Adjunctive therapy with V-5 Immunitor (V5) for the treatment of tuberculosis patients: a meta-analysis.

Objective: To evaluate the effectiveness and safety of V-5 immunitor (V5) added to chemotherapy of tuberculosis (TB) patients. Methods: The databases Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, SCI, CBM, VIP and CNKI were searched. Randomized controlled trials (RCT) and controlled clinical trials (CCT) of V5 immunitor with or without a placebo-control as adjuvant therapy in the chemotherapy of TB patients were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 5.3 software by The Cochrane Collaboration. Results: Four studies were included. At the end of the follow-up period, pooled RR (Risk Ratio) and its 95% CI of sputum smear conversion rate were 4.91 (3.32, 7.28) in drug-sensitive, drug-resistant TB patients or HIV-TB co-infection patients. When analyzing inflammation biomarkers including ESR and leukocyte accounts, pooled mean difference and its 95% CI of ESR and leukocyte accounts were -7.62 (-9.55,-5.68) and-2.13 (-2.58,-1.68), respectively. As to body weight, pooled mean difference and its 95% CI were 0.96 (-1.13, 3.05) in TB patients. Two clinical trials were included for analyzing temperature after using V5 immunitor, pooled mean difference and its 95% CI were-0.34 (-0.46, -0.22) in TB patients. These results suggested that V5 immunitor holds important promise in improving sputum conversion to AFB- and inhibiting inflammatory reaction in TB patients, but showed no significant promotion to the increase in body weight based on this meta-analysis. Compared with the control group, V5 immunitor may have some potential in decreasing the temperature of TB patients. No systemic adverse events were reported. Conclusion: Added to chemotherapy, V5 immunitor seems to be helpful in the treatment of TB patients in terms of improving sputum conversion and reducing inflammatory reactions.