOI: 10.12793/tcp.2021.29.e24
Ki Young Huh, Kyung-Sang Yu, Hyeong-Seok Lim, Hyungsub Kim
{"title":"Trends of clinical trials from 2017 to 2019 in Korea: an integrated analysis based on the Ministry of Food and Drug Safety (MFDS) and the Clinical Research Information Service (CRIS) registries.","authors":"Ki Young Huh,&nbsp;Kyung-Sang Yu,&nbsp;Hyeong-Seok Lim,&nbsp;Hyungsub Kim","doi":"10.12793/tcp.2021.29.e24","DOIUrl":"https://doi.org/10.12793/tcp.2021.29.e24","url":null,"abstract":"<p><p>Public disclosure of approved clinical trials in a reliable registry can provide the transparency of the study. Although the registration of clinical trials has increased remarkably, the integrity of the data is not always satisfactory. In this study, we analyzed public clinical trial databases updated by the Ministry of Food and Drug Safety (MFDS) and Clinical Research Information Service (CRIS) registry to provide an overview of the trends of clinical trials approved between 2017 and 2019 in Korea. Information on clinical trials approved between January 1, 2017 and December 31, 2019 was collected from two databases. Trial information was categorized and summarized by study phase, therapeutic area, and location of the participating centers. A total of 655 to 715 clinical trials were newly approved annually by MFDS during the period from 2017 to 2019. Phase 1 clinical trials accounted for the largest proportion (31.0%), followed by phase 3 (29.5%), investigator-initiated trials (24.1%), phase 2 (14.6%), and phase 4 (0.5%). The number of clinical trials classified as an <i>Antineoplastic and immunomodulating agent</i> was the greatest (40.1%) regardless of the study phase. The similar result was obtained from CRIS registry where therapeutic area <i>Neoplasms</i> (15.9%) accounted for the largest number. The number of clinical trials performed in Seoul and Gyeonggi-do was approximately 70% of the total trials. In conclusion, our study provided a comprehensive overview of clinical trials in Korea from 2017 to 2019. The discrepancy between clinical trial registries could be resolved by introducing standardized database and guidelines.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f7/23/tcp-29-186.PMC8718355.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39816368","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}
引用次数: 1
QTc prolongation in patients with COVID-19: a retrospective chart review. COVID-19患者QTc延长:回顾性图表回顾
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-11-25 DOI: 10.12793/tcp.2021.29.e20
Suphannika Prateepjarassaeng Pornwattanakavee, Watcharapong Priksri, Nattawut Leelakanok
{"title":"QTc prolongation in patients with COVID-19: a retrospective chart review.","authors":"Suphannika Prateepjarassaeng Pornwattanakavee,&nbsp;Watcharapong Priksri,&nbsp;Nattawut Leelakanok","doi":"10.12793/tcp.2021.29.e20","DOIUrl":"10.12793/tcp.2021.29.e20","url":null,"abstract":"<p><p>Drug-induced corrected QT (QTc) prolongation can cause Torsade de Pointes (TdP) which leads to severe arrhythmia or sudden cardiac death. However, information on the prevalence of QTc prolongation in coronavirus disease 2019 (COVID-19) patients and risk factors is limited. A retrospective chart review was conducted in COVID-19 patients admitted to Chonburi Hospital from April to October 2020. The outcomes were the incidence of QTc prolongation and prevalence of risk factor QTc prolongation. We included 29 COVID-19 patients. After treatments were initiated, QTc prolongation occurred in 17 patients (58.62%). QT prolongation could be found as early as two days after the treatment initiation (median = 6 days interquartile range [IQR], 4-7). The median QTc interval in those 17 patients increased from 410 (IQR, 399.5-425.0) ms to 460 (453.50-466.50) ms, with the maximum QTc interval of 488 ms. They were treated with multiple drugs that were reported as a cause of QTc prolongation. 64.71% (n = 11) of them were treated with chloroquine. The median TdP risk score in patients with and without QTc prolongation was 3 (IQR, 2-3) and 2 (IQR, 1-2), respectively. The percentage of patients with comorbidities including atrial fibrillation, bradycardia, concomitant use of diuretics, diabetes, electrolyte imbalance was higher in patients with QTc prolongation. COVID-19 patients were treated with multiple drugs that were reported as a cause of QTc prolongation. COVID-19 patients with QTc prolongation had more comorbidities that are risk factors for QTc prolongation.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/da/cf/tcp-29-197.PMC8718354.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39816369","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}
引用次数: 2
