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

Time to Clinical Stability

The criteria for clinical stability require meeting all five of the following indicators: Body temperature ≤ 37.8°C for more than 24 hours; Resting heart rate ≤ 100 beats per minute; Resting respiratory rate ≤ 24 breaths per minute; Systolic blood pressure ≥ 90 mmHg; Oxygen saturation (SpO₂) ≥ 90% (or arterial oxygen partial pressure ≥ 60 mmHg on room air). During the treatment period, log cards will be issued to monitor and record vital signs (temperature, respiration, blood pressure, heart rate, and SpO₂) every 12 hours. The time to clinical stability will be calculated based on these records

Improvement of Clinical Symptoms

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.

Length of Hospital Stay

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.

Confusion, Urea, Respiratory rate, Blood pressure, and Age ≥65 Score (CURB-65 score).

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.

Traditional Chinese Medicine Syndrome Efficacy Evaluation

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%.