Bloodletting Acupuncture at Sifeng Points (EX-UE-10) for Regulating Th1/Th2 Balance in Pediatric Mycoplasma Pneumonia

Summary

This protocol describes a randomized controlled trial to evaluate the immunomodulatory effects of adjunctive Sifeng point (EX-UE-10) acupuncture on the Th1/Th2 balance in children with Mycoplasma pneumoniae pneumonia receiving standardized antibiotic treatment.

Abstract

Mycoplasma pneumoniae is a common cause of pneumonia in children, and the emergence of macrolide-resistant strains underscores the need to explore effective adjunctive therapies. This article introduces a randomized controlled trial protocol to evaluate the clinical and immunological effects of acupuncture as an adjunctive therapy. The study includes children diagnosed with Mycoplasma pneumoniae pneumonia who are receiving standardized azithromycin treatment. The primary objective is to determine whether a specific acupuncture procedure applied to the fingers can modulate the host's immune response by altering serum levels of interferon-γ (IFN-γ) and interleukin-4 (IL-4), which reflect the Th1/Th2 cell balance. This method describes the case selection criteria, randomization grouping, a detailed acupuncture intervention protocol, and assessment of clinical symptoms and immunological markers. This study aims to provide scientific evidence for the application of acupuncture as a non-pharmacological intervention, with the expectation of shortening the course of pediatric pneumonia and reducing its inflammatory response.

Introduction

Community-acquired pneumonia in children remains a significant cause of morbidity, with Mycoplasma pneumoniae being one of the primary pathogens. The increasing prevalence of macrolide-resistant Mycoplasma pneumoniae complicates treatment, often leading to prolonged disease courses^1,2, thereby heightening the need for alternative or adjunctive therapies. Acupuncture is a technique involving the insertion of fine needles into specific body points for therapeutic purposes and is currently being investigated as a non-pharmacological intervention for various inflammatory diseases

Protocol

This study was approved by the Ethics Committee of Jiangning Hospital Affiliated to Nanjing Medical University (approval number: 2021-03-057-k01). The study will adhere to the Declaration of Helsinki. Written informed consent was obtained from the guardians of all participants prior to enrollment. This study was registered with the Chinese Clinical Trial Registry, registration number: ChiCTR2200064052.

1. Patient screening and enrollment

1. Refer to the diagnostic criteria for Mycoplasma pneumoniae pneumonia¹¹ and confirm a diagnosis of Mycoplasma pneumoniae (MP) pneumonia if the following ....

Results

Baseline characteristics

Random allocation sequences were generated using statistical software and distributed via sealed, opaque envelopes. A total of 60 participants were randomly assigned to either the control group (n = 30) or the treatment group (n = 30). Statistical analysis confirmed no significant differences in baseline demographic or clinical data between the two groups (P > 0.05), ensuring comparability (Table 1). The control group inclu.......

Discussion

This study demonstrates that combining bloodletting therapy at the Sifeng points (EX-UE-10) with standard antibiotic treatment can significantly accelerate the clinical recovery process in children with Mycoplasma pneumoniae pneumonia (MPP). Compared to the control group receiving antibiotics alone, the treatment group exhibited faster resolution of fever and cough, as well as more pronounced reductions in clinical severity scores. These improvements were accompanied by the anticipated immunomodulatory effects: .......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Opaque sealed envelopes	Nanjing Kongdu Printing Co., Ltd.	201701	For randomization and group allocation
Puncture-resistant sharps container	Lixinyuan Plastic Industry Co., Ltd.	KMT-15Y	For safe disposal of used needles
Refrigerated benchtop centrifuge	Thermo Fisher Scientific	75002476	Used for serum separation (1,000 x g, 10 min, 4 °C)
Sterile dry cotton balls	Zhende Medical Co., Ltd.	202203121B	For post-procedure pressure and cleaning
Ultralow temperature freezer	Haier Biomedical	DW-86L578J	For long-term storage of serum samples (-80 °C)
Venous blood collection needles	Guangzhou Improve Medical Instruments Co., Ltd.	220123	For obtaining 3 mL venous blood samples