laquinimod对复发缓解型多发性硬化症患者mri监测疾病活动性的影响:一项多中心、随机、双盲、安慰剂对照IIb期研究
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科米G，普利齐A，罗瓦里斯M，阿布拉姆斯基O，阿尔比苏T，博伊科A，戈尔德R，哈夫多瓦E，科莫里S，塞尔马吉K, Sharrack B，菲利皮M
laquinimod对复发缓解型多发性硬化症患者mri监测疾病活动性的影响:一项多中心、随机、双盲、安慰剂对照IIb期研究
《柳叶刀》2008年6月21日;371(9630):2085-92。doi: 10.1016 / s0140 - 6736(08) 60918 - 6。
- PubMed ID
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18572078 (PubMed视图］
- 摘要
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背景:一项为期24周的II期试验显示，每天给复发缓解型多发性硬化症患者0.3 mg laquinimod耐受性良好，并减少了活动性病变的形成。在一项为期36周的双盲、安慰剂对照IIb期研究中，我们评估了每日口服0.3和0.6 mg laquinimod对mri监测的疾病活动性的影响。方法:这项研究在9个国家的51个中心进行。纳入标准为入组前一年有一次或多次复发，MRI筛查中至少有一次钆增强(GdE)病变。在筛选的720名患者中，306名符合条件的患者入选。年龄在18-50岁的患者被随机分配到安慰剂组(n=102)、拉奎尼mod 0.3 mg /天(n=98)或0.6 mg /天(n=106)。大脑MRI扫描和临床评估在第4周、基线和第12周至第36周每月进行。主要结局是第24、28、32和36周时GdE病变的累积数量。主要终点的主要分析是在意向治疗队列中完成的。该研究已在ClinicalTrials.gov上注册，注册号为NCT00349193。 FINDINGS: Compared with placebo, treatment with laquinimod 0.6 mg per day showed a 40.4% reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans (simple means 4.2 [SD 9.2] vs 2.6 [5.3], p=0.0048); treatment with 0.3 mg per day showed no significant effects (3.9 [5.5] vs placebo, p=0.6740). Both doses of laquinimod were well tolerated, with some transient and dose-dependent increases in liver enzymes. A case of Budd-Chiari syndrome-ie, a thrombotic venous outflow obstruction of the liver-occurred after 1 month of exposure in a patient with underlying hypercoagulability who received 0.6 mg laquinimod. Anticoagulant treatment resulted in a decline of liver enzymes to normal without any clinical signs of hepatic decompensation. INTERPRETATION: In patients with relapsing-remitting multiple sclerosis, 0.6 mg per day laquinimod significantly reduced MRI-measured disease activity and was well tolerated.
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