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Table 2 Flowchart for the present study

From: Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol

Item

Screening visit day

1st month

2nd month

3rd month

4th month

5th month

6th month

7th month

8th month

9th month

10th month

11th month

Informed consent

√

           

Basic informationa

√

           

Epidemiological investigationb

√

           

Underlying diseasec

√

           

Allocation

√

           

Intervention

 

√

√

√

√

√

√

√

√

√

√

√

 Chemotherapeutic drugs + No.1 + No.3 compound

 

√

√

√

√

√

√

√

√

√

√

√

 Chemotherapeutic drugs + No. 1 placebo + No. 3 placebo

 

√

√

√

√

√

√

√

√

√

√

√

 Chemotherapeutic drugs + No. 2 + No. 4 compound

 

√

√

√

√

√

√

√

√

√

√

√

 Chemotherapeutic drugs + No. 2 placebo + No. 4 placebo

 

√

√

√

√

√

√

√

√

√

√

√

Outcome measure

            

 Cure rate

           

√

 Time to sputum culture conversion

           

√

 Lesion absorption rate

√

  

√

  

√

    

√

 Cavity closure rate

√

  

√

  

√

    

√

The effect rate of TCM syndrome

√

  

√

  

√

    

√

Clinical manifestationsa

√

√

√

√

√

√

√

√

√

 

√

√

Chest CT

√

  

√

  

√

    

√

Culture of M.tba,b

√

√

√

√

√

√

√

√

√

√

√

√

Acid-Fast Bacilli sputum smeard,e

√

√

√

√

√

√

√

√

√

√

√

√

DSTd,e

√

√

√

√

√

√

√

√

√

√

√

√

Safety assessments

            

 Physical examinationd

√

√

√

√

√

√

√

√

√

√

√

√

 Vital signsd,f

√

√

√

√

√

√

√

√

√

√

√

√

 Physical examinationd

√

√

√

√

√

√

√

√

√

√

√

√

 Complete ophthalmological examinationd

√

√

√

√

√

√

√

√

√

√

√

√

 Blood routined

√

√

√

√

√

√

√

√

√

√

√

√

 Urine routined

√

√

√

√

√

√

√

√

√

√

√

√

 Liver functiond

√

√

√

√

√

√

√

√

√

√

√

√

 Kidney functiond

√

√

√

√

√

√

√

√

√

√

√

√

 Electrocardiogramd

√

√

 

√

       

√

 Blood glucose

√

√

 

√

       

√

 Adverse events recordedd,g

√

√

√

√

√

√

√

√

√

√

√

√

  1. CT computed tomography; DST drug susceptibility testing; M.tb: Mycobacterium tuberculosis; TCM traditional Chinese medicine
  2. aBasic information includes age, gender, height, weight, occupation, education, religion, income, residence, etc.
  3. bEpidemiological information includes: smoking, drinking, floating population, vagrant, use of corticosteroids, use of immunosuppressive agents, working within dusty, high-temperature or high-humidity environments, presence of silicosis, pneumoconiosis, pulmonary infection, traveling long distances, contact with TB or MDR-PTB patients, long term use of antibiotics, etc.
  4. cUnderlying diseases include: AIDS, hepatitis B, chronic obstructive pulmonary disease, asthma, diabetes, nervous system disease, hyperthyroidism, hypothyroidism, hypertension, hyperlipidemia, hyperuricemia, cardiovascular disease, autonomic dysfunction, hyperlipidemia, pulmonary malignancy, etc.
  5. dThese examinations or experiments will be conducted in each subject on the day of screening and each week during months 1–3
  6. eAfter the 11-month treatment, M.tb identification and DST will be performed monthly from months 12–16. The aim of the study is to assess whether MDR-PTB patients are cured by the end of month 11
  7. fVital signs include pulse rate, blood pressure, and respiratory rate
  8. gAdverse events include: systemic reactions (allergic reaction, headache, fever, fatigue), respiratory system (upper respiratory tract infection, spontaneous, lung infection, lung inflammation), digestive system (vomiting, impaired liver function, nausea, bloating, gastrointestinal discomfort, constipation, diarrhea, oral discomfort, dysphagia), skin system (mucocutaneous reactions, induration, erythema, edema, rash, pruritus), neurological system (neuro-cerebellar reactions, psychiatric disorder, reduced muscle strength, paresthesia). Musculoskeletal reactions (arthralgia, arthritis, myalgia). Laboratory test results (elevated erythrocytes, reduced hemoglobin, elevated hemoglobin, reduced leukocytes, elevated leukocytes, elevated platelets, reduced platelets, elevated uric acid, elevated urinary red blood cells, urine leukocytosis, elevated urinary protein, elevated urine, elevated alanine aminotransferase, elevated aspartate aminotransferase, reduced total bilirubin, elevated total bilirubin, reduced blood urea nitrogen, elevated blood urea nitrogen, reduced creatinine, elevated creatinine)