重组人干扰素β1b治疗复发缓解型多发性硬化症的安全性及临床疗效

目的观察重组人干扰素β1b(rhIFNβ1b)治疗复发缓解型多发性硬化症(RRMS)的安全性及临床疗效。方法选择20名健康志愿者,分为1.5、3、6和9MIU4个剂量组,每天按剂量皮下注射1次rhIFNβ1b,连续注射8d,观察药物的安全性、耐受性和药代动力学。选择101例RRMS患者,随机分为观察组(52例)和对照组(49例),每周3次分别注射6MIU的rhIFNβ1b和25mg人血白蛋白,用药1年后,2组均注射6MIU的rhIFNβ1b,每周3次,用药1年。定期随访并进行各项指标及核磁共振成像(MRI)检查,观察药物的临床疗效,同时进一步观察安全性。结果安全性观察显示,rhIFNβ1b在9MIU剂量范围内耐受性良好。观察组和对照组分别注射rhIFNβ1b后,可显著减少RRMS患者头部与脊髓中病灶数量或缩小病灶体积,并显著降低复发率,且随着用药时间的延长,效果更加明显。结论rhIFNβ1b安全性和耐受性良好,临床影象学评价疗效显著。

Safety and Clinical Efficacy of Recombinant Human Interferon β1b for Treatment of Relapsing-Remitting Multiple Sclerosis

Objective To observe the safety and clinical efficacy of recombinant human interferon β1b (rhIFNβ1b) for treatment of relapsing-remitting multiple sclerosis(RRMS). Methods Twenty healthy volunteers were divided into four groups and injected s. c. with rhIFNβ1b at dosages of 1.5, 3, 6 and 9 MIU respectively, once a day for 8 d, and observed for safety, tolerance and pharmacokinetics. The patients with RRMS were divided into trial(n = 52)and control(n = 49)groups randomly, and injected with 6 MIU of rhIFN β1b and 25 mg of human albumin respectively, 3 times a week for 12 months, then both injected with 6 MIU of rhIFNβ1b, 3 times a week for 12 months. All the patients were followed up periodically, determined for various indexes and examined by MRI to evaluate the curative effect and further observe the safety. Results The rhIFNβ1b at a dosage of 9 MIU was well-tolerant. MRI showed that, after treatment with rhIFNβ1b, the numbers and sizes of foci as well as relapse rates of patients in trial and control groups decreased significantly, and the curative effect increased with the increasing time for treatment. Conclusion The rhIFNβ1b was safe and well-tolerant, and showed significantly curative effect on RRMS as proved by MRI.