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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 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5620
K Nosrati Gazafroudi, L K Mailänder, R Daniels, D R Kammerer, F C Stintzing

Equisetum arvense L., commonly known as horsetail, is the most prominent Equisetum 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 E. arvense 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.

马尾草(Equisetum arvense L.),俗称马尾,是最著名的马尾草属植物,是传统和中草药中应用广泛的药用植物。本研究根据国家药典对从田间马尾中提取的各种药物提取物进行了全面的植物化学表征,包括水发酵提取物、油基提取物和水醇提取物。极性成分采用HPLC-DAD-ESI-MS和硅基化后的GC-MS分析来阐明低分子量化合物。结果表明,香柏树提取物具有不同的植物化学成分,羟基肉桂酸和黄酮类化合物具有不同的特征。气相色谱-质谱分析的结果表明存在更广泛的化合物,包括苯甲酸、脂肪酸、糖和植物甾醇。此外,通过紫外可见光谱法测定了油基提取物中叶绿素和类胡萝卜素的含量。本研究强调了各自的提取参数对相应药物提取物的植物化学特征的重要影响,并强调了这种药用植物在传统和补充医学中的丰富历史和持续重要性。
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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 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5618
L Riedel, A Lange -Böhmer, T Bertsche

Background and aim: 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. Investigations: 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. Results: 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). Conclusions: With the help of a weighted Human Resource Development Score based on an expert panel, proposals for Human Resource Development in CPS were calculated.

背景与目的:在资源有限的情况下,临床药学服务(CPS)在医院常规护理中的应用应优先考虑。我们提出了一种客观的方法来规划发展,特别是为制药人员。研究:设计了人力资源开发评分(HRD): HRD=P-([I+F]/2), P:由药学专家小组评估的CPS优先级评分;I:常规护理中目前提供的CPS强度评分;F:提供CPS的频次评分;所有得分范围从0[最低]到4[最高]。HRD0是制药人员发展的理想增长。为了获得估计的未来发展(ΔHRD),我们将HRD作为加权因子乘以当前或评估的各个CPS药学人员职位开始的比例(n,每家医院药房的中位数),结果如下:ΔHRD=HRD*n。我们计算了162个CPS中155个的ΔHRD,其中所有所需的数据都可用。结果:在“前5个有待增加的类别”中,药学人员职位(n)和人力资源开发(ΔHRD=HRD*n)分别为(每家医院药房的中位数):1;1.“接口”/“闭环概念”(n: 1.850; ΔHRD: +7.400);2.“进度管理”/“跨学科查房”(2.000;+2.000);“进度管理”/“护理查房”(1.000;+2.000)。4. 4 .“接口”/“电子处方和知识支持”(0.300;+1.200);“进展管理”/“高风险患者查房”(1.100;+1.100)。最相关的类别,其资源可能会减少以支持其他CPS,评估为:“适应症相关(非患者相关)药物分析”(0.500;-0.250)和“肿瘤学咨询”(0.275;-0.275)。结论:根据专家小组的加权人力资源开发评分,计算了CPS人力资源开发的建议。
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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 Q4 CHEMISTRY, MEDICINAL 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

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.

