International journal of clinical pharmacology and therapeutics最新文献

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Risk factors for severe neutropenia in patients with cytomegalovirus infection treated with ganciclovir: A retrospective observational study. 更昔洛韦治疗巨细胞病毒感染患者严重中性粒细胞减少的危险因素:一项回顾性观察研究
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-15 DOI: 10.5414/CP204795
Naoto Kimura, Ryosuke Ota, Atsushi Hirata
{"title":"Risk factors for severe neutropenia in patients with cytomegalovirus infection treated with ganciclovir: A retrospective observational study.","authors":"Naoto Kimura, Ryosuke Ota, Atsushi Hirata","doi":"10.5414/CP204795","DOIUrl":"https://doi.org/10.5414/CP204795","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the baseline neutrophil count as a risk factor for ganciclovir-induced neutropenia in greater detail.</p><p><strong>Materials and methods: </strong>This retrospective observational study included patients who received ganciclovir at Kindai University Nara Hospital between April 2006 and June 2023. Exclusion criteria were as follows: patients under 18 years of age, those who received chemotherapy within 2 weeks prior to ganciclovir administration, those who underwent blood transfusions or received granulocyte colony-stimulating factor injections during the observation period, those treated for fewer than 2 days, patients with a baseline neutrophil count < 1,000 cells/mm<sup>3</sup>, and patients with missing data on any study variables. The primary endpoint was the occurrence of severe neutropenia, which was analyzed using Cox regression analysis and the Cochran-Armitage trend test.</p><p><strong>Results: </strong>To the 345 patients who met the inclusion criteria, exclusion criteria were applied, and 158 were ultimately identified as eligible patients. Patients with baseline neutrophil counts < 1,500 cells/mm<sup>3</sup> were at significantly higher risk of severe neutropenia compared to those with baseline counts ≥ 4,000 cells/mm<sup>3</sup> (HR = 16.86, 95% CI = 1.64 - 173.50, p = 0.018). Additionally, the incidence of severe neutropenia tended to increase significantly as the baseline neutrophil count decreased (p < 0.001).</p><p><strong>Conclusion: </strong>These findings underscore the importance of monitoring baseline neutrophil counts before initiating ganciclovir treatment, particularly in patients with conditions associated with low neutrophil levels, such as hematological disorders.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636975","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}
引用次数: 0
Bioequivalence of tamsulosin 0.4 mg film-coated sustained-release tablet formulations in healthy subjects under fasting conditions. 空腹条件下坦索罗辛0.4 mg膜包膜缓释片在健康人体内的生物等效性
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-15 DOI: 10.5414/CP204708
Raymond R Tjandrawinata, Danang Agung Yunaidi, Yantirta Indra Kurniawan, Clarasintha Nindyatami, Ismail Dwi Saputro, Syifa Anugriani Aziswan, Vicky Achmad Ginanjar, Liana W Susanto
{"title":"Bioequivalence of tamsulosin 0.4 mg film-coated sustained-release tablet formulations in healthy subjects under fasting conditions.","authors":"Raymond R Tjandrawinata, Danang Agung Yunaidi, Yantirta Indra Kurniawan, Clarasintha Nindyatami, Ismail Dwi Saputro, Syifa Anugriani Aziswan, Vicky Achmad Ginanjar, Liana W Susanto","doi":"10.5414/CP204708","DOIUrl":"https://doi.org/10.5414/CP204708","url":null,"abstract":"<p><p>This open-label, randomized, single-dose, 4-period, 2-sequence, fully replicated study was conducted to evaluate the bioequivalence of tamsulosin 0.4 mg sustained-release film-coated tablet manufactured by PT Dexa Medica, Indonesia, and Harnal OCAS 0.4 mg prolonged-release tablet manufactured by Astellas Pharma Europe B.V., the Netherlands, imported by PT Combiphar, Indonesia, under fasting conditions in 28 healthy adult Indonesian males. Subjects were randomly assigned to receive the test formulation (1 single tablet of 0.4 mg) or the reference formulation (1 single tablet of 0.4 mg) orally in each of the 4 study periods, according to the full replicate design. Therefore, over the 4 complete periods, each subject received 2 administrations of the test formulation and 2 administrations of the reference formulation, with each administration separated by a 7-day washout period. The plasma concentration of tamsulosin from the blood samples was analyzed using validated ultra-performance liquid chromatography with tandem mass spectroscopy detection (UPLC-MS/MS), and