Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

Improvement in clinical symptoms is defined as at least two of the four main clinical symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) showing an improvement of at least one grade, with no worsening of the other symptoms.

The grade of clinical symptoms is divided into four levels:

None Mild Moderate Severe The number of cases with clinical symptom improvement is calculated as the ratio of improved cases to the total cases in each group.

The length of hospital stay is calculated as the number of days from admission to when the patient meets the discharge criteria.

Discharge Criteria include:

Body temperature normal for more than 24 hours; Resting heart rate ≤ 100 beats/min; Resting respiratory rate ≤ 24 breaths/min; Systolic blood pressure ≥ 90 mmHg; Oxygen saturation ≥ 90% (or arterial oxygen partial pressure ≥ 60 mmHg on room air).

If the patient can be transitioned to oral medication and does not require further management for complications or mental disorders, discharge may be considered.

The Confusion, Urea, Respiratory rate, Blood pressure, and Age ≥65 Score (CURB-65 score) is a clinical tool used to assess the severity of community-acquired pneumonia (CAP) and the associated mortality risk based on five clinical indicators(On a 5-point scale, 5 is the worst and 0 is the best.):

Confusion (assessed by changes in mental status) ：0-5 score Urea (blood urea nitrogen level >7 mmol/L) ：0-5 score Respiratory rate (≥30 breaths/min) ：0-5 score Blood pressure (systolic BP <90 mmHg or diastolic BP ≤60 mmHg) ：0-5 score Age (≥65 years) ：0-5 score The total score is calculated by adding points for each indicator, with a higher score indicating more severe disease and higher risk of mortality.

Based on the Guidelines for Clinical Research of Traditional Chinese Medicine New Drugs, each symptom is rated on a scale of None, Mild, Moderate, and Severe (4 levels).

Primary symptoms (e.g., cough, sputum production, chest pain, and dyspnea) are scored 0, 2, 4, and 6 points, respectively.

Secondary symptoms (e.g., fever, thirst, flushed face, yellow urine, constipation, and abdominal distention) are scored 0 or 1 point, depending on their presence or absence.

For the Phlegm-Heat Obstructing the Lungs syndrome, the overall score is calculated by summing the points for primary and secondary symptoms before and after treatment. The treatment outcomes are classified into four levels:

Clinical Recovery: Syndrome score reduction ≥95%. Significant Improvement: Syndrome score reduction ≥70%. Effective: Syndrome score reduction ≥30%. Ineffective: Syndrome score reduction <30%.

Based on the Antimicrobial Drug Clinical Research Guidelines, the efficacy is classified into four levels:

Clinical Recovery: At the end of treatment, the patient's clinical symptoms, signs, major laboratory tests, and microbiological tests have all returned to normal.

Significant Improvement: At the end of treatment, the patient's condition has noticeably improved, but one of the four key indicators (symptoms, signs, laboratory tests, or microbiological tests) has not fully returned to normal.

Progress: At the end of treatment, the patient's condition has shown some improvement, but not enough to be considered significant.

Ineffective: At the end of treatment, the patient's condition has not improved or has worsened.

Chest imaging examinations will be performed on both groups of subjects before and after treatment, as well as at the end of the follow-up, to observe the changes in lung imaging. The degree of pneumonia absorption will be recorded using the evaluation scale.

Evaluation Process: Two radiology experts will independently assess and score the imaging results, and the average score will be taken.

Assessment Points: The evaluations will be conducted on Day 0, Day 7 (or at discharge), and at 12 weeks during follow-up.

This method helps assess the extent of pneumonia absorption and track changes in lung conditions over time.

The microbiological results of both groups of patients during hospitalization will be recorded. Pathogen clearance is defined as follows:

Clearance: If no pathogen is detected in more than three consecutive tests. Replacement: If the original pathogen is no longer detected and a new pathogen is identified.

Not cleared: If the pathogen load does not decrease, or although the pathogen load has decreased, it has not been completely cleared.

The readmission rate includes the all-cause readmission rate and pneumonia-related readmission rate:

All-cause readmission refers to patients being readmitted for any disease, with the admission criteria based on relevant disease guidelines.

Pneumonia-related readmission refers to patients being readmitted due to a recurrent lung infection, with admission criteria based on the "Chinese Guidelines for the Diagnosis and Treatment of Adult Community-Acquired Pneumonia (2016 edition)", using the CURB-65 score to determine the need for hospitalization.