OBJECTIVE: To predict the targets of Bufei Huoxue capsule( 补肺活血胶囊, BFHX) using network pharmacology analysis and to explore its effects and functional targets in a silicotic rat model. METHODS: The drug and dise...OBJECTIVE: To predict the targets of Bufei Huoxue capsule( 补肺活血胶囊, BFHX) using network pharmacology analysis and to explore its effects and functional targets in a silicotic rat model. METHODS: The drug and disease targets were correlated through network pharmacology analysis to explore the targets and signaling pathways of BFHX affecting silicosis. NR8383 cells were cultured to verify the core genes and pathways. A rat model of silicosis was established to verify whether the mechanism behind SiO2-caused pulmonary fibrosis was alleviated by BFHX(0.82 g/kg) and how it affected key targets and pathways. RESULTS: Overlapping BFHX and silicotic gene targets produced 159 interactive targets, and 55 were screened by network topology analysis. The results of gene ontology and Kyoto encyclopedia of genes and genomes enrichment analyses suggested that BFHX could affect silicosis through the nucleotide-like receptor containing pyrin domain 3(NLRP3) inflammasome. In NR8383 cells, the expression of core genes related to the NLRP3 inflammasome could be inhibited by BFHX treatment. BFHX reduced the degree of alveolitis and collagen deposition, attenuating pulmonary fibrosis in Si O2-induced rat model. Pulmonary macrophage pyroptosis after SiO2 exposure was observed under transmission electron microscopy. BFHX alleviated the morphological characteristics of pyroptosis. BFHX also reduced the expression of NLRP3, caspase-1, interleukin-1 beta(IL-1β), IL-18, IL-6, and tumor necrosis factor-alpha in lung tissues of silicotic rat model. BFHX affected the K ion content in bronchoalveolar lavage fluid when assessed by energy dispersive spectrometer testing. The expression of CD68+ and CD206+ were also reduced after BFHX intervention. CONCLUSION: NOD-like receptor signaling is vital for BFHX's effects on silicosis. It exerts anti-pulmonary fibrosis effects by inhibiting pulmonary macrophage pyroptosis and polarization through NLRP3 inflammasome activation.展开更多
Objective:Critical effective constituents were identified from Bufei Yishen formula(BYF),a traditional herbal compound and combined as effective-constituent compatibility(ECC)of BYF I,which may have potential bioactiv...Objective:Critical effective constituents were identified from Bufei Yishen formula(BYF),a traditional herbal compound and combined as effective-constituent compatibility(ECC)of BYF I,which may have potential bioactive equivalence to BYF.Methods:The active constituents of BYF were identified using four cellular models and categorised into Groups 1(Bufeiqi),2(Bushen),3(Huatan)and 4(Huoxue)according to Chinese medicinal theory.An orthogonal design and a combination method were used to determine the optimal ratios of effective constituents in each group and the ratios of‘‘Groups 1 to 4"according to their pharmacological activity.We also comprehensively assessed bioactive equivalence between the BYF and the ECC of BYF I in a rat model of chronic obstructive pulmonary disease(COPD).Results:We identified 12 active constituents in BYF.The numbers of constituents in Groups 1 to 4 were 3,2,5 and 2,respectively.We identified the optimal ratios of effective constituents within each group.In Group1,total ginsenosides:Astragalus polysaccharide:astragaloside IV ratio was 9:5:2.In Group 2,icariin:schisandrin B ratio was 100:12.5.In Group 3,nobiletin:hesperidin:peimine:peiminine:kaempferol ratio was4:30:6.25:0:0.In Group 4,paeoniflorin:paeonol ratio was 4:1.An orthogonal design was then used to establish the optimal ratios of Group 1,Group 2,Group 3 and Group 4 in ECC of BYF I.The ratio for total ginsenosides:Astragalus polysaccharide:astragaloside IV:icariin:schisandrin B:nobiletin:hesperidin:peimine:paeoniflorin:paeonol was determined to be 22.5:12.5:5:100:12.5:4:30:6.25:25:6.25.A comprehensive evaluation confirmed that ECC of BYF I presented with bioactive equivalence to the original BYF.Conclusion:Based on the ECC of traditional Chinese medicine formula method,the effective constituents of BYF were identified and combined in a fixed ratio as ECC of BYF I that was as effective as BYF itself in treating rats with COPD.展开更多
OBJECTIVE: To study the therapeutic effect Bufei granule, which is a traditional Chinese drug that can enhance the immune function of the lung, on patients with stable chronic obstructive pulmonary disease(COPD).METHO...OBJECTIVE: To study the therapeutic effect Bufei granule, which is a traditional Chinese drug that can enhance the immune function of the lung, on patients with stable chronic obstructive pulmonary disease(COPD).METHODS: This is a randomized, double blinded,placebo-controlled, and multicenter clinical study.Three medical centers in Tianjin, China, participated in the trial. A total of 140 patients with stable COPD were enrolled and randomized into two groups, with 70 patients in each. The treatment group was treated with Bufei granule, while the control group received Bufei placebo. The pharmacological treatment lasted for 12 weeks from the date of enrollment. Then, the indexes of patients were observed. Data were analyzed to study the effect of Bufei granule, with the frequency of acute exacerbation as the primary outcome. Traditional Chinese Medicine syndromes,Modified British Medical Research Council dyspnea scale score, St.George's respiratory questionnaire scores, pulmonary function, and serum inflammatory marker levels [including interleukin-6(IL-6), interleukin-8, tumor necrosis factor-α, and transformation growth factor-β1]were the secondary outcomes.RESULTS: During the 12-week treatment, treatment and control groups had no adverse reactions.The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05,except for the level of IL-6.CONCLUSION: Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation, improving the quality of life,and alleviating the severity of inflammation.展开更多
OBJECTIVE To explore the antioxidant effect of Bufei Yishen granules on chronic obstructive pulmo⁃nary disease(COPD)and investigate its underlying mechanism.METHODS Forty-eight rats were randomly divided into normal,m...OBJECTIVE To explore the antioxidant effect of Bufei Yishen granules on chronic obstructive pulmo⁃nary disease(COPD)and investigate its underlying mechanism.METHODS Forty-eight rats were randomly divided into normal,model,Bufei Yishen granules(BY)and N-acetylcysteine(NAC)groups,12 rats in each group.The stable COPD rat model was duplicated by using repeated cigarette smoke exposure combined with Klebsiella bacterial infection for 12 weeks(week 1-12),and the corresponding drugs were administered for the next 8 weeks(week 13-20).Minute volume(MV),tidal volume(TV)and peak expiratory flow(PEF)were measured by whole body plethysmography(WBP)system every 4 weeks.Before sacrificed,forced vital capacity(FVC)and forced expiratory volume 0.1(FEV0.1)were measured byPFT system.The pathological changes of lung tissue were observed by pathological techniques.Heme oxygenase 1(HO-1),superoxide dismutase 1(SOD1)and Nrf2 in lung tissue were measured by immunohisto-hemical method.The total anti oxidizing capability(T-AOC),lipid peroxide(LPO)in rat serum were measured.The expression of Nrf2,HO-1 andγ-glutamyl cysteine synthetase(γ-GCS)mRNA in lung tissue was detected by quantitative polymerase chain reac⁃tion(qPCR).The protein expression of Keap1,Nrf2 and HO-1 in lung tissue were detected by Western blotting.RESULTS①Lung function:compared with normal group,the MV in model group was significantly decreased at week 8(P<0.01),the TV and PEF were significantly decreased at week 4(P<0.01).At week 20,compared with model group,MV,TV,and PEF in the BY and NAC groups were significantly increased(P<0.01);compared with the NAC group,MV,TV,and PEF in BY group were significantly increased(P<0.01).At the end of week 20,the FVC and FEV0.1 in model group were significantly lower than that in normal group(P<0.01).Compared with model group,the FVC and FEV0.1 in the BY and NAC groups were significantly increased(P<0.05).