Jankovic J, Gilden J L, Hiner B C, Kaufmann H, Brown D C, Coghlan C H, Rubin M, Fouad-Tarazi F M
Department of Neurology, Baylor College of Medicine, Houston, Texas 77030.
Am J Med. 1993 Jul;95(1):38-48. doi: 10.1016/0002-9343(93)90230-m.
To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure.
Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years).
After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level).
Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p < 0.001 versus placebo). Midodrine improved (p < 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%).
We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.
研究米多君治疗自主神经功能衰竭所致体位性低血压患者的疗效和安全性。
97例体位性低血压患者被随机分配至一项为期4周的双盲、安慰剂对照研究，有1周的安慰剂导入期。患者年龄在22至86岁之间（平均61岁）。
在1周的导入期后，安慰剂或剂量为2.5毫克、5毫克或10毫克的米多君每日给药3次，持续4周。安慰剂组和2.5毫克米多君组在整个双盲期接受固定剂量。接受5毫克或10毫克米多君的患者给予的剂量每周增加2.5毫克，直至达到指定剂量。疗效评估基于给药后1小时站立收缩压的改善以及体位性低血压症状（晕厥、头晕/头重脚轻、虚弱/疲劳和精力不足）的改善。
米多君（10毫克）使站立收缩压升高22毫米汞柱（28%，与安慰剂相比，p<0.001）。与安慰剂相比，米多君改善了（p<0.05）以下体位性低血压症状：头晕/头重脚轻、虚弱/疲劳、晕厥、精力不足、站立能力受损和抑郁情绪。总体副作用主要为轻度至中度。安慰剂组22%的患者报告了一种或多种副作用，而米多君治疗组为27%。米多君治疗的患者中有74例中的10例（13.5%）报告了头皮瘙痒/刺痛，最为常见。其他报告的副作用包括仰卧位高血压（8%）和尿急感（4%）。
我们得出结论，米多君是治疗与自主神经功能衰竭相关的中重度体位性低血压的有效且耐受性良好的治疗方法。