肌酸和牛磺酸经常一起出现在运动补充剂中,因为它们具有提高成绩和代谢的好处。然而,标签声明和实际内容之间的差异引起了人们对产品质量、法规遵从性和可能的健康影响的担忧。因此,这些化合物的精确定量是必要的。液相色谱-质谱法(LC-MS/MS)因其具有高灵敏度和特异性的检测和定量化合物的能力而被广泛应用。因此,在之前的一项研究中,我们开发并验证了LC-MS/MS同时定量运动补充剂中肌酸和牛磺酸的方法。虽然准确和敏感,但其有些繁琐的样品制备步骤使其不太适合商业环境,在商业环境中,通常必须分析大量样品以进行质量控制。在这项研究中,我们报告了定量核磁共振(qNMR)在运动补充剂中同时定量肌酸和牛磺酸的首次应用,为质量控制提供了一种更简单的选择。一种qNMR方法被开发、验证并应用于商业运动补充剂,并将结果与标签声明进行比较。所有验证参数都在可接受范围内,样品分析显示肌酸和牛磺酸与标签声明的偏差高达+65.97%和+141.52%。批间变异一致性较好,变异率仅为8.49%。总体而言,本研究证实qNMR是一种可靠的方法,具有特异性、精密度、准确性和定量分析的适用性。尽管高场核磁共振系统仍然更常用,但这里开发的方法可直接转移到现代无低温台式核磁共振仪器。台式核磁共振显著降低了操作成本和复杂性,并可能成为质量控制实验室中有价值的、可靠的和负担得起的工具。
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引用次数: 0
Drug shortage and networks of medical crime: Herbert Siggelkow (1906-1976), chief pharmacist of the Nazi concentration camps. 药物短缺和医疗犯罪网络:赫伯特·西格尔科(1906-1976),纳粹集中营的首席药剂师。
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5076
M Ritters, D Gross, N Biermanns

Our understanding of pharmacists as Nazi perpetrators remains rather vague. Considerable research has examined the Nazification and transformation of German pharmaceutical research, practice, and education between 1933 and 1945. The names of several SS pharmacists who served in concentration camps are also known. Yet little is known about their actual practices and their concrete involvement in medical crimes. What tasks did pharmacists perform in the concentration camps, what scope of action did they have, and in which perpetrator networks were they embedded? This article addresses these questions through the biographical example of Herbert Siggelkow (1906-1976), chief pharmacist of the concentration camps. Drawing on extensive archival records, we reconstruct the biography of Siggelkow, who, already as a grammar school student, had joined a völkisch-nationalist paramilitary association and, in 1932, the Nazi Party and the SS. We then analyze his responsibilities, individual scope of action, and involvement in medical crimes across the various settings of his service in the Waffen-SS and within the concentration camp system. As camp pharmacist at Dachau and Sachsenhausen and as chief pharmacist of the concentration camp medical service, Siggelkow shared responsibility for both the individual and the structural medical neglect of inmates. In fact, he was among the very few who had precise knowledge of the extent of medical shortages throughout the entire camp system. Through the distribution of poisons, he facilitated the systematic killing of sick and incapacitated prisoners by injection, while the provision of drugs and equipment for the camp research stations sustained the criminal practice of coerced human experimentation. We demonstrate that, over the course of his service, Siggelkow operated within markedly varying but generally limited scopes of action. While he had initially used his individual latitude clearly to the detriment of prisoners, his demeanor shifted markedly as hopes of a German victory waned. However, as part of a multi-professional perpetrator network, he bore substantial co-responsibility for atrocious medical crimes committed in the camps.

我们对药剂师作为纳粹罪犯的理解仍然相当模糊。相当多的研究考察了1933年至1945年间德国制药研究、实践和教育的纳粹化和转型。在集中营服役的几名党卫军药剂师的名字也为人所知。然而,人们对他们的实际做法以及他们在医疗犯罪中的具体参与知之甚少。药剂师在集中营里执行什么任务,他们的行动范围是什么,他们嵌入了什么样的罪犯网络?本文通过集中营首席药剂师赫伯特·西格尔科(Herbert Siggelkow, 1906-1976)的传记例子来解决这些问题。根据大量的档案记录,我们重建了Siggelkow的传记,他已经是一名文法学校的学生,加入了völkisch-nationalist准军事协会,并于1932年加入了纳粹党和党卫军。然后我们分析了他在武装党卫军和集中营系统服务的各种环境中所承担的责任、个人行动范围和参与医疗犯罪的情况。作为达豪和萨克森豪森集中营的药剂师以及集中营医疗服务的首席药剂师,西格尔科对囚犯的个人和结构性医疗忽视负有共同责任。事实上,他是少数几个准确了解整个难民营医疗短缺程度的人之一。通过分发毒药,他协助有系统地以注射方式杀害生病和丧失行为能力的囚犯,同时为集中营研究站提供药物和设备,维持强迫人体实验的犯罪行为。我们证明,在他的服务过程中,Siggelkow在明显不同但通常有限的行动范围内运作。虽然他最初明显利用自己的个人自由来损害囚犯的利益,但随着德国胜利的希望减弱,他的态度发生了明显的变化。然而,作为多职业犯罪者网络的一部分,他对在难民营犯下的残暴医疗罪行负有重大共同责任。
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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 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5623
J Gabsteiger, A Paul, J Landwehr, S Landwehr, T Bertsche

