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Global prescription patterns and practices: Utilization of statins in diabetes management across nations. 全球处方模式和实践:他汀类药物在各国糖尿病管理中的应用。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_770_24
Smruti Besekar, Sangita Jogdand, Satyawan Singh Patel

Cardiovascular disease (CVD) poses a significant risk for individuals with type 2 diabetes mellitus (T2DM), and statins are integral in preventing such complications. However, global statin prescription practices often diverge from clinical guidelines, which can lead to suboptimal cardiovascular outcomes. This review examines global trends in statin prescription patterns in T2DM management, focusing on adherence to clinical guidelines, gaps in statin utilization, and the impact on cardiovascular health. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses-2 guidelines, this systematic review analyzed eight studies on statin prescription trends, guideline adherence, and therapy intensity, revealing significant global variations in prescription practices. Notably, higher prescription rates were found in Asia compared to Africa and certain developed nations. Despite recommendations, high-intensity statins were underutilized globally, with many patients receiving moderate- or low-intensity therapy. Inappropriate statin use was also observed in low-risk T2DM patients, raising concerns about unnecessary exposure to potential adverse effects. The findings underscore the urgent need for improved adherence to clinical guidelines, particularly for high-risk T2DM patients, and highlight the importance of addressing these barriers. To optimize cardiovascular outcomes, the review emphasizes enhanced physician education, better implementation of guidelines, and targeted strategies to optimize statin therapy. Addressing these gaps could lead to a reduction in CVD risk and improved outcomes for patients with T2DM globally.

心血管疾病(CVD)对2型糖尿病(T2DM)患者构成重大风险,他汀类药物在预防此类并发症中不可或缺。然而,全球他汀类药物处方实践往往偏离临床指南,这可能导致次优心血管结果。本综述探讨了T2DM治疗中他汀类药物处方模式的全球趋势,重点关注临床指南的遵守、他汀类药物使用的差距以及对心血管健康的影响。根据系统评价和荟萃分析-2指南的首选报告项目,本系统评价分析了8项关于他汀类药物处方趋势、指南依从性和治疗强度的研究,揭示了处方实践中显著的全球差异。值得注意的是,与非洲和某些发达国家相比,亚洲的处方率更高。尽管有推荐,但高强度他汀类药物在全球范围内未得到充分利用,许多患者接受的是中等或低强度治疗。在低风险T2DM患者中也观察到不适当的他汀类药物使用,这引起了对不必要的潜在不良反应的担忧。研究结果强调了迫切需要提高临床指南的依从性,特别是对高危T2DM患者,并强调了解决这些障碍的重要性。为了优化心血管预后,本综述强调加强医师教育,更好地实施指南,并有针对性地优化他汀类药物治疗。解决这些差距可能导致全球2型糖尿病患者心血管疾病风险的降低和预后的改善。
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引用次数: 0
Prescribing trends of fixed-dose combination of domperidone and proton-pump inhibitor across tertiary care centers in India, is the combination rational? 印度三级医疗中心多潘立酮和质子泵抑制剂固定剂量联合用药趋势,这种联合用药合理吗?
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_744_23
Ajay Kumar Shukla, Sameer Uttamrao Khasbage, Ratinder Jhaj, Balakrishnan Sadasivam, Jerin Jose Cherian, Preeta Kaur Chugh, C D Tripathi, Chetna K Desai, Prakruti Parth Patel, Niyati A Trivedi, Janki Chauhan, Jayanthi Mathaiyan, S Manikandan, Ramasamy Raveendran, Pooja Gupta, Sandhya Kaustubh Kamat, Raakhi Kaliprasad Tripathi, Yashashri Shetty, Suparna Chatterjee, Debaleena Das, Atiya R Faruqui, Sujith J Chandy, Harihar Dikshit, Hitesh Mishra, Sukalyan Saha Roy, Rajiv Kumar, Rupa Joshi, Ajay Prakash, Bikash Medhi, Nilima Kshirsagar

Background: There have been concerns over the rationality of prescribing practices of fixed-dose combinations (FDCs) available in India. The FDC of domperidone and pantoprazole recently emerged as a top-selling product at Janaushadhi Kendras in India.

