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Reactive Oxygen Species Scavenger in Acute Intracerebral Hemorrhage Patients: A Multicenter, Randomized Controlled Trial
Kim M, Byun J, Chung Y, Lee SU, Park JE, Park W, Park JC, Ahn JS, Lee S
Stroke. 2021;:Strokeaha120032266
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Abstract
BACKGROUND AND PURPOSE Patients with intracerebral hemorrhage (ICH) have oxidative stress. Oxidative stress contributes to the development and progression of perihematomal edema (PHE) in brain hemorrhage patients. We hypothesized that reactive oxygen species (ROS) scavengers might have a neuroprotective role in the acute period of patients with ICH. METHODS This prospective, multicenter, single-blind, randomized study was conducted between June 2017 and October 2019. Intracranial bleeding, including spontaneous ICH, secondary ICH due to vascular anomalies, venous thrombosis, neoplasms, or hemorrhagic infarction, were included in our study. These ROS scavengers were given for 14 days with a dose of N-acetylcysteine 2000 mg/d and selenium 1600 µg/d intravenously. Other patients received a placebo. The primary outcome was hemorrhage and PHE volume changes in 2-week follow-up computed tomography between ROS scavenger versus placebo groups. RESULTS In total, 448 patients were enrolled with 123 patients remaining after applying the inclusion and exclusion criteria. There were no significant differences in baseline characteristics between the ROS scavenger (n=57) and placebo (n=66) groups. No significant differences in baseline hematoma and PHE volumes were observed but 2 weeks follow-up computed tomography showed significant differences in PHE volume (21.90±17.63 versus 30.66±32.35, P<0.01) and PHE ratio (1.19±0.73 versus 2.05±1.27, P<0.01). Among clinical factors, time to reach target Richmond Agitation Sedation Scale (5.98 hours [95% CI, 4.82-7.241 versus 8.42 hours], [95% CI, 6.57-10.77], P<0.01) and the length of intensive care unit stays (6.46 days [95% CI, 2.38-10.55 versus 12.66 days], [95% CI, 8.47-16.85], P<0.01) were significantly shortened among patients who received ROS scavengers than among patients who did not receive ROS scavenger. CONCLUSIONS ROS scavenger showed a significantly reduced PHE volume, time to reach target Richmond Agitation Sedation Scale, and shortened length of intensive care unit stay in patients with acute ICH. Early and high doses of ROS scavengers in a combination regimen may have played a key role in obtaining a favorable outcome in our study.
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Effect of scheduled second-look endoscopy on peptic ulcer bleeding: a prospective randomized multicenter trial
Park SJ, Park H, Lee YC, Choi CH, Jeon TJ, Park JC, Kim JH, Youn YH, Kim YJ, Kim JH, et al
Gastrointestinal Endoscopy. 2017;87((2):):457-465
Abstract
BACKGROUND AND AIM This study aimed to investigate the effectiveness of scheduled second-look EGD with endoscopic hemostasis on peptic ulcer rebleeding and sought to identify the risk factors related to the need for second-look EGD. METHODS We prospectively randomized patients who had endoscopically confirmed bleeding peptic ulcer with stigmata of active bleeding, visible vessel, or adherent clot into 2 groups between August 2010 and January 2013. Hemoclip application or thermal coagulation, and/or epinephrine injection were allowed for initial endoscopic therapy. Same dosage of proton pump inhibitor was injected intravenously. The study group received scheduled second-look EGD 24 to 36 hours after the initial hemostasis, and further therapy was applied if endoscopic stigmata persisted, as above. Those patients who developed rebleeding underwent operation or radiologic intervention despite the additional endoscopic therapy. Outcome measures included rebleeding, amount of transfusion, duration of hospitalization, and mortality. RESULTS After initial endoscopic hemostasis, 319 eligible patients were randomized into two groups. Sixteen (10.1%) and nine (5.6%) patients developed rebleeding (p=0.132), respectively. There was also no difference in surgical intervention (0, 0% vs. 1, 0.6%, p>0.999) or radiologic intervention (3, 1.9% vs 2, 1.2%, p=0.683), median duration of hospitalization (6.0 vs 5.0 days, p=0.151), amount of transfusion (2.4+/-1.7 vs 2.2+/-1.6 units, p=0.276), and mortality (2, 1.3% vs 2, 1.2%, p>0.999) between the 2 groups. Multivariate analysis showed that grade 3-4 of endoscopists' estimation to successfulness of initial hemostasis, history of NSAID use, and larger amounts of blood transfusions (≥ four units of RBC) were the independent risk factors of rebleeding. CONCLUSIONS A single EGD with endoscopic hemostasis is not inferior to scheduled second-look endoscopy in terms of reduction in rebleeding rate of peptic ulcer bleeding. Repeat endoscopy would be helpful in the patients with unsatisfactory initial endoscopic hemostasis, use of NSAIDs, and larger amounts of transfused blood.