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Development and Pilot Testing of a Pharmacist-Led β-Lactam Allergy Risk Assessment Tool for Chinese Patients. 药师主导的中国患者β-内酰胺过敏风险评估工具的研制与中试。
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-28 DOI: 10.31083/Pharmazie51744
Xiunan Yue, Nan Shang, Wanying Chen, Xiaojun Zheng
{"title":"Development and Pilot Testing of a Pharmacist-Led β-Lactam Allergy Risk Assessment Tool for Chinese Patients.","authors":"Xiunan Yue, Nan Shang, Wanying Chen, Xiaojun Zheng","doi":"10.31083/Pharmazie51744","DOIUrl":"https://doi.org/10.31083/Pharmazie51744","url":null,"abstract":"<p><strong>Background: </strong>β-lactam allergy labels (BALs) are commonly found in patient records but are often inaccurate. This can lead to suboptimal antibiotic selection, increased healthcare costs, and antimicrobial resistance. Most existing risk assessment tools were developed in Western settings and are not applicable in Chinese clinical contexts. This study developed and pilot-tested a pharmacist-led BAL risk assessment tool tailored to the Chinese healthcare environment.</p><p><strong>Methods: </strong>The study was conducted in three phases: (1) A systematic review of 90 studies to identify key β-lactam allergy risk factors; (2) Grounded theory and text co-occurrence analysis to extract high-risk features and construct the assessment framework; and (3) A pilot implementation in a tertiary hospital to evaluate the tool's feasibility, clinical impact, and patient outcomes using a quasi-experimental design.</p><p><strong>Results: </strong>The final tool comprised eight dimensions, 35 subdimensions, and over 1328 distinct coded nodes. Of the 289 patients involved in the pilot, 18.7% were classified as high risk. Compared with patients with BALs but without high-risk features, those at lower risk had significantly shorter hospital stays (8.5 ± 4.3 vs. 10.6 ± 5.5 days; <i>p</i> < 0.001), reduced hospitalization costs (17,800 ± 6200 vs. 21,000 ± 7500; <i>p</i> = 0.0011), and lower allergy event rates (0% vs. 6.5%; <i>p</i> = 0.002). β-lactam use increased (75.3% vs. 40.3%; <i>p</i> < 0.001), whereas second-line antibiotic use decreased (24.7% vs. 59.7%; <i>p</i> < 0.001). The tool also demonstrated high feasibility, achieving a 100% completion rate and strong adherence among pharmacists.</p><p><strong>Conclusion: </strong>This pharmacist-led risk assessment tool has strong potential for accurately identifying high-risk β-lactam allergy patients and optimising antimicrobial stewardship in Chinese hospitals. Further large-scale validation is warranted.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51744"},"PeriodicalIF":1.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antiemetic Efficacy of Dexamethasone Omission in Antiemetic Therapy During Highly Emetogenic Chemotherapy for Breast Cancer. 高致吐性乳腺癌化疗中地塞米松遗漏止吐效果观察。
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-28 DOI: 10.31083/Pharmazie51804
Wataru Suzuki, Kenichi Suzuki, Takashi Yokokawa, Kazuo Kobayashi, Takeshi Aoyama, Takahito Sugisaki, Naoki Shibata, Masahiro Hatori, Kazuyoshi Kawakami, Toshimi Takano, Masakazu Yamaguchi
{"title":"Antiemetic Efficacy of Dexamethasone Omission in Antiemetic Therapy During Highly Emetogenic Chemotherapy for Breast Cancer.","authors":"Wataru Suzuki, Kenichi Suzuki, Takashi Yokokawa, Kazuo Kobayashi, Takeshi Aoyama, Takahito Sugisaki, Naoki Shibata, Masahiro Hatori, Kazuyoshi Kawakami, Toshimi Takano, Masakazu Yamaguchi","doi":"10.31083/Pharmazie51804","DOIUrl":"https://doi.org/10.31083/Pharmazie51804","url":null,"abstract":"<p><strong>Background: </strong>Dexamethasone is typically included in the anti-emetic regimens during the administration of anticancer drugs. However, the incidence and severity of nausea and vomiting in patients receiving anticancer therapy, for whom dexamethasone must be avoided to prevent the recurrence of diabetes mellitus or hepatitis, remain unknown.