Methods: This cross-sectional study is a part of the prescription research which was conducted under the Indian Council of Medical Research (ICMR) Task Force Project on Rational Use of Drugs at 13 tertiary healthcare centers across the countries that were part of the ICMR-Rational Use of Medicine Centres Network. An assessment of rationality for prescribing practices of FDC of domperidone and proton-pump inhibitors (PPIs) was done based on the available guidelines and evidence from the literature.

Results: In this study, 8839 outpatient prescriptions were analyzed in which FDCs with domperidone and PPI were prescribed in 481 (5.44%) cases. The FDC containing domperidone + PPI was prescribed for nausea and vomiting in 10.81% of cases. The dose was not mentioned in 55% of prescriptions; the dose of domperidone up to 30 mg/day was mentioned in 42.41% of prescriptions and more than 30 mg/day in 2.28% of prescriptions. In 89.18% of cases, it was prescribed to patients under 60 years of age.

Conclusions: This study has shown a lack of rationality in the prescribing practices in FDC containing domperidone and PPI in terms of indications, dose, frequency, duration, and administration instructions.

背景:人们一直对印度现有固定剂量联合用药(fdc)处方做法的合理性感到担忧。多潘立酮和泮托拉唑的FDC最近成为印度Janaushadhi Kendras最畅销的产品。方法:这项横断面研究是处方研究的一部分,该研究是在印度医学研究委员会(ICMR)工作组合理使用药物项目下进行的,该项目在13个三级医疗保健中心进行,这些中心是ICMR-合理使用医学中心网络的一部分。根据现有的指南和文献证据,对多潘立酮和质子泵抑制剂(PPIs)的FDC处方实践的合理性进行了评估。结果:本研究共收集8839张门诊处方,其中481例(5.44%)使用fdc联合多潘立酮和PPI。10.81%的患者使用含多潘立酮+ PPI的FDC治疗恶心和呕吐。55%的处方中没有提到剂量;42.41%的处方中提到多潘立酮剂量≤30 mg/d, 2.28%的处方中提到剂量大于30 mg/d。在89.18%的病例中,60岁以下的患者使用该药。结论:本研究显示含多潘立酮和PPI的FDC在适应症、剂量、频率、持续时间和给药说明等方面的处方实践缺乏合理性。
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引用次数: 0
Topical application of standardized capsicum and rosemary extracts promotes hair growth in testosterone induced alopecia in Wistar rats: Histological and morphometric evaluation. 局部应用标准辣椒和迷迭香提取物促进Wistar大鼠睾酮诱导脱发的毛发生长:组织学和形态计量学评估。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_636_24
Alaa Youssef Eid, Dalia A Al-Mahdy, Rabab H Sayed, Mouchira A Choucry, Hesham El-Askary

Introduction: Alopecia, a common condition causing hair loss, leads to decreased self-esteem worldwide. Natural extracts such as rosemary (Rosmarinus officinalis L.) and capsicum (Capsicum annuum L.), traditionally used for various medicinal purposes in Egypt, are widely utilized in treatments for androgenetic alopecia and hair care products. However, these extracts lack market standardization and clear specifications, leading to inconsistent and unpredictable effects.

Objectives: This study aims to investigate the effects of standardized rosemary and capsicum extracts on testosterone-induced androgenetic alopecia in rats to ensure consistent quality and safety in marketed hair care products.

Materials and methods: The study involved preparing standardized rosemary and capsicum extracts and developing simple, accurate, sensitive, rapid, and reproducible methods for both. The extracts were tested on adult male Wistar rats with testosterone-induced alopecia, using a 2% finasteride solution as a reference standard. Visual and microscopic evaluations were conducted to measure three hair follicle parameters: diameter, length, and density.

Results: This study demonstrated the potent effects of standardized rosemary and capsicum extracts on hair growth parameters over 21 days; the application of 0.075% of standardized capsicum extract significantly improved hair growth parameters, including follicle density, length, and diameter. Furthermore, standardized rosemary extracts at 3% and 5% concentrations showed significant improvements across all measured parameters, particularly in hair follicle density.

Conclusions: This study highlights the potential of standardized rosemary and capsicum extracts in promoting hair growth parameters, including hair follicle density, length, and diameter. It will pave the way for more effective natural-based androgenetic alopecia treatment.

