International journal of clinical pharmacology and therapeutics最新文献

{"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":""},"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}

{"title":"Anti-neurodegenerative treatment in Alzheimer's disease: Multifaceted mechanisms of action of berberine.","authors":"Dandan Song, Congmin Zhang","doi":"10.5414/CP204725","DOIUrl":"10.5414/CP204725","url":null,"abstract":"<p><strong>Background: </strong>Berberine, a traditional Chinese medicine, has demonstrated significant therapeutic influences in treating diabetes, obesity, and diarrhea, among other conditions. It has exhibited potential therapeutic benefits for various neurodegenerative diseases, namely, Alzheimer's disease (AD), Huntington's disease (HD), and Parkinson's disease (PD).</p><p><strong>Aims: </strong>This study aims to elucidate the mechanism behind berberine pharmacological action in treating AD.</p><p><strong>Materials and methods: </strong>We search the articles published in PubMed and CNKI and summarize the mechanism of berberine in AD.</p><p><strong>Results: </strong>In recent years, as research into the pharmacology of berberine has deepened, researchers have discovered its strong neuroprotective properties. The ability of berberine to enhance cognitive function is thought to result from inhibiting the spread of AD-related proteins, reducing oxidative stress and inflammation, increasing choline levels, and regulating autophagy.</p><p><strong>Conclusion: </strong>This review explores the latest research on berberine in AD, suggesting that berberine and its analogs may offer a promising new approach to treating the condition.</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":"144199034","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":"Immune-mediated hepatitis caused by toripalimab: A case report.","authors":"Taoyan Lin, Ping Zheng, Yilei Li, Jing Cai","doi":"10.5414/CP204647","DOIUrl":"10.5414/CP204647","url":null,"abstract":"<p><p>Toripalimab, a humanized anti-PD-1 monoclonal antibody, is widely employed in the treatment of non-small cell lung cancer (NSCLC) and various other malignancies. However, there have been no reported cases linking prolonged administration of toripalimab to immune-mediated hepatitis (IMH). Typically, immune checkpoint inhibitor (ICI)-related IMH manifests within the first few weeks or months following the initiation of therapy. In this report, we presented a case of IMH in a patient with NSCLC following ~ 17 months of toripalimab treatment. IMH induced by toripalimab may occur at any time during treatment, underscoring the need for clinicians to remain vigilant in monitoring for adverse reactions. Throughout toripalimab treatment, careful attention must be paid to the symptoms, diagnosis, and pathological features of IMH. Glucocorticoids, such as methylprednisolone, can effectively reduce liver enzyme markers like aspartate aminotransferase and alanine aminotransferase in patients experiencing toripalimab-induced IMH.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"287-292"},"PeriodicalIF":0.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673832","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":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-21","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":"Rifampicin in combination treatments for methicillin-resistant staphylococcal prosthetic joint infections: Claims database evaluation using a cohort of 52,588 hip arthroplasty patients.","authors":"Ayaka Nitta, Mitsuhiro Goda, Takahiro Niimura, Toshiki Kajihara, Maki Sato, Masayuki Chuma, Kei Kawada, Kaito Tsujinaka, Koji Miyata, Yuki Kono, Fuka Aizawa, Kenta Yagi, Yuki Izawa-Ishizawa, Keisuke Ishizawa","doi":"10.5414/CP204740","DOIUrl":"10.5414/CP204740","url":null,"abstract":"<p><strong>Background: </strong>Hip arthroplasty is a common surgical procedure effective for pain relief and maintaining walking function. Prosthetic joint infection (PJI) is a serious complication. Rifampicin combination therapy is widely used to treat PJIs caused by <i>Staphylococcus aureus</i> or coagulase-negative <i>Staphylococcus</i>, which are challenging to treat due to biofilm formation. However, its effectiveness is unclear. The effectiveness of anti-methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) antibiotics combined with rifampicin is also unclear.</p><p><strong>Objective: </strong>This study assessed the effectiveness and safety of MRSA antibiotics combined with rifampicin for treating methicillin-resistant staphylococcal PJI using a Japanese clinical database.</p><p><strong>Materials and methods: </strong>This retrospective analysis used the claims database to examine data on PJI after hip arthroplasty among patients aged 20 years or older who were treated with anti-MRSA antibiotics, with or without rifampicin, from 2014 to 2021. The primary outcome was defined as no revision arthroplasty, while the safety outcomes were renal dysfunction and hypersensitivity.</p><p><strong>Results: </strong>Among 52,588 patients who underwent hip replacement or artificial head insertion surgeries, 53 were treated for PJI with anti-MRSA antibiotics and received debridement, antibiotics, and implant retention, with 33 without rifampicin and 20 with rifampicin. The incidence of revision arthroplasty did not differ significantly between the two groups (3 vs. 5 patients; log-rank test, p = 0.195). The incidence of adverse events was similar between the two groups.</p><p><strong>Conclusion: </strong>In this analysis, rifampicin combination therapy provided no additional benefit in treating methicillin-resistant PJI after hip replacement surgery. If used together, close monitoring for the occurrence of adverse effects is advised.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110592","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":"https://doi.org/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":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-13","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":"Serum potassium is a critical risk factor for cardiac arrhythmias in acute heart failure patients treated with levosimendan: A retrospective study in a cohort of 250 patients.","authors":"Wenguang Liu, Xiaowu Wang, Dong Wu, Zhen Ma, Bin Ning","doi":"10.5414/CP204692","DOIUrl":"https://doi.org/10.5414/CP204692","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to investigate the risk factors associated with developing cardiac arrhythmias in patients with acute heart failure treated with levosimendan.