②Oxidative indexes:Compared with Normal group,T-AOCin serum was significantly decreased in Model group,while LPO was significantly increased(P<0.01).Compared with the Model,T-AOC in BY and NAC groups was significantly increased(P<0.01),and the LPO was significantly decreased(P<0.05,P<0.01).There were no difference between the BTG and NAC.③Nrf2 signaling:Nrf2 and HO-1 in lung tissue were mainly expressed in the cytoplasm and part of the nucleus of alveolar epithelial cells.SOD1 protein was mainly distributed in bronchial epithelial cells and alveolar septa.Compared with normal group,the expression of Nrf2 in the model group was increased(P<0.01),and HO-1 and SOD1 were decreased(P<0.01).Compared with the model,the expression of Nrf2 in the BY group was significantly increased(P<0.05),and HO-1 and SOD1 in BY and NAC groups were both increased(P<0.01).Compared with the NAC group,the expression of HO-1 in BY group was increased(P<0.01).Compared with normal group,the Nrf2 mRNA expression of lung tissue in the model was significantly increased(P<0.01),the HO-1 andγ-GCS mRNA was decreased(P<0.01).Compared with model group,the Nrf2,HO-1,andγ-GCS mRNA in the BY group were increased(P<0.01),the HO-1,andγ-GCS mRNA in NAC group were increased(P<0.01).Compared with normal group,the Nrf2 protein expression of lung tissue in the model group was significantly increased(P<0.01),and HO-1 protein expression was significantly decreased(P<0.01).Compared with the model,the Nrf2 and HO-1 protein in NAC and BY groups was significantly increased(P<0.01).CONCLUSION Bufei Yishen gran⁃ules has beneficial curative effect in COPD rats,and has the same antioxidation effect as NAC,the mechanism may be involved in upregulating Nrf2 signaling.展开更多
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-blinde...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)展开更多
目的探究补肺益肾祛痰纳气法联合布地格福治疗阳虚痰阻型慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期患者疗效。方法选取95例COPD稳定期患者作为研究对象,按照随机数字法分为对照组(48例)和试验组(47例)。两...目的探究补肺益肾祛痰纳气法联合布地格福治疗阳虚痰阻型慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期患者疗效。方法选取95例COPD稳定期患者作为研究对象,按照随机数字法分为对照组(48例)和试验组(47例)。两组均予以基础治疗,对照组采用布地格福治疗,试验组采用补肺益肾祛痰纳气法+布地格福治疗,均治疗3个月。比较两组治疗前后中医证候积分、肺功能[第1秒用力呼气容积占预计值百分比(forced expiratory volume in the first second as a percentage of predicted value,FEVl%pred)、FEVl/用力肺活量(forced vital capacity,FVC)、最大呼气中段流量(maximum mid-expiratory flow,MMEF)、峰值流速(peak expiratory flow,PEF)]、气道重塑指标[基质金属蛋白酶(matrix metalloproteinase,MMP)-9、基质金属蛋白酶抑制因子(tissue inhibitor of metalloproteinase,TIMP)-1、MMP-9/TIMP-1]、炎性指标[白细胞介素(interleukin,IL)-8、肿瘤坏死因子(tumor necrosis factor,TNF)-α]、血管内皮功能指标[内皮素(endothelin,ET)、一氧化氮(nitric oxide,NO)]、活动能力[6 min步行测验(six-minute walking test,6MWT)、呼吸困难指数(modified medical research council,mMRC)问卷]。结果治疗3个月后,两组中医证候积分、血清IL-8、TNF-α、ET、MMP-9水平及MMP-9/TIMP-1均降低,且试验组各指标降幅均高于对照组(P<0.05);两组FEV1%pred、FEVl/FVC、MMEF、PEF、血清NO、TIMP-1水平、6MWT均升高,且试验组各指标升幅均高于对照组(P<0.05)。结论补肺益肾祛痰纳气法联合布地格福治疗阳虚痰阻型COPD稳定期,能有效改善患者内皮功能,减轻气道重构,抑制炎性反应,进而缓解临床症状,提高肺功能,促进日常活动能力复旧。展开更多
基金Jiangsu Natural Science Foundation Youth Program:Regulation of Alveolar Macrophage Pyroptosis based on (Never in Mitosis Gene A)-Related Kinase 7/Nucleotide-like Receptor Containing Pyrin Domain 3 Inflammasome to Explore the Mechanism of Bufei Huoxue Capsule on Pulmonary Fibrosis in Silicosis (No. BK20220236)Key Research and Development Project of Xuzhou City:Evaluation of Pyroptosis Induced by Nucleotide-like Receptor Containing Pyrin Domain 3 Inflammasome Activation in Pneumoconiosis Patients by Bronchoalveolar Lavage Fluid Ion Assay Combined with High-Resolution Computed Tomography Quantitative Analysis (KC22212)Youth Medical Science and Technology Innovation Project of Xuzhou Municipal Health Commission and Development Fund of Affiliated Hospital of Xuzhou Medical University:Study on the Regulation of Various Cytokines and the Effect of c-Jun Activation Domain-Binding Protein 1 on Immune Response in Lung Cancer (XWKYHT20210565, XYFY2020051)。