简介:脱发是一种常见的导致脱发的疾病,在世界范围内导致自尊下降。迷迭香(Rosmarinus officinalis L.)和辣椒(capsicum annuum L.)等天然提取物在埃及传统上用于各种药用目的,被广泛用于治疗雄激素性脱发和护发产品。然而,这些提取物缺乏市场标准化和明确的规格,导致效果不一致和不可预测。目的:本研究旨在探讨标准迷迭香和辣椒提取物对睾酮诱导的雄激素性脱发大鼠的影响,以确保市场上销售的护发产品的质量和安全性。材料与方法:制备标准的迷迭香和辣椒提取物,建立简便、准确、灵敏、快速、重复性好的方法。以2%非那雄胺溶液为参比标准,对睾酮诱导脱发的成年雄性Wistar大鼠进行试验。进行了视觉和显微镜评估,以测量三个毛囊参数:直径,长度和密度。结果:本研究证实了标准化迷迭香和辣椒提取物在21天内对头发生长参数的有效影响;0.075%标准辣椒提取物可显著改善毛囊密度、毛囊长度和毛囊直径等毛发生长参数。此外,3%和5%浓度的标准迷迭香提取物在所有测量参数中都有显着改善,特别是在毛囊密度方面。结论:本研究强调了标准化迷迭香和辣椒提取物在促进头发生长参数方面的潜力,包括毛囊密度、长度和直径。它将为更有效的天然雄激素性脱发治疗铺平道路。
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引用次数: 0
Evaluation of acceptability and feasibility of using manual pill organizers and pill reminder apps for improving medication adherence among elderly population from rural Maharashtra. 评估使用手动药丸整理器和药丸提醒应用程序提高马哈拉施特拉邦农村老年人服药依从性的可接受性和可行性。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_960_24
Radhika K Nimkar, Rajesh W Balkhande, Rakesh S Patil, Dhiraj M Agarwal, Aditi A Apte

Background: Approximately 40%-75% of elderly individuals suffering from chronic diseases are nonadherent to medications. Manual pill organizers (MPO) and pill reminder apps (PRAs) are simple interventions that can improve medication adherence. This was a mixed-methods study to understand the feasibility and acceptability of MPO and a locally developed PRA amongst elderly individuals from rural Maharashtra.

Materials and methods: Sixty elderly individuals aged 60-80 years taking three or more oral medications with access to a smartphone were randomized to receive MPO, PRA, or MPO + PRA for 3 months (n = 30). The outcome measures included acceptability and feasibility using qualitative methods, and usability was measured using a system usability scale.

Results: Both MPO and PRA demonstrated good system usability and ease of independent use. The findings of the qualitative study highlighted reduced dependency on caregivers, reduced chance of missing a pill, and ease of carrying medicines during travel as benefits of MPO. User-friendliness, ability to take medication on time, and caregivers' satisfaction were reported benefits with PRA. Reported challenges included initial hesitancy, the additional workload of filling the MPO, alarm malfunctions, and dependency on family members for using PRA. Medication nonadherence due to forgetfulness significantly improved from 52% to 65% at baseline to 90%-100% at the end as reported using Medication Adherence Rating System-5. Participants in the combined group did not report any difficulty using the two interventions together.

Conclusion: The study demonstrates good feasibility and acceptability of MPOs and indigenously developed PRA either alone or in combination among the Indian rural elderly population. CTRI registration: CTRI/2024/01/061975 (Registered on- January 29, 2024).

