Etanercept （益赛普）治疗类风湿性关节炎长期有效（转自丁香园）

骞骞蔷薇

       纽约（路透社健康栏目）消息，欧美科学家研究表明：益赛普治疗类风湿性关节炎安全长效。

       据《风湿病年鉴》报道，斯德哥尔摩Karolinska 大学医院的Lars Klareskog博士及其同事，对549名类风湿性关节炎患者先作了开放式临床试验随后完成了益赛普的随机安慰剂对照研究。所有患者在参加初次研究前对更改抗风湿药都出现不良反应。
  
       接下来的研究中，给予受试者益赛普25 mg日两次，最终有371名患者（占总受试者68%）持续服用3年，其中11%的患者因效果不明显停药，13%的患者因副作用停药。最常见的副作用是上呼吸道感染和注射部位反应。

       用药3年的患者，78％的患者达到了ACR20缓解标准，51％的患者达到了ACR50缓解标准，27％的患者达到了ACR70缓解标准。维持和改善了多数关节肿胀和疼痛的早期缓解。

       在初期研究中3个月后疾病活动分数从基线5.1降到3.0，3年时降到2.6 。另外，整个研究的健康评估问卷表明症状改善保持长期不变。
经过3年的治疗后，科学家得出结论，益赛普显示出安全长效的特性，是临床实践中长期治疗的优选。

Etanercept Shows Long-Term Action Against RA
NEW YORK (Reuters Health) Dec 19 - Etanercept (Enbrel) appears safe and has ongoing efficacy in the treatment of rheumatoid arthritis (RA), European and US researchers report.
Dr. Lars Klareskog of Karolinska University Hospital, Stockholm and colleagues studied 549 RA patients in an extension open-label trial following completion of two randomized placebo-controlled studies of etanercept. All patients had shown an inadequate response to disease modifying anti-rheumatic drugs before taking part in the original studies.
In the continuing extension, published in the December issue of Annals of the Rheumatic Diseases, participants received etanercept 25 mg twice daily. In total, 371 (68%) took the agent for 3 years. Primary reasons for withdrawal were lack of efficacy in 11% and adverse events in 13%. The most frequent events included upper respiratory infection and injection-site reactions.
At 3 years, American College of Rheumatology (ACR) response rates were 78% for ACR20, 51% for ACR50 and 27% for ACR70. Earlier reductions in the number of swollen and painful joints were maintained and improved upon.
Disease Activity Score fell from 5.1 at baseline to 3.0 after 3 months in the initial study and to 2.6 at 3 years. In addition, there was a sustained improvement in Health Assessment Questionnaire scores over the course of the study.
The researchers conclude that after 3 years of treatment, "etanercept showed sustained efficacy and a favorable safety profile" and is an option for long-term treatment in clinical practice.
https://profreg.medscape.com/px/getlogin.do?urlCache=aHR0cDovL3d3dy5tZWRzY2FwZS5jb20vdmlld2FydGljbGUvNTQ5NjMw

庄雅婷

用药3个月后降了2.1，3年后降0.4，是不是3个月以后就可以考虑停药了呀？

骞骞蔷薇

庄雅婷 发表于 2013-6-14 18:18
用药3个月后降了2.1，3年后降0.4，是不是3个月以后就可以考虑停药了呀？

{:soso_e121:} 不可以这么算的~
未治疗之前，临床试验人员疾病活动分数较高，使用生物制剂后，分数降低的比较明显。而在长期使用生物制剂之后，已经达到了缓解标准，疾病活动分数变低，降低的幅度自然会减慢的。蔷薇打一个不是很恰当的比喻，这种情况就跟发达国家GDP增长缓慢的现象很像。

使用生物制剂一般是按标准剂量(50 mg／周)持续治疗，直至达到临床缓解或病情低活动度后接着再维持缓解治疗至少6个月，才可以逐渐考虑减药和停药的问题，具体的方案还需要咨询主管医生的意见。