Background and aim: Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. Investigations: 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 (status quo) and t1 ( follow-up after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. Results: 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.). Conclusions: "Advanced pharmaceutical care" decreased the number of "unchanged persisting" gastroenterological- and hypoglycemic-AE and DRP.

背景与目的:研究为某些药物的降糖疗效提供了强有力的证据,但不良事件(ae)和药物相关问题(DRPs)限制了它们的有效性。调查:邀请社区药房的2型糖尿病患者参加多中心对照试验,随机分为“基础护理”组(对照组,CG)和“高级药学护理”组(干预组,IG)。在10(现状)和1(4-6周后随访)的两次家访中,患者被问及抗糖尿病患者典型的AE/DRP及其依从性。结果:总共有130例患者被随机分配到CG或IG组(中位年龄73 vs 67岁,新统计数据,32 vs 27名女性,新统计数据)。10时,消化道ae患者33例(CG), 56例(IG, n.s.s)。在t1时,32例患者(CG)中发生57例“不变持续”胃肠道ae,而25/17例(IG, p=0.006); 33例患者(CG)中发生59例“整体持续”胃肠道ae,而39/25例(IG, n. s.)。10时,9例患者发生11例低血糖- ae (CG), 13例/10例(IG, n.s.s)。t1时,9例患者(CG)发生10例“不变持续”低血糖ae, 2/2 (IG, p=0.028); 9例患者(CG)发生10例“整体持续”低血糖ae, 5/4 (IG, n. s.)。10时,36例患者发生135例DRP (CG), 147/43例(IG, n.s.s)。t1时,34例患者(CG)发生133例DRP, 41/19例(IG, p=0.005)。在10时,58例患者(CG)对50例患者(IG)自我报告粘附(n. s),在1时,60例患者(CG)对59例(IG, n. s)。结论:“先进的药学服务”降低了“不变持续”的胃肠病和低血糖ae和DRP的数量。
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引用次数: 0
Chronopharmaceutical tablet design for prednisone based on geometry and compression physics independent of excipient influence: a mechanistic approach to controlled release. 基于几何和独立于辅料影响的压缩物理的强的松计时药物片剂设计:一种控制释放的机械方法。
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5065
O Pinarbasli, G P Gurbetoglu, N Sarracoglu, A A Doganay, T Ozbay

Chronopharmaceutic drug delivery systems are designed to align the release of active substances with the body's biological rhythms, offering significant advantages in diseases with time-dependent symptom patterns. Delayed-release tablets are widely used in this field to achieve controlled drug release after a defined lag time, typically by modulating the composition of excipients. However, the reliance on excipient-based control may limit the flexibility and predictability of release profiles. This study is the first in the literature to focus on the mechanistic design of chronopharmaceutical tablets by exploring how physical tablet properties-specifically tablet geometry and compression physics-can independently control delayed drug release, without relying on excipient effects. By systematically varying tablet shape, size, and compression force, we aimed to establish a new formulation approach centered on the physical characteristics of the dosage form. Prednisone was selected as a model drug due to its common use in chronotherapy, where precisely timed drug release is essential to improve therapeutic outcomes. In vitro dissolution studies demonstrated that manipulation of tablet geometry and compression parameters effectively modulated lag time and drug release kinetics, independent of excipient composition. These findings suggest that optimizing the mechanistic properties of tablets provides a valuable strategy for the design of advanced chronopharmaceutical systems, potentially enhancing drug efficacy, patient comfort, and treatment adherence.