文摘OBJECTIVE: To predict the targets of Bufei Huoxue capsule( 补肺活血胶囊, BFHX) using network pharmacology analysis and to explore its effects and functional targets in a silicotic rat model. METHODS: The drug and disease targets were correlated through network pharmacology analysis to explore the targets and signaling pathways of BFHX affecting silicosis. NR8383 cells were cultured to verify the core genes and pathways. A rat model of silicosis was established to verify whether the mechanism behind SiO2-caused pulmonary fibrosis was alleviated by BFHX(0.82 g/kg) and how it affected key targets and pathways. RESULTS: Overlapping BFHX and silicotic gene targets produced 159 interactive targets, and 55 were screened by network topology analysis. The results of gene ontology and Kyoto encyclopedia of genes and genomes enrichment analyses suggested that BFHX could affect silicosis through the nucleotide-like receptor containing pyrin domain 3(NLRP3) inflammasome. In NR8383 cells, the expression of core genes related to the NLRP3 inflammasome could be inhibited by BFHX treatment. BFHX reduced the degree of alveolitis and collagen deposition, attenuating pulmonary fibrosis in Si O2-induced rat model. Pulmonary macrophage pyroptosis after SiO2 exposure was observed under transmission electron microscopy. BFHX alleviated the morphological characteristics of pyroptosis. BFHX also reduced the expression of NLRP3, caspase-1, interleukin-1 beta(IL-1β), IL-18, IL-6, and tumor necrosis factor-alpha in lung tissues of silicotic rat model. BFHX affected the K ion content in bronchoalveolar lavage fluid when assessed by energy dispersive spectrometer testing. The expression of CD68+ and CD206+ were also reduced after BFHX intervention. CONCLUSION: NOD-like receptor signaling is vital for BFHX's effects on silicosis. It exerts anti-pulmonary fibrosis effects by inhibiting pulmonary macrophage pyroptosis and polarization through NLRP3 inflammasome activation.
基金supported by the National Natural Science Fundation of China(No.81973822,81130062,81603473)National Public Welfare Industry Research Project-Traditional Chinese Medicine Industry(No.201507001-01)National Key Research and Development Program of China(No.2018YFC1704806)。
文摘Objective:Critical effective constituents were identified from Bufei Yishen formula(BYF),a traditional herbal compound and combined as effective-constituent compatibility(ECC)of BYF I,which may have potential bioactive equivalence to BYF.Methods:The active constituents of BYF were identified using four cellular models and categorised into Groups 1(Bufeiqi),2(Bushen),3(Huatan)and 4(Huoxue)according to Chinese medicinal theory.An orthogonal design and a combination method were used to determine the optimal ratios of effective constituents in each group and the ratios of‘‘Groups 1 to 4"according to their pharmacological activity.We also comprehensively assessed bioactive equivalence between the BYF and the ECC of BYF I in a rat model of chronic obstructive pulmonary disease(COPD).Results:We identified 12 active constituents in BYF.The numbers of constituents in Groups 1 to 4 were 3,2,5 and 2,respectively.We identified the optimal ratios of effective constituents within each group.In Group1,total ginsenosides:Astragalus polysaccharide:astragaloside IV ratio was 9:5:2.In Group 2,icariin:schisandrin B ratio was 100:12.5.In Group 3,nobiletin:hesperidin:peimine:peiminine:kaempferol ratio was4:30:6.25:0:0.In Group 4,paeoniflorin:paeonol ratio was 4:1.An orthogonal design was then used to establish the optimal ratios of Group 1,Group 2,Group 3 and Group 4 in ECC of BYF I.The ratio for total ginsenosides:Astragalus polysaccharide:astragaloside IV:icariin:schisandrin B:nobiletin:hesperidin:peimine:paeoniflorin:paeonol was determined to be 22.5:12.5:5:100:12.5:4:30:6.25:25:6.25.A comprehensive evaluation confirmed that ECC of BYF I presented with bioactive equivalence to the original BYF.Conclusion:Based on the ECC of traditional Chinese medicine formula method,the effective constituents of BYF were identified and combined in a fixed ratio as ECC of BYF I that was as effective as BYF itself in treating rats with COPD.