</p><p><strong>Methods: </strong>This retrospective, observational study evaluated nausea and vomiting in patients with breast cancer who underwent highly emetogenic chemotherapy, including anthracycline and cyclophosphamide, for breast cancer. In all patients, dexamethasone was completely omitted from the standard antiemetic regimen for reasons such as hepatitis, and only palonosetron and aprepitant were administered.</p><p><strong>Results: </strong>For the 82 evaluated cases, the incidence of nausea was 84.1%, vomiting was 14.6%, and the complete response (CR) rate was 8.5%. In addition, the incidence rate of grade 2 or higher nausea (CTCAE ver. 4) was 47.6%, and the proportion of cases in which anticancer drug doses were reduced in the subsequent course due to nausea and vomiting was 2.4%. Factor analysis showed that treatment regimens, age, drinking history, history of prior chemotherapy, and reasons for omitting dexamethasone had no significant effects on the incidence of chemotherapy-induced nausea and vomiting.</p><p><strong>Conclusions: </strong>This study confirmed that the antiemetic effect of only administering palonosetron and aprepitant is insufficient for patients receiving highly emetogenic chemotherapy in whom dexamethasone cannot be administered. Prophylactic administration of other antiemetic drugs is necessary to effectively manage nausea and vomiting in patients receiving anticancer therapy who cannot receive dexamethasone.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51804"},"PeriodicalIF":1.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Shaping Dendrimers for Active Oxygen Delivery: An Emerging Strategy for Targeting Tumor Microenvironments. 塑造树状大分子用于活性氧输送:一种针对肿瘤微环境的新兴策略。
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-28 DOI: 10.31083/Pharmazie51801
Musa Albatsh
{"title":"Shaping Dendrimers for Active Oxygen Delivery: An Emerging Strategy for Targeting Tumor Microenvironments.","authors":"Musa Albatsh","doi":"10.31083/Pharmazie51801","DOIUrl":"https://doi.org/10.31083/Pharmazie51801","url":null,"abstract":"<p><p>Reactive oxygen species (ROS) have been identified as one of the critical factors in cancer development. ROS have been linked to cancer at all stages, and their applications in cancer treatment have gained attention due to their concentration-dependent implications: (1) low to moderate levels as fundamental signaling molecules, and (2) higher levels in cancer cells as a unique characteristic of cancer and cytotoxic agents. However, resistance and off-target effects are the main barriers that can hinder and limit the therapeutic efficacy of chemotherapies. The main reason for that is the complex tumor microenvironment such as hypoxia. Developing drug nanocarriers that can target ROS represents a potential delivery platform to overcome these barriers. For instance, doxorubicin-encapsulated ROS (nitric oxide) micelles accumulated 6.7-fold more drug in PC3-Luc cancer cells than when using this drug alone. Regrettably, the past studies have merely discussed the micelle alone as a nanocarrier for the delivery of ROS-based therapy in cancer without exploring dendrimers. Instead, this review examines the structural design of dendrimers tailored for oxygen transport, their conjugation with ROS-generating therapies, and therapeutic applications in photodynamic therapy, radiotherapy, and chemotherapy. Besides, it also discusses the translational challenges and future perspectives for ROS-based dendrimers. For the first time, this work also critically compares various dendrimer types and generations, oxygen-delivery strategies, drug loading properties, <i>in vitro</i>/<i>in vivo</i> outcomes, and toxicity data. A dedicated section discussing biodistribution, clearance, biocompatibility, and regulatory considerations of dendrimers was also explored in this study. Finally, this review concludes that the dendrimers can be engineered to carry and deliver active oxygen by using the following delivery strategies: (1) addition of oxygen carriers, (2) enzyme functionalization, (3) the incorporation of photosensitizers and metal ions, and (4) surface alterations.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51801"},"PeriodicalIF":1.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Prophylactic Opioid Rescue for Breakthrough Pain Due to Body Movement: A Multicenter Retrospective Study. 阿片类药物预防治疗突发性肢体运动疼痛的有效性和安全性:一项多中心回顾性研究。
