■患有胸椎6级(T6)以上脊髓损伤(SCI)的个体经历自主神经系统的下降皮质控制受损,这使他们容易血压(BP)不稳定,包括低血压,直立性低血压(OH),和自主神经反射异常(AD)。然而,许多人没有报告这些BP紊乱的症状,因为很少有治疗方案被证明对SCI人群安全有效,大多数人仍未得到治疗。
■这项调查的主要目的是确定米多君(10mg)规定的TID或BID在家庭环境中的作用,与安慰剂相比,在30天的BP,研究撤回,在SCI低血压个体中,与OH和AD相关的症状报告。
■参与者被随机分配接受米多君/安慰剂或安慰剂/米多君,其间有2周的冲洗期,参与者和研究者均对随机化顺序不知情.研究药物每天服用2或3次,根据他们的睡眠/觉醒时间表,BP,在每次给药前和给药后1小时并在一天中定期记录任何相关症状。
■招募了19名SCI患者;然而,9在完成完整协议之前退出。在两个30天的监测期内,共收集了19名参与者的1892个BP记录(75±48个记录/参与者/30天)。与安慰剂相比,米多君的平均30天收缩压显着增加(114±14vs.96±11mmHg,分别为;P=0.004),与安慰剂相比,米多君显着减少了低血压血压记录的数量(38.7±41.9vs.分别为73.3±40.6;P=0.01)。然而,与安慰剂相比,米多君增加了血压的波动,没有改善OH的症状,但与AD相关的症状强度显著恶化(P=0.03)。
■在家庭环境中施用米多君(10mg)有效地增加了BP并降低了低血压的发生率;然而,这些有益效果是以恶化的BP不稳定性和AD症状强度为代价的。
Individuals with spinal cord injury (SCI) above thoracic level-6 (T6) experience impaired descending cortical control of the autonomic nervous system which predisposes them to blood pressure (BP) instability, including includes hypotension, orthostatic hypotension (OH), and autonomic dysreflexia (AD). However, many individuals do not report symptoms of these BP disorders, and because there are few treatment options that have been proven safe and effective for use in the SCI population, most individuals remain untreated.
The primary aim of this investigation was to determine the effects of midodrine (10 mg) prescribed TID or BID in the home environment, compared to placebo, on 30-day BP,
study withdrawals, and symptom reporting associated with OH and AD in hypotensive individuals with SCI.
Participants were randomly assigned to received midodrine/placebo or placebo/midodrine, with a 2-weeks washout period in between, and both the participants and investigators were blinded to randomization order.
Study medication was taken 2 or 3 times/day, depending on their sleep/wake schedule, BP, and any related symptoms were recorded before and 1 h after each dosage and periodically throughout the day.
Nineteen individuals with SCI were recruited; however, 9 withdrew prior to completion of the full protocol. A total of 1892 BP recordings (75 ± 48 recordings/participant/30-day period) were collected in the 19 participants over the two 30-day monitoring periods. Average 30-day systolic BP was significantly increased with midodrine compared to placebo (114 ± 14 vs. 96 ± 11 mmHg, respectively; P = 0.004), and midodrine significantly reduced the number of hypotensive BP recordings compared to placebo (38.7 ± 41.9 vs. 73.3 ± 40.6, respectively; P = 0.01). However, compared to placebo, midodrine increased fluctuations in BP, did not improve symptoms of OH, but did significantly worsen the intensity of symptoms associated with AD (P = 0.03).
Midodrine (10 mg) administered in the home environment effectively increases BP and reduces the incidence of hypotension; however these beneficial effects come at the expense of worsened BP instability and AD symptom intensity.