基金Supported by the National Natural Science Fund of China(No.30672681)International Cooperation Project of Ministry of Science and Technology of China(No.2011DFA32750)
文摘OBJECTIVE: To study the therapeutic effect Bufei granule, which is a traditional Chinese drug that can enhance the immune function of the lung, on patients with stable chronic obstructive pulmonary disease(COPD).METHODS: This is a randomized, double blinded,placebo-controlled, and multicenter clinical study.Three medical centers in Tianjin, China, participated in the trial. A total of 140 patients with stable COPD were enrolled and randomized into two groups, with 70 patients in each. The treatment group was treated with Bufei granule, while the control group received Bufei placebo. The pharmacological treatment lasted for 12 weeks from the date of enrollment. Then, the indexes of patients were observed. Data were analyzed to study the effect of Bufei granule, with the frequency of acute exacerbation as the primary outcome. Traditional Chinese Medicine syndromes,Modified British Medical Research Council dyspnea scale score, St.George's respiratory questionnaire scores, pulmonary function, and serum inflammatory marker levels [including interleukin-6(IL-6), interleukin-8, tumor necrosis factor-α, and transformation growth factor-β1]were the secondary outcomes.RESULTS: During the 12-week treatment, treatment and control groups had no adverse reactions.The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05,except for the level of IL-6.CONCLUSION: Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation, improving the quality of life,and alleviating the severity of inflammation.
基金National Natural Science Foundation of China(81130062and 81403367)
文摘OBJECTIVE To explore the antioxidant effect of Bufei Yishen granules on chronic obstructive pulmo⁃nary disease(COPD)and investigate its underlying mechanism.METHODS Forty-eight rats were randomly divided into normal,model,Bufei Yishen granules(BY)and N-acetylcysteine(NAC)groups,12 rats in each group.The stable COPD rat model was duplicated by using repeated cigarette smoke exposure combined with Klebsiella bacterial infection for 12 weeks(week 1-12),and the corresponding drugs were administered for the next 8 weeks(week 13-20).Minute volume(MV),tidal volume(TV)and peak expiratory flow(PEF)were measured by whole body plethysmography(WBP)system every 4 weeks.Before sacrificed,forced vital capacity(FVC)and forced expiratory volume 0.1(FEV0.1)were measured byPFT system.The pathological changes of lung tissue were observed by pathological techniques.Heme oxygenase 1(HO-1),superoxide dismutase 1(SOD1)and Nrf2 in lung tissue were measured by immunohisto-hemical method.The total anti oxidizing capability(T-AOC),lipid peroxide(LPO)in rat serum were measured.The expression of Nrf2,HO-1 andγ-glutamyl cysteine synthetase(γ-GCS)mRNA in lung tissue was detected by quantitative polymerase chain reac⁃tion(qPCR).The protein expression of Keap1,Nrf2 and HO-1 in lung tissue were detected by Western blotting.RESULTS①Lung function:compared with normal group,the MV in model group was significantly decreased at week 8(P<0.01),the TV and PEF were significantly decreased at week 4(P<0.01).At week 20,compared with model group,MV,TV,and PEF in the BY and NAC groups were significantly increased(P<0.01);compared with the NAC group,MV,TV,and PEF in BY group were significantly increased(P<0.01).At the end of week 20,the FVC and FEV0.1 in model group were significantly lower than that in normal group(P<0.01).Compared with model group,the FVC and FEV0.1 in the BY and NAC groups were significantly increased(P<0.05).