Clinical study and mechanism discussion on the efficacy and safety of Bufei Formula granule in patients with chronic obstructive pulmonary disease with lung-kidney qi deficiency at stable stage

Start Date01 Oct 2024

Sponsor / Collaborator

Nanfang Hospital

CTR20160782 / CompletedPhase 2

补肺颗粒用于慢性阻塞性肺疾病稳定期有效性和安全性随机、双盲、安慰剂、计量-效应对照Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, dose-response controlled phase II clinical trial on the efficacy and safety of Bufei granules in the stable phase of chronic obstructive pulmonary disease

1.初步评价补肺颗粒用于慢性阻塞性肺疾病（ COPD）稳定期（肺脾肾虚、痰瘀互结证）的有效性； 2.观察补肺颗粒的安全性； 3.探索补肺颗粒用于 COPD 稳定期的最佳用药剂量。

[Translation]

1. To preliminarily evaluate the effectiveness of Bufei Granules in the treatment of chronic obstructive pulmonary disease (COPD) in the stable stage (lung, spleen and kidney deficiency, phlegm and blood stasis syndrome); 2. To observe the safety of Bufei Granules; 3. To explore the optimal dosage of Bufei Granules in the stable stage of COPD.

Start Date10 Apr 2017

Sponsor / Collaborator

Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

[+1]

100 Clinical Results associated with Bufei Granules

100 Translational Medicine associated with Bufei Granules

100 Patents (Medical) associated with Bufei Granules

Literatures (Medical) associated with Bufei Granules

01 Jul 2024·Chinese Journal of Integrative Medicine

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

Article

Author: Xiao, He-Ping ; Zhang, Shun-Xian ; Zhang, Hui-Yong ; Lu, Zhen-Hui ; Zhang, Hui-Qiang ; Zheng, Pei-Yong ; Chu, Nai-Hui ; Zhang, Xia ; Zhang, Shao-Yan ; Qiu, Lei

OBJECTIVETo assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB).METHODSA 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.RESULTSA total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an 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.CONCLUSIONSSupplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850).

01 Feb 2023·Molecular DiversityQ3 · CHEMISTRY

An in silico and in vitro integrated analysis method to reveal the curative mechanisms and pharmacodynamic substances of Bufei granule on chronic obstructive pulmonary disease

Q3 · CHEMISTRY

Article

Author: Liu, Wei ; Jiao, Xin-Yi ; Shang, Zhi-Xian ; Liang, Liu-Yi ; Li, Rong ; Li, Zheng ; Liu, Rui ; Ma, Yuan-Yuan

Chronic obstructive pulmonary disease (COPD) is a common respiratory disease with high disability and mortality. Clinical studies have shown that the Traditional Chinese Medicine Bufei Granule (BFG) has conspicuous effects on relieving cough and improving lung function in patients with COPD and has a reliable effect on the treatment of COPD, whereas the therapeutic mechanism is vague. In the present study, the latent bronchodilators and mechanism of BFG in the treatment of COPD were discussed through the method of network pharmacology. Then, the molecular docking and molecular dynamics simulation were performed to calculate the binding efficacy of corresponding compounds in BFG to muscarinic receptor. Finally, the effects of BFG on bronchial smooth muscle were validated by in vitro experiments. The network pharmacology results manifested the anti-COPD effect of BFG was mainly realized via restraining airway smooth muscle contraction, activating cAMP pathways and relieving oxidative stress. The results of molecular docking and molecular dynamics simulation showed alpinetin could bind to cholinergic receptor muscarinic 3. The in vitro experiment verified both BFG and alpinetin could inhibit the levels of CHRM3 and acetylcholine and could be potential bronchodilators for treating COPD. This study provides an integrating network pharmacology method for understanding the therapeutic mechanisms of traditional Chinese medicine, as well as a new strategy for developing natural medicines for treating COPD.

01 Jan 2020·Evidence-Based Complementary and Alternative MedicineQ4 · MEDICINE

Effect of Traditional Chinese Medicine Bufei Granule on Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta‐Analysis Based on Existing Evidence

Q4 · MEDICINE

ReviewOA

Author: Li, Xinju ; Li, Qing ; Fan, Yihua ; Wen, Xinyan ; Wang, Fangyuan ; Zhang, Qiang ; Guo, Yi

This systematic review and meta‐analysis aimed at evaluating the effect of traditional Chinese medicine (TCM) Bufei granule on stable chronic obstructive pulmonary disease (COPD). We retrieved data from PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials, CNKI, Wanfang, and WeiPu (VIP) for studies focusing on whether the TCM Bufei granule would be effective in treating stable COPD. No language restriction and blinding were used. All trials involved were examined based on the standards of the Cochrane Handbook, and Review Manager 5.3 software was applied for analyzing data. We included four studies involving 599 patients with stable COPD. When compared to placebo treatment, TCM Bufei granule intervention exhibited improvement in the forced expiratory volume in one second (FEV1) (standardized mean difference (SMD) = 0.70; range, 0.50–0.91; I2 = 0%), forced vital capacity (FVC) (SMD = 0.43; range, 0.23–0.62; I2 = 0%), FEV1 percentage of predicted value (FEV1%) (SMD = 0.57; range, 0.38–0.76; I2 = 4%), and FEV1/FVC (SMD = 0.69; range, 0.50–0.87; I2 = 0%). There was a statistically significant difference in St George’s Respiratory Questionnaire scores between the TCM Bufei granule and placebo treatments (SMD = −1.29; range, −2.32 to −0.26, I2 = 97%). None of the studies reported any adverse events. Therefore, TCM Bufei granule intervention could help in improving the lung function and quality of life in patients with stable COPD.

100 Deals associated with Bufei Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Research Institute Branch of Tianjin Zhongxin Pharmaceutical Group Co., Ltd.	10 Apr 2017
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.	10 Apr 2017

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