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作者

Yue-E Wu Jing Cao Li Wang Ying-Ji Wei Hui-Xin Liu Lei Qi Wen Zhang Feng Liu Zhong-Jiao Zhu Xu-Tao Fan Sheng Wang Cong Chen Xiang-Ze Liu Ying Li Zhong-Zheng Sun Jing-Bo Pan Chao-Qun Yang John Van Den Anker Qiang Zhang Wei Zhao

作者单位

²Department of Orthopaedic Surgery, Shandong Public Health Clinical Center, Shandong University, Jinan, China ⁴Department of Orthopaedic Surgery, Qilu Hospital of Shandong University, Jinan, China ⁷Department of Spinal Surgery, Tengzhou Central People’s Hospital, Tengzhou, China ⁵Department of Spine Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China ³Department of Orthopedics, Linyi Mental Health Center, Linyi, China ¹⁵5Department of Spine Surgery, Jinan Third People’s Hospital, Jinan, China ⁶Department of Orthopedic Surgery, Taian City Central Hospital, Taian, China ⁹Department of Spinal Surgery, Affiliated Hospital of Shandong Second Medical University, Weifang, China ¹Department of Clinical Pharmacy, Institute of Clinical Pharmacology, Key Laboratory of Chemical Biology (Ministry of Education), NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, School of Pharmaceutical Sciences, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China ¹⁰0Department of Orthopedics, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China People’s Hospital, Weifang, China ¹¹1Department of Orthopedics, Weifang NO ¹⁴4Department of Orthopedics, Yantaishan Hospital Affiliated to Binzhou Medical University, Yantai, China ¹³3Department of Spinal Surgery, PKUCare Luzhong Hospital, Zibo, China ¹²2Department of Tuberculosis, Zibo Infectious Diseases Hospital, Zibo, China ⁸Department of Spine Surgery, Affiliated Hospital of Jining Medical University, Jining, China

刊名

Frontiers in Pharmacology

年份

2025

卷号

Vol.16

关键词

mild spinal tuberculosis short-course regimen rifapentine moxifloxacin non-inferiority

摘要

BackgroundSpinal tuberculosis is the most common form of osteoarticular infection, with recommended anti-tuberculosis treatment durations typically being long , even for mild cases, increasing the risks of drug resistance, toxicity, and poor patient adherence. This study aims to explore, in patients with mild spinal tuberculosis, whether a new combination of anti-tuberculosis drugs could shorten the treatment duration.Methods and AnalysisThis trial is an open-label, randomized, controlled, non-...更多

BackgroundSpinal tuberculosis is the most common form of osteoarticular infection, with recommended anti-tuberculosis treatment durations typically being long , even for mild cases, increasing the risks of drug resistance, toxicity, and poor patient adherence. This study aims to explore, in patients with mild spinal tuberculosis, whether a new combination of anti-tuberculosis drugs could shorten the treatment duration.Methods and AnalysisThis trial is an open-label, randomized, controlled, non-inferiority trial comparing the efficacy and safety of a short-course regimen [6-month anti-TB regimen] containing rifapentine and moxifloxacin with empirical long-course regimen [12-month anti-TB regimen] in the treatment of patients with mild spinal tuberculosis. Patients diagnosed with mild spinal tuberculosis who meet the inclusion and exclusion criteria will be recruited and randomized in a 1:1 ratio to either of the two arms. Empirical long-course regimen includes rifampin, isoniazid, pyrazinamide and ethambutol , while short-course regimen includes rifapentine, moxifloxacin, isoniazid and pyrazinamide . The primary outcomes are TB-recurrence rate at 24 months after completion of treatment and proportion of participants with grade 3 or higher adverse events during treatment with study medications.DiscussionThis trial will provide evidence whether a short-course regimen of anti-TB drugs is non-inferior to the empirical long-course regimen in patients with mild spinal tuberculosis. If non-inferiority is established, it will contribute to a more optimized treatment for spinal tuberculosis.Clinical Trial RegistrationThis study is registered with https://clinicaltrials.gov/ct2/show/NCT06917495 as NCT06917495.收起

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