背景:大约40%-75%患有慢性疾病的老年人不坚持药物治疗。手动药丸组织者(MPO)和药丸提醒应用程序(PRAs)是可以提高服药依从性的简单干预措施。这是一项混合方法研究,旨在了解MPO和当地开发的PRA在马哈拉施特拉邦农村老年人中的可行性和可接受性。材料和方法:60名60-80岁的老年人,服用三种或三种以上口服药物,并可使用智能手机,随机分为MPO、PRA或MPO + PRA,为期3个月(n = 30)。结果测量包括使用定性方法的可接受性和可行性,使用系统可用性量表测量可用性。结果:MPO和PRA均表现出良好的系统可用性和易于独立使用。定性研究的结果强调了MPO的好处,即减少了对护理人员的依赖,减少了遗漏药片的机会,并且在旅行中更容易携带药品。用户友好性,按时服药的能力和护理人员满意度是PRA的益处。报告的挑战包括最初的犹豫、填写MPO的额外工作量、警报故障以及依赖家庭成员使用PRA。根据药物依从性评分系统-5的报告,由于健忘导致的药物不依从性从基线时的52% - 65%显著改善到最后的90%-100%。联合组的参与者没有报告同时使用两种干预措施有任何困难。结论:本研究在印度农村老年人群中单独或联合使用mpo和本土开发的PRA均具有良好的可行性和可接受性。CTRI注册:CTRI/2024/01/061975(注册日期- 2024年1月29日)。
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引用次数: 0
Hemoglobin estimation by the classical method should be adhered to for understanding anemia following lead exposure: Old is gold. 为了了解铅暴露后的贫血,应坚持用经典方法进行血红蛋白估计:老是金。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_605_24
Sumanpreet Kaur, Deepak Kumar, Rajasri Bhattacharyya, Dibyajyoti Banerjee
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引用次数: 0
Effects of zinc status on cell cycle and viability: An in vitro study in monocytes (THP-1) and muscle (Rhabdomyosarcoma) cells. 锌状态对细胞周期和活力的影响:单核细胞(THP-1)和肌肉(横纹肌肉瘤)细胞的体外研究。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_227_23
Sarath Babu Srivalliputturu, Srinivasa Reddy Yathapu

Monocyte and muscle cells are considered Zn reservoirs and sensitive to Zn fluctuations, especially in terms of viability. The current study aimed to understand the effect of Zn sufficiency and deficiency on THP-1 monocyte and rhabdomyosarcoma (RD) muscle cell lines. Zinc sufficiency was maintained by supplementing 25 µM of Zn, whereas varying degrees of deficiency were created with intracellular Zn chelator-TPEN in serum-free medium. Cell viability was assessed by MTT assay and the Zn deficiency effect on cell cycle stage was determined through flow cytometry analysis. Zn sufficiency has no-observable effect on cell viability, however, Zn deficiency has a significant positive (P < 0.05) effect on cell death. Cell-cycle analysis has shown a significant higher percentage of THP-1, and RD cells were arrested at Sub-G1 stage in zinc deficiency. Results suggest that cells have the tendency of adaptation to sub-optimal zinc depletion. Further, subnormal level of zinc affected THP-1 and RD cell viability by increasing the cell death at the Sub-G1 stage.

单核细胞和肌肉细胞被认为是锌的储藏库,对锌的波动很敏感,尤其是在活力方面。本研究旨在了解锌充足和缺乏对THP-1单核细胞和横纹肌肉瘤(RD)肌肉细胞系的影响。在无血清培养基中,添加25µM锌可以维持锌的充足性,而细胞内锌螯合剂- tpen则会造成不同程度的缺锌。MTT法检测细胞活力,流式细胞术检测缺锌对细胞周期的影响。锌充足对细胞活力无显著影响,而锌缺乏对细胞死亡有显著正影响(P < 0.05)。细胞周期分析显示THP-1的比例显著升高,缺锌时RD细胞阻滞在亚g1期。结果表明,细胞有适应次优锌缺乏的倾向。此外,亚正常水平的锌通过增加亚g1期的细胞死亡来影响THP-1和RD细胞的活力。
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引用次数: 0
A simple patch test (empty tablet cover patch test) demonstrating ornidazone as offending agent in a patient of fixed drug eruption: Report of a clinical case, a new modified technique and systematic review of literature. 一种简单的贴片试验(空片盖贴片试验)证实奥硝唑是固定药疹患者的起效剂:1例临床病例报告、一种新的改良技术及文献系统复习。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_708_22
R Balamurugan, Phulen Sarma, Prabhakaran Nagendran, Deepthi Slesser Nicodemus, Sushil Sharma

