Etanercept 治疗类风湿性关节炎长期有效

2006-12-23 00:00 来源:丁香园 作者:dang1555 译
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纽约(路透社健康栏目)12月19日消息,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》12月刊报道,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.

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