International journal of clinical pharmacology and therapeutics最新文献

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Association of antibiotic treatment for second-trimester GBS with reduced miscarriage risk: Probiotic intervention shows no benefit. 妊娠中期GBS的抗生素治疗与流产风险降低的关系:益生菌干预显示无益处。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-18 DOI: 10.5414/CP204790
Mei-Ling Guo, Ya-Nuan Chen, Jian-Hong Fang, Wei-Hong Qi
{"title":"Association of antibiotic treatment for second-trimester GBS with reduced miscarriage risk: Probiotic intervention shows no benefit.","authors":"Mei-Ling Guo, Ya-Nuan Chen, Jian-Hong Fang, Wei-Hong Qi","doi":"10.5414/CP204790","DOIUrl":"10.5414/CP204790","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the colonization rate of group B <i>Streptococcus</i> (GBS) during the second trimester of pregnancy, the correlation between GBS infection and miscarriage as well as the impact of intervention on pregnancy outcomes.</p><p><strong>Materials and methods: </strong>228 GBS-positive pregnant women at 14 - 28 weeks of gestation were divided into 3 groups according to their preferences to receive medical intervention: group A (antibiotic group, n = 54) received oral antibiotic, group B (probiotic group, n = 96) received oral probiotic, and group C (non-intervention group, n = 78) received no drug treatment. 300 GBS-negative pregnant women were selected voluntarily and randomly as the control group (group D). The incidence of miscarriage-related conditions, negative conversion rate of GBS were compared between the 4 groups. Perinatal outcomes were compared between the GBS persistent positive and negative groups.</p><p><strong>Results: </strong>GBS colonization rate was 14.7%. The incidence of threatened miscarriage and miscarriage in group A were 1.85 and 1.85%, both of which were lower than those in group B at 21.9 and 6.3%, and group C at 33.3 and 7.7%, with all differences being statistically significant (p < 0.05). The incidence of threatened miscarriage and miscarriage in group B and group C were significantly higher than those in group D at 3.3 and 2.7% (p < 0.05). The negative conversion rate of GBS in group A was significantly higher than that in group C (14.8 vs. 2.7%, p < 0.05). There was a difference in the incidence of fetal distress, premature delivery, premature rupture of the fetal membrane, chorioamnionitis, and neonatal infection between the continuously positive and negative pregnant women (p < 0.05).</p><p><strong>Conclusion: </strong>GBS colonization rate was 14.7% in the second trimester of pregnancy. GBS infection can increase the risk of threatened miscarriage and miscarriage as well as the risk of adverse pregnancy outcomes. Early intervention with antibiotics can increase the negative conversion rate of GBS, reduce the incidence of threatened miscarriage and miscarriage, and ameliorate the adverse outcome of pregnancy. The effect of probiotic intervention on the negative conversion of GBS was insignificant.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080628","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
Analgesia using sufentanil and sufentanil plus dexmedetomidine following cesarean section and effect on placental hypoxia-inducible factors. 剖宫产术后舒芬太尼与舒芬太尼联合右美托咪定镇痛及对胎盘缺氧诱导因子的影响。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-18 DOI: 10.5414/CP204733
Xiaoling Lv, Xiaoping Lin, Long Ma
{"title":"Analgesia using sufentanil and sufentanil plus dexmedetomidine following cesarean section and effect on placental hypoxia-inducible factors.","authors":"Xiaoling Lv, Xiaoping Lin, Long Ma","doi":"10.5414/CP204733","DOIUrl":"10.5414/CP204733","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the analgesic effect of sufentanil plus dexmedetomidine following cesarean section and to determine its influence on placental hypoxia-inducible factors.</p><p><strong>Materials and methods: </strong>A cohort of 150 puerperae who underwent prenatal examinations and cesarean section in our hospital were randomized into a control group (n = 75) and a study group (n = 75). Anesthesia and analgesia were carried out using sufentanil alone in the control group and sufentanil plus dexmedetomidine in the study group. Measurements were made before anesthesia (T0), 5 minutes (T1) and 10 minutes (T2) after anesthesia, and immediately after delivery (T3) and after the end of surgery (T4).</p><p><strong>Results: </strong>Mean arterial pressure (MAP) and heart rate (HR) decreased in both groups at T1 - T4 compared with T0, but were higher in the study group compared to the control group (p < 0.05). The visual analogue scale (VAS) score, and levels of substance P (SP), neuropeptide Y (NPY) and malondialdehyde (MDA) in the study group were lower than those in the control group (p < 0.05). The beginning and duration of labor and the dose of analgesics within the 48-hour observation period were all lower in the study group compared to the control group (p < 0.05).</p><p><strong>Conclusion: </strong>Sufentanil plus dexmedetomidine can effectively maintain hemodynamic stability during cesarean section without marked changes in placental hypoxia-inducible factors and oxidative stress responses and has a limiting effect on the secretion of pain mediators.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080596","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