A 49-year-old male presented with the complaints of sudden-onset redness and watering of both the eyes following the intake of fixed drug combination of ofloxacin-ornidazole for diarrhea. Following this, he developed redness of both the lips and blisters in the upper lip. He also developed erythematous macules in the medial aspects of the right lower thigh and ventral aspects of the right leg. Ocular examination showed conjunctival redness with diffuse corneal punctate epithelial erosions in both the eyes. The patient had a similar history affecting the same region 1 year back following the intake of the same combination medicine. To find out the specific inciting agent and owing to unavailability of Finn chamber, we developed a new modified skin patch test using empty tablet cover with three chambers, incorporated with ornidazole, Vaseline (petroleum jelly), and ofloxacin, respectively, and applied on the healed affected lesions. Modified patch test was positive for ornidazole at 48 h. Ornidazole-induced fixed drug eruption (FDE) affecting cornea is a rare and unique in our case report. The patient was then educated about the offending medication and advised to avoid in the future. We also conducted a systematic review of FDEs associated with ornidazole exposure. We searched PubMed and Google Scholar with specific keywords to finally retrieve 14 case reports of ofloxacin induced FDEs, which were further reviewed.

男性,49岁,主因服用氧氟沙星-奥硝唑联合固定药物治疗腹泻后,双眼突然发红、流泪。在此之后,他的双唇开始发红,上唇也出现了水泡。右下大腿内侧和右腿腹侧也出现红斑。眼部检查显示双眼结膜红肿伴弥漫性角膜点状上皮糜烂。患者在1年前服用同一种联合药物后,同一部位有类似的病史。为了找出具体的刺激剂,由于芬室的缺乏,我们开发了一种新的改良皮肤贴试验,使用三室空片套,分别加入奥硝唑、凡士林(凡士林)和氧氟沙星,应用于愈合的患处。改良斑贴试验48 h奥硝唑阳性。奥硝唑致角膜固定药疹(FDE)的发生在我们的病例报告中是罕见且独特的。然后对患者进行了有关不良药物的教育,并建议其今后避免使用。我们还对与奥硝唑暴露相关的FDEs进行了系统回顾。我们用特定关键词检索PubMed和谷歌Scholar,最终检索到14例氧氟沙星诱导FDEs的报告,并对其进行进一步的综述。
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引用次数: 0
Cardioprotective potential of shikonin in cardiac hypertrophy is mediated through PKM2/c-Myc/PTBP1/HIF-1α signaling pathway. 紫草素对心肌肥厚的保护作用是通过PKM2/c-Myc/PTBP1/HIF-1α信号通路介导的。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_742_24
Mohd Rihan, Shyam Sunder Sharma

Introduction: Chronic sympathetic stress contributes significantly to the cardiac hypertrophy (CH) development. Currently, several pharmacological agents and surgical options are available for the treatment of CH. However, available treatment options are associated with side effects and surgical complications. The published reports indicated the PKM2 substantial role in numerous illnesses. Furthermore, the effect of shikonin (SK), a nonselective PKM2 inhibitor, on PKM2/c-Myc/PTBP1/HIF-1α signaling in the CH model has never been explored. Thus, in this study, we explore the effect of SK on the PKM2-mediated c-Myc/PTBP1/HIF-1α signaling pathway in isoproterenol (ISO)-induced CH.

Materials and methods: The preclinical rat model of pathological CH was developed by subcutaneous (s.c.) administration of ISO (5 mg/kg/day) over 14 days. ISO-treated rats were orally received SK (2 and 4 mg/kg/day) for a period of 14 days. After all treatment completion, animals were anesthetized for electrocardiogram (ECG), blood pressure, and ventricular function recording. Afterward, animal blood samples were isolated, and then animals were sacrificed for further molecular and histopathology studies.

Results: Fourteen days treatment of SK showed significant improvement in ECG, fibrosis, inflammation, and cardiac function. Moreover, PKM2, PTBP1, c-Myc, and HIF-1α expressions were upregulated, while PKM1 expression was downregulated in ISO-treated rats, which was reversed by SK treatment in ISO-induced CH rats.

Conclusion: Thus, our results demonstrated that SK modulates the PKM2/c-Myc/PTBP1/HIF-1α pathway mediated by PKM2 inhibition, which might be responsible for SK-mediated cardioprotection in ISO-induced CH.