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-27 DOI: 10.31083/Pharmazie51655
Ryo Taguchi, Rei Tanaka, Eiji Kose, Shiho Hirashima, Mayako Uchida, Hisamitsu Takase
{"title":"Efficacy and Safety of Prophylactic Opioid Rescue for Breakthrough Pain Due to Body Movement: A Multicenter Retrospective Study.","authors":"Ryo Taguchi, Rei Tanaka, Eiji Kose, Shiho Hirashima, Mayako Uchida, Hisamitsu Takase","doi":"10.31083/Pharmazie51655","DOIUrl":"https://doi.org/10.31083/Pharmazie51655","url":null,"abstract":"<p><strong>Background: </strong>Prophylactic opioid rescue therapy is often used to manage cancer-related pain. However, the effect of prophylactic rescue therapy in suppressing increases in breakthrough pain due to body movements has not yet been investigated. Therefore, this study aimed to compare the efficacy and safety of prophylactic rescue therapy before and after administration.</p><p><strong>Methods: </strong>This multicenter, retrospective survey was conducted in Japan. Participants were patients with cancer who received prophylactic strong opioid rescue therapy for the first time. The primary endpoint was the suppression of an increase in pain, assessed using a Numerical Rating Scale (NRS), before and after administration of prophylactic rescue due to body movement.</p><p><strong>Results: </strong>The overall analysis (193 cases) showed that prophylactic rescue suppressed the increase in the median NRS value by 3.00 (interquartile range: 1.00-4.00, <i>p</i> < 0.001). In addition, subgroup analysis by purpose (meals/bathing/rehabilitation/radiation therapy/others) also showed a significant reduction in the increase in NRS, with all categories exhibiting a decrease of 2.00 or more.</p><p><strong>Conclusions: </strong>Prophylactic opioid rescue with appropriate patient selection can effectively suppress breakthrough pain caused by body movement.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51655"},"PeriodicalIF":1.0,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
MC4R Antagonists: A Promising New Hope for the Treatment of Cachexia and Wasting Diseases. MC4R拮抗剂:治疗恶病质和消耗性疾病的新希望
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-27 DOI: 10.31083/Pharmazie51802
Jiajia Shi, Jiaying Xiong, Chao Hao, Ling Huang, Yin Chen
{"title":"MC4R Antagonists: A Promising New Hope for the Treatment of Cachexia and Wasting Diseases.","authors":"Jiajia Shi, Jiaying Xiong, Chao Hao, Ling Huang, Yin Chen","doi":"10.31083/Pharmazie51802","DOIUrl":"https://doi.org/10.31083/Pharmazie51802","url":null,"abstract":"<p><p>Melanocortin-4 receptor (MC4R) is a key receptor in the hypothalamus regulating appetite and energy metabolism. Research has indicated that MC4R agonists have demonstrated potential for weight loss; its antagonists may stimulate appetite and weight gain, showing potential therapeutic applications in patients with anorexia or cachexia or those requiring weight restoration. However, the signaling mechanism, clinical applications, and safety profile of MC4R antagonists still require in-depth investigation. The purpose of this review is to comprehensively summarize the research progress of MC4R antagonists, analyze their mechanism of action and clinical applications, evaluate their safety profile, and explore future research directions. Future studies should focus on developing safer and more effective MC4R antagonists and exploring the therapeutic potential of MC4R in other diseases.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51802"},"PeriodicalIF":1.0,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Different Effects of the Anticonvulsant Drugs Phenytoin and Phenobarbital on Forskolin-Induced BeWo Syncytialization. 抗惊厥药物苯妥英和苯巴比妥对福斯克林诱导的BeWo合胞的不同影响。
IF 1 4区 医学
Pharmazie Pub Date : 2026-04-23 DOI: 10.31083/Pharmazie51799
