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目的探讨β-1a干扰素治疗多发性硬化症的临床疗效与安全性。方法54例入选病例随机分为β-1a干扰素治疗组或安慰剂组,治疗组每次皮下注射β-1a干扰素20mg,每周3次,维持2年。用药患者在最初6个月中每月作1次神经系统检查,之后每3个月查1次。所有病人每年做2次MRI检查,并对所获数据进行统计学分析。结果β-1a干扰素治疗的病人第1年和第2年的复发率比安慰剂组有明显降低(治疗组平均每人1.62次,安慰剂组2.78次);复发危险性减低27%;首次复发时间推迟3个月(20mg组),并且无复发的病人比例大大提高(P<0.05)。治疗组病人注射部位的局部反应很常见,但大多轻微。结论在降低复发率、减轻残障程度和改善MRI病灶等方面,用皮下β-1a干扰素治疗多发性硬化疗效确切,不良反应小。
Objective To investigate the clinical efficacy and safety of β-1a interferon in the treatment of multiple sclerosis. Methods Fifty-four selected patients were randomly divided into β-1a interferon group and placebo group. The treatment group was injected subcutaneously with β-1a interferon 20 mg three times per week for 2 years. Patients in the first six months of treatment for a neurological examination every month, then check every 3 months. All patients did 2 MRI exams each year, and the data were statistically analyzed. Results The relapse rates at 1 year and 2 years in patients treated with β-1a were significantly lower than those in placebo patients (mean 1.62 for treatment and 2.78 for placebo), 27% for risk of relapse, The relapse time was delayed 3 months (20mg group), and the proportion of patients with no recurrence was significantly increased (P <0.05). The local response to the injection site in the treatment group was common, but mostly mild. Conclusions The treatment of multiple sclerosis with subcutaneousβ-1a interferon is effective in reducing the recurrence rate, reducing the degree of disability and improving the MRI lesion. The adverse reaction is small.