Efficacy and safety of Feishu acupoint drug penetration therapy combined with antibiotics in the treatment of bacterial pneumonia in children:study protocol for a randomized controlled trial

Not Applicable

Conditions: Pediatric pneumonia

Registration Number: ITMCTR2200006632

Lead Sponsor: The First Affiliated Hospital of Henan University of Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Diagnostic standards of Western medicine
(1) Imaging (chest X-ray or chest CT) is consistent with the characteristics of bacterial pneumonia: new or progressive invasive inflammatory changes in the lungs. Thoracic x-ray may show punctate, speckled infiltration of lung parenchyma; Or see the texture of the inner band in both lungs increases, blurs or appears striped shadows, or even gathers into a network; Or see darker hilar shadow, or even infiltrates around the hilar. CT of the chest is visible: speckle-like, nodular density increased shadows can be seen; Or thickened lung texture and speckly density-increasing shadows may be seen.
(2) Acute course (= 5 days);
(3) At least three clinical manifestations are consistent with the following signs or symptoms of lower respiratory tract infection:
New onset or worsening cough;
Purulent sputum or a change in the nature of sputum;
Axillary temperature = 38.5 °C;
Dyspnea or shortness of breath or hypoxemia (SPO2 saturation in indoor air= 92% (sea level) or 90% = (plateau));
Auscultation of the lungs consistent with auscultation of pneumonia (coarser or decreased breath sounds may be heard in the early stages, and dry and wet rales or tubular breath sounds may be heard in the later stages);
White blood cell count > 10×109/L, percentage of neutrophils > 50%;
· C-reactive protein > 10 mg/L;
· PCT>0.5µg/L
2. Diagnostic criteria of traditional Chinese medicine
Consistent with TCM pneumonia wheezing? TCM Dialectic Standards for Wind Fever Depression Lung Evidence: Guidelines for the Diagnosis and Treatment of Common Pediatric Diseases in Traditional Chinese Medicine[1] of the Chinese Association of Traditional Chinese Medicine [2012)
Wind fever depressed lungs:
Main symptoms: fever; cough; Wheezing and inciting the nose; Cough up yellow sputum or smell sputum in the throat.
Secondary symptoms: nasal congestion and runny nose or yellow nose; Pharyngeal redness; Headache; Reddish complexion; Thirst; Constipation; Less yellow urine.
Tongue vein fingerprint: tongue red; Moss thin yellow; Pulse float, fingerprint float purple.
With at least 2 main symptoms + at least 2 secondary symptoms, with reference to the tongue pulse fingerprint, you can diagnose.
Criteria for case inclusion
(1) Meet the above-mentioned diagnostic standards of Western medicine and the dialectical standards of traditional Chinese medicine;
(2) 1< age =5 years old, gender is not limited;
(3) Can be admitted to the hospital for routine treatment;
(4) The child's legal guardian is informed and consents to receive treatment.

Exclusion Criteria

(1) Confirming or suspecting that pneumonia is caused by a non-community-acquired bacterial pathogen;
(2) Non-infectious causes of pulmonary infiltration, such as pulmonary embolism, chemical pneumonia caused by inhalation, etc.;
(3) Pleural empyema (excluding non-purulent pneumonic pleural effusions);
(4) including but not limited to pneumonia complicated with bronchial asthma, bronchial foreign bodies, pneumonia complicated with measles, whooping cough, circulating colds, pneumonia with other serious primary diseases of the lungs;
(5) Those who are previously allergic to ß-lactam antibiotic components;
(6) Those who use antibiotics within 72 hours before enrollment;
(7) Previous history of epilepsy or convulsions, except for children with clear records of febrile seizures;
(8) Infection may require simultaneous use of systemic corticosteroids;
(9) There is evidence of an immediate life-threatening disease, including but not limited to current or imminent respiratory failure, acute heart failure, shock, acute liver failure, active gastrointestinal bleeding;
(10) Those with primary diseases such as heart, liver, kidney, digestive and hematopoietic systems;
(11) Pneumonia complicated with diarrhea;
(12) Allergic constitution, allergic to the acupuncture point patch of traditional Chinese medicine;
(13) any situation that the researcher believes would compromise the child's safety or data quality;
(14) Those who are unable or unwilling to comply with the procedures and restrictions specified in the study.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical recovery rate;Antibiotic days;

Secondary Outcome Measures

Name	Time	Method
Complete deheating rate;The number of days of complete defervescence;The incidence of the indications for transfer to the ICU is achieved;Disease efficacy;TCM evidence of therapeutic effect;White blood cell count;c-Reactive protein;