Journal of Pharmaceutical Health Care and Sciences最新文献

Background: Multiple myeloma is an incurable hematologic malignancy. Although novel treatments have improved outcomes, many patients continue to relapse and eventually develop treatment resistance. Elranatamab, a bispecific antibody, has demonstrated promising efficacy in patients with relapsed/refractory multiple myeloma. However, clinical experience with elranatamab remains limited, and its immunomodulatory effects may increase the risk of opportunistic infections and viral reactivation. Here, we describe hepatitis B virus (HBV) reactivation in a patient with resolved HBV infection who was treated with elranatamab.

Case presentation: A 76-year-old man with resolved HBV infection and treatment-resistant multiple myeloma received elranatamab. HBV DNA was not detected prior to treatment. On day 17 after initiation, an outpatient specimen returned as detectable but below the assay's lower limit of quantification (< 1.0 log10 IU/mL). Elranatamab was discontinued due to hypotension, and the patient was subsequently hospitalized one week later with pneumonia. On day 78 after initiation, HBV DNA increased to 3.6 log10 IU/mL with transaminase elevation; tenofovir alafenamide 25 mg once daily was started the same day, after which HBV DNA declined to below the lower limit of quantification.

Conclusions: Although elranatamab-specific information on HBV reactivation is limited, this case highlights a clinically relevant risk. Clinicians should remain vigilant for reactivation in patients receiving elranatamab, particularly those with resolved infection. Regular HBV DNA monitoring and prompt initiation of nucleos(t)ide analog therapy are essential to prevent severe complications, including fulminant hepatitis. Additionally, in the context of profound hypogammaglobulinemia during or after elranatamab, intravenous immunoglobulin may be considered to mitigate infection risk.

Background: Congenital cytomegalovirus (CMV) infection is a major cause of neonatal morbidity. However, optimizing ganciclovir (GCV) dosing in preterm infants is complicated by immature renal function and developmental pharmacokinetics. Population pharmacokinetic (PPK) parameters for GCV and valganciclovir (VGCV) have been reported, but data remain limited for extremely low birth weight infants. We aimed to characterize longitudinal changes in GCV clearance in a preterm infant with congenital CMV infection using Bayesian modeling.

Methods: GCV/VGCV were administered over a 15-week period, with concurrent therapeutic drug monitoring. Individual parameters were estimated using a previously published PPK model and a postnatal age-based maturation function in NONMEM. Scr clearance was measured at two time points using the 24-h urine collection method.

Results: GCV clearance increased from 0.048 to 0.273 L/hr/kg from postnatal day 30 to day 93, whereas VGCV bioavailability remained stable (~ 52-55%). Scr clearance values matched estimated GCV clearance, supporting the validity of the model. The maturation function indicated that tubular secretion likely contributes to accelerated drug elimination. Late-phase GCV clearance exceeded typical glomerular filtration rate, indicating possible catch-up in renal function.

Conclusion: Renal maturation should be considered in addition to body weight when adjusting GCV dosing in preterm infants. This case highlights the importance of aligning individualized dosing strategies with the developmental physiology of preterm neonates.

Background: Premenstrual syndrome (PMS) is a prevalent and often debilitating health conditions affecting women of reproductive age. The natural PMSoff supplement contains several active ingredients, including spirulina, whey protein, calcium citrate, vitamin B1, chamomile, turmeric, marigold, lavender, saffron, valerian, and aftimoon. This clinical trial aimed to assess the efficacy and safety of PMSoff, a natural supplement, in alleviating the symptoms of PMS.

Methods: In this double-blind, randomized trial, women diagnosed with PMS were randomly assigned to receive either PMSoff or placebo. The primary objective of the study was to evaluate the impact of PMSoff on symptom severity, with secondary objectives focusing on safety and adherence. The primary outcome of this study was the severity of PMS symptoms, evaluated using the Daily Record of Severity of Problems (DRSP) questionnaire. The secondary outcome focused on the presence of premenstrual dysphoric disorder (PMDD), a more severe and debilitating form of PMS. Symptom severity was assessed at multiple time points: pre-intervention, one month post-intervention, and two months post-intervention.

Results: Of the 255 randomized participants, 218 (85.4%) patients aged 14 to 30 years were enrolled and completed the clinical trial. No significant difference was observed between groups at baseline characteristics. Medication adherence in the first and second month of treatment was reported 72%. Following one month of treatment, the intervention group showed a significant reduction in DRSP scores compared to the control group (P-value = 0.043). This reduction became even more pronounced after two months of taking the supplement (P-value = 0.001). In patients with PMDD, a more severe form of PMS, a statistically significant difference emerged two months after the intervention (P-value = 0.04), indicating that the PMSoff was effective in alleviating PMDD-related symptoms, particularly during the second month of treatment.

Conclusion: The results of this randomized placebo-controlled clinical trial were suggestive of the use of PMSoff in patients with PMS and PMDD to ameliorate its unpleasant symptoms, with sustained improvements observed over two months of treatment. Our findings suggest that PMSoff could be a viable alternative or adjunct to conventional pharmacological treatments for PMS and PMDD. Further studies are still demanded to explore the long-term effects, mechanisms of action, and broader applicability of this supplement.

Trial registration: Trial Registry Date: 2025-03-02, Trial Registry number: IRCT20190810044500N30.

Background: The concept of shifting from a patient-centered to person-centered approach in pharmacy practice has been proposed. Patient-centered care focuses on the individual patient, whereas person-centered care focuses on a holistic understanding of the individual, taking not only medications but also daily life into account. This shift requires effective communication between patients and pharmacists. Although question prompt lists (QPLs) exist for patients and doctors, the same is not available for pharmacists focused on a person-centered approach. This study aimed to develop a question prompt list to talk with your pharmacists (QPLP) focusing on a person-centered approach to facilitate communication with patients.

Methods: This study aimed to develop the QPLP in three steps. In the first step, six medical pharmaceutical researchers with pharmacist qualifications and two patient researchers prepared an initial draft of the QPLP, referencing existing QPLs used by patients to prepare questions for doctors before consultation. A focus group interview was then conducted with eight patients, and a QPLP drafted. Finally, a modified Delphi method was used to evaluate and collect opinions, and the QPLP was finalized.

Results: A QPLP comprising 16 questions was developed with patient participation in a three-step process. The content was categorized into five sections: "Medicines," "How to Take Medicines," "Daily Life," "Treatment," and "Consumer Health Information." The questions covered concerns regarding medicines, difficulties in using medicines, issues in daily life during treatment, treatment-related problems, authenticity of health information, and community health and exercise information.

Conclusions: In this study, we developed a novel QPLP to enhance communication between patients and pharmacists, focusing on a person-centered approach with active patient involvement. Future studies should investigate the contribution of the developed QPLP in improving patient-pharmacist communication. These questions may encourage both healthy people and patients to seek health advice from pharmacists.

Background: Many osteoarthritis patients incorporate dietary supplements and nutraceuticals into their self-management strategies. Community pharmacists play a pivotal role in patient education by identifying potential drug interactions and guiding the evidence-based and safe use of dietary supplements. This study aims to assess the real-world practice of Iranian pharmacists in managing osteoarthritis, with a specific focus on dietary supplement counseling, using the mystery shopper method.

Methods: This cross-sectional study was carried out in 225 active community pharmacies. Two female mystery shoppers performed a two-step scenario. In the first step, the mystery shopper requested an avocado/soybean supplement for knee pain from the pharmacist. In the second step, if the pharmacist did not inquire about the consumer or their medication history, the mystery shopper stated that the supplement was intended for her 64-year-old father, who was taking warfarin. All conversations were audio-recorded, and the pharmacists' practice was documented.

Results: Only 15 pharmacists inquired about the intended user. During step 1, only seven pharmacists successfully identified the potential warfarin- avocado/soybean interaction. In step 2, after receiving additional patient-specific details, the recognition rate increased to 29 pharmacists. However, no pharmacists provided further information about additional interactions, adverse effects, or contraindications related to avocado/soybean supplements. Only the seven pharmacists explained how to use the avocado/soybean supplement, while nine pharmacists obtained medical history, and eight pharmacists gathered medication history.

Conclusion: Pharmacists provide limited and insufficient counseling on dietary supplements for osteoarthritis, highlighting a significant gap in patient education and the safe use of dietary supplements.

Background: Cisplatin-associated acute kidney injury (C-AKI) is a major complication of cisplatin therapy. Although two clinical prediction models have been developed for the US population, their external validity in the Japanese population remains unclear. This study aimed to evaluate the external validity of these models and compare their predictive performances in a Japanese cohort.

Methods: We assessed the performance of two C-AKI prediction models developed by Motwani et al. and Gupta et al. in a retrospective cohort of 1,684 patients treated with cisplatin at Iwate Medical University Hospital. C-AKI was defined as a ≥ 0.3 mg/dL increase in serum creatinine or a ≥ 1.5-fold rise from baseline. Severe C-AKI was defined as a ≥ 2.0-fold increase or renal replacement therapy initiation. Model performance was evaluated using discrimination (area under the receiver operating characteristic curve [AUROC]), calibration, and decision curve analysis (DCA). Logistic recalibration was applied to adapt the model to the local population.

Results: The discriminatory performance for C-AKI was similar between the Gupta and Motwani models (AUROC, 0.616 vs. 0.613; p = 0.84). However, the Gupta model showed better discrimination of severe C-AKI (AUROC, 0.674 vs. 0.594; p = 0.02). Both models exhibited poor initial calibrations, which improved after recalibration. The recalibrated models yielded a greater net benefit in the DCA, with the Gupta model demonstrating the highest clinical utility in severe C-AKI.

Conclusions: Both models demonstrated discriminatory ability, with the Gupta model showing particular utility in predicting severe C-AKI. Given the observed miscalibration, recalibration is essential before applying these models in Japanese clinical practice.

Background: The combination of apalutamide, a nonsteroidal androgen receptor inhibitor, with androgen deprivation therapy enhances survival in patients with metastatic castration-sensitive prostate cancer. However, apalutamide exhibits complex pharmacokinetics and dose-dependent adverse effects, necessitating dose adjustments to optimize its therapeutic outcomes. To facilitate effective monitoring, a high-performance liquid chromatography (HPLC) system coupled with an ultraviolet (UV) detector was developed for quantifying plasma concentrations of apalutamide and its active metabolite, N-desmethylapalutamide.

Main body: This method employed an ODS18 column (100 mm × 2.1 mm) with UV detection at 254 nm. The mobile phase comprised 20 mM acetate buffer (pH 5.0) and acetonitrile in a 60:40 ratio, and the run time was 10 min. The precision and accuracy were validated according to guidelines issued by the Food and Drug Administration (FDA). Long-term stabilities of the analytes were confirmed at both - 20 and - 80 °C over periods of 2 and 4 weeks. Peaks for enzalutamide (internal standard), N-desmethylapalutamide, and apalutamide were detected at 4.4, 5.8, and 7.7 min, respectively. Calibration curves demonstrated linearity within a concentration range of 0.5-20 µg/mL for both analytes in human plasma (R² = 0.9999). Additionally, the intraday and interday variability and stability remained within FDA guidelines.

Short conclusion: This work therefore presents a robust and simple HPLC-UV method for the simultaneous quantification of apalutamide and N-desmethylapalutamide in clinical therapeutic drug monitoring.