El-Nagdy Nadine K, Mansour Noha O, Diab Adel Al-Hady Ahmed, Soliman Moetaza M
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Department of Pharmacy Practice, Faculty of Pharmacy, Delta University for Science and Technology, Gamasa, Egypt.
Pharmacotherapy. 2025 May;45(5):264-272. doi: 10.1002/phar.70018. Epub 2025 Apr 16.
Midodrine has been primarily studied as an adjunctive oral therapy to reduce the need for vasopressors in intensive care units (ICU). Nonetheless, the available results evaluating midodrine as an adjuvant therapy in the treatment of septic shock are limited and inconclusive. This study aims to evaluate the efficacy of midodrine, specifically focusing on its effect on mortality outcomes in patients with septic shock.
This was an open-label randomized controlled trial. Patients with septic shock (n = 100) were randomized to either the control group, who received intravenous norepinephrine, or the midodrine group, who received intravenous norepinephrine and midodrine 10 mg every 8 h. The primary outcome was the 28-day in-hospital mortality. Secondary outcomes were 7-day ICU mortality, average dose of norepinephrine, duration of intravenous norepinephrine, ICU length of stay (LOS), and in-hospital LOS.
The 28-day mortality rate was 68% in the control group compared to 54% in the midodrine group (risk difference -14% (95% confidence interval (CI)) -32.9% to 4.9%). Similarly, the 7-day ICU mortality rate was 56% in the control group and 42% in the midodrine group (risk difference -14% (95% CI -33.4% to 5.4%)). The average intravenous norepinephrine dose in the midodrine group was significantly lower compared to the control group (mean difference 0.06 (95% CI 0.01-0.11), p = 0.002). However, midodrine did not have a significant impact on the duration of intravenous norepinephrine use (mean difference 0.66 (95% CI -0.56 to 1.88)). Midodrine did not significantly shorten the course of hospitalization. There was no significant difference in median ICU LOS between the control group and the midodrine group (4 vs. 5 days, respectively).
The findings did not demonstrate a significant reduction in mortality with adjuvant midodrine use in the treatment of septic shock. Midodrine appears to reduce the need for vasopressors. However, our findings did not support that midodrine shortens the duration of vasopressor use nor the course of hospitalization for patients with septic shock.
米多君主要作为一种辅助口服疗法进行研究，以减少重症监护病房（ICU）中血管升压药的使用需求。尽管如此，评估米多君作为脓毒性休克辅助治疗的现有结果有限且尚无定论。本研究旨在评估米多君的疗效，特别关注其对脓毒性休克患者死亡率的影响。
这是一项开放标签的随机对照试验。脓毒性休克患者（n = 100）被随机分为对照组（接受静脉注射去甲肾上腺素）或米多君组（接受静脉注射去甲肾上腺素和每8小时10毫克米多君）。主要结局是28天住院死亡率。次要结局包括7天ICU死亡率、去甲肾上腺素平均剂量、静脉注射去甲肾上腺素持续时间、ICU住院时间（LOS）和住院LOS。
对照组的28天死亡率为68%，而米多君组为54%（风险差异-14%（95%置信区间（CI））-32.9%至4.9%）。同样，对照组的7天ICU死亡率为56%，米多君组为42%（风险差异-14%（95%CI -33.4%至5.4%））。米多君组的静脉注射去甲肾上腺素平均剂量显著低于对照组（平均差异0.06（95%CI 0.01 - 0.11），p = 0.002）。然而，米多君对静脉注射去甲肾上腺素的使用持续时间没有显著影响（平均差异0.66（95%CI -0.56至1.88））。米多君并未显著缩短住院疗程。对照组和米多君组的中位ICU LOS无显著差异（分别为4天和5天）。
研究结果未显示在脓毒性休克治疗中使用辅助性米多君可显著降低死亡率。米多君似乎可减少血管升压药的使用需求。然而，我们的研究结果不支持米多君可缩短脓毒性休克患者血管升压药使用持续时间或住院疗程。
