International journal of clinical pharmacology and therapeutics最新文献

{"title":"Imipenem cilastatin sodium-associated thrombocytopenia in an older patient: A case report and literature review.","authors":"Weizhen Qiao, C. Chang, Qiuhui Wang, Xiaodong Cao, Xiuhong Zhang","doi":"10.5414/CP204215","DOIUrl":"https://doi.org/10.5414/CP204215","url":null,"abstract":"Imipenem cilastatin sodium, as a member of a new generation of β-lactam antibiotics, has a broad spectrum of antibacterial activity and a very wide range of application. Thrombocytopenia has been reported as a rare adverse event in several studies of patients treated with imipenem cilastatin sodium. In this study, we present a case of thrombocytopenia associated with imipenem cilastatin sodium in an older patient. The 78-year-old male patient with pulmonary infection was initiated on anti-infection therapy with imipenem cilastatin sodium. On the 9th day after imipenem cilastatin sodium administration, the patient experienced a sudden and dramatic decrease in platelet count. Similarly, on the 4th day after the re-administration of imipenem cilastatin sodium for anti-infection therapy, the patient's platelet count showed a remarkable downward trend again. A time correlation between the drug therapy and the occurrence of platelet reaction was found. The patient's platelet count gradually returned to the normal level on the 6th day after the first drug withdrawal and the 13th day after the second drug withdrawal, respectively. Considering the widespread use of imipenem cilastatin sodium, healthcare providers should improve the notification of thrombocytopenia associated with imipenem cilastatin sodium.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46135902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Activated charcoal can be used to aid the diagnosis of an overdose of dabigatran etexilate.","authors":"Nurzat Hurman, Songsong Lu","doi":"10.5414/CP204225","DOIUrl":"https://doi.org/10.5414/CP204225","url":null,"abstract":"The direct-acting oral anticoagulant dabigatran etexilate (DE prevent systemic thromboembolism and cerebral apoplexy in patients with nonvalvular atrial fibrillation. On September 22, 2021, an 86-year-old female patient in Peking University People's Hospital presented with a severely reduced fibrinogen level and significantly prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT). She had a history of hypertension, hyperlipidemia, arrhythmia, and a 1-year history of taking DE (110 mg, p.o., b.i.d.). She had no apparent bleeding tendency but had abnormalities in coagulation markers. She denied taking a DE overdose. Before deciding whether to transfuse plasma for replacement therapy, the attending physician wanted to ascertain if the abnormal results resulted from the drug or the abnormal coagulation mechanism of the patient. Tentatively, we used activated charcoal to treat plasma and then retested her coagulation markers: all coagulation tests nearly returned to normal levels. Hence, the cause was a DE overdose. Re-investigation revealed that she had lived alone in the previous week and possibly mistook the number of doses taken due to confusion. DE was withdrawn, and diuretics (Furosemide injection, 40 mg, QD2) were administered simultaneously to accelerate drug excretion. Five days after drug withdrawal, the coagulation tests returned to normal levels. This case report shows that activated charcoal could be used to show that the coagulation disorder was caused by a DE overdose, thereby providing support for the clinical diagnosis and treatment.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"1 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70963236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-drug interaction between apalutamide and atorvastatin through breast cancer resistance protein in an outpatient.","authors":"Ayako Watanabe, K. Momo, Katsumi Tanaka, Masaki Kida, Remi Kuchira, Hiromi Koshizuka, Kota Nishimura, M. Morita, Masahiro Yamamoto, Tadanori Sasaki","doi":"10.5414/CP204198","DOIUrl":"https://doi.org/10.5414/CP204198","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48900084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interferon α-induced lupus-like reaction in a mycosis fungoides patient: A case report.","authors":"Farahnaz Fatemi Naeini, Maral Yazdanpanah, Fatemeh Mohaghegh, P. Rajabi, Elham T. Tabatabaei","doi":"10.5414/CP204003","DOIUrl":"https://doi.org/10.5414/CP204003","url":null,"abstract":"Mycosis fungoides (MF) is the most common form of cutaneous T-cell lymphomas and interferon α is one of the treatment modalities for MF patients. So far, various side effects have been reported in connection with interferon use, including lupus-like reaction, which is relatively rare and classified as an injection-site reactions (ISR). We report a 38-year-old female with history of MF for 2 years who developed cutaneous lesions at the sites of interferon α-2b injections. There are few reports of lupus-like reaction due to therapy with interferon in malignant melanoma and multiple sclerosis (MS) patients, but there is no report in the literature about this side effect among patients with MF.