慢性交感神经应激在心肌肥厚(CH)的发展中起着重要作用。目前,有几种药物和手术方案可用于治疗CH。然而,可用的治疗方案与副作用和手术并发症有关。已发表的报告表明PKM2在许多疾病中起着重要作用。此外,在CH模型中,紫草素(SK)(一种非选择性PKM2抑制剂)对PKM2/c-Myc/PTBP1/HIF-1α信号通路的影响从未被研究过。因此,在本研究中,我们探讨了SK对异丙肾上腺素(ISO)诱导CH中pkm2介导的c-Myc/PTBP1/HIF-1α信号通路的影响。材料和方法:通过皮下注射ISO (5 mg/kg/天),持续14天,建立病理CH的临床前大鼠模型。给iso处理的大鼠口服SK(2和4 mg/kg/天),持续14天。治疗结束后,麻醉动物,记录心电图、血压和心室功能。随后,分离动物血液样本,然后处死动物进行进一步的分子和组织病理学研究。结果:SK治疗14天后,心电图、纤维化、炎症和心功能均有明显改善。此外,PKM2、PTBP1、c-Myc和HIF-1α的表达在iso处理的大鼠中上调,而PKM1的表达下调,在iso诱导的CH大鼠中SK处理逆转了这一现象。结论:因此,我们的研究结果表明,SK调节PKM2抑制介导的PKM2/c-Myc/PTBP1/HIF-1α通路,这可能是SK介导的iso诱导CH的心脏保护的原因。
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引用次数: 0
Acute accidental methotrexate poisoning: Fatal consequences - An Indian experience. 急性意外甲氨蝶呤中毒:致命的后果-印度的经验。
IF 1.5 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 Epub Date: 2025-07-09 DOI: 10.4103/ijp.ijp_363_24
Mauli M Shah, Priya K Ghoghara, Shree Dhanani, Keyur Patel, Pragya A Nair

Methotrexate (MTX) is a versatile drug used in various fields, including oncology and rheumatology, acting by inhibitory effects on DNA synthesis and cellular replication. While low-dose MTX is a first-line treatment for rheumatoid arthritis and psoriasis, overdose or incorrect dosing can lead to severe toxicity. We present three cases of accidental MTX poisoning, highlighting the diverse clinical manifestations and challenges in management. Patients presented with fever, weakness, mucocutaneous lesions, and pancytopenia, necessitating intensive care and supportive treatment. These cases underscore the importance of proper dosing, patient education, and pharmacist vigilance to prevent medication errors. Heightened awareness among clinicians is crucial to promptly recognize and manage MTX toxicity, ensuring the safe and effective use of this valuable therapeutic agent. Further research is needed to optimize dosing strategies and enhance safety measures for MTX administration.

甲氨蝶呤(MTX)是一种用途广泛的药物,通过抑制DNA合成和细胞复制而被广泛应用于包括肿瘤学和风湿病学在内的各个领域。虽然低剂量甲氨蝶呤是治疗类风湿性关节炎和牛皮癣的一线药物,但过量或不正确的剂量会导致严重的毒性。本文报告三例甲氨蝶呤意外中毒病例,强调其不同的临床表现和处理上的挑战。患者表现为发热、虚弱、皮肤粘膜病变和全血细胞减少,需要重症监护和支持性治疗。这些病例强调了正确给药、患者教育和药剂师警惕以防止用药错误的重要性。提高临床医生的认识对于及时识别和管理MTX毒性,确保安全有效地使用这一宝贵的治疗剂至关重要。需要进一步的研究来优化给药策略和加强MTX给药的安全措施。
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引用次数: 0
Targeted active surveillance of branded generic deferasirox in pediatric thalassemia patients in a tertiary care hospital of India: A pharmacovigilance study. 印度三级医院儿童地中海贫血患者对品牌非专利去铁宁的靶向主动监测:一项药物警戒研究
IF 1.4 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-03-01 Epub Date: 2025-06-13 DOI: 10.4103/ijp.ijp_88_23
Mousumee Panigrahi, Trupti Rekha Swain, Rabindra Kumar Jena, Ashutosh Panigrahi, Nishant Debta

Introduction: Deferasirox is a newer oral iron chelator which needs to be given for at least 1 year to see a significant decrease in serum ferritin level in thalassemia patients with chronic iron overload. This study aimed to assess the safety profile of branded generic deferasirox in pediatric thalassemia cases, as it has not been studied in eastern India, especially in real-world settings.

