【病例学习第1期】Graves’ Disease（Grave’s病）

From Pharmacy Times(www.pharmacytimes.com)
Thanks to the author Craig I. Coleman, PharmD(Dr. Coleman is an assistant professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.)

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Graves’ Disease

LG is a 34-year-old woman who presented to her primary care physician (PCP) 6 months ago with symptoms of palpitations, heat intolerance, anxiety, and tremor. She was diagnosed with hyperthyroidism as a result of Graves’ disease and was started on propylthiouracil (PTU) 100 mg by mouth 3 times daily. After several months, LG was successfully managed to a euthyroid state and her PTU dose was gradually tapered to her current maintenance dose of PTU 150 mg daily. During her most recent follow-up with her PCP, LG was given a prescription for methimazole (MMI) 10 mg daily and was told to begin this therapy in place of PTU. Somewhat concerned, LG brings the prescription to the pharmacy and asks the pharmacist, “Why does my medication need to be changed? The other pill was working for me.” How should the pharmacist respond? Craig I. Coleman, PharmD Dr. Coleman is an assistant professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.


ANSWER

The pharmacist should assure LG that she is receiving an appropriate alternative to PTU, as MMI is considered a safer option in certain patient populations due to the risk of PTU-related acute liver failure. Both belonging to the thionamide class, PTU and MMI carry FDA approval for the treatment of hyperthyroidism and until recently both agents have been considered first-line in adult patients. In April 2009, the FDA and the American Thyroid Association recommended (see Bahn RS. Thyroid. 2009;19:673-674) that PTU not be prescribed as first-line therapy in most adults or children based on reports of PTU-related serious liver injury from both the FDA Adverse Event Reporting System and liver transplantation monitoring programs. It is estimated that 1 in 10,000 adults taking PTU develop PTU-related acute liver failure, which may occur at any point in therapy with a sudden onset and rapid progression to liver failure. Instances where PTU is recommended over MMI include the initiation of therapy in the first trimester of pregnancy or in the setting of life-threatening thyrotoxicosis or thyroid storm. Given LG is of child-bearing age, the pharmacist should also counsel LG on the teratogenic risk (category D) of MMI and the importance of using effective birth control while on therapy.

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Grave’s病（GD 毒性弥漫性甲状腺肿）

LG是一名34岁的妇女，6个月前因为出现心悸、怕热、焦虑和震颤而就诊，被诊断为Grave’s病引起的甲亢，并开始服用丙硫氧嘧啶片（PTU）治疗，剂量为100mg，口服，每日三次。
几个月后，LG服用的PTU逐渐减量至目前使用的150mg/d，甲状腺功能恢复正常。在她最近一次复诊时，医生给她开出了“甲巯咪唑（MMI），10mg，QD”的处方，并被告知开始服用甲巯咪唑以取代PTU治疗。
为了解更多的信息，LG把处方拿到药房，并向药师咨询：“为什么要换药？原来的药已经控制很好了。”药师应该怎么回答？Coleman（Craig I. Coleman） 博士是药房助理教授，同时也是康涅狄格药学院药物经济学和结果研究组的主任。

答 案
药师应该使LG确信她将要使用一个合适的药物取代PTU治疗，因为MMI被认为是某些存在PTU相关性急性肝衰竭风险患者更安全的选择，MMI和PTU两个药都属于硫氨基类，均被FDA 批准用于甲亢的治疗，直到最近一直作为成人甲亢治疗的一线药物。2009年4月，FDA和美国甲状腺协会建议（参见Bahn RS. Thyroid. 2009;19:673-674）PTU不能作为大部分成人和儿童的一线治疗处方用药，主要是因为FDA不良事件呈报系统和肝移植监测系统均有PTU导致严重肝损伤的报告。据估计，每10,000名服用PTU的患者中有1名患者会发展成PTU 相关的急性肝衰，可能发生在治疗的任何时候，突然发病并很快进展至肝衰竭。大量的例证表明PTU比MMI更多的推荐用于作为妊娠头三个月的初始治疗或危及生命的甲状腺毒症或甲亢危象的治疗。LG是育龄妇女，药师应提醒LG服用MMI（妊娠分类为D级）有导致胎儿畸形的风险及治疗期间采取可靠避孕措施的重要性。

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