Journal of Pharmaceutical Health Care and Sciences最新文献

Aim: Kampo medicines, which are covered under national health insurance, are widely accessible and affordable in Japan; however, knowledge about their current prescription practices remains limited. This study investigated the outpatient prescription practices of Kampo formulations at Kyoto University Hospital from April 2011 to March 2023.

Results: Kampo medicine was prescribed in all medical departments. A total of 42,453 prescriptions were recorded during the study period, with an average of 3,538 prescriptions per year. The gynecology and obstetrics department had the highest number of Kampo prescriptions, followed by anesthesiology. The anesthesiology department prescribed various formulations for 12 years. The usage rate of Processed Aconite Root-containing formulations increased with increasing patient age, reaching 3.3% in individuals in their teens, 6.6% in their twenties, 13.3% in their thirties, and over 30% in their eighties and nineties.

Conclusion: The substantial use of Kampo medicines across various departments indicates their critical role in specialized and general medical practice. The adaptability and personalized approach of treatments using Kampo medicines in the anesthesiology department are evident from the dynamic prescription patterns. Notably, the increasing use of Processed Aconite Root-containing formulations with advancing patient age suggests a potential age-related preference or therapeutic indication. These findings underscore the integral role of Kampo medicine in modern clinical practice and emphasize the necessity of further research into its age-specific applications and departmental prescribing trends.

Background: Pazopanib (PAZ) is an oral multi-kinase inhibitor used in the treatment of advanced soft tissue sarcoma. Gastric acid suppressants such as proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) may reduce PAZ absorption by increasing gastric pH, potentially affecting its efficacy. This study aimed to evaluate the impact of concomitant use of acid suppressants on progression-free survival (PFS) and safety in patients with soft tissue sarcoma.

Methods: This retrospective study included patients with advanced or metastatic soft tissue sarcoma who were treated with PAZ at a single institution between 2015 and 2022. Patients were divided into two groups: those who received PAZ with concomitant acid suppressants (AS combination group) and those who did not (non-AS group). The primary outcome was PFS. Kaplan-Meier curves were used to estimate survival, and group differences were compared using the log-rank test. Multivariable Cox proportional hazards regression was performed to adjust for confounding factors.

Results: A total of 99 patients were included (77 in the AS combination group, 22 in the non-AS group). The median PFS was 116 days in the AS combination group and 403 days in the non-AS group (hazard ratio [HR]: 1.42; 95% confidence interval [CI]: 0.68-2.85; P = 0.361). No statistically significant difference in PFS was observed. Adverse events of any grade occurred in 84% of patients in the AS combination group and 68% in the non-AS group. Grade ≥ 3 adverse events occurred in 33 patients (43%) in the AS combination group and 9 patients (41%) in the non-AS group.

Conclusions: In our cohort of sarcoma patients, the concomitant use of acid-suppressive agents was not associated with a statistically significant difference in PFS. However, the substantial numerical difference in median PFS observed between the groups (403 days vs. 116 days), coupled with the study's limited sample size, suggests a potentially clinically meaningful negative effect that warrants caution and further investigation in larger, prospective studies. Our findings, therefore, do not rule out a detrimental interaction and underscore the need for careful consideration when co-prescribing these agents with pazopanib in this patient population.

Background: Triple Whammy (TW) therapy, a combination of renin-angiotensin system inhibitors (RASIs), diuretics, and non-steroidal anti-inflammatory drugs (NSAIDs), is associated with an increased risk of acute kidney injury (AKI). However, there is no consensus regarding the impact of NSAID type on the risk of AKI. Therefore, in this study, we evaluated the incidence and risk of NSAID-induced AKI in patients taking concomitant RASIs and diuretics, focusing on NSAID type.

Methods: We conducted an observational retrospective cohort study using a Japanese medical claims database. In the cohort analysis, 41,904 patients who received concomitant RASIs, diuretics, and newly added NSAIDs between April 2020 and March 2021 were included to estimate AKI incidence. In the case-crossover analysis, 2,909 patients who developed AKI while on RASIs and diuretics were analyzed to assess the short-term risk associated with NSAID use. Incidence rates were calculated using the person-year method. Conditional logistic regression was used to estimate adjusted odds ratios (aOR), accounting for surgical procedures and concomitant AKI risk drugs.

