International journal of clinical pharmacology and therapeutics最新文献

{"title":"Epithelial-mesenchymal transition biomarkers in patients with acute exacerbation of COPD are indicative of disease severity, disease progression, and risk of readmission.","authors":"Xiaohua Chou, Qian Zhang, Yuanqin Li, Xinran Qiu, Qian Sha, Yongli Gu, Daoli Jiang","doi":"10.5414/CP204769","DOIUrl":"10.5414/CP204769","url":null,"abstract":"<p><strong>Aims: </strong>To explore the association of epithelial-mesenchymal transition (EMT)-related biomarkers with an increase in disease severity/progression leading to readmission with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).</p><p><strong>Materials and methods: </strong>A prospective and observational study was conducted, involving patients admitted for AECOPD. Serum levels of EMT-related biomarkers (E-cadherin, zonula accludens-1 (ZO-1), vimentin and α-smooth muscular actin (α-SMA) were measured at patient admission. The clinical outcomes were 12-month AECOPD-related readmission risk, time to the first AECOPD-related readmission after discharge and number of 12-month AECOPD-related readmissions.</p><p><strong>Results: </strong>A total of 168 patients were included in the study, of whom 54 had at least one readmission for AECOPD during the 12-month follow-up period. Low serum levels of E-cadherin (< 279.7 ng/mL, adjusted odds ratio (aOR) = 9.434, p = 0.000), and high serum levels of vimentin (≥ 263.2 pg/mL, aOR = 7.116, p = 0.008), and α-SMA (≥ 460.8 pg/mL, aOR = 11.653, p = 0.000) were associated with an increased risk of AECOPD-related readmissions. Patients with low serum levels of E-cadherin and high serum levels of α-SMA exhibited the highest risk of AECOPD-related readmission. Additionally, low serum levels of E-cadherin and high serum levels of vimentin and α-SMA were associated with a shorter time to the first AECOPD-related readmission, and an increased number of 12-month AECOPD-related readmissions.</p><p><strong>Conclusion: </strong>Low serum levels of E-cadherin and high serum levels of vimentin and α-SMA are associated with an increase in disease severity/progression leading to AECOPD-related readmissions during a 12-month follow-up period. Moreover, simultaneous evaluation of E-cadherin and α-SMA levels enhances the accuracy in identifying patients who are likely to be re-hospitalized with AECOPD.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"530-541"},"PeriodicalIF":0.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953310","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":"Exogenous insulin antibody syndrome in type 2 diabetes with diabetic ketoacidosis: A case report and literature review.","authors":"Murong Xu, Li Xia, Rong Xiao, Datong Deng","doi":"10.5414/CP204819","DOIUrl":"10.5414/CP204819","url":null,"abstract":"<p><strong>Background: </strong>Exogenous insulin antibody syndrome (EIAS) is a rare allergic reaction triggered by exogenous insulin. It typically manifests as recurrent hypoglycemia during insulin use. In some cases, patients may also experience significant elevation in their blood glucose levels.</p><p><strong>Case report: </strong>We review a case of type 2 diabetes mellitus complicated by diabetic ketoacidosis. The patient exhibited a significant increase in his blood glucose level and demonstrated a substantial insulin resistance. Only through the administration of a large amount of insulin, it was possible to gradually reduce his blood glucose level. Notably, laboratory examination revealed a significant elevation in the patient's blood insulin autoantibody. Based on these findings, the patient was diagnosed with EIAS and used glucocorticoids during treatment. Subsequently, the patient's required insulin dose decreased significantly, and the blood glucose level was effectively controlled.</p><p><strong>Conclusion: </strong>EIAS can significantly increase blood glucose levels and impair the hypoglycemic effect of insulin. In patients with acute metabolic disorders, such as ketoacidosis, glucocorticoid therapy can be considered.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"561-566"},"PeriodicalIF":0.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799031","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":"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":"457-474"},"PeriodicalIF":0.7,"publicationDate":"2025-10-01","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}