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43551982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relative bioavailability of ertugliflozin tablets containing the amorphous form versus tablets containing the cocrystal form","authors":"V. Sahasrabudhe, Kyle T. Matschke, Haihong Shi, A. Hickman, A. Kong, Barbara Rodríguez Spong, B. Nickerson, K. Arora","doi":"10.5414/CP204212","DOIUrl":"https://doi.org/10.5414/CP204212","url":null,"abstract":"Objectives: Ertugliflozin is a selective sodium-glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes in adults. In its natural form, ertugliflozin exists as an amorphous solid with physicochemical properties that prevent commercial manufacture. The commercial product was developed as an immediate-release tablet, consisting of an ertugliflozin-L-pyroglutamic acid cocrystal of 1 : 1 molar stoichiometry as the active pharmaceutical ingredient. The ertugliflozin cocrystal may partially dissociate when exposed to high humidity for extended periods, leading to the formation of free amorphous ertugliflozin. Therefore, a study was conducted to estimate the relative bioavailability of ertugliflozin when administered in non-commercial formulated tablets containing the amorphous form vs. the cocrystal form. Materials and methods: In this phase 1, open-label, randomized, two-period, two-sequence, single-dose crossover study, 16 healthy subjects received 15 mg immediate-release ertugliflozin in its amorphous and cocrystal forms under fasted conditions, separated by a washout period of ≥ 7 days. Blood samples were collected post-dose for 72 hours to determine plasma ertugliflozin concentrations. Results: Mean ertugliflozin plasma concentration-time profiles were nearly superimposable following administration of the amorphous and cocrystal forms. The 90% confidence intervals for the geometric mean ratios for AUCinf and Cmax were wholly contained within the pre-specified criteria for similarity (70 – 143%), as well as the acceptance range for bioequivalence (80 – 125%). Most adverse events were mild in intensity. Conclusion: Any dissociation of ertugliflozin to the amorphous form that occurs in tablets containing the cocrystal will not have any clinically meaningful impact on the oral bioavailability of ertugliflozin.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 1","pages":"317 - 326"},"PeriodicalIF":0.8,"publicationDate":"2022-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48527262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of MwPharm 3.30 and MwPharm ++ a Windows version of pharmacokinetic software for PK/PD monitoring of vancomycin: A priori modeling.","authors":"B. Koristkova, Eliška Vavreckova, Kristyna Schön, I. Kacířová, H. Brozmanova, M. Grundmann","doi":"10.5414/CP204151","DOIUrl":"https://doi.org/10.5414/CP204151","url":null,"abstract":"OBJECTIVE\u0000To evaluate the possibility of population-based dose optimization with the aid of MwPharm modeling and to find the best model in the Windows version (WIN).\u0000\u0000\u0000MATERIALS\u000025 patients repeatedly examined for vancomycin (mean age 63 ± 14 years, body weight 88 ± 21 kg, median dose 1 g/12 h).\u0000\u0000\u0000METHODS\u0000Trough concentrations predicted by WIN models \"vancomycin_adult_k_C2\", \"#vancomycin_adult_C2\", \"vancomycin_adult_C2\", and \"vancomycin adult\" DOS model (DOS) were compared with the measured value.\u0000\u0000\u0000STATISTICS\u0000The percentage prediction error (%PE) calculated as (predicted - measured)/measured values, Blandt-Altman plot, root mean square error (RMSE), Pearson's coefficient of rank correlation (R). Data is presented as mean ± SD. Student's t-test was used for prediction precision evaluation.\u0000\u0000\u0000RESULTS\u0000The %PE varied from +44.4 ± 65.2% to +76.5 ± 84.3%, p < 0.001. \"#vancomycin_adult_C2\" model produced the lowest %PE among WIN models as well as the lowest RMSE (79) and Blandt-Altman bias (-4.01 ± 7.59), but the Pearson's correlation (0.6843, p = 0.0002) was less tight. DOS model produced the second lowest RMSE (81), %PE (+45.9 ± 66.6%), and Blandt-Altman bias (-4.83 ± 6.97) and highest Pearson's R (0.7847, p < 0.0001). \"vancomycin_adult_C2\" produced the third best prediction: RMSE (113), %PE (62.8 ± 92.6%), Blandt-Altman bias (-6.78 ± 11.2) but Pearson's R was the poorest (0.5773, p = 0.0025).