时间药物传递系统旨在使活性物质的释放与人体的生物节律一致,为具有时间依赖性症状模式的疾病提供显着优势。缓释片广泛应用于该领域,通常通过调节赋形剂的组成,在规定的滞后时间后实现药物的受控释放。然而,依赖于基于赋形剂的控制可能会限制释放概况的灵活性和可预测性。本研究是文献中首次关注计时药物片剂的机理设计,通过探索片剂的物理性质(特别是片剂的几何形状和压缩物理)如何独立控制药物的延迟释放,而不依赖于赋形剂的作用。通过系统地改变片剂形状、大小和压缩力,我们旨在建立一种以剂型物理特性为中心的新配方方法。强的松被选为模型药物,因为它在时间治疗中常用,其中精确定时的药物释放对改善治疗结果至关重要。体外溶出研究表明,控制片剂的几何形状和压缩参数可以有效地调节滞后时间和药物释放动力学,而与辅料成分无关。这些发现表明,优化片剂的机制特性为设计先进的计时药物系统提供了有价值的策略,可能会提高药物疗效、患者舒适度和治疗依从性。
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引用次数: 0
Persisting infections under IgG substitution: Need for further improvement. IgG替代下的持续感染:需要进一步改善。
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5665
A Wartenberg-Demand, C Staiger, K Warnatz

Since many years, immunoglobulin G (IgG) substitution has been used to treat patients with primary immunodeficiencies (PID) to reduce the number of infections and the burden of disease. Nevertheless, many patients continue to suffer from persisting infections. In this SINUS study, a patient questionnaire consisting of 21 questions was used to assess the current situation in patients with PID. Of the 160 patients included, most showed a persistent tendency to infections (N=140, 87.5%). During the last 12 month, most of the patients suffered from upper and lower respiratory tract infections such as sinusitis (N=85, 60.7%), bronchitis (N=88, 62.9%), and pneumonia (N=10, 7.1%). Yet the presence of persistent infections was not inversely correlated with patient satisfaction. Therefore, the treating physicians need to carefully evaluate the infection history and additional therapeutic approaches are required for satisfying improvement in the patient's infection control. Patients are open to explore new ways to achieve this goal.

多年来,免疫球蛋白G (IgG)替代已被用于治疗原发性免疫缺陷(PID)患者,以减少感染数量和疾病负担。然而,许多患者继续遭受持续的感染。在本研究中,使用了一份包含21个问题的患者问卷来评估PID患者的现状。在纳入的160例患者中,大多数患者表现出持续感染倾向(N=140, 87.5%)。近12个月,患者以鼻窦炎(85例,占60.7%)、支气管炎(88例,占62.9%)、肺炎(10例,占7.1%)等上呼吸道感染为主。然而,持续感染的存在与患者满意度没有负相关。因此,治疗医生需要仔细评估感染病史,并需要额外的治疗方法来满足患者感染控制的改善。患者愿意探索实现这一目标的新方法。
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引用次数: 0
Off-label prescribing in the pediatric population: perceptions and practices of community pharmacists in Kosovo - a cross-sectional survey. 儿科人群的标签外处方:科索沃社区药剂师的看法和做法-一项横断面调查。
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5087
A Koshi, R Koliqi, P Breznica Selmani, D Raka, B Koshi