Ocrelizumab use before pregnancy and neonatal B-cell depletion: A case report. 妊娠前使用奥克雷单抗和新生儿b细胞耗竭:1例报告。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-04 DOI: 10.5414/CP204853
Georgios Eleftheriou, Anna Sangiovanni, Raffaella Butera, Mariapina Gallo, Andrea Giampreti, Lorella Faraoni, Marco Cirronis, Maria Gioia Contessa, Giuseppe Bacis
{"title":"Ocrelizumab use before pregnancy and neonatal B-cell depletion: A case report.","authors":"Georgios Eleftheriou, Anna Sangiovanni, Raffaella Butera, Mariapina Gallo, Andrea Giampreti, Lorella Faraoni, Marco Cirronis, Maria Gioia Contessa, Giuseppe Bacis","doi":"10.5414/CP204853","DOIUrl":"10.5414/CP204853","url":null,"abstract":"<p><p>Ocrelizumab is a recombinant humanized IgG1 monoclonal antibody that depletes B lymphocytes by binding their surface antigen CD20 and is approved for the relapsing forms of multiple sclerosis (MS). Several studies report that in utero exposure to ocrelizumab is not associated with an increased risk of malformations, and very few cases of neonatal B-cell count depletion are described after therapy ending shortly before conception or during early pregnancy. We report the first case of transient and complete neonatal B-cell depletion, while conception took place 3 months after the last administration.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992256","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
Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024). 使用FAERS数据库对狼疮性肾炎患者进行为期42个月(2021 - 2024)的voclosporin IV期安全性评估。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204726
Bo Gu, Bing Lv, Jia Tang
{"title":"Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024).","authors":"Bo Gu, Bing Lv, Jia Tang","doi":"10.5414/CP204726","DOIUrl":"https://doi.org/10.5414/CP204726","url":null,"abstract":"<p><strong>Objective: </strong>Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data.</p><p><strong>Materials and methods: </strong>AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals.</p><p><strong>Results: </strong>We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4 - 208 days), with ~ 43% of AEs occurring within the first month of commencing voclosporin therapy.</p><p><strong>Conclusion: </strong>Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144952899","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
Expression of the genes QPRT, RAB26, and SRPRB in cancer tissue from patients with triple-negative breast cancer as a biomarker for diagnosis, pharmacotherapy strategy, and survival: Evidence from bioinformatic database analysis
. QPRT、RAB26和SRPRB基因在三阴性乳腺癌患者癌组织中的表达作为诊断、药物治疗策略和生存的生物标志物:来自生物信息学数据库分析的证据
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204751
Yarui Liu, Ying Zeng
{"title":"Expression of the genes QPRT, RAB26, and SRPRB in cancer tissue from patients with triple-negative breast cancer as a biomarker for diagnosis, pharmacotherapy strategy, and survival: Evidence from bioinformatic database analysis\u2029.","authors":"Yarui Liu, Ying Zeng","doi":"10.5414/CP204751","DOIUrl":"https://doi.org/10.5414/CP204751","url":null,"abstract":"<p><strong>Objective: </strong>To screen differentially expressed genes (DEGs) in triple-negative breast cancer (TNBC) by bioinformatic methods and explore their relationship between TNBC prognosis and related biological functions.</p><p><strong>Materials and methods: </strong>Microarray dataset GSE65194 was downloaded from Gene Expression Omnibus (GEO) database. The whole TNBC-related datasets were downloaded from The Cancer Genome Atlas (TCGA) database. After screening DEGs in R software, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were performed to predict the function of these DEGs. The survival curve examination of the DEGs was performed based on TCGA database and Kaplan-Meier plotter website. In addition, the gene-drug interaction network was explored using the Comparative Toxicogenomics Database (CTD).</p><p><strong>Results: </strong>A total of 2,496 up-regulated and 142 down-regulated DEGs were revealed in GEO database and TCGA database simultaneously. The GO and KEGG analysis revealed enrichment in regulation of nucleobase, nucleoside, nucleic acid metabolism, DNA binding, and integrin family cell surface interactions. Furthermore, up-regulation of quinolinate phosphoribosyl transferase (<i>QPRT</i>), member RAS oncogene family (<i>RAB26</i>), and SRP receptor subunit beta (<i>SRPRB</i>) were significantly associated with survival in TNBC patients.</p><p><strong>Conclusion: </strong><i>QPRT</i>, <i>RAB26,</i> and <i>SRPRB</i> may be three potential novel prognostic biomarkers for TNBC and will provide potential guidance value for future research on TNBC.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953321","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