</p><p><strong>Materials and methods: </strong>A retrospective analysis was conducted in patients diagnosed with acute heart failure or acute exacerbation of chronic heart failure treated with levosimendan. The patients were divided into arrhythmia and non-arrhythmia groups based on the presence of rapid-type arrhythmias. Logistic regression analysis was used to identify independent risk factors for levosimendan-induced arrhythmias.</p><p><strong>Results: </strong>Among the 250 patients, 49 (19.60%) experienced nine types of cardiac arrhythmias, the most common being atrial fibrillation (28.57%). The highest incidence of arrhythmias occurred within 48 hours of levosimendan infusion (77.6%). Multivariate analysis indicated that the lowest serum potassium concentration within 5 days after drug administration (odds ratio (OR) 0.410, p = 0.010, 95% confidence interval (CI) 0.209 - 0.805), micro-pump speed of > 0.2 μg/kg/min (OR 3.106, p = 0.039, 95% CI 1.584 - 11.789), and concomitant use of drugs that prolong the QT interval (OR 4.226, p = 0.001, 95% CI 1.850 - 9.657) were independent risk factors for levosimendan-induced arrhythmias. The incidence of arrhythmias increased when the lowest serum potassium concentration within 5 days after drug administration was below 3.94 mmol/L.</p><p><strong>Conclusion: </strong>This study identified risk factors associated with levosimendan-induced arrhythmias. Clinicians should monitor at-risk patients when administering levosimendan. When using levosimendan in clinical practice, it is necessary to maintain a serum potassium concentration above 3.94 mmol/L.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964425","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":"The vancomycin dosage calculator: Prediction superiority and validation in a comparison of four algorithms using retrospective data from non-critical patients aged 18 to 59 years.","authors":"Chuzhu Huang, Jia Wang, Yan Chen, Yilin Huang, Zhuomin Wu","doi":"10.5414/CP204793","DOIUrl":"https://doi.org/10.5414/CP204793","url":null,"abstract":"<p><strong>Aim: </strong>This study aimed to evaluate the current status of vancomycin population pharmacokinetic modeling and assess four pharmacokinetic prediction models for predicting vancomycin blood levels in patients receiving intravenous vancomycin at our hospital. The goal was to establish a basis for personalized vancomycin dosing to minimize adverse reactions.</p><p><strong>Materials and methods: </strong>This retrospective study analyzed patients receiving intravenous vancomycin treatment for infections at the First Affiliated Hospital of Shantou University Medical College from January 2021 to December 2023. Patient data, including demographics and vancomycin treatment specifics, were retrieved from the hospital's integrated healthcare workstation. We evaluated the predictive performance of four vancomycin dosing algorithms using PE, APE, and p-value to assess their accuracy in forecasting steady-state vancomycin blood trough concentrations. Additionally, paired t-tests were conducted to examine the correlation between measured and predicted values across the four models.</p><p><strong>Results: </strong>The Vancomycin Individualized Dosing Platform, Smart Dose as well as the Vancomycin Dosage Recommendation and Blood Concentration Prediction System had substandard mean prediction errors and mean absolute prediction errors, all of which were poorly predictive for all age groups.</p><p><strong>Conclusion: </strong>Of the four pharmacokinetic prediction models assessed, only the Vancomycin Calculator accurately predicted vancomycin dosing for adult non-critical patients aged 18 - 59 years at our hospital. The other three models demonstrated suboptimal performance and did not achieve the necessary level of predictive accuracy. It is essential to exercise caution when using unvalidated pharmacokinetic models. Although the Vancomycin Calculator performed well, the other models need thorough validation before being used clinically, especially in diverse populations and settings.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994375","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 severe psoriasis in a hospice care patient using secukinumab, an inhibitor of interleukin-17A expression: Treatment response and changes in quality of life.","authors":"Yu Zhou, Xueting Ma, Hong Guo, Shaokai Zhang","doi":"10.5414/CP204787","DOIUrl":"https://doi.org/10.5414/CP204787","url":null,"abstract":"<p><p>Secukinumab, a fully human monoclonal antibody that antagonizes interleukin-17A (IL-17A), has proven efficacious in the management of moderate to severe plaque psoriasis. Secukinumab has established itself as an effective treatment for plaque psoriasis, offering rapid and sustained symptom improvement. However, more research is warranted to assess its efficacy and safety in elderly patients, where clinical data is currently lacking. We describe an 84-year-old female presented with stable angina pectoris needed to be hospice cared. She had more than 30 years history of plaque psoriasis. The patient underwent treatment with secukinumab for two weeks. The skin lesions had been decreased rapidly and this greatly improved quality life of this patient. We report the clinical use of secukinumab in the treatment of elderly psoriasis and biologicals may be a new strategy for hospice care of patients with psoriasis.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997986","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":"Selpercatinib blood trough concentration after gastrectomy with <i>RET</i> fusion-positive thyroid cancer: A case report.","authors":"Naoya Tonomura, Takeo Yasu, Chisato Doi, Satoshi Yamaguchi, Ayumi Mori","doi":"10.5414/CP204816","DOIUrl":"https://doi.org/10.5414/CP204816","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021775","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}