A randomized controlled double-masked trial of albuterol add-on therapy in patients with multiple sclerosis.
A randomized controlled double-masked trial of albuterol add-on therapy in patients with multiple sclerosis.
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DOI：
10.1001/archneurol.2010.222
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发表时间：
2010-09
影响因子：
--
通讯作者：
Reddy, Susheel
中科院分区：
文献类型：
--
作者：
Khoury, Samia J.;Healy, Brian C.;Kivisakk, Pia;Viglietta, Vissia;Egorova, Svetlana;Guttmann, Charles R. G.;Wedgwood, Josiah F.;Hafler, David A.;Weiner, Howard L.;Buckle, Guy;Cook, Sandra;Reddy, Susheel
白介素12(IL-12)是一种促进辅助性T细胞亚型1生成的细胞因子，在多发性硬化症中升高。沙丁胺醇是一种β2-肾上腺素能激动剂，可以减少IL-12的表达，因此我们测试了沙丁胺醇作为醋酸格列酮治疗的附加治疗的效果。目的：探讨沙丁胺醇作为补充治疗开始治疗的患者的临床和免疫学效果。单中心双盲临床试验。学术研究。患有复发缓解型多发性硬化症的受试者。在这项单中心双掩蔽临床试验中，复发缓解型多发性硬化症患者被随机分成两组，分别接受皮下注射醋酸格雷替莫(20毫克)加每日口服安慰剂2年，或皮下注射醋酸格雷替莫(20毫克)加每日口服沙丁胺醇2年。主要临床疗效评价为2年时多发性硬化功能复合体的变化，主要免疫学终点为各研究时间点IL-13和干扰素γ表达的变化。这项试验的证据分类等级为每个问题的C级，因为这是第一个涉及醋酸格列酮和沙丁胺醇疗效的II类临床试验。44名受试者被随机分成两组，分别接受格列替莫加沙丁胺醇或格列替莫加安慰剂治疗，其中39名受试者参与了分析。在6个月(P=.005)和12个月(P=0.04)时间点，醋酸格列酮加沙丁胺醇组的多发性硬化症功能复合体有改善，但在24个月时间点没有改善。首次复发时间在醋酸格列酮+沙丁胺醇组中也观察到延迟(P=.03)。免疫学方面，两组IL-13和干扰素-γ的产生均下降，且在12个月时观察到对IL-13的治疗效果(P<；0.05)。不良反应一般较轻，只有3例中度或严重不良反应被认为与治疗有关。在多发性硬化症患者中，使用醋酸格列酮和沙丁胺醇的治疗耐受性良好，并改善了临床结果。
Interleukin 12 (IL-12), a cytokine that promotes generation of helper T cells subtype 1, is increased in multiple sclerosis. Albuterol sulfate, a β2-adrenergic agonist, reduces IL-12 expression, so we tested the effect of albuterol as an add-on treatment to glatiramer acetate therapy. To investigate the clinical and immunologic effects of albuterol treatment as an add-on therapy in patients starting glatiramer acetate treatment. Single-center double-masked clinical trial. Academic research. Subjects with relapsing-remitting multiple sclerosis. In this single-center double-masked clinical trial, subjects with relapsing-remitting multiple sclerosis were randomized to receive a subcutaneous injection of glatiramer acetate (20 mg) plus an oral dose of placebo daily for 2 years or a subcutaneous injection of glatiramer acetate (20 mg) plus an oral dose of albuterol daily for 2 years. The primary clinical efficacy measurement was the change in Multiple Sclerosis Functional Composite at 2 years, and the primary immunologic end point was the change in expression of IL-13 and interferon γ at each study time point. The classification level of evidence from this trial is C for each question, as this is the first class II clinical trial addressing the efficacy of glatiramer acetate plus albuterol. Forty-four subjects were randomized to receive glatiramer acetate plus albuterol or glatiramer acetate plus placebo, and 39 subjects contributed to the analysis. Improvement in the Multiple Sclerosis Functional Composite was observed in the glatiramer acetate plus albuterol group at the 6-month (P = .005) and 12-month (P = .04) time points but not at the 24-month time point. A delay in the time to first relapse was also observed in the glatiramer acetate plus albuterol group (P = .03). Immunologically, IL-13 and interferon-γ production decreased in both treatment groups, and a treatment effect on IL-13 production was observed at the 12-month time point (P < .05). Adverse events were generally mild, and only 3 moderate or severe events were considered related to the treatment. Treatment with glatiramer acetate plus albuterol is well tolerated and improves clinical outcomes in patients with multiple sclerosis.
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影响因子：
9.9
作者：
French, Jacqueline;Gronseth, Gary
通讯作者：
Gronseth, Gary
影响因子：
12.8
作者：
Martin, R;Gran, B;Pinilla, C
通讯作者：
Pinilla, C
影响因子：
3.3
作者：
Nicoletti, F;Patti, F;Reggio, A
通讯作者：
Reggio, A
影响因子：
3.3
作者：
WIEGMANN, K;MUTHYALA, S;CHELMICKASCHORR, E
通讯作者：
CHELMICKASCHORR, E
影响因子：
3.3
作者：
Dhib-Jalbut, S;Chen, M;Martin, R
通讯作者：
Martin, R