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Efficacy and Safety of bufei jiedu granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial

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Chinese Journal of Integrative Medicine 2024年第7期30卷 579-587页

作者： ZHANG Shao-yan QIU Lei ZHANG Shun-xian XIAO He-ping CHU Nai-hui ZHANG Xia ZHANG Hui-qiang ZHENG Pei-yong ZHANG Hui-yong LU Zhen-hui Institute of Respiratory Diseases Longhua Hospital Shanghai University of Traditional Chinese Medicine Clinical Research Center Shanghai University of Traditional Chinese Medicine Department of Tuberculosis Shanghai Pulmonary HospitalTongji University Department of Tuberculosis Beijing Chest Hospital Capital Medical University Department of Tuberculosis the Second Hospital of Nanjing Department of Tuberculosis the First Hospital Affiliated to Xinxiang Medical College

Objective: To assess the efficacy and safety of bufei jiedu(BFJD) granules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis(MDR-PTB). Methods: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD granules or placebo groups(1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months(6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life(QoL) of patients. Adverse reactions were monitored during and after the trial. Results: A total of 216 cases completed the trial, 111 in the BFJD granules group and 105 in the placebo group. BFJD granules, as adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo(58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion(5 months vs. 11 months). The cavity closure rate of the BFJD granules group(50.6%, 43/85) was higher than that of the placebo group(32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group(all Pgranules group and 2.6%(4/156) in the placebo group. Conclusions: Supplementing BFJD granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rate, and rapidly improved QoL of patients with MDR-PTB(Registration No. ChiCTR-TRC-

关键词： alternative medicine Chinese herbal formula bufei jiedu granules multidrug-resistant tuberculosis long-course chemotherapy regimen randomized controlled trial

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