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促甲状腺激素释放激素(TRH)治疗肌萎缩侧索硬化症的双盲、安慰剂对照试验。

A double-blind, placebo-controlled trial of TRH in amyotrophic lateral sclerosis.

作者信息

Caroscio J T, Cohen J A, Zawodniak J, Takai V, Shapiro A, Blaustein S, Mulvihill M N, Loucas S P, Gudesblatt M, Rube D

出版信息

Neurology. 1986 Feb;36(2):141-5. doi: 10.1212/wnl.36.2.141.

DOI:10.1212/wnl.36.2.141
PMID:3080693
Abstract

A double-blind, placebo-controlled trial of single doses of thyrotropin releasing hormone (TRH) was performed on 12 patients with amyotrophic lateral sclerosis. Each patient was given subcutaneous injections of TRH 150 mg or placebo, and IV infusions of TRH 500 mg or placebo at 72- to 96-hour intervals. Eight motor and functional ratings were scored at regular intervals after each injection. Side effects were seen in all patients and were obvious to patients and examiners, making true blinding impossible. Nevertheless, statistically significant improvement was seen only in dynametric strength 1 hour after subcutaneous injection (p less than 0.05). Significant improvement occurred, in one patient only, on subjective speech testing during IV infusion of TRH. In none of six other ratings was there a significant difference between TRH and placebo. Subjective improvement was noted by 11 of 12 patients.

摘要

对12例肌萎缩侧索硬化患者进行了单剂量促甲状腺激素释放激素(TRH)的双盲、安慰剂对照试验。每位患者每隔72至96小时皮下注射150毫克TRH或安慰剂,并静脉输注500毫克TRH或安慰剂。每次注射后定期对八项运动和功能指标进行评分。所有患者均出现副作用,患者和检查者都能明显察觉,因此无法实现真正的盲法。尽管如此,仅在皮下注射后1小时的握力方面观察到有统计学意义的改善(p<0.05)。在静脉输注TRH期间,仅1例患者在主观言语测试中有显著改善。在其他六项指标中,TRH与安慰剂之间均无显著差异。12例患者中有11例注意到有主观改善。

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