A Randomized, Double-blind Controlled Study to Determine the Effectiveness, Safety and Tolerability of Actoferon® Compared to Betaferon® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS)

开始日期2011-10-20

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项与干扰素β-1b生物类似药(AMEGA Biotech) 相关的文献（医药）

1998-12-01·Journal of Endocrinological Investigation2区 · 医学

Occurrence of thyroid autoimmunity and dysfunction throughout a nine-month follow-up in patients undergoing interferon-β therapy for multiple sclerosis

2区 · 医学

Article

作者: M. Rotondi ; C. M. Mone ; A. Oliviero ; A. M. Sinisi ; G. Mazziotti ; A. Bellastella ; A. Del Buono ; P. Profice ; Carlo Carella ; B. Biondi

Thyroid autoimmunity and dysfunction are a well known side effect of IFN alpha therapy for viral hepatitis and tumors, while the IFN beta effects on the thyroid gland in neurological patients have not been studied. The aim of this longitudinal study was to look for the appearance of thyroid autoimmunity as well as for the occurrence of overt thyroid disease in the patients affected by multiple sclerosis (MS) treated with IFN beta 1b. Eight patients (4 males, 4 females) undergoing r-IFN beta 1b treatment (8 M.U. every other day for 9 months) for relapsing remitting multiple sclerosis entered the study. We have analyzed thyroid function parameters and auto antibody levels before and after 1, 2, 3, 6 and 9 months of therapy. None of them referred to familiar thyroid pathology or presented clinically overt thyroid disease except for one patient (case 4) who showed TPO-Ab pretreatment positivity and another (case 8) who was in therapy with Levothyroxine 100 microg/die for multinodular goiter. The number of patients with appearance of thyroid antibodies has slowly increased, until the third month of therapy with 3 patients out of 7 positive for TPO-Ab. The only case of overt thyroid dysfunction reported by us appeared after nine months of therapy and consisted of a hypothyroidism. Our data suggest that short-term interferon beta treatment is able to induce thyroid autoimmunity (42.8%) and dysfunction (12.5%).

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB08	DB00068

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适应症	国家/地区	公司	日期
多发性硬化症	伊朗	AMEGA Biotech	2014-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ECTRIMS2022	N/A	复发-缓解型多发性硬化	140	Actoferon®	鹹憲鹹範築鑰憲顧鬱範(膚簾觸製鹹壓繭繭淵醖) = 夢繭築獵餘艱壓鬱齋願憲網餘遞範鏇積齋壓鬱 (廠窪衊繭壓蓋鬱蓋艱襯 ) 更多	积极	2022-10-12
				Betaferon®	鹹憲鹹範築鑰憲顧鬱範(膚簾觸製鹹壓繭繭淵醖) = 簾積積襯鹽醖鬱糧襯鏇憲網餘遞範鏇積齋壓鬱 (廠窪衊繭壓蓋鬱蓋艱襯 ) 更多