Severe Pneumonia Complicated with Gastrointestinal Dysfunction
Conditions
Interventions
treatment group:Tiaochangfang rectal infusion
control group:Conventional Western medicine treatment
Sponsors
Inner Mongolia Hospital Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnostic Criteria Pneumonia Diagnostic Criteria Diagnosis requires meeting any one of the first four criteria plus the fifth criterion while excluding: Tuberculosis Lung tumors Non-infectious interstitial lung disease Pulmonary edema Atelectasis Pulmonary embolism Pulmonary eosinophilic infiltration Pulmonary vasculitis Including: 1) New-onset or worsening cough/sputum production with purulent sputum with or without chest pain; 2) Fever; 3) Signs of lung consolidation and/or moist rales; 4) Peripheral WBC >10×10?/L or 30 breaths/min; 2) PaO2/FiO2 <250 mmHg; 3) Multilobar infiltrates; 4) Altered mental status and/or disorientation; 5) BUN =7 mmol/L; 6) Hypotension requiring aggressive fluid resuscitation. Gastrointestinal Dysfunction Diagnostic Criteria Based on the 2012 European Society of Intensive Care Medicines AGI grading system AGI grade II (gastrointestinal dysfunction) is defined as: Impaired digestion and absorption failing to meet nutritional/fluid needs but without systemic impact. Manifestations include: Gastroparesis with significant gastric retention/reflux; Lower gastrointestinal paralysis; Diarrhea; Intra-abdominal hypertension grade I (IAP:12–15 mmHg); Blood in gastric contents/stool; Food intolerance (<20 kcal/kg BW/day via enteral nutrition after 72h). Inclusion Criteria Meets Western diagnostic criteria for severe pneumonia with gastrointestinal dysfunction; TCM syndrome differentiation: Phlegm-heat and bowel excess syndrome requiring: At least 3 items from: 1) Severe cough or chest pain; 2) Yellow/white sticky sputum; 4) Dry stool or abdominal distension; Plus at least 1 item from: 3) Fever thirst; 5) Red tongue with yellow/greasy coating or rapid/slippery pulse. Age =18 years; Signed informed consent by patient or legal representative.
Exclusion criteria
Exclusion criteria: Patients with severe primary diseases of the cardiovascular cerebrovascular hepatic renal hematopoietic or endocrine systems; patients with malignancies psychiatric disorders or dementia; Patients participating in other clinical trials; Patients taking other traditional Chinese medicine or Mongolian medicine preparations during the trial period; Pregnant or lactating women; Patients with allergic constitution or known allergies to the investigational drugs; Patients deemed by investigators as unable to complete the study or comply with study requirements (due to administrative reasons or other factors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| short-chain fatty acids; G protein-coupled receptor 43;D-lactate;interleukin(IL)-6;intestinal fatty acid binding protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Necrosis Factor-Alpha;C reactive protein;White Blood Cell Count;Neutrophil Percentage;procalcitonin; | — |
Countries
China
Contacts
Public ContactZhaoJian
Inner Mongolia Hospital Traditional Chinese Medicine Hospital
Outcome results
None listed