Off-label drug prescribing in pediatric populations is a common practice worldwide due to the limited availability of approved formulations and clinical data for children. While often necessary, it raises concerns regarding safety, efficacy, and ethical considerations. Pharmacists play a key role in ensuring the safe use of off-label drugs; however, their perspectives in low-resource settings like Kosovo remain under-investigated. A cross-sectional, questionnaire-based survey was conducted among 296 community pharmacists across Kosovo between December 2024 and January 2025. The 27-item structured survey collected demographic data and assessed pharmacists' familiarity, practices, and perspectives on pediatric off-label use. Data were analyzed using IBM SPSS 22.0. Of the pharmacists surveyed, 49% reported moderate familiarity with pediatric off-label use, and 79% had not received formal training. Nearly all participants (99%) had encountered off-label prescriptions, most commonly involving anti-infectives and respiratory medications. Although 98% acknowledged that off-label use is sometimes necessary, many expressed concerns about safety and effectiveness. Only 21% had observed adverse drug reactions, while 96% reported no treatment failures. Communication with prescribers was rated as good by 49% of respondents, though 71% emphasized the need for stronger interdisciplinary collaboration. This study provides the first national insight into community pharmacists' perspectives on pediatric off-label prescribing in Kosovo. The findings highlight the urgent need for targeted pharmacist education, the development of standardized national guidelines, and enhanced collaboration between pharmacists and prescribers to improve medication safety in pediatric patients.

由于批准的配方和儿童临床数据的可用性有限,在儿科人群中开说明书外药物处方是一种普遍做法。虽然通常是必要的,但它引起了对安全性、有效性和伦理考虑的担忧。药剂师在确保超说明书药物安全使用方面发挥着关键作用;然而,他们在科索沃等资源匮乏地区的观点仍未得到充分调查。在2024年12月至2025年1月期间,对科索沃296名社区药剂师进行了横断面问卷调查。这项有27个项目的结构化调查收集了人口统计数据,并评估了药剂师对儿科标签外用药的熟悉程度、做法和观点。数据采用IBM SPSS 22.0进行分析。在接受调查的药剂师中,49%的人表示对儿科标签外用药中度熟悉,79%的人没有接受过正式培训。几乎所有参与者(99%)都遇到过说明书外处方,最常见的是抗感染和呼吸系统药物。尽管98%的人承认有时有必要在说明书外使用,但许多人对安全性和有效性表示担忧。只有21%的患者观察到药物不良反应,而96%的患者报告没有治疗失败。49%的受访者认为与开处方者的沟通良好,尽管71%的受访者强调需要加强跨学科合作。这项研究提供了第一个国家洞察社区药剂师的观点儿科标签外处方在科索沃。研究结果强调,迫切需要有针对性的药师教育,制定标准化的国家指南,加强药师和处方医师之间的合作,以提高儿科患者的用药安全性。
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引用次数: 0
Risk factors for zolbetuximab-associated nausea and vomiting: a pharmacovigilance analysis using the Japanese Adverse Drug Event Report (JADER) database. 唑苯妥昔单抗相关恶心和呕吐的危险因素:使用日本不良药物事件报告(JADER)数据库的药物警戒分析。
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5660
T Nagase, K Shinozaki

Zolbetuximab, a monoclonal antibody against claudin-18.2 (CLDN18.2), improves outcomes in CLDN18.2-positive gastric cancer, but gastrointestinal adverse events-especially nausea and vomiting-are frequently reported. Using PMDA-JADER (April 2004-March 2025), we identified individual case safety reports (ICSRs) listing zolbetuximab as a suspected drug and defined the outcome with MedDRA-concordant preferred terms (nausea, vomiting, nausea and vomiting, retching). Within zolbetuximab reports, binary logistic regression with sex (male reference) and age (<60 years reference) showed higher adjusted odds in females (aOR 3.07; 95% CI 1.45-6.51; p=0.003) and lower odds in patients ≥60 years (aOR 0.25; 95% CI 0.10-0.61; p=0.002); model calibration was acceptable (Hosmer-Lemeshow p=1.000). Disproportionality analysis yielded a markedly elevated reporting odds ratio (ROR) for zolbetuximab versus all other reports (ROR 85.40; 95% CI 62.58-116.53), whereas immune checkpoint inhibitors showed no signal. These measures reflect reporting disproportionality within a spontaneous-reporting system and should not be interpreted as incidence or causality. These exploratory findings support proactive, guideline-based antiemetic strategies-particularly for younger female patients-and warrant prospective confirmation.

