دورية أكاديمية
Efficacy and safety of an innovative short-course regimen containing clofazimine for treatment of drug-susceptible tuberculosis: a clinical trial.
العنوان: | Efficacy and safety of an innovative short-course regimen containing clofazimine for treatment of drug-susceptible tuberculosis: a clinical trial. |
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المؤلفون: | Zheng X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Gui X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Yao L; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ma J; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., He Y; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Lou H; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Gu J; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ying R; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Chen L; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Sun Q; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Liu Y; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ho CM; Department of Mechanical and Aerospace Engineering, University of California, Los Angeles, CA, USA.; Department of Bioengineering, University of California, Los Angeles, CA, USA., Lee BY; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Clemens DL; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Horwitz MA; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Ding X; Institute for Personalized Medicine, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, People's Republic of China., Hao X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Yang H; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Sha W; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China. |
المصدر: | Emerging microbes & infections [Emerg Microbes Infect] 2023 Dec; Vol. 12 (1), pp. 2187247. |
نوع المنشور: | Randomized Controlled Trial; Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101594885 Publication Model: Print Cited Medium: Internet ISSN: 2222-1751 (Electronic) Linking ISSN: 22221751 NLM ISO Abbreviation: Emerg Microbes Infect Subsets: MEDLINE |
أسماء مطبوعة: | Publication: 2019- : [Philadelphia, PA] : Taylor & Francis Original Publication: New York : NPG, 2012-2018. |
مواضيع طبية MeSH: | Clofazimine*/adverse effects , Tuberculosis*/drug therapy, Humans ; Prothionamide ; Drug Therapy, Combination ; Antitubercular Agents/adverse effects ; Pyrazinamide/adverse effects ; Treatment Outcome ; Isoniazid |
مستخلص: | In preclinical studies, a new antituberculosis drug regimen markedly reduced the time required to achieve relapse-free cure. This study aimed to preliminarily evaluate the efficacy and safety of this four-month regimen, consisting of clofazimine, prothionamide, pyrazinamide and ethambutol, with a standard six-month regimen in patients with drug-susceptible tuberculosis. An open-label pilot randomized clinical trial was conducted among the patients with newly diagnosed bacteriologically-confirmed pulmonary tuberculosis. The primary efficacy end-point was sputum culture negative conversion. Totally, 93 patients were included in the modified intention-to-treat population. The rates of sputum culture conversion were 65.2% (30/46) and 87.2% (41/47) for short-course and standard regimen group, respectively. There was no difference on two-month culture conversion rates, time to culture conversion, nor early bactericidal activity ( P > 0.05). However, patients on short-course regimen were observed with lower rates of radiological improvement or recovery and sustained treatment success, which was mainly attributed to higher percent of patients permanently changed assigned regimen (32.1% vs. 12.3%, P = 0.012). The main cause for it was drug-induced hepatitis (16/17). Although lowering the dose of prothionamide was approved, the alternative option of changing assigned regimen was chosen in this study. While in per-protocol population, sputum culture conversion rates were 87.0% (20/23) and 94.4% (34/36) for the respective groups. Overall, the short-course regimen appeared to have inferior efficacy and higher incidence of hepatitis but desired efficacy in per-protocol population. It provides the first proof-of-concept in humans of the capacity of the short-course approach to identify drug regimens that can shorten the treatment time for tuberculosis. |
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فهرسة مساهمة: | Keywords: Short-course treatment; clofazimine; parabolic response surface; pulmonary tuberculosis; randomized clinical trial |
المشرفين على المادة: | D959AE5USF (Clofazimine) 76YOO33643 (Prothionamide) 0 (Antitubercular Agents) 2KNI5N06TI (Pyrazinamide) V83O1VOZ8L (Isoniazid) |
تواريخ الأحداث: | Date Created: 20230306 Date Completed: 20230321 Latest Revision: 20230322 |
رمز التحديث: | 20230322 |
مُعرف محوري في PubMed: | PMC10026740 |
DOI: | 10.1080/22221751.2023.2187247 |
PMID: | 36872899 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2222-1751 |
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DOI: | 10.1080/22221751.2023.2187247 |