Int J Clin Pharmacol Ther
· 2025 Nov · PMID 40736189
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A patient with advanced small cell lung cancer presented with systemic skin pigmentation, a rare and severe skin adverse reaction during treatment with osimertinib. Osimertinib-induced hyperpigmentation is rarely reporte...A patient with advanced small cell lung cancer presented with systemic skin pigmentation, a rare and severe skin adverse reaction during treatment with osimertinib. Osimertinib-induced hyperpigmentation is rarely reported, According to the patient's condition, adverse drug reactions, and drug efficacy, osimertinib was the urgently needed treatment regimen, and 80 mg of osimertinib was continued. Therefore, we hope this case can provide experience for clinicians to identify adverse reactions of the drug and ensure the safety of patients.
PURPOSE: To evaluate skin toxicity associated with immune checkpoint inhibitors (ICIs) using data mining and the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). MATERIALS AND METHODS: Data...PURPOSE: To evaluate skin toxicity associated with immune checkpoint inhibitors (ICIs) using data mining and the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). MATERIALS AND METHODS: Data on skin toxicity associated with the use of ICIs were retrieved for the period January 2011 to September 2023. Analysis was done using various methods, including reporting odds ratio (ROR) estimates, proportional reporting ratios (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker estimates (MGPS). Mortality and hospitalization data were also assessed. RESULTS: A total of 8,129 skin toxicity reports concerning "ICIs" as the "primary suspected cause" were documented, accounting for 18.89% of all reported adverse events. Anti-PD-1 agents showed the highest incidence of skin toxicity, whereas anti-CTLA-4 monotherapy was associated with the most significant changes in ROR, PRR, empirical Bayesian geometric mean (EBGM), and information component (IC) values. The median onset of toxicity was 17 days after commencement of ICI treatment, consistent across sexes, age groups, and ICI types. The highest mortality rate occurred with anti-PD-1 treatment (11.37%), and there was a significant difference in mortality rates between different ICI treatments (monotherapy vs. combination therapy) (p = 0.03). CONCLUSION: Differences are present between ICI regimens in the pattern of skin toxicity with anti-PD-1 therapies exhibiting the highest incidence of skin toxicity and mortality rates, while anti-CTLA-4 therapies showed the most marked signals.
Ye P, Zhang H, Lyu Q
… +4 more, Zhang W, Xu Y, Ye X, Guo X
Int J Clin Pharmacol Ther
· 2025 Nov · PMID 40662741
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OBJECTIVE: 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 VigiB...OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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)). CONCLUSION: 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.
OBJECTIVE: This study aimed to investigate the baseline neutrophil count as a risk factor for ganciclovir-induced neutropenia in greater detail. MATERIALS AND METHODS: This retrospective observational study included pati...OBJECTIVE: This study aimed to investigate the baseline neutrophil count as a risk factor for ganciclovir-induced neutropenia in greater detail. MATERIALS AND METHODS: 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, 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. RESULTS: 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 were at significantly higher risk of severe neutropenia compared to those with baseline counts ≥ 4,000 cells/mm (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). CONCLUSION: 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.
Tjandrawinata RR, Yunaidi DA, Kurniawan YI
… +5 more, Nindyatami C, Saputro ID, Aziswan SA, Ginanjar VA, Susanto LW
Int J Clin Pharmacol Ther
· 2025 Oct · PMID 40662739
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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...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, AUC, C, t, and T) were calculated. The 90% confidence interval (CI) for the test/reference geometric mean ratio (GMR) of the AUC was 80.2 - 98.4%, and for AUC it was 80.5 - 120.1%. The 90% CI GMR of C was 89.3 - 107.7%. All parameters were within the 90% CI GMR acceptance criteria of 80.0 - 125.0%. The T and t 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.
Wang DQ, Hu FB, Wang W
… +4 more, Dou HJ, Ling L, Zheng CB, Guo Y
Int J Clin Pharmacol Ther
· 2025 Oct · PMID 40643182
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BACKGROUND: 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)....BACKGROUND: 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). AIMS: To investigate the effects of omega-3 fatty acids on delirium in patients with sepsis. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: Omega-3 fatty acids may effectively reduce the risk of delirium in sepsis patients, highlighting their potential as a therapeutic intervention in this population.
Aanaimuthu R, Rajendran SR, Mudharaikal T
… +3 more, Sivasamy J, Suresh R, Srinivasan S
Int J Clin Pharmacol Ther
· 2025 Oct · PMID 40643181
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UNLABELLED: 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, particular...UNLABELLED: 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. OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
AIMS: To investigate prescription patterns in children and adolescents receiving treatment for primary hypertension. MATERIALS AND METHODS: Cumulative prescriptions within the 12-month period before the index date were a...AIMS: To investigate prescription patterns in children and adolescents receiving treatment for primary hypertension. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Int J Clin Pharmacol Ther
· 2025 Sep · PMID 40599109
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OBJECTIVE: 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 cabotegra...OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND: Berberine, a traditional Chinese medicine, has demonstrated significant therapeutic influences in treating diabetes, obesity, and diarrhea, among other conditions. It has exhibited potential therapeutic benef...BACKGROUND: 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). AIMS: This study aims to elucidate the mechanism behind berberine pharmacological action in treating AD. MATERIALS AND METHODS: We search the articles published in PubMed and CNKI and summarize the mechanism of berberine in AD. RESULTS: 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. CONCLUSION: 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.
