Ntsekhe M, Wiysonge C, Volmink J A, Commerford P J, Mayosi B M
Cardiac Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa.
QJM. 2003 Aug;96(8):593-9. doi: 10.1093/qjmed/hcg100.
There is controversy regarding the effectiveness of corticosteroids in tuberculous pericarditis, particularly in patients who are immunocompromised by HIV.
To determine the effectiveness of adjuvant corticosteroids in tuberculous pericarditis.
Systematic review of randomized controlled trials.
We searched the Cochrane Infectious Diseases Group trials register (June 2002), the Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (January 1966 to March 2003), EMBASE (1980 to May 2002), and the reference lists of existing reviews, for randomized and quasi-randomized controlled trials of adjuvant corticosteroids in the treatment of suspected tuberculous pericarditis. We also contacted organizations and individuals working in the field. Two reviewers independently assessed trial quality and extracted data. We used meta-analysis with a fixed effects model to calculate the summary statistics, provided there was no statistically significant heterogeneity, and expressed results as relative risk.
Four trials with a total of 469 participants met our criteria. Three (total n = 411) tested adjuvant steroids in participants with suspected tuberculous pericarditis in the pre-HIV era. Fewer participants died in the intervention group, but the potentially large reduction in mortality was not statistically significant (relative risk RR 0.65, 95%CI 0.36-1.16, n = 350; p = 0.14). One trial with 58 patients that enrolled HIV-positive individuals also showed a promising but non-significant trend on mortality (RR 0.50, 95%CI 0.19-1.28; p = 0.15). There was no significant beneficial effect of steroids on re-accumulation of pericardial effusion or progression to constrictive pericarditis. Patients with pericardial effusion were significantly more likely to be alive with no functional impairment at 2 years following treatment. However, the effect was not sustained in a sensitivity analysis that included patients who were lost to follow-up.
Steroids could have large beneficial effects on mortality and morbidity in tuberculous pericarditis, but published trials are too small to be conclusive. Large placebo-controlled trials are required, and should include sufficient numbers of HIV-positive and HIV-negative participants, and an adequate adjuvant steroid dose.
关于皮质类固醇在结核性心包炎中的疗效存在争议，尤其是在因感染HIV而免疫功能低下的患者中。
确定辅助性皮质类固醇在结核性心包炎中的疗效。
对随机对照试验的系统评价。
我们检索了Cochrane传染病组试验注册库（2002年6月）、Cochrane对照试验注册库（2002年第2期）、MEDLINE（1966年1月至2003年3月）、EMBASE（1980年至2002年5月）以及现有综述的参考文献列表，以查找辅助性皮质类固醇治疗疑似结核性心包炎的随机和半随机对照试验。我们还联系了该领域的组织和个人。两名评价员独立评估试验质量并提取数据。如果不存在统计学上的显著异质性，我们使用固定效应模型进行荟萃分析来计算汇总统计量，并将结果表示为相对风险。
四项试验共469名参与者符合我们的标准。三项试验（共n = 411）在HIV流行前时代对疑似结核性心包炎患者测试了辅助性类固醇。干预组死亡的参与者较少，但死亡率的潜在大幅降低在统计学上并不显著（相对风险RR 0.65，95%CI 0.36 - 1.16，n = 350；p = 0.14）。一项纳入58名HIV阳性个体的试验也显示出死亡率有前景但不显著的趋势（RR 0.50，95%CI 0.19 - 1.28；p = 0.15）。类固醇对心包积液的再积聚或进展为缩窄性心包炎没有显著的有益作用。心包积液患者在治疗后2年存活且无功能障碍的可能性显著更高。然而，在一项包括失访患者的敏感性分析中，该效果未持续。
皮质类固醇可能对结核性心包炎的死亡率和发病率有很大的有益作用，但已发表的试验规模太小，无法得出结论。需要进行大规模的安慰剂对照试验，且应包括足够数量的HIV阳性和HIV阴性参与者，以及合适的辅助性类固醇剂量。