Results: Among 41,904 patients, 54 developed AKI (20.0 [95% CI: 14.8-25.6] per 1,000 person-years). The incidence rate ratio of TW to RASIs and diuretics without NSAIDs was 2.08 [95% CI: 1.58-2.74]. Case-crossover analysis showed an aOR of 1.44 [95% CI: 1.17-1.78] for AKI associated with NSAID use. No substantial differences were observed between COX-2 selective and nonselective NSAIDs (aOR: 0.99 [95% CI: 0.66-1.50]).

Conclusions: The addition of NSAIDs to RASIs and diuretics significantly increased AKI risk, emphasizing the need for careful monitoring regardless of the NSAID type.

Background: The evaluation of endogenous insulin secretory capacity is important in the selection of diabetes treatment. C-peptide, which is secreted in equivalent amounts as insulin, is a versatile test for this evaluation. Urinary C-peptide is widely used because it is less invasive. Sacubitril/valsartan, used to treat hypertension and chronic heart failure, has been reported to increase urinary C-peptide levels; however, its effect on endogenous insulin secretion remains unknown. In this report, we present a case in which insulin secretory capacity was evaluated according to a glucagon stimulation test in addition to urinary C-peptide levels in a patient receiving sacubitril/valsartan.

Case presentation: A male patient in his 50s with type 2 diabetes and hypertension, without renal dysfunction, was treated with sacubitril/valsartan. The results of the glucagon stimulation test showed a C-peptide change of 2.28, and the C-peptide index on the same day was 1.25, indicating normal endogenous insulin secretory capacity. In contrast, 24-h urinary C-peptide excretion was abnormally high at 615.2 µg/day. After discontinuation of sacubitril/valsartan, urinary C-peptide excretion decreased over time (615.2 to 369.0 µg/day), but blood glucose levels did not increase during this period.

Conclusions: In this case, 24-h urinary C-peptide excretion was abnormally elevated despite preserved endogenous insulin secretory capacity, as assessed by the glucagon stimulation test. Although this observation is based on a single case and cannot be generalized, it suggests that sacubitril/valsartan may interfere with the interpretation of urinary C-peptide levels. Therefore, in such clinical contexts, dynamic tests such as the glucagon stimulation test may serve as a useful adjunct to avoid potential overestimation of insulin secretory capacity when relying solely on urinary C-peptide levels.

Introduction: Diabetic neuropathy is a prevalent and debilitating complication of type 2 diabetes, resulting in functional impairments. Crocin, a bioactive constituent of saffron (Crocus sativus), has long been utilized in traditional medicine for its potential therapeutic effects. This study aimed to evaluate the efficacy of Crocin in alleviating neuropathic symptoms in patients with type 2 diabetes.

Methods: In this triple-blind, randomized, placebo-controlled clinical trial, patients with type 2 diabetes and confirmed peripheral neuropathy were randomly assigned to receive either 15 mg/day of Crocin or a matching placebo for 12 weeks. Neuropathic symptoms were assessed using the Total Symptom Score (TSS), Visual Analog Scale (VAS), and the Michigan Neuropathy Screening Instrument (MNSI) at baseline and at 3-week intervals.

Results: Forty-two patients completed the study, with 21 participants in each group. By week 9, the Crocin group exhibited a significantly lower mean TSS (5.1 ± 1.39) compared to the placebo group (6.6 ± 1.00, P = 0.005). Similarly, VAS scores, reflecting pain intensity, were significantly reduced in the Crocin group at both weeks 6 and 9 (P = 0.019). MNSI scores at week 9 also favored the Crocin group (5.7 ± 1.1 vs. 6.8 ± 0.9, P = 0.03).

Conclusion: Crocin may offer promising therapeutic benefits in reducing pain and neuropathic symptoms in patients with type 2 diabetes. Its neuroprotective, antioxidant, and antihyperglycemic properties may contribute to these effects. While the findings support the potential beneficial effect of crocin in the management of diabetic neuropathy, further large-scale and more robust clinical trials are warranted to validate these results.

Trial registration: https//irct.ir/ IRCT20190810044500N8, Registration date 01/01/2021.

Background: The risk of hemorrhagic complications in patients with chronic liver disease during invasive procedures should be considered. Patients with low platelet counts were administered platelet products prior to procedures based on a physician's judgment. However, there are no standards for allocating the bleeding risk associated with each procedure, platelet counts to avoid these risks, or methods for determining platelet counts. In this study, we evaluated whether pharmacists could reduce the use of platelet products by suggesting thrombopoietin receptor agonists using protocol-based pharmacotherapy management to assess procedural bleeding risk and platelet counts.