A validated simple LC-MS/MS method for quantifying trimethylamine N-oxide (TMAO) using a surrogate matrix and its clinical application. 采用替代基质定量三甲胺n -氧化物(TMAO)的LC-MS/MS方法及其临床应用
IF 0.9
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-11-23 DOI: 10.12793/tcp.2021.29.e19
Yufei Li, Jihyun Kang, Yujin Lee, Jae-Yong Chung, Joo-Youn Cho
{"title":"A validated simple LC-MS/MS method for quantifying trimethylamine <i>N</i>-oxide (TMAO) using a surrogate matrix and its clinical application.","authors":"Yufei Li,&nbsp;Jihyun Kang,&nbsp;Yujin Lee,&nbsp;Jae-Yong Chung,&nbsp;Joo-Youn Cho","doi":"10.12793/tcp.2021.29.e19","DOIUrl":"https://doi.org/10.12793/tcp.2021.29.e19","url":null,"abstract":"<p><p>Trimethylamine <i>N</i>-oxide (TMAO) is a small molecular amine oxide generated from dietary choline and carnitine through intestinal microbial metabolism. Recently, TMAO has attracted much public attention as its role in disease progression has been proven in many clinical studies. The plasma concentration of TMAO in humans was found to be positively associated with the increased risk of many diseases including cardiovascular diseases and chronic kidney diseases. To achieve accurate and sensitive quantitation of TMAO for clinical applications, we established and validated a simple quantitative method using a liquid chromatography tandem mass spectrometry (LC-MS/MS) system. We constructed an eight-point calibration curve in an artificial surrogate matrix instead of the commonly used biological matrices to avoid interference from the endogenous TMAO. The calibration curve showed excellent linearity in the range of 1 to 5,000 ng/mL, with a correlation coefficient (R<sup>2</sup>) higher than 0.996 in each validation batch. Moreover, both the intra-day and inter-day assays achieved satisfactory precision and accuracy results ranging from 1.65-7.15% and 96.36-111.43%, respectively. Further, this method was cross-validated using a human plasma matrix and applied to a clinical pharmacology study. Overall, these results demonstrate that the developed quantitation method is applicable in clinical research for monitoring disease progression and evaluating drug effects.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6c/ed/tcp-29-216.PMC8718357.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39818623","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}
引用次数: 2
Medication selection for the treatment of acute infective diarrhea in Thai pharmacies: a qualitative study. 泰国药房治疗急性感染性腹泻的药物选择:一项定性研究。
IF 1.1
Translational and Clinical Pharmacology Pub Date : 2021-12-01 Epub Date: 2021-12-16 DOI: 10.12793/tcp.2021.29.e22
Nattawut Leelakanok, Arpa Petchsomrit, Janthima Methaneethorn, Suphannika Prateepjarassaeng Pornwattanakavee
{"title":"Medication selection for the treatment of acute infective diarrhea in Thai pharmacies: a qualitative study.","authors":"Nattawut Leelakanok, Arpa Petchsomrit, Janthima Methaneethorn, Suphannika Prateepjarassaeng Pornwattanakavee","doi":"10.12793/tcp.2021.29.e22","DOIUrl":"10.12793/tcp.2021.29.e22","url":null,"abstract":"<p><p>World Health Organization (WHO) released the treatment manual of diarrhea in 2005. We aimed to investigate the rationale for selecting medications for acute infective diarrhea in Thai community pharmacies and to see if the selection complied with the WHO manual. A theoretical 18-year-old patient with acute infective diarrhea was used for interviews. The protocol and materials for the research were approved by Institutional Review Board. A total of 30 drugstore personnel were selected by convenience sampling and included. The first author manually coded, extracted for themes, and translated the transcript. Participants did not dispense oral rehydration salt because of the feeling that diarrhea was not severe. Absorbents were dispensed because they were perceived as the first-line medication for noninfective or mild diarrhea. Antibiotics were dispensed because of the concerns for the prognosis and the expected patient pressure. None provided zinc to the patient because of the lack of knowledge of the indication of zinc. We found that dispensing for acute infective diarrhea in Thai drugstores deviated from the WHO treatment guideline. The reasons were that the pharmacy personnel were not practicing evidence-based medicine, the lack of knowledge, the patient pressure, the unavailability of products, and the perceived availability of information in local guidelines.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9f/6f/tcp-29-206.PMC8718353.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39816370","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}
引用次数: 0
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