Concentrated oral enteral nutrition (EN) formulas are used when adequate energy intake is required despite limited feeding volume, but their compatibility with tablets has not been fully evaluated. We observed computed tomography (CT) findings suggestive of gastrointestinal retention of magnesium oxide (MgO) tablets in an older inpatient receiving concentrated EN and performed an exploratory in vitro disintegration study. Clinical medication, nutrition, and CT data were reviewed retrospectively. The CT attenuation and diameter of intraluminal tablet-like structures were compared with those of an intact MgO tablet scanned in water. For in vitro testing, MgO tablets were evaluated using Japanese Pharmacopoeia-based disintegration testing in purified water, simulated gastric fluid, and simulated intestinal fluid, with or without 30-min pre-exposure to Recovery K5, a concentrated oral EN formula. Direct disintegration in Recovery K5 was also examined as a worst-case condition. Results were summarized descriptively. CT showed three discrete high-attenuation intraluminal structures measuring 9.0–9.4 mm and 501–880 HU, findings compatible with suspected undisintegrated MgO tablets. Without pre-exposure, MgO tablets disintegrated within 8–10 s. After pre-exposure to Recovery K5, mean disintegration times increased to 338.5–422.2 s. In Recovery K5 itself, tablets remained incompletely disintegrated beyond 10,020 s. This brief report does not establish definitive causality, but it identifies a clinically relevant signal supported by in vitro evidence. These findings support pharmacist-led review of the actual administration sequence, water volume, and dosage-form selection when MgO tablets are administered concomitantly with Recovery K5, a concentrated oral EN formula.
Long-acting injectable (LAI) antipsychotics are commonly used to address poor adherence. However, their effects on prescribed oral doses remain unclear. This study investigated LAI-related changes in antipsychotic dose. This retrospective study included 33 Japanese patients with schizophrenia who began treatment with one of the following LAIs: risperidone long-acting injection biweekly (RLAI), paliperidone palmitate long-acting injection monthly (PP), or aripiprazole hydrate prolonged release injection monthly (AOM). Prescribed drugs and doses were recorded at seven time points, from 4 weeks before to 24 weeks after LAI initiation. Doses were converted to chlorpromazine (CP) equivalents, and dose changes were assessed. Effects of disorder duration and age at LAI initiation were also evaluated. After LAI initiation, significant dose increases were observed in PP- and AOM-treated patients but not in those receiving RLAI. In AOM-treated patients,
The association of prescription proposal after telephone follow up (TFU) initiated by health insurance-covered pharmacy-based pharmacists (hereinafter “community pharmacists”) having oncology-related professional certification with patients’ quality of life (QOL) has not been elucidated. This study investigated changes in QOL before and after prescription proposals following TFUs in cancer patients receiving outpatient chemotherapy. Cancer patients undergoing outpatient chemotherapy, who used Akebono Pharmacy Medical Branch and received TFU between August 2023 and July 2025 were analyzed. Follow-up was conducted using a Telephone Follow-up Form. Adverse events were assessed through open-ended questions, and severity was graded based on the Common Terminology Criteria for Adverse Events. QOL was assessed using the European Quality of Life Five Dimensions Five Levels (EQ-5D-5L) scale. Among 107 community pharmacist-initiated prescription proposals, 84 resulted in prescription changes, and QOL improved significantly after prescription changes (p < 0.001). By adverse event type, the severity (grade) of pain, nausea, and constipation was also mitigated significantly after prescription changes (p < 0.001, p = 0.002, p = 0.037, respectively). This study suggests that community pharmacist-initiated prescription proposals based on TFU may contribute to favorable QOL outcomes through mitigating adverse events in cancer patients undergoing outpatient chemotherapy. However, some patients showed QOL improvement even though the adverse event grade remained unchanged. These results suggest that QOL assessment using the EQ-5D-5L in cancer patients undergoing outpatient chemotherapy may complement adverse event grades by capturing changes in patients' subjective health status.