Zhang L, Geng C, Wang M
… +17 more, Chen W, Li F, Wang X, Wang X, Zang A, Niu Z, Zhao F, Yang H, Sun H, Song H, Liu W, Yu F, Jia X, Tong J, Che X, Bai L, Deng X
OBJECTIVE: To determine the pharmacokinetic properties and bioequivalence of a reference doxorubicin injectable formulation (Caelyx) and the test formulation, a newly developed doxorubicin hydrochloride liposome injectio...OBJECTIVE: 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. MATERIALS AND METHODS: The study was multicentric, randomized, open-label, two-treatment, two-period, two-sequence, single dose with crossover. The dose, equivalent to 50 mg/m, was administered intravenously on the first day of each 28-day treatment period. Blood samples were collected at appropriate intervals for estimation of C, AUC, and AUC for free, encapsulated, and total doxorubicin, as well as partial AUC (AUC, AUC) for encapsulated doxorubicin. RESULTS: The 90% confidence intervals (CI) for the geometric mean ratio (GMR) of the primary endpoints for determination of bioequivalence namely, C, AUC, and AUC for free doxorubicin and encapsulated doxorubicin, and the 90% CIs for the secondary endpoints C, AUC, and AUC for total doxorubicin and partial exposure parameters AUC and AUC 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). CONCLUSION: 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.
Nitta A, Goda M, Niimura T
… +11 more, Kajihara T, Sato M, Chuma M, Kawada K, Tsujinaka K, Miyata K, Kono Y, Aizawa F, Yagi K, Izawa-Ishizawa Y, Ishizawa K
Int J Clin Pharmacol Ther
· 2025 Aug · PMID 40396698
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BACKGROUND: 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...BACKGROUND: 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 or coagulase-negative , which are challenging to treat due to biofilm formation. However, its effectiveness is unclear. The effectiveness of anti-methicillin-resistant (MRSA) antibiotics combined with rifampicin is also unclear. OBJECTIVE: This study assessed the effectiveness and safety of MRSA antibiotics combined with rifampicin for treating methicillin-resistant staphylococcal PJI using a Japanese clinical database. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
AIMS: 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 (A...AIMS: 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. MATERIALS AND METHODS: 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. RESULTS: 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. DISCUSSION AND CONCLUSION: 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.
OBJECTIVE: To present a case of encephalopathy after the administration of an iodinated contrast medium in a coronary angiography procedure. CASE SUMMARY: A 75-year-old male heart transplant recipient with cardiac allogr...OBJECTIVE: To present a case of encephalopathy after the administration of an iodinated contrast medium in a coronary angiography procedure. CASE SUMMARY: 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. DISCUSSION: 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. CONCLUSION: 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.
BACKGROUND: A simple and rapid assay method is urgently required in clinical settings to monitor the efficacy and safety of antibiotics in pediatric patients with urinary tract infection (UTI). AIMS: To develop a cost-ef...BACKGROUND: A simple and rapid assay method is urgently required in clinical settings to monitor the efficacy and safety of antibiotics in pediatric patients with urinary tract infection (UTI). AIMS: To develop a cost-effective high-performance liquid chromatography-ultraviolet (HPLC-UV) method to simultaneously determine cefaclor and cefmetazole concentrations in the urine of pediatric patients with UTI. MATERIALS AND METHODS: Calibration curves were used to validate the linear ranges of cefaclor (31.25 - 500 µg/mL) and cef-metazole (62.5 - 1,000 µg/mL). RESULTS: The developed method showed satisfactory precision: intra-day coefficients of variations (CV) 1.1 - 7.6% and inter-day CV of 3.7 - 13.8% for cefaclor, and intra-day CV of 0.5 - 5.9% and inter-day CV of 4.5 - 13.2% for cefmetazole. The validity of the method was confirmed using urine bag samples from infants with UTI. The urinary concentrations of cefaclor and cefmetazole in infants with UTI were 313.5 μg/mL and 1,572.5 μg/mL, respectively. CONCLUSION: We developed and validated an HPLC-UV method for the simultaneous measurement of cefaclor and cefmetazole in pediatric patients with UTI. The assay is rapid, cost-effective, and suitable for therapeutic drug monitoring.
Int J Clin Pharmacol Ther
· 2025 Aug · PMID 40338118
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AIM: 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 intrav...AIM: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Int J Clin Pharmacol Ther
· 2025 Aug · PMID 40338117
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OBJECTIVES: This study aimed to investigate the risk factors associated with developing cardiac arrhythmias in patients with acute heart failure treated with levosimendan. MATERIALS AND METHODS: A retrospective analysis...OBJECTIVES: This study aimed to investigate the risk factors associated with developing cardiac arrhythmias in patients with acute heart failure treated with levosimendan. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.