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Effects of Shenfu injection on inflammatory factors and immune function in children with Mycoplasma pneumoniae: A
Honglian Pei1, Youfeng Ma1, Lin Wang2
1Department of Pediatrics, Shenzhen Samii International Medical Center, Shenzhen, Shenzhen Province, China.
Background:
Mycoplasma pneumoniae (MP) is a common infectious respiratory disease in pediatrics, and macrolide antibiotics are the optimal treatment option. In recent years, there is a significant increase in the resistance of this pathogen to macrolide antibiotics, which makes the clinical treatment of this disease increasingly complex. Shenfu injection (SFI), a herbal extract injection, has advantages of improving immune function, reducing inflammatory reaction, improving curative effect and shortening the course of disease in the treatment of pediatric MP. However, there is a lack of rigorous clinical studies to evaluate the effects of SFI on inflammatory factors and immune function in children with MP.
Methods:
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial protocol. The objective of this study is to evaluate the effect of SFI on inflammatory factors and immune function in children with MP. Patients meeting the inclusion criteria were randomized in a ratio of 1:1 to either the treatment group (azithromycin + 100 mL 5% glucose injection + 50 mL SFI) or the control group (azithromycin + 150 mL 5% glucose injection). Patients in both groups received the standard treatment for 7 days. The levels of inflammatory factor indexes (C-reactive protein, interleukin-6, interleukin-10, tumor necrosis factor-α) and immune function indexes (immunoglobulin G, immunoglobulin A, immunoglobulin M) in both groups were measured at the beginning of treatment, on the 3rd day of treatment and at the end of treatment. Besides, the time of improvement in clinical symptoms (duration of cough, time of disappearance of lung rales, time of fever reduction, and time of disappearance of lung X-ray infiltrative shadow) and adverse effects in both groups were recorded. Finally, the data were statistically analyzed by SPSS 20.0 software.
Discussion:
In this study, an evaluation was conducted on the effects of SFI on inflammatory factors and immune function in pediatric MP. The results of this experiment will provide a clinical basis for the adjuvant treatment of pediatric MP with SFI.
Trial Registration:
OSF Registration number.
Insights
Shenfu injection (SFI) may improve inflammatory and immune responses in pediatric Mycoplasma pneumoniae (MP) infections. This study evaluated SFI as an adjunctive therapy to standard treatment for pediatric MP.
Area of Science:
- Pediatric infectious diseases
- Respiratory medicine
- Pharmacology and therapeutics
Background:
- Mycoplasma pneumoniae (MP) is a common pediatric respiratory pathogen.
- Increasing macrolide antibiotic resistance complicates MP treatment.
- Shenfu injection (SFI) shows potential for improving outcomes in pediatric MP.
Purpose of the Study:
- To evaluate the efficacy of Shenfu injection (SFI) as an adjunctive therapy for pediatric Mycoplasma pneumoniae (MP) infection.
- To assess the effects of SFI on inflammatory factors and immune function in children with MP.
- To provide a clinical basis for SFI use in pediatric MP treatment.
Main Methods:
- Prospective, randomized, double-blind, placebo-controlled clinical trial.
- Participants received azithromycin with either SFI or placebo for 7 days.
- Measured inflammatory markers (CRP, IL-6, IL-10, TNF-α) and immune function indexes (IgG, IgA, IgM).
- Assessed clinical symptom improvement and adverse effects.
Main Results:
- The study protocol aims to evaluate the effects of SFI on inflammatory and immune markers.
- Clinical symptom improvement and adverse events will be recorded and analyzed.
- Statistical analysis will be performed using SPSS 20.0 software.
Conclusions:
- This study will provide a clinical basis for the adjuvant treatment of pediatric MP with SFI.
- The findings are expected to inform clinical practice regarding SFI use in pediatric respiratory infections.
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