Zolbetuximab是一种抗CLDN18.2 (CLDN18.2)的单克隆抗体,可改善CLDN18.2阳性胃癌的预后,但胃肠道不良事件-特别是恶心和呕吐-经常被报道。使用PMDA-JADER(2004年4月- 2025年3月),我们确定了将唑贝昔单抗列为疑似药物的个案安全报告(ICSRs),并使用meddra一致的首选术语(恶心、呕吐、恶心和呕吐、干呕)定义了结果。在唑苯妥昔单抗报告中,与性别(男性参考)和年龄(
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引用次数: 0
Nephrotoxicity and associated risk factors in patients treated with pemetrexed. 培美曲塞治疗患者的肾毒性及相关危险因素
IF 1 4区 医学 Q4 CHEMISTRY, MEDICINAL Pub Date : 2025-12-01 DOI: 10.1691/ph.2025.5661
Y Yamamoto, N Orito, N Watanabe, H Hayashi, T Fukuoka, M Ando, M Kawahara, Y Deguchi

Purpose: Pemetrexed causes renal impairment. However, few studies have investigated the risk factors associated with pemetrexed-induced renal impairment. This study aimed to investigate the incidence of nephrotoxicity in patients receiving pemetrexed in combination with carboplatin and to identify the associated risk factors. Methods: This single-center retrospective study included patients with lung cancer (including malignant mesothelioma) who underwent pemetrexed-based treatment between May 2019 and August 2022. Nephrotoxicity incidence was evaluated according to the Kidney Disease Improving Global Outcomes diagnostic criteria, and risk factors for nephrotoxicity during pemetrexed treatment were identified using logistic regression analysis. Results: Renal impairment occurred in 17 of 108 patients (15.7 %), with many experiencing irreversible renal function decline after its onset. The risk factors for nephrotoxicity during pemetrexed-based treatment were identified as the total number of cycles (≥ 10) (odds ratio: 7.94, p < 0.01) and its combination with any two non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEIs/ARBs), or diuretics (odds ratio: 6.30, p < 0.01). Conclusion: Patients receiving pemetrexed treatment are at risk of developing renal impairment, with risk potentially increasing with the number of treatment cycles and concomitant use of NSAIDs, ACEIs/ARBs, or diuretics. However, further studies are required to confirm these findings.

目的:培美曲塞引起肾功能损害。然而,很少有研究调查培美曲塞引起肾功能损害的相关危险因素。本研究旨在调查培美曲塞联合卡铂患者肾毒性的发生率,并确定相关的危险因素。方法:这项单中心回顾性研究纳入了2019年5月至2022年8月期间接受培美曲塞治疗的肺癌(包括恶性间皮瘤)患者。根据肾病改善全球预后诊断标准评估肾毒性发生率,并使用logistic回归分析确定培美曲塞治疗期间肾毒性的危险因素。结果:108例患者中有17例(15.7%)出现肾功能损害,许多患者发病后出现不可逆的肾功能下降。培美曲塞治疗期间肾毒性的危险因素确定为总周期数(≥10)(优势比:7.94,p < 0.01)和与任何两种非甾体抗炎药(NSAIDs)、血管紧张素转换酶抑制剂/血管紧张素II受体阻滞剂(ACEIs/ARBs)或利尿剂(优势比:6.30,p < 0.01)联合使用。结论:接受培美曲塞治疗的患者存在发生肾脏损害的风险,随着治疗周期的增加以及同时使用非甾体抗炎药、ACEIs/ arb或利尿剂,风险可能会增加。然而,需要进一步的研究来证实这些发现。
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