04167nas a2200781   4500000000100000008004100001653001000042653002200052653003000074653001100104653002000115653001900135653001100154653001800165653002600183653000900209653001800218653002300236653003100259653003000290653001700320653002200337100001400359700001400373700001200387700001300399700001100412700001400423700001200437700001400449700001300463700001400476700001600490700001300506700001300519700001500532700001300547700001300560700001600573700001900589700001200608700001200620700001400632700001200646700001200658700001300670700001300683700001300696700001400709700001200723700001400735700001400749700001200763700001400775700001100789700001100800700001000811700001600821700001100837700001200848700003000860245007900890856007500969300001201044490000801056520230701064022001403371       2014                            d10aAdult10aCardiac Tamponade10aCombined Modality Therapy10aFemale10aGlucocorticoids10aHIV Infections10aHumans10aImmunotherapy10aKaplan-Meier Estimate10aMale10aMycobacterium10aPericardiocentesis10aPericarditis, Constrictive10aPericarditis, Tuberculous10aPrednisolone10aTreatment Failure1 aMayosi BM1 aNtsekhe M1 aBosch J1 aPandie S1 aJung H1 aGumedze F1 aPogue J1 aThabane L1 aSmieja M1 aFrancis V1 aJoldersma L1 aThomas K1 aThomas B1 aAwotedu AA1 aMagula N1 aNaidoo D1 aDamasceno A1 aChitsa Banda A1 aBrown B1 aManga P1 aKirenga B1 aMondo C1 aMntla P1 aTsitsi J1 aPeters F1 aEssop MR1 aRussell J1 aHakim J1 aMatenga J1 aBarasa AF1 aSani MU1 aOlunuga T1 aOgah O1 aAnsa V1 aAje A1 aDanbauchi S1 aOjji D1 aYusuf S1 aIMPI Trial Investigators 00aPrednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.  uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4912834/pdf/nihms5772.pdf  a1121-300 v3713 a<p><strong>BACKGROUND: </strong>Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis.</p>

<p><strong>METHODS: </strong>Using a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo, administered in five injections over the course of 3 months. Two thirds of the participants had concomitant human immunodeficiency virus (HIV) infection. The primary efficacy outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis.</p>

<p><strong>RESULTS: </strong>There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo (23.8% and 24.5%, respectively; hazard ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P=0.66) or between those who received M. indicus pranii immunotherapy and those who received placebo (25.0% and 24.3%, respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P=0.81). Prednisolone therapy, as compared with placebo, was associated with significant reductions in the incidence of constrictive pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P=0.009) and hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P=0.04). Both prednisolone and M. indicus pranii, each as compared with placebo, were associated with a significant increase in the incidence of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to 10.03; P=0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P=0.03, respectively), owing mainly to an increase in HIV-associated cancer.</p>

<p><strong>CONCLUSIONS: </strong>In patients with tuberculous pericarditis, neither prednisolone nor M. indicus pranii had a significant effect on the composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. (Funded by the Canadian Institutes of Health Research and others; IMPI ClinicalTrials.gov number, NCT00810849.).</p>
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