首页|Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis:A Multi-center,Double-Blinded and Randomized Controlled Trial

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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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 P＜0.01).Overall,the death rates in the two groups were not significantly different;5.1% (8/156)in the BFJD Granules 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-12002850)

alternative medicineChinese herbal formulaBufei Jiedu Granulesmultidrug-resistant tuberculosislong-course chemotherapy regimenrandomized controlled trial

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

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Institute of Respiratory Diseases,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai(200032),China

Clinical Research Center,Shanghai University of Traditional Chinese Medicine,Shanghai(200032),China

Department of Tuberculosis,Shanghai Pulmonary Hospital,Tongji University,Shanghai(200433),China

Department of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing(101100),China

Department of Tuberculosis,the Second Hospital of Nanjing,Nanjing(210003),China

Department of Tuberculosis,the First Hospital Affiliated to Xinxiang Medical College,Henan Province(453100),China

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National Major Science and Technology Projects of Infectious DiseasesNational Major Science and Technology Projects of Infectious DiseasesTraditional Chinese Medicine Innovation Team of Shanghai Municipal Health CommissionThree-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai(2023-2025)

2008ZX100050112012ZX10005-0082022CX010GWVI-11.1-08

2024

10.1007/s11655-024-3812-7

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(7)