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回顾性分析甲泼尼龙脉冲治疗格雷夫斯眼病患者的疗效,重点观察不良反应。

RETROSPECTIVE ANALYSIS OF PATIENTS WITH GRAVES ORBITOPATHY TREATED BY PULSES OF METHYLPREDNISOLONE, WITH A FOCUS ON ADVERSE EVENTS.

出版信息

Endocr Pract. 2018 Jul;24(7):652-657. doi: 10.4158/EP-2018-0047.

DOI:10.4158/EP-2018-0047
PMID:30048166
Abstract

OBJECTIVE

Graves orbitopathy (GO) is an extrathyroidal manifestation of autoimmune thyroid disease. Early treatment with glucocorticoids in appropriately selected patients is recommended for active, moderate to severe, and sight-threatening disease. The recently published European Group on Graves Orbitopathy guidelines re-evaluated the recommended doses of intravenous methylprednisolone (ivMP) in response to the potential for adverse effects. We retrospectively reviewed our patient cohort treated with our ivMP protocol and analyzed the side effects of this treatment when given during hospitalization in our tertiary referral center.

METHODS

Between May 2007 and May 2017, a total of 171 consecutive patients with active, moderate to severe, or sight-threatening GO were treated with ivMP in a cumulative dose of 7.5 grams, given monthly in three hospital sessions. Adverse events were reported using Version 4 of Common Terminology Criteria for Adverse Events.

RESULTS

Ninety-two percent of patients who started the treatment were able to finish it; 5% did not finish the study due to adverse events, and 3% did not finish the treatment protocol because of noncompliance. The most common adverse events were asymptomatic changes in laboratory values (liver enzymes), psychiatric disorders, and infectious complications. None of the patients in the study died during the ivMP treatment, including those patients who experienced adverse effects or discontinued the protocol because of noncompliance.

CONCLUSION

High-dose ivMP for active, moderate to severe, and sight-threatening GO, when applied cautiously in carefully selected and monitored patients, is generally safe during the treatment period.

ABBREVIATIONS

AE = adverse effect; CAS = clinical activity score; CTCAE = Common Terminology Criteria for Adverse Events; DM = diabetes mellitus; EUGOGO = European Group on Graves Orbitopathy; GC = glucocorticoid; GO = Graves orbitopathy; ivMP = intravenous methylprednisolone.

摘要

目的

格雷夫斯眼病(GO)是一种自身免疫性甲状腺疾病的甲状腺外表现。对于活动期、中重度和威胁视力的疾病,建议在适当选择的患者中早期使用糖皮质激素进行治疗。最近发表的《欧洲 Graves 眼病专家组指南》重新评估了静脉甲基强的松龙(ivMP)的推荐剂量,以应对潜在的不良反应。我们回顾性地审查了我们使用 ivMP 方案治疗的患者队列,并分析了在我们的三级转诊中心住院期间给予这种治疗的副作用。

方法

在 2007 年 5 月至 2017 年 5 月期间,171 例活动期、中重度或威胁视力的 GO 患者连续接受了 ivMP 治疗,累积剂量为 7.5 克,每月分三次在医院进行。使用不良反应通用术语标准 4.0 版报告不良事件。

结果

92%开始治疗的患者能够完成治疗;5%因不良反应未完成研究,3%因不遵从而未完成治疗方案。最常见的不良反应是实验室值(肝酶)的无症状变化、精神障碍和感染并发症。在研究期间,没有患者在接受 ivMP 治疗时死亡,包括那些经历不良反应或因不遵从而停止治疗方案的患者。

结论

对于活动期、中重度和威胁视力的 GO,谨慎地应用于精心选择和监测的患者,大剂量 ivMP 治疗通常在治疗期间是安全的。

缩写词

AE = 不良反应;CAS = 临床活动评分;CTCAE = 不良事件通用术语标准;DM = 糖尿病;EUGOGO = 欧洲 Graves 眼病专家组;GC = 糖皮质激素;GO = Graves 眼病;ivMP = 静脉甲基强的松龙。

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