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临时代用配制和给予维 A 酸混悬剂治疗急性早幼粒细胞白血病。

Extemporaneous compounding and administration of tretinoin slurry for acute promyelocytic leukemia.

机构信息

Northwestern Medicine, Chicago, IL, USA.

UW Health, Madison, WI, USA.

出版信息

J Oncol Pharm Pract. 2021 Oct;27(7):1779-1783. doi: 10.1177/1078155221990091. Epub 2021 Jan 26.

Abstract

INTRODUCTION

Acute promyelocytic leukemia (APL) is a potentially curable malignancy with 4-year overall survival rates >90%. Early complications from the disease or its treatment may result in a loss of oral access and require alternative administration of medications. Tretinoin has been the backbone of APL therapy since the late 1990s and is only available as a liquid filled capsule.

CASE REPORT

Two patients with high-risk APL were unable to safely swallow tretinoin capsules due to complications of their disease.

MANAGEMENT & OUTCOME: We prepared a tretinoin slurry using tretinoin 10 mg capsules, sterile water, and mineral oil at a ratio of 1 capsule to 2.75 mL sterile water to 1.25 mL mineral oil. This was successfully administered to both patients and no doses of tretinoin slurry were missed by either patient. In the patient who has long-term follow up available, a complete remission was achieved.

DISCUSSION

Due to tretinoin's known teratogenicity, this capsule should not be crushed, cut, or open, which limits its use in patients without oral access. Alternative routes of administration, such as via a nasogastric tube or sublingually, have not been safe and effective. By preparing a tretinoin slurry in our hazardous extemporaneous compounding area, we were able to safely and effectively prepare a tretinoin slurry that was successfully administered to two patients. This alternative preparation did not alter long-term outcomes and represents a viable option for patients who do not have oral access.

摘要

简介

急性早幼粒细胞白血病(APL)是一种具有潜在治愈可能的恶性肿瘤,其 4 年总生存率>90%。疾病本身或其治疗引起的早期并发症可能导致丧失口服途径,需要替代给药方式。维甲酸自 20 世纪 90 年代末以来一直是 APL 治疗的基础药物,只能以填充液体的胶囊形式提供。

病例报告

两名高危 APL 患者因疾病并发症而无法安全吞咽维甲酸胶囊。

处理方法和结果

我们使用 10mg 维甲酸胶囊、无菌水和矿物油以 1 个胶囊至 2.75ml 无菌水至 1.25ml 矿物油的比例制备维甲酸混悬液。该混悬液成功地用于这两名患者,且两名患者均未漏用任何剂量。在有长期随访数据的患者中,达到完全缓解。

讨论

由于维甲酸具有明确的致畸性,因此不应将该胶囊压碎、切割或打开,这限制了其在无口服途径的患者中的使用。其他给药途径,如通过鼻胃管或舌下给药,既不安全也无效。通过在我们的危险临时配制区域制备维甲酸混悬液,我们能够安全有效地制备维甲酸混悬液,并成功地用于两名患者。这种替代制剂并未改变长期结局,对于无法口服的患者是一种可行的选择。

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