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在多发性硬化症的临床试验中是否存在安慰剂效应?文献综述。

Does a placebo-effect exist in clinical trials on multiple sclerosis? Review of the literature.

作者信息

La Mantia L, Eoli M, Salmaggi A, Milanese C

机构信息

Istituto Neurologico C. Besta, Milano, Italy.

出版信息

Ital J Neurol Sci. 1996 Apr;17(2):135-9. doi: 10.1007/BF02000844.

DOI:10.1007/BF02000844
PMID:8797067
Abstract

To verify whether the outcome in placebo-treated MS patients actually corresponds to that expected on the basis of the natural history and pretrial evolution of the disease, we here review the results of clinical trials conducted according to a placebo-controlled, randomized design, regardless of the experimental therapy used. The frequency of relapse in remitting-relapsing patients decreases during follow-up, and disability in progressive cases increases more slowly than before enrollment. These data should be borne in mind when evaluating the impact of experimental drugs on the natural course of the disease.

摘要

为了验证安慰剂治疗的多发性硬化症(MS)患者的实际结局是否真的与基于该疾病自然史和治疗前病程所预期的结局相符,我们在此回顾根据安慰剂对照、随机设计开展的临床试验结果,而不考虑所使用的实验性疗法。复发缓解型患者的复发频率在随访期间降低,进展型患者的残疾进展速度比入组前更慢。在评估实验性药物对疾病自然病程的影响时,应牢记这些数据。

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PROBLEMS OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS: REPORT BY THE PANEL ON THE EVALUATION OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS.多发性硬化症治疗的实验性试验问题:多发性硬化症治疗实验性试验评估小组报告
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一项关于硫唑嘌呤治疗多发性硬化症疗效的双盲研究:最终报告。
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Low-dose (7.5 mg) oral methotrexate reduces the rate of progression in chronic progressive multiple sclerosis.低剂量(7.5毫克)口服甲氨蝶呤可降低慢性进展性多发性硬化症的进展速度。
Ann Neurol. 1995 Jan;37(1):30-40. doi: 10.1002/ana.410370108.
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Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).评估多发性硬化症的神经功能损伤:扩展残疾状态量表(EDSS)
Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
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Intrathecally administered natural human fibroblast interferon reduces exacerbations of multiple sclerosis. Results of a multicenter, double-blind study.鞘内注射天然人成纤维细胞干扰素可减少多发性硬化症的发作。一项多中心双盲研究的结果。
Arch Neurol. 1987 Jun;44(6):589-95. doi: 10.1001/archneur.1987.00520180013008.
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Systemic recombinant alpha-2 interferon therapy in relapsing multiple sclerosis.系统性重组α-2干扰素治疗复发型多发性硬化症。
Arch Neurol. 1986 Dec;43(12):1239-46. doi: 10.1001/archneur.1986.00520120023011.
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The natural history of multiple sclerosis.多发性硬化症的自然病史。
Can J Neurol Sci. 1987 Aug;14(3):255-61. doi: 10.1017/s0317167100026573.
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A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.Cop 1治疗复发缓解型多发性硬化症的一项试点试验。
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