Dexamethasone (DEX), a type of corticosteroid, is widely used as an essential component of antiemetic prophylaxis in chemotherapy and chemoradiotherapy. However, corticosteroid is associated with adverse events, including delirium. Although dose reduction of the causative agent is generally recommended when adverse events occur, evidence regarding the feasibility of DEX dose reduction in emetogenic regimens, particularly weekly paclitaxel/carboplatin with concurrent radiotherapy (weekly PAC/CBDCA + RT), is limited. We present two cases of successful DEX dose reduction in patients undergoing weekly PAC/CBDCA + RT who developed delirium suspected to be associated with DEX. In both cases, DEX was initially administered at 6.6 mg for antiemetic prophylaxis. Following the development of delirium, the DEX dose was gradually decreased; the absence of nausea and vomiting was considered in assessing the feasibility of dose reduction. After dose reduction, the symptoms of delirium improved, with no apparent deterioration in antiemetic control based on objective clinical assessment, including CTCAE assessment and the absence of rescue antiemetic use. One patient discontinued chemotherapy because of persistent hematologic toxicity. These two cases suggest that a gradual reduction of DEX dosage may be considered as a potential management strategy for selected patients undergoing weekly PAC/CBDCA + RT when steroid-related adverse events, such as delirium, occur. Careful monitoring and personalized adjustment of antiemetic regimens may facilitate the treatment continuation while maintaining antiemetic control of treatment, even in moderate emetogenic chemoradiotherapy settings.
Cefepime (CFPM)-associated neurotoxicity is linked to elevated plasma concentrations, particularly in patients with impaired renal function. Although cystatin C-based estimated glomerular filtration rate (eGFRcys) has been proposed as a potentially superior marker of renal function for dose optimization, its clinical applicability for predicting CFPM exposure remains insufficiently established. We developed a clinically applicable high-performance liquid chromatography (HPLC) method for plasma CFPM quantification and evaluated the clinical utility of eGFRcys, with particular focus on its discordance with creatinine clearance (Ccr). This prospective study enrolled 22 hospitalized patients receiving CFPM. Steady-state trough concentrations were measured using the developed HPLC method. Overexposure was defined as ≥ 16 µg/mL, based on a previously reported threshold associated with an increased risk of cefepime neurotoxicity. Associations between trough concentrations and renal function indices were evaluated using Spearman’s correlation, and the impact of discordance between Ccr and body surface area-adjusted eGFRcys [eGFRcys(BSA)] on CFPM exposure was investigated. The HPLC assay demonstrated excellent analytical performance, including high precision and robust chromatographic separation under polypharmacy conditions, enabling reliable quantification in routine clinical practice. Despite Ccr-guided dosing, 55
Therapeutic drug monitoring (TDM) is essential for drugs with narrow therapeutic ranges and high pharmacokinetic variability. However, significant barriers hinder TDM implementation. Outsourcing of testing can delay timely clinical decision-making, with possible delays of up to 1 week. Additionally, management of analyte-specific certified reference material (CRM) presents substantial operational challenges, particularly for unstable compounds. The present study therefore developed and validated a high-performance liquid chromatography (HPLC) method based on relative molar sensitivity (RMS) of stable non-analyte reference materials (carbamazepine and caffeine) to quantify five clinically important analytes—acetaminophen, two beta-lactam antibiotics (cefmetazole and cefazolin), and amiodarone and its active metabolite, N-desethylamiodarone. RMS values were calculated as the ratio of the analyte and non-analyte reference material calibration curve slopes. CRM solutions were used at 6 to 10 concentrations per analyte. HPLC analysis utilized analyte-specific detection wavelengths in the range 240–275 nm. For validation, control serum samples were spiked at 2 or 3 concentrations per analyte and processed via spin-column solid-phase extraction. Quantitative accuracy was assessed by comparing the RMS-based results with conventional absolute calibration methods. All calibration curves demonstrated excellent linearity, with correlation coefficients in the range 0.9993–1.0000. Calibration curve slope reproducibility was high, with relative standard deviations of 0.3
Guideline-directed medical therapy (GDMT) improves outcomes in heart failure with reduced ejection fraction (HFrEF). However, implementation remains suboptimal, and evidence for inpatient pharmacist-led interventions is limited. We evaluated the association between a pharmacist-led electronic medical record (EMR)-embedded checklist and GDMT use in hospitalized patients with acute heart failure. A single-center, retrospective, non-randomized study with a historical control group was conducted. Adult patients hospitalized with acute heart failure from October 2021 to March 2023 were enrolled. Patients admitted between October 2022 and March 2023 formed the pharmacist-led GDMT checklist intervention group, whereas those admitted between October 2021 and March 2022 served as historical controls. Primary outcomes were discharge implementation and new initiation rates of individual GDMT agents (renin–angiotensin system inhibitors, beta-blockers, mineralocorticoid receptor antagonists [MRA], sodium–glucose cotransporter-2 inhibitors [SGLT2i]) and quadruple therapy. Exploratory multivariable logistic regression was performed for quadruple therapy use at discharge in patients with HFrEF. Secondary outcomes included target-dose achievement, exploratory 90-day heart failure readmission, and all-cause mortality. A total of 103 patients were included (49 controls, 54 intervention). Among patients with HFrEF (22 controls, 23 intervention), the intervention group had higher prescription rates of MRA (87.0
Oral semaglutide, a glucagon-like peptide-1 receptor agonist, improves glycemic control and reduces body weight in patients with type 2 diabetes. Although proton pump inhibitors (PPIs) have been reported to slightly increase the absorption of oral semaglutide, the impact of 24-week co-administration of PPIs on clinical efficacy and safety remains unclear. This retrospective study included patients with type 2 diabetes who initiated treatment with oral semaglutide between March 2021 and August 2024. The primary outcome was the change in the HbA1c at week 24. The secondary outcomes included the change in body weight and discontinuation of oral semaglutide due to gastrointestinal adverse events at week 24. Patients were divided into two groups according to PPI co-administration. Propensity score matching was performed to balance the baseline characteristics between the groups. Changes in HbA1c and body weight were analyzed using a linear mixed-effects model, and discontinuation rates were compared using Fisher’s exact test. Among the 114 eligible patients, 30 received concomitant PPIs. After propensity score matching, 27 patients were included in each group. At week 24, the estimated mean change in HbA1c and body weight (95
As a component of clinical decision support systems, medication alert systems (MAS) play an important role in preventing medication errors. However, their effectiveness is often limited by alert fatigue. Comprehensive data on the implementation and use of specific MAS functions in clinical practice in Japan are limited. Therefore, this study aimed to clarify the implementation of specific MAS functions and identify challenges in real-world use. This was a questionnaire-based study conducted among pharmacists at 65 hospitals in Iwate Prefecture, Japan. This questionnaire assessed MAS implementation, functionality, and pharmacists’ satisfaction with MAS, while distinguishing between alerts for physicians (primary alerts) and pharmacists (secondary alerts). Satisfaction was assessed using a 7-point Likert scale. Responses were summarized using medians and interquartile ranges (IQR). Of the 65 hospitals, 41 responded to the questionnaire (response rate: 63.1
Bevacizumab-induced gastrointestinal perforation is a potentially fatal adverse event. However, duodenal perforations are rare. Conversely, patients with cancer often have concomitant rheumatoid arthritis and may be treated with a combination of anti-rheumatic drugs and symptomatic medications; however, the effects of these concomitant medications on bevacizumab-related perforation remain understudied. This report describes the case of a patient with ovarian cancer and a history of anti-rheumatic drug treatment who developed early-onset duodenal perforation during bevacizumab-containing chemotherapy, highlighting the importance of assessing the risk of duodenal perforation and the provision of multidisciplinary management. The patient was a woman in her 50s with ovarian cancer that metastasized to the para-aortic lymph nodes. She was diagnosed with platinum-sensitive recurrence, and combination therapy with gemcitabine, carboplatin, and bevacizumab was initiated. She was also taking iguratimod and methotrexate for rheumatoid arthritis treatment. The patient developed sudden abdominal pain during the second course of chemotherapy and presented to the emergency department. A computed tomography (CT) scan revealed free gas, raising the suspicion of gastrointestinal perforation. Emergency laparotomy confirmed a duodenal perforation that was surgically covered with the ligamentum teres hepatis. A perforation of <1 cm was found in the anterior wall of the duodenal bulb, but the postoperative course was uneventful. The patient was discharged on postoperative day 7 and continued chemotherapy without bevacizumab. Postoperative upper endoscopy revealed an H2 stage ulcer. When administering bevacizumab to patients with ovarian cancer and multiple perforation risk factors, careful consideration should be given to evaluating existing ulcers, appropriately using concomitant medications, and modifying perforation risk factors to avoid serious adverse events. Therefore, collaboration between a multidisciplinary team, including oncologists, rheumatologists, and pharmacists, is crucial for appropriate drug use and continuous monitoring.
Everolimus (EVL) is widely used as an immunosuppressive agent in combination with calcineurin inhibitors, including tacrolimus (TAC), after liver transplantation. Posaconazole (PSCZ) is a triazole antifungal agent used for the treatment and prophylaxis of invasive fungal infections. Because PSCZ is a potent inhibitor of cytochrome P450 (CYP) 3A4, clinically significant drug–drug interactions with CYP3A substrates may occur. Although both EVL and TAC are primarily metabolized by CYP3A4, quantitative clinical data regarding the relationship between EVL and PSCZ remain limited. We report the case of a living-donor liver transplant patient receiving EVL and TAC who was treated with PSCZ for suspected allergic bronchopulmonary mycosis. During PSCZ therapy, the concentration/dose (C/D) ratios of EVL and TAC increased by approximately 15-fold and 6-fold, respectively. The PSCZ trough concentration reached 8.8 µg/mL, and the serum potassium level decreased 2.5 mmol/L. Both the magnitude of increase in TAC exposure and increase in EVL exposure were more pronounced than those reported previously. Excessive PSCZ exposure may have augmented CYP3A inhibition, and the greater dependence of EVL metabolism on CYP3A compared to TAC likely contributed to the marked elevation in EVL exposure. This case suggests that the drug–drug interaction between EVL and PSCZ may be more pronounced than that between TAC and PSCZ in certain cases with high PSCZ concentrations. When PSCZ is co-administered with EVL, close monitoring of the EVL concentration is recommended. Therapeutic drug monitoring of PSCZ may also be considered in selected cases to optimize safety and avoid excessive exposure, particularly when adverse events are suspected or clinically significant drug–drug interactions are anticipated.
Interprofessional collaboration between physicians and pharmacists is important for ensuring medication safety. Community pharmacists play a vital role in this process through prescription recommendations to physicians. Assertiveness, defined as a communication style that attempts to enhance mutual understanding while respecting both oneself and others, is recognized as useful for making prescription recommendations. Based on the concept of assertiveness, “functional assertiveness,” which focuses on achieving tasks while maintaining interpersonal relationships, has been proposed and the Functional Assertiveness Scale (FAS) was developed to evaluate it. Although functional assertiveness has been reported to be useful for achieving the task of ensuring medication safety while maintaining professional relationships with physicians, its applicability to community pharmacists has not been verified. This study aimed to investigate the reliability and validity of the FAS for Japanese community pharmacists and evaluate its utility. A cross-sectional study was conducted using an online questionnaire targeting 2,190 community pharmacists between July and September 2025. Structural validity was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Internal consistency was assessed using Cronbach’s α coefficient. Construct validity was verified by calculating Spearman’s rank correlation coefficients between FAS scores and the Assertive Self-expression (AS) score of the Interprofessional Assertiveness Scale. Analysis was performed on 415 participants (mean age 41.0 years; 54.9
Geographic and sectoral maldistribution of pharmacists has become a critical challenge for Japan’s healthcare system. While the number of community pharmacists continues to rise, the chronic shortage of hospital pharmacists persists. This study aimed to clarify longitudinal career trajectories, inter-sector mobility, and predictors of leaving employment among early‑career pharmacists in Japan, using nationwide census‑based data covering all licensed pharmacists. We conducted an eight‑year longitudinal cohort study using individual‑level data from the Statistics of Physicians, Dentists and Pharmacists from 2012 to 2020. The cohort included 7,242 pharmacists (3,458 men and 3,784 women) who obtained their pharmacist license in 2011–2012 and were continuously identified in all five survey waves. Employment sectors were categorized into 10 groups. Using generalized estimating equations (GEE), we analyzed the odds of being “unemployed” (defined as having no institutional affiliation), adjusting for gender, survey year, and age. At baseline (2012), hospital and community pharmacists accounted for 84.6
Everolimus (EVR), which is widely used in heart transplant recipients, has been associated with drug-induced lung injury. Although EVR-associated lung injury has been reported in patients with malignancies and recipients of other solid organ transplants, its incidence and risk factors in heart transplant recipients remain unclear. Krebs von den Lungen-6 (KL-6) is a serum biomarker widely used in the assessment of interstitial lung diseases and may reflect pulmonary involvement, including drug-induced lung injury. This study aimed to determine the incidence and risk factors for KL-6 elevation after EVR administration in heart transplant recipients. This retrospective observational study included patients who received a heart transplant at the University of Tokyo Hospital from June 2006 to April 2021. The patients were categorized into two groups: those who received EVR after heart transplantation (EVR group) and those who did not (non-EVR group). Multivariable logistic regression analysis was performed in the EVR group to identify independent risk factors for KL-6 elevation (defined as a peak level ≥ 500 U/mL). Receiver operating characteristic (ROC) analysis was used to determine optimal cutoff values, and a composite risk score was constructed. Event-free survival was evaluated using the Kaplan–Meier method. Seventy-three patients were included (58 in the EVR group and 15 in the non-EVR group). Peak serum KL-6 levels were significantly higher in the EVR group than in the non-EVR group (320 [235–509] vs. 157 [127–263] U/mL, p = 0.002). KL-6 elevation occurred in 27.6
To investigate immune-related adverse events (irAEs) in patients with non-small cell lung cancer receiving immune checkpoint inhibitor (ICI) therapy, and to identify clinical factors associated with irAE onset, thus supporting safer immunotherapy through effective monitoring. This retrospective cohort study was conducted at Tohoku Medical and Pharmaceutical University Hospital over approximately 5 years. Hospitalized patients with non-small cell lung cancer who received immune checkpoint inhibitors for the first time were included. Physicians and pharmacists evaluated the occurrence, severity, and timing of irAEs. Cox proportional hazards regression and Fine–Gray competing risk analyses were performed to identify factors associated with irAE development. Among the 203 enrolled patients, 92 (45.3
Vascular endothelial growth factor (VEGF) inhibitors are widely used anticancer agents that suppress tumor angiogenesis and improve outcomes in various solid tumors. However, these therapies are frequently associated with adverse renal and vascular events, particularly hypertension and proteinuria, which may compromise treatment continuity and patient quality of life. Although hypertension has long been considered a major contributor to VEGF inhibitor–induced proteinuria, the precise relationship between these complications remains incompletely understood. In addition, accumulating evidence suggests that endothelial dysfunction—characterized by impaired nitric oxide bioavailability, increased endothelin-1 signaling, and microvascular injury—plays a central role in the pathogenesis of these adverse events, potentially linking hypertension and proteinuria through a shared underlying mechanism. This review summarizes current evidence regarding the role of blood pressure and vascular endothelial dysfunction in the development of proteinuria during VEGF inhibitor therapy. Multiple clinical studies have demonstrated that both baseline and on-treatment blood pressure are associated with an increased risk of proteinuria. However, the causal relationship between hypertension and proteinuria remains uncertain. Hypertension may contribute to glomerular injury by increasing intraglomerular pressure, but it may also represent a parallel manifestation of endothelial injury caused by VEGF signaling blockade. Emerging evidence suggests that vascular endothelial dysfunction plays a key role in this process. Studies using flow-mediated dilation and reactive hyperemia index measurements have demonstrated impaired endothelial function during VEGF inhibitor therapy. In addition, alterations in endothelial-derived vasoactive mediators, including reduced nitric oxide bioavailability and increased endothelin-1 signaling, have been reported. Taken together, VEGF inhibitor–induced proteinuria likely results from complex interactions between systemic hypertension, endothelial dysfunction, and glomerular microvascular injury. Further translational and prospective clinical studies are needed to clarify the causal mechanisms and optimize strategies for prediction, prevention, and management of this complication.
BackgroundPolypharmacy, defined as the inappropriate use of multiple concomitant medications, represents a major concern in elderly care and is associated with drug-drug interactions, adverse effects, and poor medication adherence. Previous studies have emphasized the importance of proactive pharmacist involvement in addressing polypharmacy. However, evidence regarding patient outcomes following pharmaceutical interventions remains limited. This study aimed to evaluate whether community pharmacists could contribute to optimizing medication therapy among elderly patients living in the community. Pharmaceutical interventions targeting polypharmacy were implemented with consideration of patient characteristics and caregiver perspectives.MethodsQuestionnaire surveys were conducted among elderly patients receiving six or more daily medications and among caregivers, including helpers and visiting nurses. Cases involving potentially inappropriate prescriptions were identified in elderly outpatients, and deprescribing proposals were communicated to the respective prescribing physicians with patient consent. Follow-up assessments were conducted at least four weeks after intervention in patients whose medications had been deprescribed.ResultsAmong elderly respondents, 32.7% expressed a desire to reduce the number of oral medications. Caregivers frequently reported challenges associated with patients receiving multiple prescriptions. Following pharmacist-led interventions, the number of prescribed medications decreased, particularly within the gastrointestinal and pain medication categories. Most patients reported no worsening of symptoms, and some indicated that medication administration had become easier.ConclusionsThese findings suggest that community pharmacists may contribute to improving the quality of medication therapy in elderly outpatients through community-based interventions targeting polypharmacy.