②Oxidative indexes:Compared with Normal group,T-AOCin serum was significantly decreased in Model group,while LPO was significantly increased(P<0.01).Compared with the Model,T-AOC in BY and NAC groups was significantly increased(P<0.01),and the LPO was significantly decreased(P<0.05,P<0.01).There were no difference between the BTG and NAC.③Nrf2 signaling:Nrf2 and HO-1 in lung tissue were mainly expressed in the cytoplasm and part of the nucleus of alveolar epithelial cells.SOD1 protein was mainly distributed in bronchial epithelial cells and alveolar septa.Compared with normal group,the expression of Nrf2 in the model group was increased(P<0.01),and HO-1 and SOD1 were decreased(P<0.01).Compared with the model,the expression of Nrf2 in the BY group was significantly increased(P<0.05),and HO-1 and SOD1 in BY and NAC groups were both increased(P<0.01).Compared with the NAC group,the expression of HO-1 in BY group was increased(P<0.01).Compared with normal group,the Nrf2 mRNA expression of lung tissue in the model was significantly increased(P<0.01),the HO-1 andγ-GCS mRNA was decreased(P<0.01).Compared with model group,the Nrf2,HO-1,andγ-GCS mRNA in the BY group were increased(P<0.01),the HO-1,andγ-GCS mRNA in NAC group were increased(P<0.01).Compared with normal group,the Nrf2 protein expression of lung tissue in the model group was significantly increased(P<0.01),and HO-1 protein expression was significantly decreased(P<0.01).Compared with the model,the Nrf2 and HO-1 protein in NAC and BY groups was significantly increased(P<0.01).CONCLUSION Bufei Yishen gran⁃ules has beneficial curative effect in COPD rats,and has the same antioxidation effect as NAC,the mechanism may be involved in upregulating Nrf2 signaling.
基金Supported by National Major Science and Technology Projects of Infectious Diseases(Nos.2008ZX10005011 and 2012ZX10005-008)Traditional Chinese Medicine Innovation Team of Shanghai Municipal Health Commission(No.2022CX010)Three-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai(2023–2025,No.GWVI-11.1-08)。
文摘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)
文摘目的探究补肺益肾祛痰纳气法联合布地格福治疗阳虚痰阻型慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期患者疗效。方法选取95例COPD稳定期患者作为研究对象,按照随机数字法分为对照组(48例)和试验组(47例)。两组均予以基础治疗,对照组采用布地格福治疗,试验组采用补肺益肾祛痰纳气法+布地格福治疗,均治疗3个月。比较两组治疗前后中医证候积分、肺功能[第1秒用力呼气容积占预计值百分比(forced expiratory volume in the first second as a percentage of predicted value,FEVl%pred)、FEVl/用力肺活量(forced vital capacity,FVC)、最大呼气中段流量(maximum mid-expiratory flow,MMEF)、峰值流速(peak expiratory flow,PEF)]、气道重塑指标[基质金属蛋白酶(matrix metalloproteinase,MMP)-9、基质金属蛋白酶抑制因子(tissue inhibitor of metalloproteinase,TIMP)-1、MMP-9/TIMP-1]、炎性指标[白细胞介素(interleukin,IL)-8、肿瘤坏死因子(tumor necrosis factor,TNF)-α]、血管内皮功能指标[内皮素(endothelin,ET)、一氧化氮(nitric oxide,NO)]、活动能力[6 min步行测验(six-minute walking test,6MWT)、呼吸困难指数(modified medical research council,mMRC)问卷]。结果治疗3个月后,两组中医证候积分、血清IL-8、TNF-α、ET、MMP-9水平及MMP-9/TIMP-1均降低,且试验组各指标降幅均高于对照组(P<0.05);两组FEV1%pred、FEVl/FVC、MMEF、PEF、血清NO、TIMP-1水平、6MWT均升高,且试验组各指标升幅均高于对照组(P<0.05)。结论补肺益肾祛痰纳气法联合布地格福治疗阳虚痰阻型COPD稳定期,能有效改善患者内皮功能,减轻气道重构,抑制炎性反应,进而缓解临床症状,提高肺功能,促进日常活动能力复旧。
