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Randomized Controlled Trial Multicenter Study
Personalised Variable vs Fixed Dose Systemic Corticosteroid Therapy in Hospitalized Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Prospective, Multicentered, Randomised, Open-Label Clinical Trial.
- Li Li, Nana Zhao, Xiangyu Ma, Fenfen Sun, Binfeng He, Zhen Qin, Kui Wu, Xingsheng Wang, Qian Zhao, Shisi Zhang, Naifu Nie, Dong Luo, Bin Sun, Ye Shen, Yong He, Fuqiang Wen, Jinping Zheng, Paul Jones, and Guoqiang Cao.
- Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.
- Chest. 2021 Nov 1; 160 (5): 1660-1669.
BackgroundSystemic corticosteroids for the treatment of COPD exacerbations decrease treatment failure and shorten the length of hospitalization. However, the optimal dose is unclear.Research QuestionIs personalized-dose corticosteroid administered according to a dosing scale more effective than fixed-dose corticosteroid administration in hospitalized patients with COPD with exacerbations?Study Design And MethodsThis was a prospective, randomized, open-label trial. In-hospital patients with COPD with exacerbations were randomly assigned at a 1:1 ratio to either the fixed-dose group (receiving the equivalent of 40 mg of prednisolone) or the personalized-dose group for 5 days. The primary end point was a composite measure of treatment failure that included in-hospital treatment failure and medium-term (postdischarge) failure. Secondary end points were length of stay and cost.ResultsA total of 248 patients were randomly assigned to the fixed-dose group (n = 124) or personalized-dose group (n = 124). One patient in each group was not included in the intention-to-treat population because of incorrect initial COPD diagnosis. Failure of therapy occurred in 27.6% in the personalized-dose group, compared with 48.8% in the fixed-dose group (relative risk, 0.40; 95% CI, 0.24-0.68; P = .001). The in-hospital failure of therapy was significantly lower in the personalized-dose group (10.6% vs 24.4%; P = .005), whereas the medium-term failure rate, adverse event rate, hospital length of stay, and costs were similar between the two groups. After treatment failure, a lower additional dose of corticosteroids and a shorter duration of treatment were needed in the personalized-dose group to achieve control of the exacerbation. In the personalized-dose cohort, those receiving 40 mg or less had an average failure rate of 44.4%, compared with 22.9% among those receiving more than 40 mg (P = .027).InterpretationPersonalized dosing of corticosteroids reduces the risk of failure because more patients were provided with a higher initial dose, especially > 60 mg, whereas 40 mg or less was too low in either group.Clinical Trial RegistrationClinicalTrials.gov; No.: NCT02147015; URL: www.clinicaltrials.gov.Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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