Cohort Study on the Efficacy of Traditional Chinese Medicine Syndrome Differentiation Scheme in Adjuvant Treatment of Severe Pneumonia Based on the Real World
Overview
- Phase
- Not Applicable
- Intervention
- traditional Chinese medicine (TCM)
- Conditions
- Community-Acquired Infections
- Sponsor
- Henan University of Traditional Chinese Medicine
- Enrollment
- 1016
- Locations
- 1
- Primary Endpoint
- 90-day mortality
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a multicenter, prospective cohort study, with syndrome differentiation and treatment of traditional Chinese medicine as the exposure factor. Patients using syndrome differentiation of traditional Chinese medicine combined with conventional treatment of Western medicine are classified as the treatment cohort of Integrated Chinese and Western medicine, and patients using conventional treatment of Western medicine only are classified as the treatment cohort of Western medicine
Detailed Description
Severe pneumonia is a severe respiratory disease with high mortality, many complications and poor prognosis. Traditional Chinese medicine has certain curative effect in the adjuvant treatment of severe pneumonia, but there is a lack of systematic TCM syndrome differentiation scheme and its curative effect evaluation in the real medical environment. The cohort study on the efficacy of TCM syndrome differentiation scheme in the adjuvant treatment of severe pneumonia is conducive to providing new evidence for the optimization and evidence-based evaluation of TCM treatment scheme for severe pneumonia. Therefore, this study took severe pneumonia as the research object, standardized use of traditional Chinese medicine diagnosis and treatment scheme as the exposure factor, carried out a multi center prospective cohort study, used the 90 day mortality, 28 day mortality, treatment failure rate, etc., to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of severe pneumonia, and provided evidence for the application and promotion of traditional Chinese medicine in severe pneumonia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •It met the diagnostic criteria of severe pneumonia;
- •Age ≥ 18 years old, regardless of gender.
- •Voluntary treatment.
- •Sign the informed consent form.
Exclusion Criteria
- •Pregnant or lactating women;
- •Patients with mental illness who are unable to cooperate or unwilling to cooperate with follow-up;
- •Those who are participating in clinical trials of other drugs;
- •Known allergic to therapeutic drugs.
Arms & Interventions
Treatment cohort of integrated traditional Chinese and Western Medicine
Taking the use of traditional Chinese medicine syndrome differentiation treatment as the exposure factor, the continuous use of traditional Chinese medicine for 3-5 days was defined as mild exposure, continuous use of traditional Chinese medicine for 6-10 days as moderate exposure, and continuous use of traditional Chinese medicine for more than 10 days as severe exposure. The exposure group was treated with syndrome differentiation of traditional Chinese medicine combined with conventional Western Medicine (treatment cohort of integrated traditional Chinese and Western Medicine).
Intervention: traditional Chinese medicine (TCM)
Western medicine treatment queue
The non exposure group (Western medicine treatment cohort) used conventional western medicine treatment but not standardized TCM syndrome differentiation treatment.
Intervention: non traditional Chinese medicine (non-TCM)
Outcomes
Primary Outcomes
90-day mortality
Time Frame: Mortality on the 90th day of treatment
Calculate the proportion of patients who died of the disease on the 90th day of treatment
Secondary Outcomes
- 28-day mortality(Calculate the proportion of patients who died of the disease on the 28th day after discharge)
- treatment failure rate(Early treatment failure was defined as clinical deterioration within 72 hours of treatment. Late treatment failure between 72 hours and to 28 days.)
- time to clinical stability(every day in the treatment.)
- ICU stay time(the 28 days of the treatment phase.)
- hospitalization time(the 28 days of the treatment phase)
- Mechanical ventilation time(the 28 days of the treatment phase)
- SOFA score(The sofa scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge were counted.)
- Quality of life(The scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge were counted)
- TCM syndrome score(The TCM syndrome scores of the first, seventh, fourteenth, twenty-first and twenty-eight days and the first, second and third months after discharge were counted)
- 90 day readmission rate(The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded)