Journal of Pharmaceutical Health Care and Sciences最新文献

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.

Background: V-Raf murine sarcoma viral oncogene homolog B1 (BRAF) mutations are present in approximately 5% of Japanese patients with colorectal cancer (CRC) who receive BRAF-targeted triplet therapy, consisting of encorafenib (a BRAF inhibitor), binimetinib (a mitogen-activated protein kinase inhibitor [MEKi]), and cetuximab. This combination therapy is associated with an increased risk of cardiac dysfunction (CD), primarily attributed to MEKi. However, the detailed clinical course of this adverse event remains unclear. Here, we report a case of severe symptomatic CD that developed during this triplet therapy.

Case presentation: The patient was a 70-year-old Japanese man diagnosed with BRAF-mutated CRC with multiple metastases. BRAF-targeted triplet therapy was initiated as a third-line treatment. His baseline left ventricular ejection fraction (LVEF) was 66% and he had no history of heart disease. On Day 106, a pharmacist conducting the patient's consultation suspected CD associated with binimetinib because of symptoms such as deterioration of general condition and dyspnea. The pharmacist immediately recommended an echocardiography that revealed a significant decline in LVEF to 33%. The patient was referred to a cardiologist and treatment with enalapril, followed by bisoprolol, was initiated while triplet therapy was discontinued. Within 1 week of treatment interruption, the patient's general condition improved rapidly and his symptoms resolved. Therefore, cancer treatment was resumed as doublet therapy without binimetinib. Under close multidisciplinary monitoring, no recurrence of CD symptoms was observed. Doublet therapy was continued until Day 168, when disease progression occurred. This exceeded the median progression-free survival reported in the phase III BEACON-CRC trial.

Conclusions: This case highlights two crucial insights into BRAF/MEK inhibitor-associated CD. First, even severe symptomatic CD can be effectively managed and reversed upon immediate discontinuation of binimetinib and initiation of cardiotropic medications. Second, in such a severe case, rapid recovery is observed. Once stabilized, BRAF-targeted treatment could be continued as doublet therapy without binimetinib to ensure safety and disease control. However, regular echocardiographic surveillance is essential, with an interval shorter than 4 months, based on the clinical course of this case. Additionally, early recognition of CD may be improved by closely monitoring patients' symptoms and complaints through a multidisciplinary approach.

Background: Invasive treatment and the associated stress are known risk factors for sodium-glucose cotransporter 2 inhibitor (SGLT2i)-induced euglycemic diabetic ketoacidosis (euDKA) development. It is recommended that SGLT2is is discontinued at least 3 days prior to a scheduled surgery. However, it is unclear whether preoperative discontinuation of SGLT2is is effective and whether other factors contribute to the development of SGLT2i-induced perioperative euDKA.

Methods: We retrospectively investigated the incidence of euDKA postoperatively up to 30 days in patients receiving SGLT2is and undergoing surgery under general anesthesia. Multivariate logistic regression analysis was performed to identify the factors affecting euDKA development.

Results: Twenty-one of 1,169 eligible patients (1.8%) developed perioperative euDKA. The incidence of perioperative euDKA in patients who discontinued SGLT2is for ≥ 3 days prior to surgery was significantly lower than that in patients who did not discontinue SGLT2is for ≥ 3 days prior to surgery (p < 0.001). The multivariate analysis showed that discontinuation of SGLT2is for ≥ 3 days prior to surgery and preoperative use of insulin and glucose infusion were significant factors that affected the development of perioperative euDKA (odds ratios = 0.047 and 0.054, p = 0.003 and 0.005, respectively).

Conclusions: Our findings suggest that preoperative SGLT2i discontinuation for at least 3 days could prevent perioperative euDKA development and that preoperative insulin and glucose infusion could reduce the risk of developing euDKA, even in patients who cannot discontinue SGLT2is at least 3 days preoperatively.