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| Name | Class |
|---|---|
| Wuhan No.1 Hospital | OTHER |
| Hebei Provincial Hospital of Traditional Chinese Medicine | OTHER_GOV |
| Shanghai University of Traditional Chinese Medicine | OTHER |
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The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.
This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM Group | The study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life. Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration. |
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| Non-TCM Group | All patients who do not meet the defined criteria for the TCM group will be classified into the non-TCM group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM | Drug | We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM. |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization rate | Including all-cause readmission rate and pulmonary infection readmission rate | The Rehospitalization rate within a one-year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with efficacy | The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients. | Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase |
| Health survey summary table（SF-36） |
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Selection Criteria:
Exclusion Criteria:
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Adult patients discharged after pneumonia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minghang Wang, Doctor | Contact | +86 371 66248624 | wmh107hn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiansheng Li, Doctor | The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Study Chair |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Qingdao Hiser Medical Group |
| OTHER |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
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The biological sample bank includes serum samples, plasma samples, urine samples, stool samples.
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Using SF-36 to evaluate the impact of CAP on a person's life over time |
| Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase |
| Clinical outcomes reported by patients | The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia. | Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase |
| Clinical outcomes reported by doctors | The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition. | Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase |
| nutritional status | Nutritional status related indicators. | Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage |
| Acute upper respiratory tract infection (URTI) event | It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis. | Acute upper respiratory tract infection events that occurred during the one-year follow-up period |
| Survival situation | Record the number of deaths. Record the follow-up period every 3 months. | Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase |