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风湿病学家对甲氨蝶呤、依那西普、英夫利昔单抗和阿那白滞素相关不良事件的监测。

Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events.

作者信息

Yazici Yusuf, Erkan Doruk, Paget Stephen A

机构信息

The Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York, USA.

出版信息

Arthritis Rheum. 2003 Oct;48(10):2769-72. doi: 10.1002/art.11277.

Abstract

OBJECTIVE

To determine what monitoring protocols rheumatologists use to identify adverse events in rheumatoid arthritis (RA) patients treated with methotrexate (methotrexate), etanercept (etanercept), infliximab (infliximab), and anakinra (anakinra), how often rheumatologists encounter treatment-altering adverse events in their RA patients receiving these treatments, and how they feel about and comply with the current monitoring guidelines.

METHODS

Three hundred ten physician members of the American College of Rheumatology (ACR) were notified by e-mail of a survey that was posted on our rheumatology Web site. Questions were closed-ended and multiple choice in format.

RESULTS

One hundred twenty-three responses were received (40%). Most rheumatologists reported that they utilize the ACR recommended screening tests at baseline before methotrexate treatment is initiated. Seventy-nine percent reported that treatment-altering abnormalities had occurred in <5% of their methotrexate-treated RA patients, and 88% reported that such abnormalities had occurred in <10% of such patients, in the previous 3 years. Forty-one percent believed liver function monitoring guidelines need to be changed; 59% said they would agree with new guidelines that would include a recommendation for liver function monitoring every 3-4 months. Most rheumatologists were not aware of any guidelines for monitoring by blood tests in RA patients treated with biologic agents, yet the majority reported that they order blood tests before patients start these therapies and on followup.

CONCLUSION

Our survey indicates that treatment-altering liver function abnormalities in methotrexate-treated RA patients are rare, and more than half of rheumatologists agree that a less stringent monitoring regimen should be considered. Rheumatologists and pharmaceutical companies might work together to develop guidelines for monitoring of patients treated with biologic agents.

摘要

目的

确定风湿病专家使用何种监测方案来识别接受甲氨蝶呤、依那西普、英夫利昔单抗和阿那白滞素治疗的类风湿关节炎(RA)患者中的不良事件,风湿病专家在其接受这些治疗的RA患者中遇到改变治疗的不良事件的频率,以及他们对当前监测指南的看法和遵循情况。

方法

通过电子邮件通知美国风湿病学会(ACR)的310名医师会员一项在我们风湿病学网站上发布的调查。问题为封闭式且为多项选择题格式。

结果

共收到123份回复(40%)。大多数风湿病专家报告称,他们在开始甲氨蝶呤治疗前会按照ACR推荐在基线时进行筛查测试。79%的专家报告称,在其接受甲氨蝶呤治疗的RA患者中,<5%的患者出现了改变治疗的异常情况;88%的专家报告称,在过去3年中,此类异常情况出现在<10%的此类患者中。41%的专家认为肝功能监测指南需要改变;59%的专家表示他们会同意新的指南,该指南将包括每3 - 4个月进行一次肝功能监测的建议。大多数风湿病专家不了解针对接受生物制剂治疗的RA患者进行血液检测监测的任何指南,但大多数人报告称他们会在患者开始这些治疗前及随访时进行血液检测。

结论

我们的调查表明,接受甲氨蝶呤治疗的RA患者中出现改变治疗的肝功能异常情况很少见,超过一半的风湿病专家同意应考虑采用不那么严格的监测方案。风湿病专家和制药公司可能需要共同努力制定针对接受生物制剂治疗患者的监测指南。

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