Drug interactions in hospitalized patients: Critical importance of renal disease and drug monitoring based on data from hospital departments of internal medicine in Serbia. 住院患者的药物相互作用:基于塞尔维亚医院内科数据的肾脏疾病和药物监测的至关重要性。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204648
Aneta Drndarević, Ivana Draganov, Milena Kovačević, Miljanka Vuksanović, Aleksandar Janković, Ana Kalaba, Branislava Miljković, Sandra Vezmar Kovačević
{"title":"Drug interactions in hospitalized patients: Critical importance of renal disease and drug monitoring based on data from hospital departments of internal medicine in Serbia.","authors":"Aneta Drndarević, Ivana Draganov, Milena Kovačević, Miljanka Vuksanović, Aleksandar Janković, Ana Kalaba, Branislava Miljković, Sandra Vezmar Kovačević","doi":"10.5414/CP204648","DOIUrl":"https://doi.org/10.5414/CP204648","url":null,"abstract":"<p><strong>Introduction: </strong>Drug-drug interactions (DDIs) have been associated with adverse drug reactions (ADRs) which can cause hospitalization. The aim of this study was to associate potential DDIs (pDDIs) with potential ADRs upon admission to hospital among patients on five internal medicine wards.</p><p><strong>Materials and methods: </strong>A cross-sectional study was performed on the cardiology, nephrology, endocrinology, gastroenterology, and geriatrics ward. The patients' sociodemographic characteristics, medical history, clinical and laboratory parameters were recorded.</p><p><strong>Results: </strong>In total, 474 patients participated in the study. The mean age was 69.7 ± 12.8 years. We identified 1,949 pDDIs in 389 patients (82.1%), with an average of 5.0 ± 4.7 (range 1 - 34). angiotensin-converting enzyme inhibitors, loop diuretics, aspirin, and β-blockers were most frequently involved in DDIs, and the most common possible adverse outcomes were renal failure, decreased blood pressure, bleeding, and hypoglycemia. Asthma/chronic obstructive pulmonary disease, heart failure, nephrology ward, number of medications, acute myocardial infarction and diabetes were predictive for clinically relevant pDDIs. Elevated urea and serum creatinine levels were associated with pDDIs resulting in possible renal failure. Anticoagulants were associated with Prothrombin time-international normalized ratio levels >3 (6.23; 3.80 - 10.21; p < 0.001), whereas the presence of pDDIs leading to clopidogrel inefficacy was associated with elevated troponin levels (OR 4.03; 1.96 - 8.27; p < 0.001).</p><p><strong>Conclusion: </strong>We associated comorbidities with different classes of clinically significant pDDIs and possible outcomes such as renal failure, bleeding, and clopidogrel inefficacy with appropriate laboratory parameters outside the reference range. The pDDI-associated inefficacy of clopidogrel may have caused patient hospitalization due to reinfarction.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953352","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
Relationship between the blood neutrophil:lymphocyte ratio and response to intravascular mechanical thrombectomy in acute ischemic stroke with anterior circulation large vessel occlusion. 急性缺血性卒中伴前循环大血管闭塞患者血中性粒细胞与淋巴细胞比值与血管内机械取栓反应的关系。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204643
Xinming Li, Dejiang Yang, Yanyan Wei, Yao Zhi, Lijun Lu, Zhenyu Tang
{"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}
引用次数: 0
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. 冠状动脉造影后造影剂诱导的脑病和静脉注射左乙拉西坦逆转心脏移植伴同种异体移植血管病变的证据:1例报告。
IF 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204714
Vedran Pašara, Mirna Momčilović, Andreja Bujan Kovač, Vlatko Šulentić, Romana Perković, Lucija Lučev, Marino Narančić, Daniel Lovrić
{"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}
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 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 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":"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}
引用次数: 0
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 0.7 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2025-09-01 DOI: 10.5414/CP204795
Naoto Kimura, Ryosuke Ota, Atsushi Hirata
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