补肺颗粒(Bufei Granules) - _专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

呼吸系统疾病

在研适应症-

非在研适应症

慢性阻塞性肺疾病

原研机构-

在研机构-

非在研机构

津药达仁堂集团股份有限公司中药研究院Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

2

项与补肺颗粒相关的临床试验

ChiCTR2400088298 / Suspended早期临床1期IIT

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

开始日期2024-10-01

申办/合作机构

南方医院

CTR20160782 / Completed临床2期

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

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。

开始日期2017-04-10

申办/合作机构

Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

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100 项与补肺颗粒相关的临床结果

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100 项与补肺颗粒相关的转化医学

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100 项与补肺颗粒相关的专利（医药）

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11

项与补肺颗粒相关的文献（医药）

2024-07-01·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

作者: 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).

2023-02-01·Molecular Diversity3区 · 化学

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

3区 · 化学

Article

作者: 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.

2020-01-01·Evidence-Based Complementary and Alternative Medicine4区 · 医学

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

4区 · 医学

ReviewOA

作者: 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 项与补肺颗粒相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	临床2期	中国	津药达仁堂集团股份有限公司中药研究院	2017-04-10
慢性阻塞性肺疾病	临床2期	中国	Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.	2017-04-10