Table 4 Measurement endpoints in present study

Primary endpoint

Cure rate is defined as will be five consecutive negative liquid cultures from sputum samples at a time interval of 30 days at the end of treatment

Secondary endpoints

Time to sputum culture conversion will be calculated as the interval in days between the date of treatment initiation for MDR-PTB and the date of the first of the 2 consecutive negative sputum cultures from sputa collected at least 30 days apart

Cavity change rate (%) = 100% × (number of cavity change patients/number of patients). For changes in cavity size, scar healing, and block healing or disappearance are defined as closed. A reduction in cavity size by 1/2 or more is defined as reduced, a reduction in cavity diameter by less than 1/2 is classified as unchanged, and increased cavity diameter by 1/2 or more is defined as increased. CT results were assessed and interpreted independently by two experienced radiologists who were blinded to the study design. If inconsistent, a third expert will be invited to re-read

Lesion absorption rate (%) = 100% × (number of lesion absorption subjects/number of subjects). The clinical criteria for CT changes are as follows [15], absorption of 1/2 or more of the lesions will be classified as significant absorption, while absorption of less than 1/2 of the lesions or an increase or emergence of new lesions will be classified as deterioration

Effect rate of the TCM syndrome = 100% × (clinically cured cases + cases with a notable effect + cases effectively treated)/total number of cases. The efficacy was demonstrated by four possible descriptors in accordance with the TCM clinical research principles [17], namely clinical cure, notable effect, effective or ineffective. The specific classification criteria are as follows: I) clinical cure: rate of reduction in TCM syndrome scores ≥ 95%; II) notable effect: rate of reduction in TCM syndrome scores between 70 and 95%; III) effective: reduction in TCM syndrome score between 30 and 70%; IV) ineffective: reduction in TCM syndrome scores < 30%

Safety endpoints

 Adverse events

  Systemic reaction

Allergic reaction, headache, fever, fatigue

  Laboratory tests

Elevated erythrocytes, reduced hemoglobin, elevated hemoglobin, reduced leukocytes, elevated leukocytes, elevated platelets, reduced platelets, elevated uric acid, etc

  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, induration, erythema, edema, rash, pruritus

  Neurological system

Neuro-cerebellar or psychiatric reactions, Muscle strength reduction, Paresthesia (burning, tingling), Neuro-sensory reaction

  Musculoskeletal

Arthralgia (joint pain), arthritis, myalgia

 Serious adverse events

Death, life-threatening reaction requiring inpatient hospitalization or prolongation of existing inpatient hospitalization, congenital abnormality or birth defect, persistent or significant disability or incapacity, or otherwise considered medically significant by the investigator