干扰素-β-1b治疗多发性硬化的疗效及不良反应观察

The efficacy and side effects of interferon-beta-1b on Chinese patients with multiple sclerosis

目的探讨干扰素-β-1b(IFN-β-1b)用于治疗中国多发性硬化(MS)患者的疗效及不良反应。方法对12例确诊的复发缓解型MS(RRMS)患者给予IFN-β-1b治疗,并于治疗后第4、8、12、24周随访。通过观察患者扩展的功能缺损状况量表(EDSS)评分、头MRI T2加权像病灶数量及Gd-DTPA强化病灶数量、体积的演变,综合评价IFN-β-1b治疗MS的疗效,并通过分析血常规、肝肾功能等检测指标及不良反应综合评价该药物的不良反应。结果 (1)12例患者治疗前与治疗后24周EDSS评分比较差异无统计学意义(P>0.05);(2)治疗前6个月疾病复发率为33.33%(4/12),治疗后24周内复发率41.67%(5/12),两者比较差异无统计学意义(P>0.05);(3)与治疗前相比,治疗后第12周及第24周时MRI检查发现T2病灶数量、Gd-DTPA强化病灶数量及体积均明显减少(P<0.05)。(4)治疗后第24周血清尿酸、肌酐水平〔分别为(66.64±16.15)(、295.48±165.36)μmol/L〕与治疗前〔分别为(69.07±14.70)(、319.86±113.61)μmol/L〕相比明显降低(P<0.01),血尿素氮、肝功能、血常规等血液指标与治疗前相比差异无统计学意义(P>0.05)。(5)所有患者分别出现不同程度的局部注射部位红肿、头疼、肌肉关节疼痛、发热等不良反应。结论 IFN-β-1b用于治疗MS患者在24周内可以改善影像学改变情况,但不能明显改善疾病复发和临床神经功能障碍程度;IFN-β-1b的常见不良反应为注射局部红肿、头疼、肌肉关节疼痛、发热等。

Objective To investigate the efficacy and side effects of interferon beta-lb （INF-β-1b） on multiple sclerosis （MS）. Methods Twelve patients with relapsing-remitting MS （RRMS） were treated with 250 μg INF-β-1b, which was administered subcutaneously every other day for 24 weeks. The data regarding of expanded disability status （EDSS）, the number and the volume of Gadolinium-DTPA enhanced lesions in magnetic resonance image （MRI）, hematological indexes including creatinine （CREA）, blood urea nitrogen （BUN）, uric acid （UA）, aspartate aminotransferase （AST）, alanine aminotransferase （ALT）, red blood cell count （RBC）, white blood cell count （WBC）, hemoglobin （HGB）, platelet （PLT）, and side effects were collected. The above parameters before the treatment and the 4th, 8th, 12th, 24th weeks after the treatment were evaluated separately. Results （1） Compared to pre-treatment, the EDSS scores did not change significantly （P〈0.05） at the 24th week after the treatment. （2） Compared to pre-treatment, the rate of relapses of MS did not change significantly 24 weeks after the treatment （P〉0.05）. （3） Compared to pretreatment, the volume and number of Gadolinium-DTPA enhanced lesions on T1 and the number of lesions on T2 decreased significantly （P〈0.05） at the 12th and 24th week after treatment. （4） Compared to pre-treatment [ （69. 07±14. 70）, （319. 86± 113.61） μmol/L, respectively], the level of CREA and UA decreased after treatment [ （66.64±16.15）, （295.48±165.36） μmol/L, respectively, P〈0.01], the levels of AST, ALT, BUN, RBC, HGB, PLT did not change significantly 24 weeks after treatment （P〉0.05）. （5） All the patients showed various degrees of irritation in local injection site, headache, muscle and joint pain, fever and other side effects. Conclusions The treatment of IFN-β-1b on MS patients could improve the volume of Gadolinium -DTPA enhanced lesions on T1, but could not cut down the rate of relapses and the severity of nervous system dysfunction within 24 weeks. Common side effects include local injection site irritation, headache, muscle and joint pain and fever.