\u0000\u0000\u0000CONCLUSION\u0000The lowest %PE and highest Pearson's R were achieved by the \"#vancomycin_adult_C2\" model. Due to the poor predictive performance of all MwPharm versions and models, we find all of them unsuitable for a priori vancomycin dosing management. Other software should be evaluated for routine use.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41722076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interstitial lung disease associated with combination therapy of dabrafenib and trametinib in metastatic BRAF^V600E-mutated poorly differentiated thyroid cancer: A case report and review of the literature.","authors":"Qian Zeng,&nbsp;Yili Deng,&nbsp;Longdan Zhang,&nbsp;Wei Wang","doi":"10.5414/CP204184","DOIUrl":"https://doi.org/10.5414/CP204184","url":null,"abstract":"<p><strong>Background: </strong>Thyroid cancer is the most common malignancy of the endocrine system, accounting for ~ 5% of all thyroid nodules and 1% of all systemic malignancies. <i>BRAF</i> mutations, primarily p.V600E hot spot mutations, are found in 60 - 70% of papillary thyroid cancer cases (PTC) and in 33 - 40% of fatal anaplastic thyroid cancers (ATC), also called poorly differentiated thyroid cancer. Dabrafenib was approved by the United States Food and Drug Administration (FDA) in 2018 to be applied in combination with trametinib for unresectable advanced or metastatic anaplastic thyroid cancer harboring the <i>BRAF^V600E</i> mutation. Unfortunately, there are few reports on the pathophysiology, molecular mechanism, and risk factors of interstitial lung disease induced by combined <i>BRAF</i>- and <i>MEK</i>-targeted therapy.</p><p><strong>Case presentation: </strong>We treated a 73-year-old man with metastatic <i>BRAF^V600E</i>-mutated poorly differentiated thyroid cancer using the combination of dabrafenib and trametinib. Although a significant morphologic tumor response was observed in our patient using combined <i>BRAF</i>- and <i>MEK</i>-targeted therapy, he presented with non-febrile respiratory failure, and his chest computed tomography (CT) revealed bilateral reticulation and pleural effusion. Withdrawal from dabrafenib-trametinib and administration of methylprednisolone rapidly improved his respiratory status and imaging features.</p><p><strong>Conclusion: </strong>The mechanisms of lung disease after the combined treatment with dabrafenib and trametinib are unclear. We hypothesized that dual-targeted therapy with a BRAF inhibitor, dabrafenib, and a MEK inhibitor, trametinib, might prevent the regeneration and proliferation of fibrotic epithelium in lung disease by blocking downstream proliferative signals.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 5","pages":"225-231"},"PeriodicalIF":0.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39855593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the representativeness of the German Oncology Dynamics dataset.","authors":"Svetlana Alymova,&nbsp;Karel Kostev,&nbsp;Vicky Casey,&nbsp;Nina Schmidt,&nbsp;Matthias Kalder,&nbsp;Christoph Roderburg,&nbsp;Nicole Friedersdorf","doi":"10.5414/CP204144","DOIUrl":"https://doi.org/10.5414/CP204144","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the representativeness of the German Oncology Dynamics (OD) dataset by comparing its projected patient population structure with that outlined in published epidemiological literature.</p><p><strong>Materials and methods: </strong>The OD is an international cross-sectional semi-retrospective survey collecting anonymized patient cases from a representative panel of physicians via a web-based questionnaire; the cases are quality-checked and projected to the drug-treated prevalence using physician workload information. The present study verifies the OD 2018 projected patient proportions by indication and sex against prevalence figures in IARC's Globocan and the Cancer in Germany report by the Robert Koch Institute. Additionally, age group and metastasis presence distributions in gonadotropin-releasing hormone analog (GnRHa)-treated prostate cancer patients are compared with the findings of a registry-based study: Retrospective Analysis of Patients with Prostate Cancer Initiating GnRH Agonists/Antagonists Therapy Using a German Claims Database: Epidemiological and Patient Outcomes by Hupe et al. [3].</p><p><strong>Results: </strong>The OD demonstrated a cancer type distribution similar to the comparator sources. Cancer-specific sex distribution differences could be attributed to real-world diagnosis and treatment patterns. The age group distributions of GnRH-treated prostate cancer patients did not differ significantly between the OD and the Hupe et al. [3] study according to confidence interval comparisons and a Kolmogorov-Smirnov test.