Study of Adjunctive Recombinant Human Interleukin-2 Therapy in Patients With MDR-TB (rhIL-2)
MDR TB
About this trial
This is an interventional treatment trial for MDR TB focused on measuring MDR-TB, rhIL-2, immunotherapy
Eligibility Criteria
Inclusion Criteria:
Patients had/were:
- a confirmed case of MDR-TB;
- aged 18-70 years old;
- a chest CT showing visible lung lesions, with or without holes;
- a fasting plasma glucose of less than 7.8 mol/L and a normal fundus examination, if they were diabetic;
- voluntarily joined this study and signed an informed consent form.
Exclusion Criteria:
- two or more total allergies or any drug or food allergies;
- resistant to some drugs of this program;
- severe disorders of liver, kidney, or hematologic system functions;
- any metabolic diseases, autoimmune diseases, endocrine diseases, cancer, or HIV/AIDS;
- a long-term use of immunosuppressive agents;
- a blood system dysfunction;
- a history of mental illness or epilepsy;
- pregnant or lactating;
- participated in another clinical trial in the last 3 months or were currently participating in other ongoing clinical trials;
- long-term alcohol abuse>10 years and more than two alcoholic drinks per day);
- any other factor rendering them unsuitable to participate in this project, such as a history of unreliability.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
rhIL-2 Group
Control Group
The patients in rhIL-2 Group were given consisted of four courses of low-dose rhIL-2 plus standard anti-tuberculosis chemotherapy. rhIL-2 (500,000U/m)regiman was given subcutaneously (SC) once every other day (q.o.d.) for 30 days and four courses were carried out separately during months 1, 3, 5, and 7. Standard anti-MDR-TB chemotherapy regiman was totally 24 months,including 6-month Z+KM/AM or CM + PAS/(Pa) + PTO +LFX as an intensive phase treatment, followed by an 18-month Z + LFX + PTO + PAS/(Pa) as a consolidation phase treatment.Then all the group patients were followed up for a minimum of 36 months.
The patients in Control Group were given standard anti-tuberculosis chemotherapy regiman.Standard anti-MDR-TB chemotherapy regiman was totally 24 months,including 6-month Z+KM/AM or CM + PAS/(Pa) + PTO +LFX as an intensive phase treatment, followed by an 18-month Z + LFX + PTO + PAS/(Pa) as a consolidation phase treatment.Then all the group patients were followed up for a minimum of 36 months