Momoe Serizawa, Wakako Okuno, Kazuma Higashisaka, Mikihiro Yoshie, Kazuhiro Tamura, Yuya Haga, Yasuo Tsutsumi
{"title":"Different Effects of the Anticonvulsant Drugs Phenytoin and Phenobarbital on Forskolin-Induced BeWo Syncytialization.","authors":"Momoe Serizawa, Wakako Okuno, Kazuma Higashisaka, Mikihiro Yoshie, Kazuhiro Tamura, Yuya Haga, Yasuo Tsutsumi","doi":"10.31083/Pharmazie51799","DOIUrl":"https://doi.org/10.31083/Pharmazie51799","url":null,"abstract":"<p><strong>Background: </strong>The placenta plays important roles in pregnancy maintenance and fetal development, and chemical-induced functional or structural abnormalities can lead to adverse pregnancy outcomes. However, information on the placental effects of chemicals remains limited. To help address this gap, this study aimed to investigate the effects of two model chemicals, phenytoin and phenobarbital, on syncytialization (the fusion of cytotrophoblasts into multinucleated syncytiotrophoblasts), a critical process in placental development, using the human choriocarcinoma cell line BeWo.</p><p><strong>Methods: </strong>Phenytoin and phenobarbital, anticonvulsant drugs known to cause major congenital malformations, were each co-treated with forskolin, which promotes syncytialization in BeWo cells, for 48 h.</p><p><strong>Results: </strong>Evaluation of cell fusion showed that phenytoin significantly suppressed forskolin-induced luciferase activity, whereas phenobarbital did not. Enzyme-linked immunosorbent assay showed that the concentration of human chorionic gonadotropin beta (hCGβ) in the cell culture supernatant was decreased in phenytoin-treated syncytialized BeWo cells but increased in phenobarbital-treated cells. Western blotting also showed a similar pattern in the hCG protein expression level.</p><p><strong>Conclusion: </strong>Collectively, these results indicate that phenytoin suppresses the process of syncytialization, whereas phenobarbital does not affect cell fusion and instead enhances hCG production.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"81 1-4","pages":"51799"},"PeriodicalIF":1.0,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Phytochemical characterisation of pharmaceutical extracts from Equisetum arvense L. by HPLC-DAD-MSn and GC-MS. 用HPLC-DAD-MSn和GC-MS分析木贼药用提取物的植物化学特征。
IF 1 4区 医学
Pharmazie Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5620
Khadijeh Nosrati Gazafroudi, L K Mailänder, R Daniels, D R Kammerer, F C Stintzing
{"title":"Phytochemical characterisation of pharmaceutical extracts from <i>Equisetum arvense</i> L. by HPLC-DAD-MS<sup>n</sup> and GC-MS.","authors":"Khadijeh Nosrati Gazafroudi, L K Mailänder, R Daniels, D R Kammerer, F C Stintzing","doi":"10.1691/ph.2025.5620","DOIUrl":"10.1691/ph.2025.5620","url":null,"abstract":"<p><p><i>Equisetum arvense</i> L., commonly known as horsetail, is the most prominent <i>Equisetum</i> species and a widely used medicinal plant in traditional and herbal medicine. This study presents a comprehensive phytochemical characterisation of various pharmaceutical extracts prepared from field horsetail according to a national pharmacopoeia, including aqueous fermented extracts, oil-based extracts and hydroalcoholic extracts. Polar constituents were analysed using HPLC-DAD-ESI-MS n. GC-MS analyses following silylation were performed to elucidate low-molecular-weight compounds. The results revealed different phytochemical compositions of the <i>E. arvense</i> L. extracts, with distinct profiles of compounds including hydroxycinnamic acids and flavonoids. The results of the GC-MS investigations indicated the presence of an even broader variety of compounds, comprising benzoic acids, fatty acids, sugars, and phytosterols. Additionally, chlorophyll and carotenoid contents were quantified in the oil-based extracts by UV-VIS spectroscopy. This study underlines the significant impact of the respective extraction parameters on the phytochemical profile of the corresponding pharmaceutical extracts and highlights the rich history and continuing importance of this medicinal plant in traditional and complementary medicine.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"122-131"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Human-Resource-Development for the future provision of Clinical Pharmaceutical Services. 为将来提供临床药物服务而发展人力资源。