{"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":"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_0-t, AUC_0-∞, C_max, t_max, and T_1/2) were calculated. The 90% confidence interval (CI) for the test/reference geometric mean ratio (GMR) of the AUC_0-t was 80.2 - 98.4%, and for AUC_0-∞ it was 80.5 - 120.1%. The 90% CI GMR of C_max was 89.3 - 107.7%. All parameters were within the 90% CI GMR acceptance criteria of 80.0 - 125.0%. The T_1/2 and t_max 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":"496-504"},"PeriodicalIF":0.7,"publicationDate":"2025-10-01","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}

{"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":"485-492"},"PeriodicalIF":0.7,"publicationDate":"2025-10-01","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}

{"title":"High expression of EFNA3 in adrenocortical carcinoma and its association with prognosis.","authors":"Caihong Cao, Xiao Li, Xing Feng, Yansha Wang","doi":"10.5414/CP204767","DOIUrl":"10.5414/CP204767","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"493-495"},"PeriodicalIF":0.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682607","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":"Advantages of an abdominal anticoagulant subcutaneous injection procedure based on a personal digital assistant and positioning card system: A clinical trial with a historical control cohort.","authors":"Xue-Fen Xia, Zhi-Bo Chen, Chan-Chan Fang, Yu-Jie Xie, Fei-Fan Yan, Sui-Li Yang","doi":"10.5414/CP204754","DOIUrl":"10.5414/CP204754","url":null,"abstract":"<p><strong>Objective: </strong>Our aim in this study is to investigate the advantages of a mobile personal digital assistant (PDA)-based anticoagulant abdominal injection positioning card in the subcutaneous injection process of low molecular weight heparin (LMWH).</p><p><strong>Materials and methods: </strong>This was a historical control study. Convenience sampling was used to include 210 patients diagnosed with venous thromboembolism who received dalteparin sodium (Fragmin) injections in our department between January 2021 and December 2022. Patients were categorized into the control group and the experimental group based on the time period before and after the implementation of the PDA-based anticoagulant abdominal injection positioning card that was developed by the information research and development department of our hospital. The control group consisted of 105 patients treated before the introduction of the PDA-based card (January to December 2021), while the experimental group comprised 105 patients treated after its introduction (January to December 2022). Patients in the control group used subcutaneous injection positioning cards made of paper to determine injection sites, while those in the experimental group used the PDA-based cards to determine injection sites. Outcome measures, including the incidence of subcutaneous bleeding, time spent on the subcutaneous injection procedure, and patient satisfaction, were compared between the two groups.</p><p><strong>Results: </strong>The incidence of subcutaneous bleeding was 5.59% in the experimental group vs. 5.61% in the control group, with no statistically significant difference between the two groups (p > 0.05). The time required for the subcutaneous injection was significantly shorter in the experimental group (63.11 ± 3.59 seconds) than in the control group (83.38 ± 6.96 seconds) (p < 0.05). The patient satisfaction rate was higher in the experimental group (94.3%) than in the control group (80.0%) (p < 0.05).</p><p><strong>Conclusion: </strong>Use of the PDA-based anticoagulant abdominal injection positioning card to determine the abdominal subcutaneous injection site for LMWH does not increase the occurrence of adverse reactions of subcutaneous bleeding, and can ensure the accuracy of medication use and the safety of medication for patients, reduce the time of nursing operations, optimize the nursing process, and improve patient satisfaction.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"475-484"},"PeriodicalIF":0.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673764","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":"Relationship between the blood neutrophil:lymphocyte ratio and response to intravascular mechanical thrombectomy in acute ischemic stroke with anterior circulation large vessel occlusion.","authors":"Xinming Li, Dejiang Yang, Yanyan Wei, Yao Zhi, Lijun Lu, Zhenyu Tang","doi":"10.5414/CP204643","DOIUrl":"10.5414/CP204643","url":null,"abstract":"<p><strong>Aims: </strong>To investigate the relationship between the neutrophil:lymphocyte ratio (NLR) in peripheral venous blood and the degree of vascular reflow following mechanical thrombectomy in patients with acute ischemic stroke (AIS) and anterior circulation large vessel occlusion.