抗壞血酸、皮質類固醇和硫胺素並不能改善感染性休克的器官損傷
作者：
小柯機器人發布時間：2020/8/20 19:25:12
美國貝絲以色列女執事醫療中心Michael W. Donnino團隊研究了抗壞血酸、皮質類固醇和硫胺素對感染性休克器官損傷的影響。2020年8月18日，該研究發表在《美國醫學會雜誌》上。
抗壞血酸、皮質類固醇和硫胺素的組合已確定為感染性休克的潛在療法。
為了確定抗壞血酸、皮質類固醇和硫胺素的組合是否能減輕感染性休克患者的器官損傷，研究組進行了一項安慰劑對照、隨機、雙盲、多中心臨床試驗。2018年2月9日至2019年10月27日，在美國14個中心共招募了205位感染性休克患者。
將其隨機分組，其中103例接受靜脈外抗壞血酸、氫化可的松和硫胺素治療，每6小時一次，共4天；102例在同一時間點接受安慰劑治療。主要結局為入組至72小時的序貫器官衰竭估計（SOFA）評分變化（0-24； 0為最佳），次要結局包括腎衰竭和30天死亡率。
205名患者的平均年齡為68歲，44%為女性，其中200名（98%）至少接受1劑研究藥物，完成試驗並被納入分析（幹預組101例，安慰劑組99例）。入組後72小時內，幹預組的平均SOFA評分從9.1分降至4.4分，安慰劑組則從9.1分降至5.1分，幹預前後組間差異均無統計學意義。
幹預組中腎功能衰竭的發生率為31.7%，安慰劑組為27.3%，組間無顯著差異；幹預組的30天死亡率為34.7%，安慰劑組為29.3%，亦無顯著差異。幹預組中最常見的嚴重不良事件包括12例高血糖症、11例高鈉血症和13例新發醫院感染；安慰劑組中則分別有7例、7例和12例。
總之，抗壞血酸、皮質類固醇和硫胺素的組合治療感染性休克患者，與安慰劑相比，入組後72小時內並不能顯著改善SOFA評分。
附：英文原文
Title: Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial
Author: Ari Moskowitz, David T. Huang, Peter C. Hou, Jonathan Gong, Pratik B. Doshi, Anne V. Grossestreuer, Lars W. Andersen, Long Ngo, Robert L. Sherwin, Katherine M. Berg, Maureen Chase, Michael N. Cocchi, Jessica B. McCannon, Mark Hershey, Ayelet Hilewitz, Maksim Korotun, Lance B Becker, Ronny M Otero, Junior Uduman, Ayan Sen, Michael W. Donnino
Issue&Volume: 2020/08/18
Abstract:
Importance The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock.
Objective To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock.
Design, Setting, and Participants Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019.
Interventions Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n=103) or placebo in matching volumes at the same time points (n=102).
Main Outcomes and Measures The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0=best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses.
Results Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [4.7] points with intervention vs 9.2 to 5.1 [4.1] points with placebo; adjusted mean difference, 0.8; 95% CI, 1.7 to 0.2; P=.12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, 0.1 to 0.2; P=.58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P=.26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively).
Conclusions and Relevance In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock.
DOI: 10.1001/jama.2020.11946
Source: https://jamanetwork.com/journals/jama/article-abstract/2769467