Introduction Peripheral neuropathy (PN) is a prevalent condition in the Asia-Pacific region with a significant proportion of undiagnosed cases. Despite heterogeneous pharmacy practices across the region, clinical and operational challenges remain consistent. Community pharmacists are well-positioned to overcome these challenges but lack specific guidance for managing PN in the pharmacy setting.Aim This study aimed to develop expert consensus recommendations for community pharmacists on the early screening, assessment and management of PN.Method A modified two-round Delphi process was adopted, involving a panel of seven pharmacists from across the region. The process included a targeted literature review, yielding a total of 41 articles, two rounds of anonymous survey, and a virtual expert round table discussion (ERTD) with the panel of pharmacists to achieve consensus.Results The Delphi process yielded six consensus statements, covering the burden of PN, role of community pharmacists, early screening of patients at risk of PN, assessment and evaluation of PN patients, and guidance on management approaches of PN with neurotropic B vitamins.Conclusion These consensus statements offer practical guidance for community pharmacists to improve the early detection and management of PN in the Asia-Pacific (APAC) region, potentially enhancing patient outcomes and quality of life.
Abstract Background The healthcare system of Japan faces mounting challenges, including population aging, medical complexity, and workforce shortages. Hospital pharmacists are expected to ensure the safe and effective use of medicines and contribute to multidisciplinary care; however, their availability and functions remain uneven. The “Ward Pharmaceutical Care Fee I” (WardPharm-1) serves as an indicator of the implementation of advanced ward-based pharmaceutical care. This study investigated the national trends and associated factors of WardPharm-1 filing, focusing on pharmacist-to-bed ratios and hospital characteristics, to explore factors that may enable high-quality pharmacist services. Methods We examined national open datasets from the Ministry of Health, Labor, and Welfare for fiscal years 2021–2023, linking the “List of Registered Medical Care Providers (Medical)” and the “Hospital Bed Function Report.” Hospitals eligible for WardPharm-1 filing were identified, excluding psychiatric facilities and those not fulfilling minimum staffing standards. Per-100-bed staffing for eight healthcare professions and hospital bed counts were determined. Logistic regression and receiver operating characteristic (ROC) curve analyses determine the association between pharmacist staffing (Ph/100 beds) and WardPharm-1 filing, stratified by hospital type, Diagnosis Procedure Combination (DPC) group, and regional population density. Results Among approximately 5,800 eligible hospitals annually, 31%–34% filed WardPharm-1. Pharmacists per 100 beds (Ph/100 beds) showed the strongest association with filing (odds ratio ≈ 1.2 yearly). Median Ph/100 beds were about 5.2 in filing hospitals and 2.6 in non-filers, with ROC cutoffs of 3.7–4.0 (AUC 0.83–0.84). Filing was most frequent in general hospitals (~ 50%) and DPC university or specified hospitals (~ 90%) and least frequent in long-term care hospitals (~ 3%) and depopulated regions (< 25%). Adjusted analyses confirmed that Ph/100 beds remained significantly associated with filing, though effect sizes were modest. Conclusions Higher pharmacist-to-bed ratios were associated with higher WardPharm-1 filing rates. Filing was more common in larger and higher-function hospitals and less frequent in smaller or lower-density settings, patterns consistent with uneven workforce distribution. Although causality cannot be inferred, pharmacist staffing levels may serve as a practical indicator related to WardPharm-1 implementation.
Abstract Background Remimazolam (RMZ) is an ultrashort-acting benzodiazepine used in general anesthesia, metabolized rapidly by carboxylesterase 1, an enzyme primarily located in the liver. The Pringle maneuver (PM), an established technique commonly employed during hepatectomies to reduce bleeding, involves clamping major vessels, potentially affecting drug metabolism and clearance. Therefore, we conducted a study to investigate the changes in plasma concentration (Cp) of RMZ associated with the PM during hepatectomy and the impact on bispectral index (BIS) values. Methods This single-center prospective observational pilot study included ten patients undergoing hepatectomy using the PM. Results Our findings showed that the changes in RMZ Cp immediately following each PM tended to be higher than those before PM in six cases, though this was not observed in others. However, there was no statistically significant difference between the median RMZ Cp after the final PM (1099 [723–1386] ng/mL) and before the initial PM (707 [641–856] ng/mL). Similarly, the median BIS value after the final PM (45 [40–46]) was comparable to the BIS prior to initiation of PM (46 [44–50]). Conclusions This study suggested that RMZ may be safely administered during hepatectomies with PM in patients with Child-Pugh classification A. Trial registration Clinical trial number: not applicable.
