补肺解毒颗粒治疗耐多药肺结核疗效和安全性的多中心、随机双盲对照试验

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

doi:10.1007/s11655-024-3812-7

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补肺解毒颗粒治疗耐多药肺结核疗效和安全性的多中心、随机双盲对照试验

Original Article | Updated：2024-06-28

- 补肺解毒颗粒治疗耐多药肺结核疗效和安全性的多中心、随机双盲对照试验
- Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2024年30卷第7期页码：579-587
- Affiliations：
  
  1.Institute of Respiratory Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China
  2.Clinical Research Center, Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China
  3.Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai (200433), China
  4.Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing (101100), China
  5.Department of Tuberculosis, the Second Hospital of Nanjing, Nanjing (210003), China
  6.Department of Tuberculosis, the First Hospital Affiliated to Xinxiang Medical College, Henan Province (453100), China
- Author bio：
  
  Prof. LU Zhen-hui, E-mail: Dr_luzh@shutcm.edu.cn
- Funds：
  
  National Major Science and Technology Projects of Infectious Diseases(2008ZX10005011;2012ZX10005-008);Traditional Chinese Medicine Innovation Team of Shanghai Municipal Health Commission(2022CX010);Three-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai (2023—2025)(GWVI-11.1-08)
- DOI：10.1007/s11655-024-3812-7
  中图分类号：
- 纸质出版日期：2024-07，
  
  网络出版日期：2024-05-11，
  
  录用日期：2023-09-06
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补肺解毒颗粒治疗耐多药肺结核疗效和安全性的多中心、随机双盲对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(7):579-587.

ZHANG Shao-yan, QIU Lei, ZHANG Shun-xian, et al. Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(7):579-587.
补肺解毒颗粒治疗耐多药肺结核疗效和安全性的多中心、随机双盲对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(7):579-587. DOI： 10.1007/s11655-024-3812-7.

ZHANG Shao-yan, QIU Lei, ZHANG Shun-xian, et al. Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(7):579-587. DOI： 10.1007/s11655-024-3812-7.

摘要

目的:

评价补肺解毒颗粒加载长程化疗方案治疗耐多药肺结核 (MDR-PTB) 的疗效和安全性.

方法:

2012年12月至2016年12月

在中国18家结核病定点医院进行了一项大样本、多中心、随机双盲、安慰剂对照试验. 312例确诊的MDR-PTB患者随机分为治疗组或安慰剂组 (1:1)

两组均接受18个月的长程化疗方案 (6 Am-Lfx-P-Z-Pto

12 Lfx-P-Z-P to) 和中药补肺解毒颗粒或安慰剂治疗. 主要治疗结局为治愈率; 次要治疗结局包括痰菌阴转时间、肺部空洞变化及患者生活质量

在治疗期间监测患者不良反应发生情况.

结果:

216例患者完成了试验方案

其中治疗组111例

安慰剂组105例. 与安慰剂治疗组比较

补肺解毒颗粒加载长程化疗方案可以显著提升MDR-PTB治愈率13.6% (58.4% /44.8%

= 0.02)

并加速痰菌阴转的中位时间 (5个月 / 11个月) . 在完成治疗的患者中

补肺解毒颗粒组的空洞闭合率 (50.6%

43/85) 显著高于安慰剂组 (32.1%

26/81;

= 0.02) . 在强化期治疗结束时

SF-36量表评分与安慰剂组比较

补肺解毒颗粒组显著改善了患者的生理功能、总体健康和活力 (均

0.01) . 治疗结束时

两组患者的死亡率差异无统计学意义 (

0.05) ; 补肺解毒颗粒组为5.1% (8/156)

安慰剂组为2.6% (4/156) .

结论:

补肺解毒颗粒加载长程化疗方案显著提升了MDR-PTB患者的治愈率和空洞闭合率

同时改善了患者的生活质量 (注册号: ChiCTR-TRC-12002850) .

Abstract

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%

. 44.8%

=0.02)

and accelerated the median time to sputum-culture conversion (5 months

. 11 months). The cavity closure rate of the BFJD Granules group (50.6%

43/85) was higher than tha

t of the placebo group (32.1%

26/81;

=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

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)

关键词

Keywords

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

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