The authors' affiliations are listed in the Appendix.
N Engl J Med. 2014 Sep 18;371(12):1121-30. doi: 10.1056/NEJMoa1407380. Epub 2014 Sep 1.
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.
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.
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.
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.).
即使给予抗结核治疗，结核性心包炎仍与高发病率和死亡率相关。我们评估了辅助糖皮质激素治疗和印度分枝杆菌免疫治疗对结核性心包炎患者的疗效。
采用 2×2 析因设计，我们将 1400 例明确或可能的结核性心包炎成人患者随机分为泼尼松组或安慰剂组，疗程 6 周；并随机分为印度分枝杆菌免疫组或安慰剂组，疗程 3 个月，共 5 次皮下注射。三分之二的参与者同时感染了人类免疫缺陷病毒（HIV）。主要疗效终点为死亡、需要心包穿刺的心包填塞或缩窄性心包炎的复合终点。
泼尼松组和安慰剂组的主要结局无显著差异（分别为 23.8%和 24.5%；风险比，0.95；95%置信区间[CI]，0.77 至 1.18；P=0.66），印度分枝杆菌免疫组和安慰剂组的主要结局也无显著差异（分别为 25.0%和 24.3%；风险比，1.03；95%CI，0.82 至 1.29；P=0.81）。与安慰剂相比，泼尼松治疗显著降低了缩窄性心包炎的发生率（4.4% vs. 7.8%；风险比，0.56；95%CI，0.36 至 0.87；P=0.009）和住院率（20.7% vs. 25.2%；风险比，0.79；95%CI，0.63 至 0.99；P=0.04）。与安慰剂相比，泼尼松和印度分枝杆菌，每种药物都显著增加了癌症的发生率（1.8% vs. 0.6%；风险比，3.27；95%CI，1.07 至 10.03；P=0.03 和 1.8% vs. 0.5%；风险比，3.69；95%CI，1.03 至 13.24；P=0.03），主要是由于 HIV 相关癌症的增加。
在结核性心包炎患者中，泼尼松和印度分枝杆菌都不能显著降低死亡、心包填塞需要心包穿刺或缩窄性心包炎的复合终点发生率。（由加拿大卫生研究院和其他机构资助；IMPI ClinicalTrials.gov 编号，NCT00810849。）