</p><p><strong>Conclusion: </strong>Projected patient distributions for the OD Germany were similar to those documented in the published literature. The dissimilarities can be attributed to the low drug-treated prevalence of some cancer types and sex-specific diagnosis timeline differences. Further investigations are needed to verify the reliability of histological biomarker data as well as patient demographics in other countries.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 5","pages":"207-216"},"PeriodicalIF":0.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39876619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epidemiology and evaluation of adverse drug reactions in a Korean hospital database for spontaneous reports in the period 2009 to 2018.","authors":"H. Jeong, B. Chun, D. Kang, H. Kang","doi":"10.5414/CP204060","DOIUrl":"https://doi.org/10.5414/CP204060","url":null,"abstract":"OBJECTIVE\u0000To evaluate the epidemiology of adverse drug reactions (ADRs) in the Korean population and to identify their characteristics and factors affecting their severity.\u0000\u0000\u0000MATERIALS AND METHODS\u0000The analysis was based on the ADRs reported to the Seoul National University Hospital between 2009 and 2018. Statistical assessment (SPSS Statistics 25) included frequency analysis and the χ2-test. Risk factors were assessed using logistic regression analysis. Results were considered significant at p < 0.05.\u0000\u0000\u0000RESULTS\u0000A total of 44,122 cases were analyzed of which 24,801 (56.2%) cases concerned females and 19,321 (43.8%) males. A total of 47% of cases involved persons aged between 50 and 79 years. Antineoplastic agents, immunomodulating agents, and systemically administered anti-infective agents accounted for 57.6% of all drugs reported. Gastro-intestinal system disorders accounted for the largest proportion (25.8%) of adverse drug reactions reported. A total of 3,429 (7.8%) ADRs were reported as being in the category severe. Multivariate analysis showed that the risk of an ADR being reported as severe is higher in males than in females (OR = 1.25, 95% CI: 1.16 - 1.35), and higher in those aged 0 - 4 years (OR = 1.74, 95% CI: 1.46 - 2.08), in those aged 5 - 19 years (OR = 1.19, 95% CI: 1.07 - 1.31), and in those aged 65 years and over (OR = 1.26, 95% CI: 1.16 - 1.37), compared to those aged 20 - 64 years.\u0000\u0000\u0000DISCUSSION AND CONCLUSION\u0000From a public health perspective, ADRs are important because they are preventable. Important determinants, such as differences in specific age groups and drug classes, for the occurrence of ADRs and the occurrence of severe ADRs in particular, were identified. These determinants need to be carefully monitored in both private medical practices, clinics and hospitals. This monitoring of specific groups will involve close attention factors associated with gender, age group, and drug classes.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46297184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel intranasal treatment for anxiety disorders using amiloride, an acid-sensing ion channel antagonist: Pharmacokinetic modeling and simulation.","authors":"Mahmoud Azzeh, M. Battaglia, S. Davies, J. Strauss, P. Dogra, V. Yellepeddi","doi":"10.5414/CP204217","DOIUrl":"https://doi.org/10.5414/CP204217","url":null,"abstract":"OBJECTIVE\u0000To develop a physiologically based pharmacokinetic (PBPK) model for amiloride, an acid-sensing ion channel (ASIC) antagonist, and to simulate its pharmacokinetics in plasma and the central nervous system following intranasal administration in a virtual human population.\u0000\u0000\u0000MATERIALS AND METHODS\u0000We first developed a PBPK model of amiloride after oral administration and optimized the model using data from five clinical studies. Next, we added a nasal compartment to the amiloride oral PBPK model and parameterized using data from previous clinical studies. We simulated amiloride's pharmacokinetics in plasma, brain, and cerebrospinal fluid (CSF) after intranasal administration of amiloride at various doses in a virtual human population.\u0000\u0000\u0000RESULTS\u0000The target amiloride concentration in the central nervous system required for maximal ASIC inhibition was achieved with a 75-mg intranasal amiloride dose. However, this finding is based on simulations performed using a mathematical model and needs to be further validated with appropriate clinical data.\u0000\u0000\u0000CONCLUSION\u0000The nasal PBPK model of amiloride could be used to design future clinical studies and allow for successful clinical translation of intranasal amiloride formulation.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45178051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}