Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.
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Mayosi Bongani M, Ntsekhe Mpiko, Bosch Jackie, Pandie Shaheen, Jung Hyejung, Gumedze Freedom, Pogue Janice, Thabane Lehana, Smieja Marek, Francis Veronica, Joldersma Laura, Thomas Kandithalal M, Thomas Baby, Awotedu Abolade A, Magula Nombulelo P, Naidoo Datshana P, Damasceno Albertino, Chitsa Banda Alfred, Brown Basil, Manga Pravin, Kirenga Bruce, Mondo Charles, Mntla Phindile, Tsitsi Jacob M, Peters Ferande, Essop Mohammed R, Russell James B W, Hakim James, Matenga Jonathan, Barasa Ayub F, Sani Mahmoud U, Olunuga Taiwo, Ogah Okechukwu, Ansa Victor, Aje Akinyemi, Danbauchi Solomon, Ojji Dike, Yusuf Salim, IMPI Trial Investigators
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.).