米诺环素 多发性硬化.ppt

米诺环素在临床孤立综合征治疗中的随机对照试验
PS:米诺环素是第二代半合成四环素,抗菌谱与四环素相近,可结合细菌中的30S核糖体亚基从而抑制蛋白质合成,在四环素类中该品抗菌作用最强,对需氧和厌氧革兰氏阳性菌和革兰氏阴性菌都有一定抑制作用。

近年来发现其非抗生素性质:抗氧化、抑制Caspase-1和caspase-3活化、抗炎、免疫调节、神经保护等。用于类风关、神经保护等领域的研究。
单中心小临床试验发现米诺环素可减少多发性硬化颅内病灶。
BACKGROUND
we conducted a randomized, controlled trial to determine whether minocycline reduces the risk of conversion from a first demyelinating event (also known as a clinically isolated syndrome) to multiple sclerosis diagnosed on the basis of the 2005 McDonald criteria.
研究目的:通过RCT试验来探索米诺环素是否可降低首次脱髓鞘事件(又叫作临床孤立综合征)转化发展为多发性硬化的风险。
研究发起人:加拿大多发性硬化协会
研究起止时间:-
设计类型:随机、对照、盲法
METHODS
纳入标准:
18-60岁
180天内单次发作临床孤立脱髓鞘事件(视神经、脑干、半球、小脑、脊髓),参见2005年McDonald诊断标准。
MRI T2像:至少2处病灶直径大于3mm(其中一个卵圆形病灶位于侧脑室周围或幕下典型脱髓鞘病灶)
排除标准:其他已知原因所致脱髓鞘病变或确诊多发性硬化
Participants were eligible for inclusion in the trial if they were between 18 and 60 years of age;provided written informed consent; had had a single clinically isolated demyelinating event such as optic neuritis or a brainstem, cerebral, cerebellar, or myelopathy syndrome within the previous 180 days; and had at least two lesions larger than 3 mm in diameter on T2weighted MRI of the brain (one lesion had to be ovoid, periventricular, or infratentorial — typical of demyelinating disease). Key exclusion criteria were an alter native explanation for the event, a previous event reasonably attributable to demyelination, or a diagnosis of multiple sclerosis according to the 2005 McDonald criteria.
METHODS
研究方法:
治疗终止时间:24个月停药
或24个月内确诊为MS后停药
问卷随访24个月(症状、EDSS评分、药物副作用等)
主要指标:6个月临床孤立综合征转化为MS的比例
次要指标:①24个月转化为MS的比例;
②在6、24个月头颅MRI的改变(T2病灶体积、
T1强化病灶数、强化病灶数和新扩大病灶数总和)
RESULTS
——基线资料
P=
P=
A total of 142 eligible participants underwent randomization at 12 Canadian multiple sclerosis clinics; 72 participants were assigned to the minocycline group and 70 to the placebo group. The mean age of the participants was years, and % were women.
在12个加拿大多发性硬化诊所中,纳入符合条件的患者142例,米诺环素组72例,对照组70例,,女性患者占68.