化疗药物复方制剂用量的评估:九家复方药房之间的比较。

IF 2.3 2区 农林科学 Q1 VETERINARY SCIENCES Veterinary and comparative oncology Pub Date : 2024-12-01 Epub Date: 2024-08-20 DOI:10.1111/vco.13003
Samantha R Bajorek, Trina N Hazzah, John D Chretin, Tracy N Mills, Talon S McKee, Jennifer R Frank, Jessica L Benvin-Guzzo, Kary A Clifton, Philip J Bergman
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引用次数: 0

摘要

在兽医领域使用复方化疗制剂很常见。本研究的目的是评估来自多家兽用复方制剂药房的两种复方化疗药(氯霉素和环磷酰胺)的药量,确定来自503A和503B药房的药量是否存在差异,最后确定每个药房内药量的异质性。共抽查了九家兽药合成药房(八家 503A,一家 503B),每家药房抽查了两个不同批次的样品。每个胶囊的实际浓度都与预定(处方)浓度进行了比较。在总共获得的 68 个样本中,有 20 个样本(29%)的检测结果超出了美国食品及药物管理局可接受的 ±10% 的误差范围。其中 12 个(60%)是氯霉素,8 个(40%)是环磷酰胺。503A 环磷酰胺样本与预定剂量的平均偏差为 6.6%,而 503B 药房的样本偏差为 1.8%。503A 氯霉素样本与预定剂量的平均差异为 10.4%,而 503B 药房的样本与预定剂量的差异为 9.6%。在同一药房和同一批次中,503A 药房的异质性在 0.1% 至 51% 之间,503B 药房的异质性在 2.6% 至 7.5% 之间。同一药房不同批次药品之间的异质性,503A 药房为 0.4%至 58.3%,503B 药房为 5%至 14.8%。尽管与 503A 药房相比,503B 复方药房生产的复方环磷酰胺和氯丁氨嘧啶的药量更可靠,但无论药房名称如何,药量最终仍有可能出现差异。
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Evaluation of the Amount of Compounded Chemotherapy Drugs: A Comparison Between Nine Compounding Pharmacies.

The use of compounded formulations of chemotherapy in veterinary medicine is common. The purpose of this study was to evaluate the drug amount of two compounded chemotherapeutics (chlorambucil and cyclophosphamide) from multiple veterinary compounding pharmacies, to determine if there was a difference in drug amounts between those that came from 503A versus 503B pharmacies, and finally to determine heterogeneity in drug amounts within each individual pharmacy. Nine veterinary compounding pharmacies (eight 503A, one 503B) were sampled in total, with two different batches sampled from each pharmacy. Each capsule's actual concentration was compared to the intended (prescribed) concentration. Of the 68 total samples obtained, 20 (29%) tested outside the FDA-acceptable discrepancy of ±10%. Of these, 12 (60%) were chlorambucil and 8 (40%) were cyclophosphamide. 503A cyclophosphamide samples had an average discrepancy of 6.6% from the intended dose while samples from the 503B pharmacy had a discrepancy of 1.8%. 503A chlorambucil samples had an average discrepancy of 10.4% from the intended dose while samples from the 503B pharmacy had a discrepancy of 9.6%. Heterogeneity within the same pharmacy and batch ranged from 0.1% to 51% for the 503A pharmacies and 2.6% to 7.5% for the 503B pharmacy. Heterogeneity between different batches within the same pharmacy ranged from 0.4% to 58.3% for the 503A pharmacies and 5% to 14.8% for the 503B pharmacy. Although the drug amounts of compounded cyclophosphamide and chlorambucil manufactured by the 503B compounding pharmacy was more reliably maintained compared to that compounded by the 503A pharmacies, there was ultimately still potential for variability in drug amounts regardless of the pharmacy designation.

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来源期刊
Veterinary and comparative oncology
Veterinary and comparative oncology 农林科学-兽医学
CiteScore
4.80
自引率
9.50%
发文量
75
审稿时长
>24 weeks
期刊介绍: Veterinary and Comparative Oncology (VCO) is an international, peer-reviewed journal integrating clinical and scientific information from a variety of related disciplines and from worldwide sources for all veterinary oncologists and cancer researchers concerned with aetiology, diagnosis and clinical course of cancer in domestic animals and its prevention. With the ultimate aim of diminishing suffering from cancer, the journal supports the transfer of knowledge in all aspects of veterinary oncology, from the application of new laboratory technology to cancer prevention, early detection, diagnosis and therapy. In addition to original articles, the journal publishes solicited editorials, review articles, commentary, correspondence and abstracts from the published literature. Accordingly, studies describing laboratory work performed exclusively in purpose-bred domestic animals (e.g. dogs, cats, horses) will not be considered.
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