研究显示他克莫司治疗类风湿性关节炎优于咪唑立宾

2006-12-19 00:00 来源:丁香园 作者:wzy8wzy 译
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纽约(路透社健康版)12月13日报道——根据日本的研究人员观察,他克莫司在缓解难治性类风湿性关节炎的症状方面较咪唑立宾显示出明显的优越性。

领导研究的Dr. Shinichi Kawai告诉路透社健康版,在应用一种或更多种缓解疾病的抗风湿性药物失败后,发现“他克莫司是一种抑制神经钙蛋白的免疫抑制剂,较咪唑立宾(一种咪唑核苷免疫抑制药)显著改善RA的症状”。

Tokyo和东邦医科大学的同事Dr. Kawai指出,已经证明他克莫司在RA病人中较安慰剂更有效,但是还没有另一种药物与他克莫司比较的对照研究的报道。因此,研究者们进行了一个双盲研究,203个RA病人随机分为两组,一组服用他克莫司3毫克/天,另一组咪唑立宾50毫克,3次/日。

28周的研究结束后,他克莫司组的更多病人明显比咪唑立宾达到了一个美国风湿病学会标准的20%的反应率(分别为48.5% ,10.0%),这个研究报告发表在11月份的风湿病杂志上。

这也是真正的美国风湿病学会标准的50%的反应率(27.2%对 2.0%)。另外,11.7%的他克莫司治疗组病人获得了美国风湿病学会标准的70%的反应率,而咪唑立宾组无一达到。他克莫司组病人在许多其它评价方面(包括疼痛的关节数,病人和医生对疾病活动的评价等)也有显著的改善。他克莫司组的副反应的发生率比咪唑立宾组要高(分别为65.0 , 59.4%),但是差异没有显著性。由于副反应而终止给药率两组也相似(分别为11.7%,9.9%)。

根据这些发现,研究者们得出结论,他克莫司“有潜力成为一个有用和高效的RA治疗药物”。

Tacrolimus Better Than Mizoribine for RA: Study

NEW YORK (Reuters Health) Dec 13 - Tacrolimus appears to be significantly superior to mizoribine in relieving symptoms of refractory rheumatoid arthritis (RA), according to Japanese investigators.

"Tacrolimus, an immunosuppressant of a calcineurin inhibitor, improves RA symptoms to a significantly greater extent than mizoribine, an immunosuppressant of an imidazole nucleoside" in patients who have failed one or more disease-modifying antirheumatic drug, lead investigator Dr. Shinichi Kawai told Reuters Health.

Tacrolimus has proven more effective than placebo in RA patients, but there have been no reports of controlled studies comparing it with another agent, Dr. Kawai of Toho University School of Medicine, Tokyo and colleagues point out.

Therefore, the researchers conducted a double-blind study of 203 RA patients who were randomized to tacrolimus 3 mg once daily or mizoribine 50 mg three times daily.

At the end of the 28-week study, significantly more patients in the tacrolimus group than in the mizoribine group achieved an American College of Rheumatology 20% (ACR20) response (48.5% versus 10.0%, respectively), the researchers report in the November issue of the Journal of Rheumatology.

This was also true of the ACR50 response (27.2% versus 2.0%). In addition, 11.7% of the tacrolimus patients had an ACR70 response compared with none of the mizoribine patients.

Tacrolimus patients also did significantly better in a variety of other measures including painful joint counts and patient and physician assessments of disease activity.

The incidence of adverse events in the tacrolimus group was greater than in the mizoribine group (65.0 versus 59.4%, respectively), but the difference was not significant. Discontinuation rates due to adverse events were also similar (11.7% versus 9.9%).

In light of these findings, the researchers conclude that tacrolimus "has the potential to be a useful and highly effective treatment for RA."

http://www.medscape.com/viewarticle/549285


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