Subjects and methods: It was an observational hospital-based study in a government tertiary care teaching hospital where branded generic deferasirox is distributed free of cost to patients. One hundred and seventy-four patients were included. Safety assessment was done through active questioning about the symptoms starting after deferasirox therapy and through laboratory parameters and clinical examination.

Results: Sixty percent of patients developed adverse drug reactions (ADRs) with deferasirox during the 1-year follow-up. ADRs were more common in males than females. The highest number of ADRs was related to the gastrointestinal and hepatobiliary system. The ADRs were either mild or moderate. Compliance and number of ADRs were found to be inversely correlated.

Conclusion: ADRs of deferasirox are acceptable looking at the benefits. Regular monitoring and management of ADRs will facilitate patient compliance. However, healthcare professionals need to be alert while prescribing this drug and report any ADR, even if it is not labeled. This study found increased serum lipase and mouth ulcer as adverse effects, which are not yet labeled. These can be signals for further analysis by regulatory authorities.

deasirox是一种较新的口服铁螯合剂,需要给予至少1年才能看到慢性铁超载的地中海贫血患者血清铁蛋白水平的显着下降。本研究旨在评估品牌非专利去铁霉素在儿童地中海贫血病例中的安全性,因为它尚未在印度东部进行研究,特别是在现实环境中。研究对象和方法:这是一项以医院为基础的观察性研究,在一所政府三级医疗教学医院,该医院免费向患者分发品牌非专利去铁氨醇。174名患者被纳入研究。安全性评估是通过主动询问患者在去铁霉素治疗后的症状,并通过实验室参数和临床检查进行的。结果:在1年的随访中,60%的患者出现了去铁霉素的药物不良反应(adr)。不良反应在男性中比女性更常见。不良反应发生率最高的是胃肠道和肝胆系统。不良反应分为轻度和中度。依从性与adr数量呈负相关。结论:从疗效来看,去铁霉素的不良反应是可以接受的。定期监测和管理不良反应将有助于患者遵守规定。然而,医疗保健专业人员在开这种药时需要保持警惕,并报告任何不良反应,即使它没有标签。本研究发现血清脂肪酶升高和口腔溃疡为不良反应,尚未标记。这些可以作为监管机构进一步分析的信号。
{"title":"Targeted active surveillance of branded generic deferasirox in pediatric thalassemia patients in a tertiary care hospital of India: A pharmacovigilance study.","authors":"Mousumee Panigrahi, Trupti Rekha Swain, Rabindra Kumar Jena, Ashutosh Panigrahi, Nishant Debta","doi":"10.4103/ijp.ijp_88_23","DOIUrl":"10.4103/ijp.ijp_88_23","url":null,"abstract":"<p><strong>Introduction: </strong>Deferasirox is a newer oral iron chelator which needs to be given for at least 1 year to see a significant decrease in serum ferritin level in thalassemia patients with chronic iron overload. This study aimed to assess the safety profile of branded generic deferasirox in pediatric thalassemia cases, as it has not been studied in eastern India, especially in real-world settings.</p><p><strong>Subjects and methods: </strong>It was an observational hospital-based study in a government tertiary care teaching hospital where branded generic deferasirox is distributed free of cost to patients. One hundred and seventy-four patients were included. Safety assessment was done through active questioning about the symptoms starting after deferasirox therapy and through laboratory parameters and clinical examination.</p><p><strong>Results: </strong>Sixty percent of patients developed adverse drug reactions (ADRs) with deferasirox during the 1-year follow-up. ADRs were more common in males than females. The highest number of ADRs was related to the gastrointestinal and hepatobiliary system. The ADRs were either mild or moderate. Compliance and number of ADRs were found to be inversely correlated.</p><p><strong>Conclusion: </strong>ADRs of deferasirox are acceptable looking at the benefits. Regular monitoring and management of ADRs will facilitate patient compliance. However, healthcare professionals need to be alert while prescribing this drug and report any ADR, even if it is not labeled. This study found increased serum lipase and mouth ulcer as adverse effects, which are not yet labeled. These can be signals for further analysis by regulatory authorities.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"57 2","pages":"77-82"},"PeriodicalIF":1.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12236394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Indian Journal of Pharmacology
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