Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study

Sun Yat-sen University

Status: Completed

Conditions: Otologic Disease

Treatments: Other: Conventional Treatment; Drug: Panfoshu+Conventional Treatment（program-B）; Drug: Panfoshu+Conventional Treatment（program-A）

Study type: Interventional

Funder types: Other

Identifiers

NCT05806086

SYSKY-2022-087-01

Details and patient eligibility

About

Patients with otolaryngological diseases caused by upper respiratory tract infections, including allergic rhinitis, chronic rhinosinusitis, secretory otitis media, and oblate gland hypertrophy, were treated with all drugs from Sun Yat-sen Memorial Hospital of Sun Yat-sen University, the First Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial People's Hospital, and Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2021 to December 2022. According to the treatment methods, the patients were divided into panfosol + conventional treatment group and conventional treatment group for multicenter retrospective analysis.

Full description

FIrstly, Data of all patients were collected before and after treatment, including nasal endoscopy Lund Kennedy score, VAS scale for nasal/facial/olfactory symptoms, and ear/nose/snoring VAS scale, etc. According to the change values before and after treatment, the treatment results were divided into cure (complete control of the disease), effective (partial control of the disease), ineffective (uncontrolled disease). secondly, All participants were reviewed for gastrointestinal disturbances (nausea, abdominal pain, vomiting), skin reactions (rash, urticaria), respiratory discomfort (cough, dyspnea, asthma), and common problems (fever, fatigue, allergic reactions) after medication.

Enrollment: 480 patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. those who were diagnosed as ear, nose and throat diseases caused by upper respiratory tract infection, such as allergic rhinitis, chronic rhinosinusitis, secretory otitis media, and oblate gland hypertrophy
2. Complete clinical data were available at least once both before and after treatment

Exclusion criteria

1. Patients who are allergic to the ingredient panfosol
2. Autoimmune disease
3. Acute intestinal infection
4. Children younger than 1 year old
5. Patients diagnosed with nasopharyngeal carcinoma and other space-occupying diseases by imaging examination
6. Basic information is incomplete

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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480 participants in 3 patient groups

Panfoshu + conventional treatment group（program-A）

Experimental group

Description:

Panfoshu is commonly known as the product of bacterial dissolution. it was taken orally once a day on an empty stomach, one capsule at a time. 1 course of treatment was 6mon, which was taken 10 days a month, stopped for 20 days for 3 months, and observed for another 3 months(unmedicated). Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.

Treatment:

Drug: Panfoshu+Conventional Treatment（program-A）

Panfoshu + conventional treatment group（program-B）

Experimental group

Description:

Panfoshu was taken for 30 days in the first month, stopped in the second month, taken for 10 days and stopped for 20 days in a row for 3 months, and finally observed for 1 month. Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.

Treatment:

Drug: Panfoshu+Conventional Treatment（program-B）

conventional treatment group

Other group

Description:

Conventional medications are used to treat the relavant ear and nose symptoms.

Treatment:

Other: Conventional Treatment