Clinical Efficacy Protocol of Yinhuapinggan Granules: A Randomized, Double-Blind, Parallel, and Controlled Clinical Trial Program for the Intervention of Community-Acquired Drug-Resistant Bacterial Pneumonia as a Complementary Therapy

Abstract

Background: Community-acquired bacterial pneumonia (CABP) is an important health care concern in the worldwide, and is associated with significant morbidity, mortality, and health care expenditure. Streptococcus pneumoniae is the most frequent causative pathogen of CABP. Common treatment for hospitalized patients with CABP is empiric antibiotic therapy using β-lactams in combination with macrolides, respiratory fluoroquinolones, or tetracyclines. However, overuse of antibiotics has led to an increased incidence of drug-resistant S. pneumoniae, exacerbating the development of community-acquired drug-resistant bacterial pneumonia (CDBP) and providing a challenge for physicians to choose empirical antimicrobial therapy.Methods: Traditional Chinese medicine (TCM) is widely used as a complementary treatment for CDBP. Yinhuapinggan granules (YHPG) is widely used in the adjuvant treatment of CDBP. Experimental studies and small sample clinical trials have shown that YHPG can effectively reduce the symptoms of CDBP. However, there is a lack of high-quality clinical evidence for the role of YHPG as a complementary drug in the treatment of CDBP. Here, we designed a randomized, double-blind, placebo-controlled clinical trial to explore the efficacy and safety of YHPG. A total of 240 participants will be randomly assigned to the YHPG or placebo group in a 1:1 ratio. YHPG and placebo will be added to standard treatment for 10 days, followed by 56 days of follow-up. The primary outcome is the cure rate of pneumonia, and the secondary outcomes includes conversion rate of severe pneumonia, lower respiratory tract bacterial clearance, lactic acid (LC) clearance rate, temperature, C-reactive protein (CRP), criticality score (SMART-COP score), acute physiological and chronic health assessment system (APACHEII score) and clinical endpoint events. Adverse events will be monitored throughout the trial. Data will be analyzed according to a pre-defined statistical analysis plan. This research will disclose the efficacy of YHPG in acquired drug-resistant pneumonia.Clinical Trial Registration: https://clinicaltrials.gov, identifier ChiCTR2100047501

Qualitative and Quantitative Analysis of Chemical Components in Yinhua Pinggan Granule with High-Performance Liquid Chromatography Coupled with Q-Exactive Mass Spectrometry

“…At the same time, recent research showed that YPG and its components have significant inhibitory effects on the proliferation of the H1N1 virus [3]. Meanwhile, a randomized, double-blind, parallel, controlled clinical trial program with a total of 240 participants is in progress to test the clinical Molecules 2024, 29, 2300 2 of 23 efficacy of YPG as a complementary therapy against community-acquired drug-resistant bacterial pneumonia [4].…”

Polydatin prevent lung epithelial cell from Carbapenem-resistant Klebsiella pneumoniae injury by inhibiting biofilm formation and oxidative stress

“…PD is also an important component of traditional Chinese medicine compounds, Yinhuapinggan (YHPG) granules used to treat respiratory infections 12 – 16 . YHPG was composed of six herbs, which had the effect of clearing heat and detoxifying 17 . Investigations into the pharmacodynamics and mechanism of YHPG in animals and cells had demonstrated its antiviral, antibacterial, antipyretic, analgesic, cough relieving, and immunomodulatory effects 17 .…”

“…YHPG was composed of six herbs, which had the effect of clearing heat and detoxifying 17 . Investigations into the pharmacodynamics and mechanism of YHPG in animals and cells had demonstrated its antiviral, antibacterial, antipyretic, analgesic, cough relieving, and immunomodulatory effects 17 . In previous studies, we found that YHPG had a positive effect on the treatment of viral infectious respiratory diseases 14 .…”