Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.
Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.
复制标题
双盲、安慰剂对照交叉试验，以确定米多君对 SCI 患者认知测试期间血压的影响。
DOI：
10.1038/s41393-020-0448-0
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发表时间：
2020
期刊：
影响因子：
2.2
通讯作者：
Bauman,WilliamA
中科院分区：
文献类型：
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作者：
Wecht,JillM;Weir,JosephP;Katzelnick,CaitlynG;Chiaravalloti,NancyD;Kirshblum,StevenC;Dyson-Hudson,TrevorA;Weber,Erica;Bauman,WilliamA
研究设计临床试验目的T6以上脊髓损伤（SCI）患者自主神经系统下行皮质控制受损，易发生低血压。然而，低血压的治疗在SCI人群中并不常见，因为几乎没有安全有效的药物选择。本研究的主要目的是测试单剂量米多君（10 mg）与安慰剂相比，在认知测试期间，SCI患者的收缩压（SBP）在110 - 120 mmHg之间升高和正常化的疗效。次要目的是确定米多君对脑血流速度（CBFV）和整体认知功能的影响。SettingUnited States clinical research laboratory. MethodsForty一个健康的慢性（≥1年后损伤）SCI患者参加了这项为期2天的研究。坐位收缩压，CBFv，和认知能力进行监测之前和之后，管理相同的胶囊片剂，含有米多君或placebo.ResultsCompared安慰剂，米多君增加收缩压（4 ± 13与18 ± 24毫米汞柱，分别;p< 0.05），然而，反应差异很大，米多君（-15.7至+68.6毫米汞柱）。此外，与安慰剂相比，米多君在认知测试期间血压正常范围内的SBP记录比例没有改善。虽然较高的SBP与较高的CBFV（p= 0.02），全球认知功能没有改善与midodrine.ConclusionsThe研究结果表明，midodrine增加SBP，可能是有益的，在一些肿胀的SCI患者;然而，大异质性的反应midodrine建议仔细监测患者后administration.Clinical trials registrationNCT 02307565。
Study designClinical trial.ObjectivesIndividuals with spinal cord injury (SCI) above T6 experience impaired descending cortical control of the autonomic nervous system, which predisposes them to hypotension. However, treatment of hypotension is uncommon in the SCI population because there are few safe and effective pharmacological options available. The primary aim of this investigation was to test the efficacy of a single dose of midodrine (10 mg), compared with placebo, to increase and normalize systolic blood pressure (SBP) between 110 and 120 mmHg during cognitive testing in hypotensive individuals with SCI. Secondary aims were to determine the effects of midodrine on cerebral blood flow velocity (CBFv) and global cognitive function.SettingUnited States clinical research laboratory.MethodsForty-one healthy hypotensive individuals with chronic (≥1-year post injury) SCI participated in this 2-day study. Seated SBP, CBFv, and cognitive performance were monitored before and after administration of identical encapsulated tablets, containing either midodrine or placebo.ResultsCompared with placebo, midodrine increased SBP (4 ± 13 vs. 18 ± 24 mmHg, respectively;p< 0.05); however, responses varied widely with midodrine (−15.7 to +68.6 mmHg). Further, the proportion of SBP recordings within the normotensive range did not improve during cognitive testing with midodrine compared with placebo. Although higher SBP was associated with higher CBFv (p= 0.02), global cognitive function was not improved with midodrine.ConclusionsThe findings indicate that midodrine increases SBP and may be beneficial in some hypotensive patients with SCI; however, large heterogeneity of responses to midodrine suggests careful monitoring of patients following administration.Clinical trials registrationNCT02307565.