tailieunhanh - Báo cáo y học: " Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB,. | Butov et al. Journal of Immune Based Therapies and Vaccines 2011 9 3 http content 9 1 3 JOURNAL OF IMMUNE BASED THERAPIES AND VACCINES ORIGINAL RESEARCH Open Access Phase Ilb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis relapsed and multi-drug-resistant MDR TB 11 1 11 Dmitry A Butov Yuri N Pashkov Anna L Stepanenko Aleksandra I Choporova Tanya S Butova I Ì Z z l V I D r-y-l I r Á r Ý2 1 I li e c I e I lz- 13 Al z l z c D r I I z I I z4 I 7 it 1 Dendev Batdelger Vichiai Jirathitikal Aldar S Bourinbaiar Svetlana I Zaitzeva Abstract Placebo-controlled randomized phase 2b trial was conducted in 34 adults comprising 18 first-diagnosed 6 relapsed and 10 MDR-TB cases to investigate the safety and efficacy of an oral immune adjunct V5 . The immunotherapy N 24 and placebo N 10 arms received once-daily tablet of V5 or placebo for one month in addition to conventional anti-TB therapy ATT administered under directly observed therapy DOT . The enlarged liver total bilirubin erythrocyte sedimentation rate lymphocyte and leukocyte counts improved significantly in V5 recipients P and but remained statistically unchanged in the placebo group P and respectively . The changes in hemoglobin and ALT levels in both treatment arms were not significant. The body weight increased in all V5-treated patients by an average kg P while 6 out of 10 patients on placebo gained mean kg P . Mycobacterial clearance in sputum smears was observed in and 0 of patients on V5 and placebo P . The conversion rate in V5-receiving subjects with MDR-TB seemed to be higher than in first-diagnosed TB but the difference was not significant P . Scoring of sputum bacillary load range 3-0 at baseline and post-treatment revealed score reduction in 23 out of 24 V5 recipients from mean median 3 to 0 P 6E-010 but .

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