Methods: Among patients with chronic liver disease who were scheduled to undergo invasive procedures between August 2022 and February 2023, those who were interviewed by a pharmacist prior to the procedures were defined as the intervention group (n = 80) and the others as the non-intervention group (n = 224). The protocol was to define the procedural bleeding risk and platelet count. Pharmacists suggested prescribing a thrombopoietin receptor agonist to patients with platelet counts below the recommended counts.

Results: The use of platelet products and thrombopoietin receptor agonists was 0% and 7.5% and 3.1% and 0% in the intervention and non-intervention groups, respectively. Among the patients who were required to receive lusutrombopag, all patients in the intervention groups did not receive platelet product but lusutrombopag alone. However, the rates of patients with the recommended platelet count were not different between the intervention and non-intervention groups.

Conclusions: The use of platelet products decreases without the increased incidences of hemorrhage if pharmacists suggest prescribing thrombopoietin receptor agonists based on their assessment of the platelet count and the bleeding risk of the procedure.

Background: Medication errors in Pro Re Nata (PRN) prescriptions pose a significant threat in hospital settings, especially due to unclear prescribing practices. Despite growing attention to patient safety, documentation for PRN orders remains poor, increasing the risk of medication errors and adverse drug events. To assess the prevalence and types of PRN medication errors in hospitalized patients, identify high-risk drugs, and explore factors linked to prescribing errors.

Methods: This cross-sectional study was conducted in 2023 at an Educational and Research Hospital. It included 400 hospitalized patients who had received at least one PRN prescription. Data were collected using a standardized extraction form based on clinical guidelines and expert consultation. Chi-square tests and logistic regression were used to evaluate error trends and associated risk factors.

Results: A total of 74.1% of PRN prescriptions lacked a documented indication, and 91.1% had no recorded dosage interval. Pethidine (32.6%) was the most frequently prescribed PRN medication. The Surgical ICU showed a significantly higher number of errors (p < 0.05). Major predictors of PRN errors included missing dosage intervals and admission to high-dependency wards.

Conclusions: The high frequency of PRN prescribing errors underscores the urgent need for improved documentation and targeted training. Structured interventions such as electronic prescribing and focused medical education can help reduce errors and improve patient safety. Structured interventions such as electronic prescribing, regulatory enforcement, and focused medical education can help reduce errors and improve patient safety.

Background: Polycystic ovary syndrome (PCOS) is the most common endocrine-metabolic disorder in women of reproductive age. Crocin is known as the main component of saffron, which has antioxidant properties and has the ability to scavenge free radicals. Considering the pathophysiology of PCOS and also the anti-inflammatory and antioxidant properties of crocin in improving insulin resistance, we aimed to evaluate the efficacy of the combination of crocin and metformin compared to metformin alone in PCOS patients.

Methods: This study is a prospective, double-blind randomized controlled clinical trial. Fifty patients with PCOS and hirsutism were included from Baqaipour Obstetrics and Gynecology Clinic in Yazd and randomly assigned into the two study arms of control group [metformin and placebo (n = 25)] or intervention group [metformin and crocin (n = 25)]. Patients were administered crocin 15 mg tablets once a day in combination with metformin 500 mg twice a day for 12 weeks to complete three full periods of the monthly cycle. The studied endpoints were evaluated at the beginning and end of the study.

Results: Crocin significantly improved the serum level of follicle-stimulating hormone (FSH) (P = 0.048) and Ferriman- Gallwey score (P = 0.042) at day 90. Furthermore, crocin group had a significant improvement in terms of acne severity at the end of the study (P = 0.03), so that none of the patients in the crocin group had severe acne at the end of the study. However, the comparisons between two groups were not statistically significant for other evaluated outcomes including fasting blood sugar (FBS), dihydroepiandrosterone-sulfate (DHEA-S), luteinizing hormone (LH), dermatology life quality index (DLQI), and blood pressure (BP) at the end of the study.

Conclusion: In the present study, concurrent use of crocin along with metformin was significantly effective in ameliorating the unpleasant side effects of PCOS, including hirsutism and acne, and increasing FSH sex hormone levels in patients with PCOS.

Trial registry date: 26/08/2021, Trial Registry number: IRCT20210730052027N1.