Bu-Fei Yi-Shen Granules Reduce Acute Exacerbations in Patients with GOLD 3-4 COPD: A Randomized Controlled Trial.

Purpose: Chronic obstructive pulmonary disease (COPD) is a disease characterized by frequent acute exacerbations (AEs), especially in severe and very severe cases. We aimed to evaluate the efficacy and safety of Bu-fei Yi-shen granules (BYGs) for COPD. Patients and Methods: We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of 348 COPD patients with GOLD 3-4 COPD. The patients were randomly assigned into experimental or control groups in a 1:1 ratio. Patients in the experimental group were prescribed BYG, while those in the control group were administered a placebo, orally, twice daily, with 5 days on and 2 days off per week for 52 weeks. The outcomes included AEs, pulmonary function, clinical signs and symptoms, dyspnea scores (mMRC), quality of life scores, and a 6-minute walk test (6MWT). Results: A total of 280 patients completed the trial, including 135 patients in the experimental group and 145 in the control group. Compared to the control group, significant differences were observed in frequencies of AEs (mean difference: -0.35; 95% CI: -0.61, -0.10; P = 0.006) and AE-related hospitalizations (-0.18; 95% CI: -0.36, -0.01; P = 0.04), 6MWD (40.93 m; 95% CI: 32.03, 49.83; P < 0.001), mMRC (-0.57; 95% CI: -0.76, -0.37; P < 0.001), total symptoms (-2.18; 95% CI: -2.84, -1.53; P < 0.001), SF-36 (11.60; 95% CI: 8.23, 14.97; P < 0.001), and mCOPD-PRO (-0.45; 95% CI: -0.57, -0.33; P < 0.001) after treatment. However, there were no significant differences in mortality, pulmonary function, and mESQ-PRO scores (P > 0.05). No obvious adverse events were observed. Conclusion: BYG, as compared to a placebo, could significantly reduce the frequencies of AEs and AE-related hospitalizations for GOLD 3-4 COPD patients. Clinical symptoms, treatment satisfaction, quality of life, and exercise capacity improved. There was no significant improvement in mortality and pulmonary function.

[Effect of yifei jianpi recipe on inflammatory cells, levels of interleukin-8 and tumor necrosis factor-alpha in sputum from patients with chronic obstructive pulmonary disease].

OBJECTIVE: To explore the effect and the mechanism of yifei jianpi recipe (YFJPR) on patients with chronic obstructive pulmonary disease (COPD). METHODS: Forty patients with COPD in stable phase were randomly divided into two groups, the treated group and the control group. Indexes including the total and differential count of inflammatory cell in sputum, levels of interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-alpha), as well as the percentage of forced expiratory volume in one second in its predicted value (FEV1%) and ratio of FEV1/forced vital capacity (FVC) in patients were measured before and after treatment, and compared with those in 20 healthy subjects. RESULTS: All the indexes measured in patients before and after treatment were significantly different from those in healthy subjects (P < 0.01). Differential count of polymorphonuclear neutrophil (PMN) and levels of IL-8 and TNF-alpha in sputum in the treated group significantly decreased after treatment (P < 0.01), while the non-PMN differential count and levels of FEV1% and FEV1/FVC significantly increased (P < 0.01). But in the control group, changes only showed in increasing of FEV1% and FEV1/FVC (P < 0.05 or P < 0.01). And the effects in the treated group were better than those in the control group (P < 0.01). CONCLUSION: YFJPR can play a therapeutic role on patients with COPD by way of reducing the airway inflammatory reaction.