pharmacokinetic parameters (AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>, C<sub>max</sub>, t<sub>max</sub>, and T<sub>1/2</sub>) were calculated. The 90% confidence interval (CI) for the test/reference geometric mean ratio (GMR) of the AUC<sub>0-t</sub> was 80.2 - 98.4%, and for AUC<sub>0-∞</sub> it was 80.5 - 120.1%. The 90% CI GMR of C<sub>max</sub> was 89.3 - 107.7%. All parameters were within the 90% CI GMR acceptance criteria of 80.0 - 125.0%. The T<sub>1/2</sub> and t<sub>max</sub> of the 2 test drugs and the 2 reference drugs were not statistically different. There was no adverse effect observed during the study. Based on the study results, it was concluded that both tamsulosin formulations were bioequivalent and well tolerated.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636973","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}
引用次数: 0
Cardiovascular toxicity associated with sedative drug use: Post-market pharmacovigilance study with disproportionality analysis. 与镇静药物使用相关的心血管毒性:上市后药物警戒研究与歧化分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-15 DOI: 10.5414/CP204796
Pei Ye, Hewei Zhang, Qiang Lyu, Wangzheqi Zhang, Yidi Xu, Xiaofei Ye, Xiaojing Guo
{"title":"Cardiovascular toxicity associated with sedative drug use: Post-market pharmacovigilance study with disproportionality analysis.","authors":"Pei Ye, Hewei Zhang, Qiang Lyu, Wangzheqi Zhang, Yidi Xu, Xiaofei Ye, Xiaojing Guo","doi":"10.5414/CP204796","DOIUrl":"https://doi.org/10.5414/CP204796","url":null,"abstract":"<p><strong>Objective: </strong>To compare the toxicity of sedatives in critically ill intensive care unit patients and investigate safety concerns using the United States Food and Drug Administration Adverse Event Reporting System and VigiBase databases.</p><p><strong>Materials and methods: </strong>Disproportionality analysis was used to assess the relationships among midazolam, propofol, and dexmedetomidine and suspected adverse drug reactions. Adverse drug reactions related to sedation in the intensive care unit were identified through systematic organ classification and assessed using Standardized Regulatory Activities Medical Dictionary Analysis Queries.</p><p><strong>Results: </strong>A total of 12,102 adverse drug reactions were identified with midazolam, propofol, or dexmedetomidine as the primary suspected drug. The cardiovascular system accounted for a significant proportion of the drug reaction systems with strong signals. The strongest preferred term was neonatal hypertension (N = 9; information component = 7.11 (95% confidence interval: 5.97 - 7.87)), propofol infusion syndrome (N = 482; information component = 10.88 (95% confidence interval: 10.73 - 10.99)), and the trigemino-cardiac reflex (N = 7; information component = 10.36 (95% confidence interval: 9.06 - 11.21)) for midazolam, propofol, and dexmedetomidine, respectively. The Standardized Regulatory Activities Medical Dictionary Analysis Queries with the strongest signal across all sedatives were torsade de pointes and shock-associated conditions (N = 679; information component = 4.24 (95% confidence interval: 4.12 - 4.34)).</p><p><strong>Conclusion: </strong>These findings highlight the need for clinicians to consider cardiovascular toxicity when administering sedatives in the intensive care unit, as different sedatives exhibit different adverse reaction profiles.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636974","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}
引用次数: 0
Neurodegenerative protection with Orgaheal medium-chain triglycerides oil: Evidence from cell cultures, enzyme inhibition studies, and measurement of antioxidant and lipid-lowering properties. 有机中链甘油三酯油的神经退行性保护作用:来自细胞培养、酶抑制研究以及抗氧化和降脂特性测量的证据。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-11 DOI: 10.5414/CP204742
Rajendran Aanaimuthu, Sudesh Raj Rajendran, Tejas Mudharaikal, Jayakumar Sivasamy, Reethi Suresh, Sneha Srinivasan
{"title":"Neurodegenerative protection with Orgaheal medium-chain triglycerides oil: Evidence from cell cultures, enzyme inhibition studies, and measurement of antioxidant and lipid-lowering properties.","authors":"Rajendran Aanaimuthu, Sudesh Raj Rajendran, Tejas Mudharaikal, Jayakumar Sivasamy, Reethi Suresh, Sneha Srinivasan","doi":"10.5414/CP204742","DOIUrl":"10.5414/CP204742","url":null,"abstract":"<p><p>Neurodegenerative diseases such as Alzheimer's and Parkinson's are marked by neuronal loss due to oxidative stress, neuro inflammation, and lipid dysregulation. Medium-chain triglyceride (MCT) oil, particularly rich in caprylic acid (C8, 56%) and capric acid (C10, 43%), has shown potential neuroprotective effects through its antioxidant properties, cholinesterase inhibition, and lipid-lowering benefits.</p><p><strong>Objectives: </strong>This study aims to evaluate the neuroprotective effects of ORGAHEAL medium-chain triglyceride (MCT) oil by assessing its antioxidant activity, cholinesterase inhibition, and lipid-lowering effects in vitro.</p><p><strong>Materials and methods: </strong>Antioxidant activity was measured using 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and nitric oxide scavenging assays. Cholinesterase inhibition was studied through enzyme kinetics with Lineweaver-Burk and Dixon plots. Lipid-lowering effects were analyzed in 3T3-L1 adipocytes using Oil Red O staining and triglyceride quantification.</p><p><strong>Results: </strong>MCT oil exhibited antioxidant activity in DPPH and nitric oxide assays (IC50: 6.15 mg/mL and 29.87 mg/mL) and non-competitive inhibition of acetylcholinesterase and butyrylcholesteraseE (Ki: 31.01 mg/mL and 24.86 mg/mL). It reduced lipid accumulation and triglyceride levels in 3T3-L1 cells, potentially enhancing neuronal health by lowering oxidative damage.</p><p><strong>Conclusion: </strong>MCT oil, with caprylic acid (C8) and capric acid (C10), offers neuroprotective benefits through its antioxidant, cholinesterase inhibitory, and lipid-lowering properties. Further in vivo studies are needed to confirm its therapeutic potential.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608302","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}
引用次数: 0
Treatment of delirium in intensive care patients with sepsis using daily intravenous infusions with omega-3 fatty acids. 每日静脉输注omega-3脂肪酸治疗重症脓毒症患者谵妄。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-11 DOI: 10.5414/CP204791
De-Qiang Wang, Fang-Bao Hu, Wen Wang, Hong-Jie Dou, Lin Ling, Cong-Bo Zheng, Yong Guo
{"title":"Treatment of delirium in intensive care patients with sepsis using daily intravenous infusions with omega-3 fatty acids.","authors":"De-Qiang Wang, Fang-Bao Hu, Wen Wang, Hong-Jie Dou, Lin Ling, Cong-Bo Zheng, Yong Guo","doi":"10.5414/CP204791","DOIUrl":"10.5414/CP204791","url":null,"abstract":"<p><strong>Background: </strong>The development of delirium is closely linked to inflammatory processes. Omega-3 fatty acids can modulate the immune response and may contribute to reducing the incidence of sepsis-associated delirium (SAD).</p><p><strong>Aims: </strong>To investigate the effects of omega-3 fatty acids on delirium in patients with sepsis.</p><p><strong>Materials and methods: </strong>In a single-center clinical trial, 220 intensive care patients diagnosed with sepsis were randomly assigned to receive daily intravenous infusions of either an omega-3 fish oil emulsion or a placebo. Delirium was assessed twice daily using the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Method (CAM). The primary outcome was the duration of delirium during the first 10 days of admission. Secondary outcomes included the duration of mechanical ventilation, length of intensive care unit (ICU) stay, and mortality.</p><p><strong>Results: </strong>Compared to the control group, the omega-3 group exhibited significantly fewer days with delirium episodes (p = 0.010), shorter ICU stays (p = 0.008), and fewer mechanical ventilation days (p = 0.001). However, there was no statistically significant difference in mortality between the two groups.</p><p><strong>Conclusion: </strong>Omega-3 fatty acids may effectively reduce the risk of delirium in sepsis patients, highlighting their potential as a therapeutic intervention in this population.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608303","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}
引用次数: 0
Cabotegravir pharmacokinetics in Asian population with and without HIV. 卡波特韦在亚洲HIV感染者和非HIV感染者的药代动力学。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-02 DOI: 10.5414/CP204849
Kelong Han, Ahmed A Abulfathi, Rashmi S Mehta, Romina A Nand, Mark A Marzinke, Raphael J Landovitz, Ronald D D'Amico, Alex R Rinehart, William R Spreen, Susan L Ford
{"title":"Cabotegravir pharmacokinetics in Asian population with and without HIV.","authors":"Kelong Han, Ahmed A Abulfathi, Rashmi S Mehta, Romina A Nand, Mark A Marzinke, Raphael J Landovitz, Ronald D D'Amico, Alex R Rinehart, William R Spreen, Susan L Ford","doi":"10.5414/CP204849","DOIUrl":"10.5414/CP204849","url":null,"abstract":"<p><strong>Objective: </strong>Cabotegravir is approved for HIV treatment (with rilpivirine) and prevention. The established cabotegravir population pharmacokinetic (PPK) model included 1.2% Asian participants. We aimed to compare cabotegravir pharmacokinetics between Asian and non-Asian populations and across Asian countries.</p><p><strong>Materials and methods: </strong>Cabotegravir concentrations were collected from Asian participants in phase 1 and 3 studies. The applicability of the PPK model to Asian populations was validated by predicting the observed concentrations not included in model-building. Cabotegravir post-hoc pharmacokinetic parameters (long-acting absorption rate constant, weight-normalized apparent clearances and volumes of distribution) and exposures (trough and peak concentrations) following monthly and every-2-month regimens were estimated by fitting the PPK model to observed data. Non-Asian participants from the previous PPK dataset (1,697 males; 564 females) were used as comparator. Cabotegravir exposures in Asian and non-Asian were compared via simulations.</p><p><strong>Results: </strong>2,034 cabotegravir concentrations were collected from 162 Asian males (assigned male at birth) in China (n = 47), Japan (n = 17), Korea (n = 25), Thailand (n = 53), and Vietnam (n = 20), and 35 concentrations from 2 Asian females (assigned female at birth) in Korea. Cabotegravir pharmacokinetic parameters were similar between Asian and non-Asian participants. Cabotegravir exposures in Asian populations largely overlapped with but tended to be higher than non-Asian populations, suggesting similar efficacy. Cabotegravir exposures in Asian and non-Asian populations remained below the safety threshold, suggesting similar safety profiles. Cabotegravir pharmacokinetic parameters and exposures were similar across Asian countries.</p><p><strong>Conclusion: </strong>No dose adjustment is recommended for Asian populations with and without HIV. Cabotegravir pharmacokinetic data from any Asian country/region may guide pharmacokinetic evaluation and regulatory considerations across Asian regions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540132","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}
引用次数: 0
Primary hypertension in German children and adolescents: Low treatment rates and dominance of ACE inhibitors in an analysis of 7,482 cases for the period 2005 to 2023. 德国儿童和青少年原发性高血压:2005年至2023年7482例病例的低治愈率和ACE抑制剂的优势分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-02 DOI: 10.5414/CP204857
Jacob Christian Moll, Jens Bohlken, Kerstin Weber, Karel Kostev
{"title":"Primary hypertension in German children and adolescents: Low treatment rates and dominance of ACE inhibitors in an analysis of 7,482 cases for the period 2005 to 2023.","authors":"Jacob Christian Moll, Jens Bohlken, Kerstin Weber, Karel Kostev","doi":"10.5414/CP204857","DOIUrl":"10.5414/CP204857","url":null,"abstract":"<p><strong>Aims: </strong>To investigate prescription patterns in children and adolescents receiving treatment for primary hypertension.</p><p><strong>Materials and methods: </strong>Cumulative prescriptions within the 12-month period before the index date were analyzed for a cohort of 7,482 children and adolescents using Kaplan-Meier curves, stratified according to age group. Associations between age, sex, co-diagnoses, and the likelihood to be treated were evaluated using multivariable Cox regression.</p><p><strong>Results: </strong>The percentage of adolescents, children aged 6 years and above, and children aged up to 5 years receiving antihypertensive therapy was low (15.7% for adolescents, 12.8% for children aged 6 years and above, and 10.3% for children aged up to 5 years). The numbers receiving an angiotensin-converting enzyme (ACE) inhibitor, the most frequently prescribed drug class, were 65.4, 70.3, and 62.8%, and the numbers receiving a β-adrenergic receptor blocker, the second most commonly prescribed drug class were 19.1, 16.7, and 14.0%, respectively. Using multivariable analysis, co-diagnoses for type 1 diabetes mellitus (HR: 2.47; 95% CI: 1.72 - 3.55) and epilepsy (HR: 2.46; 95% CI: 1.74 - 3.47) were significantly correlated with an increased likelihood to receive antihypertensive therapy.</p><p><strong>Conclusion: </strong>The low number of children and adolescents with primary hypertension prescribed antihypertensive therapy is not in accord with current treatment guidelines. The reasons for this discrepancy and the effect it has on long-term cardiovascular outcomes are of considerable concern and need to be investigated.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540133","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}