IF 1 4区 医学
Pharmazie Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5618
L Riedel, A Lange -Böhmer, T Bertsche
{"title":"Human-Resource-Development for the future provision of Clinical Pharmaceutical Services.","authors":"L Riedel, A Lange -Böhmer, T Bertsche","doi":"10.1691/ph.2025.5618","DOIUrl":"10.1691/ph.2025.5618","url":null,"abstract":"<p><p><i>Background and aim:</i> To implement Clinical Pharmaceutical Services (CPS) in routine hospital care with limited resources, their use should be prioritized. We present an objectifiable approach to planning development particularly for pharmaceutical staff. <i>Investigations:</i> We designed a Human Resource Development Score (HRD): HRD=P-([I+F]/2) with P: prioritization score of CPS assessed by a pharmaceutical expert panel; I: intensity score of CPS currently offered in routine care; F: frequency score of CPS offered; all scores ranged from 0[min]4[max]. An HRD<0 indicates a future decrease, HRD=0 no change and HRD>0 a desirable increase in the pharmaceutical staff development. To obtain an estimated future development (ΔHRD), we multiplied HRD as a weighting factor by the proportion of current or evaluated for the start of the respective CPS pharmaceutical staff positions (n, median per hospital pharmacy) as follows: ΔHRD=HRD*n. We calculated the ΔHRD in 155 of 162 CPS for which all required data were available. <i>Results:</i> In the \"Top-5 categories to be increased\", the pharmaceutical staff positions (n) and the Human Resource Development (ΔHRD=HRD*n) were as follows (median per hospital pharmacy): 1. \"Interfaces\"/\"Closed-loop concepts\" (n: 1.850; ΔHRD: +7.400), 2. \"Progress-management\"/\"Interdisciplinary ward-rounds\" (2.000; +2.000), 3. \"Progress-management\"/\"Nursing ward-rounds\" (1.000; +2.000). 4. \"Interfaces\"/\"Electronic-prescription and knowledge-support\" (0.300; +1.200), 5. \"Progress-management\"/\"Ward-rounds for high-risk-patients\" (1.100; +1.100). The most relevant categories whose resources could potentially be decreased to support other CPS were assessed as: \"Indication-related (non-patient-related) drug analysis\" (0.500; -0.250) and \"Oncology consultations\" (0.275; -0.275). <i>Conclusions:</i> With the help of a weighted Human Resource Development Score based on an expert panel, proposals for Human Resource Development in CPS were calculated.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"142-148"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multicenter randomized controlled trial in patients with type 2 diabetes mellitus to evaluate an "advanced pharmaceutical care" intervention for the prevention of adverse effects and drug-related problems in a follow-uphome visit (BayPharmCareDiabetesTrail). 一项针对2型糖尿病患者的多中心随机对照试验,旨在评估“先进药物护理”干预措施在随访家访中预防不良反应和药物相关问题的效果(BayPharmCareDiabetesTrail)。
IF 1 4区 医学
Pharmazie Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5623
J Gabsteiger, A Paul, J Landwehr, S Landwehr, T Bertsche
{"title":"A multicenter randomized controlled trial in patients with type 2 diabetes mellitus to evaluate an \"advanced pharmaceutical care\" intervention for the prevention of adverse effects and drug-related problems in a <i>follow-up</i>home visit (<i>BayPharmCareDiabetesTrail</i>).","authors":"J Gabsteiger, A Paul, J Landwehr, S Landwehr, T Bertsche","doi":"10.1691/ph.2025.5623","DOIUrl":"10.1691/ph.2025.5623","url":null,"abstract":"<p><p><i>Background and aim:</i> Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. <i>Investigations:</i> Patients with type-2 diabetes mellitus of community pharmacies were invited to participate in a multicenter controlled trial and were randomized either to receive \"basic care\" (control group, CG) or \"advanced pharmaceutical care\" (intervention group, IG). In two home visits at t0 (<i>status