</p><p><strong>Materials and methods: </strong>Patients with successful reflow were divided into two groups: i) partial reflow group (mTICI = 2b) and ii) complete reflow group (mTICI = 3) according to the modified thrombolysis in cerebral infarction classification (mTICI). Basic clinical data, disease characteristics, interventional therapy and prognosis for patients in the two groups were compared, and the association with the degree of postoperative reflow determined using multivariate logistic analysis.</p><p><strong>Results: </strong>Univariate analysis of 21 cases of partial reflow and 45 cases of complete reflow showed statistically significant differences in the preoperative NLR, occluded vessel location, thrombus burden, puncture to recanalization time, thrombus removal times, and prognosis at 90 days post operation (p < 0.05 for all comparisons). Compared with patients with partial reflow, patients with complete reflow had lower NLR, more occluded vessels in the middle cerebral artery, lower thrombus burden, shorter operation time, fewer thrombectomy time and better clinical prognosis.</p><p><strong>Discussion and conclusion: </strong>Multivariate logistic regression analysis thus shows that NLR and a low thrombus burden are independent prediction factors for complete reflow in this collective of AIS patients. Patients with anterior circulation AIS coupled with low NLR and low thrombus burden prior to mechanical thrombectomy are more likely to achieve complete reflow.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"411-417"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110588","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":"Contrast medium-induced encephalopathy following coronary angiography and evidence for reversal using intravenous levetiracetam in a heart transplant patient with cardiac allograft vasculopathy: A case report.","authors":"Vedran Pašara, Mirna Momčilović, Andreja Bujan Kovač, Vlatko Šulentić, Romana Perković, Lucija Lučev, Marino Narančić, Daniel Lovrić","doi":"10.5414/CP204714","DOIUrl":"10.5414/CP204714","url":null,"abstract":"<p><strong>Objective: </strong>To present a case of encephalopathy after the administration of an iodinated contrast medium in a coronary angiography procedure.</p><p><strong>Case summary: </strong>A 75-year-old male heart transplant recipient with cardiac allograft vasculopathy underwent coronary angiography followed by percutaneous coronary intervention. An iodinated contrast medium, ioversol, was used. Two hours later, the patient had focal impaired awareness seizure (unresponsive, head and gaze deviated to the left, with oroalimentary and gestural automatisms). Brain imaging showed no acute lesions or perfusion deficits. Electroencephalography revealed the focal slowing on the right fronto-temporal and left fronto-centro-temporal region, as well as paroxysmal discharges of high voltage delta activity (encephalopathic pattern). The patient was treated with intravenous levetiracetam. The symptoms completely resolved the next day, and the patient was discharged after 5 days of hospitalization.</p><p><strong>Discussion: </strong>Contrast-induced encephalopathy (CIE) is an extremely rare complication of cardiac catheterization, with an incidence of 0.06%. Although the exact pathophysiology of this disorder is still not completely understood, it has been hypothesized that hyperosmolar contrast agent causes the shrinkage of endothelial cells, followed by the opening of tight junctions and the disruption of the blood-brain barrier resulting in direct neurotoxicity of the iodinated contrast medium.</p><p><strong>Conclusion: </strong>CIE is a rare complication of cardiac catheterization, likely under-recognized and under-diagnosed due to its variable clinical features, unremarkable or nonspecific radiological findings, and a lack of well-defined diagnostic criteria. Despite the challenging diagnosis and a lack of evidence for treatment strategies, the prognosis is good with supportive therapy.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"439-443"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965337","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":"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/m², was administered intravenously on the first day of each 28-day treatment period. Blood samples were collected at appropriate intervals for estimation of C_max, AUC_0-t, and AUC_0-∞ for free, encapsulated, and total doxorubicin, as well as partial AUC (AUC_0-48h, AUC_48h-last) 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_max, AUC_0-t, and AUC_0-∞ for free doxorubicin and encapsulated doxorubicin, and the 90% CIs for the secondary endpoints C_max, AUC_0-t, and AUC_0-∞ for total doxorubicin and partial exposure parameters AUC_0-48h and AUC_48h-last 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":"444-456"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","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}