引用次数: 0
Potentiation of paclitaxel-induced apoptosis in a non-small cell lung cancer model using the traditional Chinese drug huaier: Network pharmacology analysis, experimental verification, and clinical impact. 中药怀尔增强紫杉醇诱导的非小细胞肺癌细胞凋亡:网络药理学分析、实验验证及临床影响
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-07-01 DOI: 10.5414/CP204745
Wanrong Zheng, Fobao Lai
{"title":"Potentiation of paclitaxel-induced apoptosis in a non-small cell lung cancer model using the traditional Chinese drug huaier: Network pharmacology analysis, experimental verification, and clinical impact.","authors":"Wanrong Zheng, Fobao Lai","doi":"10.5414/CP204745","DOIUrl":"10.5414/CP204745","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"349-352"},"PeriodicalIF":0.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12188311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bioequivalence of two doxorubicin liposome formulations (LY01612 and Caelyx) using free and encapsulated doxorubicin concentrations in Chinese patients with advanced breast cancer. 两种阿霉素脂质体(LY01612和Caelyx)在中国晚期乳腺癌患者中使用游离和封装阿霉素浓度的生物等效性
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-06-02 DOI: 10.5414/CP204653
Lina Zhang, Cuizhi Geng, Mingxia Wang, Wenyan Chen, Fanfan Li, Xicheng Wang, Xinshuai Wang, Aimin Zang, Zhaofeng Niu, Fengli Zhao, Hui Yang, Hongliang Sun, Hongtao Song, Wanhui Liu, Fei Yu, Xianglei Jia, Jin Tong, Xin Che, Lingying Bai, Xuetao Deng
{"title":"Bioequivalence of two doxorubicin liposome formulations (LY01612 and Caelyx) using free and encapsulated doxorubicin concentrations in Chinese patients with advanced breast cancer.","authors":"Lina Zhang, Cuizhi Geng, Mingxia Wang, Wenyan Chen, Fanfan Li, Xicheng Wang, Xinshuai Wang, Aimin Zang, Zhaofeng Niu, Fengli Zhao, Hui Yang, Hongliang Sun, Hongtao Song, Wanhui Liu, Fei Yu, Xianglei Jia, Jin Tong, Xin Che, Lingying Bai, Xuetao Deng","doi":"10.5414/CP204653","DOIUrl":"10.5414/CP204653","url":null,"abstract":"<p><strong>Objective: </strong>To determine the pharmacokinetic properties and bioequivalence of a reference doxorubicin injectable formulation (Caelyx) and the test formulation, a newly developed doxorubicin hydrochloride liposome injection formulation (LY01612), administered as single bolus doses in Chinese patients with advanced breast cancer.</p><p><strong>Materials and methods: </strong>The study was multicentric, randomized, open-label, two-treatment, two-period, two-sequence, single dose with crossover. The dose, equivalent to 50 mg/m<sup>2</sup>, was administered intravenously on the first day of each 28-day treatment period. Blood samples were collected at appropriate intervals for estimation of C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> for free, encapsulated, and total doxorubicin, as well as partial AUC (AUC<sub>0-48h</sub>, AUC<sub>48h-last</sub>) for encapsulated doxorubicin.</p><p><strong>Results: </strong>The 90% confidence intervals (CI) for the geometric mean ratio (GMR) of the primary endpoints for determination of bioequivalence namely, C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> for free doxorubicin and encapsulated doxorubicin, and the 90% CIs for the secondary endpoints C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> for total doxorubicin and partial exposure parameters AUC<sub>0-48h</sub> and AUC<sub>48h-last</sub> of encapsulated doxorubicin, were within the range confirming that the two formulations are bioequivalent. The incidence of treatment-emergent adverse events in the test and reference product was 95.7% (44/46) and 100% (42/42), respectively (p > 0.05).</p><p><strong>Conclusion: </strong>The two formulations examined in the cohort of 48 Chinese patients with advanced breast cancer using measurements of free and encapsulated doxorubicin concentrations were bioequivalent. Both agents were well tolerated, and differences were not significant.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199044","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}
引用次数: 0
Anti-neurodegenerative treatment in Alzheimer's disease: Multifaceted mechanisms of action of berberine. 阿尔茨海默病的抗神经退行性治疗:黄连素的多方面作用机制。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-06-02 DOI: 10.5414/CP204725
Dandan Song, Congmin Zhang
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