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米多君用于改善四肢瘫痪患者运动能力的双盲、安慰剂对照试验:一项初步研究

Double-blinded, placebo-controlled trial of midodrine for exercise performance enhancement in tetraplegia: a pilot study.

作者信息

Nieshoff Edward C, Birk Thomas J, Birk Cynthia A, Hinderer Steven R, Yavuzer Gunes

机构信息

Rehabilitation Institute of Michigan, Detroit, Michigan, USA.

出版信息

J Spinal Cord Med. 2004;27(3):219-25. doi: 10.1080/10790268.2004.11753752.

Abstract

BACKGROUND/OBJECTIVE: Spinal cord injury (SCI) impairs cardiovascular autonomic responses to exercise and, depending on the level of injury, may result in hypotension and pathologic fatigue with exertion. Other clinical populations with sympathetic regulatory dysfunction, but without skeletal muscle paralysis, exhibit similar signs and symptoms. Their ability to engage in physical activity improves with elevation of blood pressure through pharmacologic treatment: Midodrine, an oral alpha-sympathomimetic agent, has been shown to be safe and efficacious for this purpose. Use of this medication in individuals with SCI merits investigation.

METHODS

Double-blind, placebo-controlled, randomized, crossover, within-subjects protocol. Four participants with chronic, motor-complete injuries from C6 to C8 underwent 4 peak exercise tests (PXT) using a wheelchair ergometer, following administration of midodrine, 5 mg, 10 mg, and placebo, in random order. Heart rate, blood pressure, oxygen consumption (VO2), and perceived exertion were measured.

RESULTS

Treatment with midodrine, 10 mg, was associated with elevated systolic blood pressure during peak exercise in 3 participants. Two participants showed a concurrent decrease in perceived exertion and increase in VO2. No adverse effects of midodrine were evident.

CONCLUSION

Midodrine enhances exercise performance in some individuals with SCI, similar to other clinical populations with cardiovascular autonomic dysfunction.

摘要

背景/目的:脊髓损伤(SCI)会损害心血管对运动的自主反应,根据损伤程度的不同,可能会导致低血压和运动时的病理性疲劳。其他存在交感神经调节功能障碍但无骨骼肌麻痹的临床人群也表现出类似的体征和症状。通过药物治疗升高血压可改善他们进行体育活动的能力:米多君,一种口服α-拟交感神经药,已被证明用于此目的是安全有效的。在脊髓损伤患者中使用这种药物值得研究。

方法

采用双盲、安慰剂对照、随机、交叉、受试者内方案。四名C6至C8慢性运动完全损伤的参与者在随机服用5毫克、10毫克米多君和安慰剂后,使用轮椅测力计进行了4次峰值运动测试(PXT)。测量心率、血压、耗氧量(VO2)和主观用力程度。

结果

10毫克米多君治疗使3名参与者在峰值运动时收缩压升高。两名参与者同时出现主观用力程度降低和VO2增加。未发现米多君有明显不良反应。

结论

米多君可提高一些脊髓损伤患者的运动表现能力,这与其他存在心血管自主神经功能障碍的临床人群类似。

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