Safety profile of tacrolimus in patients with rheumatoid arthritis
Safety profile of tacrolimus in patients with rheumatoid arthritis
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DOI：
10.1007/s10067-008-0931-z
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发表时间：
2008-11-01
影响因子：
3.4
通讯作者：
Kawai, Shinichi
中科院分区：
文献类型：
--
作者：
Akimoto, Kimiko;Kusunoki, Yoshie;Kawai, Shinichi
我们评估了他克莫司治疗类风湿关节炎的安全性。回顾性研究了2005年4月至2006年7月期间开始他克莫司治疗的42例患者，使用截至2007年6月的病历数据。采用Kaplan-Meier法评估累积治疗继续率。使用Fisher精确检验比较不同他克莫司剂量之间以及存在和不存在每种伴随药物之间的胃肠道症状。平均（+/- SD）观察期为288 +/- 238天。患者开始治疗后6个月和1年的累积治疗继续率分别为59.5%和38.1%。28例患者停用他克莫司，21例患者因不良反应而停用。胃肠道症状是最常见的不良反应（45.2%=19/42例患者），其次是感染和高血糖。9/19例有胃肠道症状的患者停用他克莫司，其中7例在开始治疗后60天内停用。恶心和呕吐导致7例患者停药（其中6例在开始治疗后60天内）。每日剂量≥ 2 mg的患者胃肠道症状的发生率高于每日剂量< 2 mg的患者。在口服他克莫司治疗类风湿关节炎期间，胃肠道症状是常见的、早期的和剂量依赖性的。然而，这些症状并不严重，也没有引起任何严重的安全问题。
We assessed the safety of tacrolimus therapy for rheumatoid arthritis. Forty-two patients who started tacrolimus therapy between April 2005 and July 2006 were investigated retrospectively using data from their medical records up to June 2007. The cumulative treatment continuation rate was assessed by the Kaplan-Meier method. Fisher's exact test was used to compare gastrointestinal symptoms between different tacrolimus doses and between the presence and absence of each concomitant medication. The mean (+/- SD) observation period was 288 +/- 238 days. The cumulative treatment continuation rate was, respectively, 59.5% and 38.1% at 6 months and 1 year after the patients started treatment. Tacrolimus was discontinued in 28 patients, and was discontinued because of adverse reactions in 21 patients. Gastrointestinal symptoms were the most common adverse reactions (45.2%=19/42 patients), followed by infections and hyperglycemia. Tacrolimus was discontinued in 9/19 patients with gastrointestinal symptoms, and was discontinued within 60 days of starting treatment in seven of them. Nausea and vomiting led to discontinuation in seven patients (within 60 days of starting treatment in six of them). The incidence of gastrointestinal symptoms was higher in patients receiving a daily dose >= 2 mg than in those receiving < 2 mg/day. During treatment of rheumatoid arthritis by oral tacrolimus therapy, gastrointestinal symptoms were common, early, and dose-dependent. However, these symptoms were not severe and did not cause any serious safety problems.