quo</i>) and t1 ( <i>follow-up</i> after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. <i>Results:</i> Totally, 130 patients were randomized to CG or IG (median age 73 vs. 67 years, n. s., 32 vs. 27 women, n. s.). At t0, 57 gastrointestinal-AE occurred in 33 patients (CG) vs. 56/31 (IG, n. s.). At t1, 57 \"unchanged persisting\" gastrointestinal-AE occurred in 32 patients (CG) vs. 25/17 (IG, p=0.006) and 59 \"overall persisting\" gastrointestinal-AE in 33 patients (CG) vs. 39/25 (IG, n. s.). At t0, 11 hypoglycemic-AE occurred in 9 patients (CG) vs. 13/10 (IG, n. s.). At t1, 10 \"unchanged persisting\" hypoglycemic-AE occurred in 9 patients (CG) vs. 2/2 (IG, p=0.028) and 10 \"overall persisting\" hypoglycemic-AE in 9 patients (CG) vs. 5/4 (IG, n. s.). At t0, 135 DRP occurred in 36 patients (CG) vs. 147/43 (IG, n. s.). At t1, 133 DRP occurred in 34 patients (CG) vs. 41/19 (IG, p=0.005). At t0, 58 patients (CG) vs. 50 patients (IG) self-reported to be adherent (n. s.) and at t1, 60 patients (CG) vs. 59 (IG, n. s.). <i>Conclusions:</i> \"Advanced pharmaceutical care\" decreased the number of \"unchanged persisting\" gastroenterological- and hypoglycemic-AE and DRP.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"149-155"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and validation of a qNMR method for the simultaneous quantification of creatine and taurine in sports supplements. 同时定量运动补充剂中肌酸和牛磺酸的qNMR方法的开发和验证。
IF 1 4区 医学
Pharmazie Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5078
R Van Der Merwe, D P Otto, W Liebenberg, H J R Lemmer, F van der Kooy
{"title":"Development and validation of a qNMR method for the simultaneous quantification of creatine and taurine in sports supplements.","authors":"R Van Der Merwe, D P Otto, W Liebenberg, H J R Lemmer, F van der Kooy","doi":"10.1691/ph.2025.5078","DOIUrl":"10.1691/ph.2025.5078","url":null,"abstract":"<p><p>Creatine and taurine are frequently found together in sports supplements due to their performance-enhancing and metabolic benefits. However, discrepancies between label claims and actual content have raised concerns about product quality, regulatory compliance, and possible health impacts. Accurate quantification of these compounds is therefore essential. Liquid chromatography mass spectrometry (LC-MS/MS) is widely used for its ability to detect and quantify compounds with high sensitivity and specificity. Therefore, in a previous study, an LC-MS/MS method was developed and validated for the simultaneous quantification of creatine and taurine in sports supplements. While accurate and sensitive, its somewhat cumbersome sample preparation step makes it less suitable for a commercial setting, where typically large numbers of samples must be analysed for quality control purposes. In this study, we report the first application of quantitative nuclear magnetic resonance (qNMR) for the simultaneous quantification of creatine and taurine in sports supplements, offering a simpler alternative for quality control. A qNMR method was developed, validated, and applied to commercial sports supplements, and the results were compared to label claims. All validation parameters fell well within acceptable limits, and sample analysis revealed deviations from label claims of up to +65.97% for creatine and +141.52% for taurine. Batch-to-batch variation of the products showed better consistency with variability only as high as 8.49%. Overall, this study confirms qNMR as a reliable method demonstrating specificity, precision, accuracy, and suitability for quantitative analysis. Although high-field NMR systems remain more commonly used, the method developed here is directly transferable to modern cryogen-free benchtop NMR instruments. Benchtop NMR significantly reduces operational costs and complexity, and may arguably become a valuable, reliable, and affordable tool in quality control laboratories.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"118-121"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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