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利鲁唑治疗肌萎缩侧索硬化症患者的长期生存分析。

An analysis of extended survival in patients with amyotrophic lateral sclerosis treated with riluzole.

作者信息

Riviere M, Meininger V, Zeisser P, Munsat T

机构信息

Benefit Canada Inc, Montreal, Quebec.

出版信息

Arch Neurol. 1998 Apr;55(4):526-8. doi: 10.1001/archneur.55.4.526.

DOI:10.1001/archneur.55.4.526
PMID:9561981
Abstract

BACKGROUND

In an attempt to better understand and define the progression of amyotrophic lateral sclerosis (ALS), we developed a classification of 5 discrete health states that reflect patients' activities of daily living. These health states were used to determine whether patients with ALS who are treated with riluzole differed from those treated with placebo.

SETTING

Clinics for patients with ALS.

DESIGN

Placebo-controlled trial of riluzole treatment in 959 patients with ALS.

INTERVENTIONS

Treatment with riluzole or placebo. MAIN DEPENDENT MEASURES: A Cox model was used to assess whether, from the initial randomization to the end of an 18-month follow-up, there was a difference in the times of transition into subsequent health states between patients treated with riluzole and those treated with placebo.

RESULTS

Our analysis showed a significant difference in the time to transit between the riluzole and the placebo groups in less severely affected cases, ie, state 2 and state A (the milder states) of ALS.

CONCLUSION

Patients receiving riluzole remained in the milder health states longer (P<.05).

摘要

背景

为了更好地理解和界定肌萎缩侧索硬化症(ALS)的病情进展,我们制定了一种对5种不同健康状态的分类方法,这些状态反映了患者的日常生活活动情况。这些健康状态被用于确定接受利鲁唑治疗的ALS患者与接受安慰剂治疗的患者是否存在差异。

设置

ALS患者诊所。

设计

对959例ALS患者进行利鲁唑治疗的安慰剂对照试验。

干预措施

使用利鲁唑或安慰剂进行治疗。主要观察指标:采用Cox模型评估从初始随机分组至18个月随访结束时,接受利鲁唑治疗的患者与接受安慰剂治疗的患者进入后续健康状态的时间是否存在差异。

结果

我们的分析显示,在病情较轻的病例中,即ALS的状态2和状态A(较轻度状态),利鲁唑组和安慰剂组之间的转变时间存在显著差异。

结论

接受利鲁唑治疗的患者在较轻健康状态下停留的时间更长(P<0.05)。

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