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依那西普治疗活动性强直性脊柱炎多中心、双盲、随机对照临床研究

A multicenter, double-blind, randomized, placebo-controlled clinical trial of etanercept treatment of Chinese patients with active ankylosing spondylitis

摘要:

目的 评价依那西普50 mg每周1次治疗活动性强直性脊柱炎(AS)的疗效与安全性.方法 为期12周(双盲期和开放期各6周)的随机、双盲、安慰剂对照的多中心临床研究.双盲治疗期治疗组和对照组受试者分别接受依那西普或安慰剂50 mg,1次/周,皮下注射;开放期均接受依那西普50 mg,1次/周,皮下注射.分别于第0、2、4、6、8、10、12周按规定完成临床评估.主要疗效指标为达到AS疗效评价(ASAS) 20%改善程度(ASAS 20)的受试者比例,次要疗效指标为达到ASAS标准中6项改善5项( ASAS5/6)的受试者比例、达到ASAS部分缓解的受试者比例、Bath强直性脊柱炎疾病活动指数(BASDAI)改善达到50%以上(BASDAI 50)的受试者比例、受试者总体评价、背痛、Bath 强直性脊柱炎功能指数(BASFI).所有受试者均进行安全性评价.结果 来自6个医院的400例受试者入选本研究,其中治疗组300例,对照组100例.381例受试者完成全部治疗,其中治疗组285例,对照组96例.双盲治疗期第2周时治疗组有55.7%的受试者达到ASAS20,对照组为17.0%,差异有统计学意义(P <0.001);至第6周时治疗组有77.5%的受试者达到ASAS 20,对照组为32.3% (P<0.001).经12周治疗,治疗组89.5%的受试者达到ASAS20.治疗组各次要疗效指标(ASAS5/6、ASAS部分缓解、BASDAI 50等)也有显著改善.最常见的不良反应为注射部位反应、肝酶水平升高,无恶性肿瘤发生,未见死亡.结论 依那西普50 mg每周1次治疗活动性AS,具有使用方便、起效迅速、疗效显著、耐受性良好的特点.

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Objective To evaluate the efficacy and safety of etanercept 50 mg once-weekly treatment of Chinese patients with active ankylosing spondylitis ( AS).Methods Four hundred patients with active AS,enrolled in six medical centers,were randomly divided into either the treatment group or the placebo group in a 3∶1 ratio.The total length of the study was 12 weeks.The first 6-week period was a double-blind placebo controlled treatment period and the second 6-week period was an open-labeled treatment period.During the first 6-week period,300 patients in the treatment group received once-weekly subcutaneous injection of etanercept (50 mg),whereas the 100 patients in the placebo group received placebo injection.During the second 6-week period,patients in both groups received etanercept (50 mg once weekly subcutaneous injection).The primary end point was the percentage of patients achieving the Assessments in Ankylosing Spondylitis (ASAS) 20% response ( ASAS 20 ) at week 6.Other outcome measures included the percentage of patients achieving ASAS 5/6,partial remission and Bath AS disease activity index 50 ( BASDAI 50) responses at week 12.Results A total of 381 patients completed the trial,including 285 patients in the etanercept group and 96 patients in the placebo group.At week 2,the percentage of patients achieving ASAS 20 in the etanercept group was 55.7%,whereas the placebo group was only 17.0% ( P < 0.001 ).At week 6,77.5% of patients in the etanercept group achieved ASAS 20 as compared with 32.3% in the placebo group ( P < 0.001 ).At the end of 12 weeks,the percentage of patients in the etanercept group achieving the ASAS 20 was 89.5%.Improvements of other measures were also significant in the etanercept group.Etanercept was well tolerated and no malignancy and life-threatening events were observed in this study.Most adverse events observed were mild injection-site reactions.Conclusion Etanercept 50 mg weekly treatment of Chinese patients with active ankylosing spondylitis is convenient,fast-acting,highly effective,and well tolerated.

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