Clinical study on modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride in the treatment of severe pneumonia.

OBJECTIVE

This study aimed to evaluate the clinical efficacy of modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride in treating severe pneumonia.

METHODS

This was a single-center, prospective, double-blind, randomized controlled trial. A total of 138 patients with severe pneumonia were randomly divided into two groups. The control group (n = 69) received ambroxol hydrochloride, while the observation group (n = 69) received modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride. Clinical efficacy, Traditional Chinese Medicine symptom scores (fever, cough, expectoration, dyspnea), arterial blood gas indicators [oxygen saturation (SaO), partial pressure of oxygen (PaO), partial pressure of carbon dioxide (PaCO)], lung function [forced expiratory volume in one second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)], and inflammatory markers [interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP)] were evaluated. Adverse events were recorded for both groups.

RESULTS

The overall efficacy rates in the combined and control groups were 98.55% and 89.86% ( < 0.05). After treatment, in both groups, symptom scores for fever, cough, expectoration, and dyspnea were reduced, with the combined group showing more significant improvement; SaO and PaO levels increased, and PaCO decreased, with the combined group achieving greater improvement; FEV1, FVC, and PEF values increased, with higher values observed in the combined group; serum IL-6, TNF-α, and CRP levels decreased, with the combined group showing more substantial reductions (all < 0.05). The incidence of adverse events was 4.35% in the combined group and 2.90% in the control group ( > 0.05).

CONCLUSION

Modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride demonstrated ideal clinical efficacy in treating severe pneumonia, alleviating symptoms and pulmonary inflammation and improving arterial blood gas indicators and lung function.