Iddrisu Abdul-Karim, Otoo Dominic, Kwasi Afa, Gumedze Freedom
Department of Mathematics and Statistics University of Energy and Natural Resources Sunyani Ghana.
Department of Statistical Sciences University of Cape Town Rondebosch South Africa.
Health Sci Rep. 2024 Feb 14;7(2):e1892. doi: 10.1002/hsr2.1892. eCollection 2024 Feb.
Tuberculous (TB) pericarditis (TBP), a TB of the heart, is linked to significant morbidity and mortality rates. Administering glucocorticoid therapy to individuals with TBP might enhance overall results and lower the likelihood of fatality. However, the actual clinical effectiveness of supplementary glucocorticoids remains uncertain. This study specifically evaluated the effects of prednisolone, prednisolone-antiretroviral therapy (ART) interaction, and other potential risk factors in reducing the hazard of the composite outcome, death, cardiac tamponade, and constriction, among TBP and human immunodeficiency virus (HIV) patients.
The data used in this study were obtained from the investigation of the Management of Pericarditis trial, a multicentre international randomized double-blind placebo-controlled factorial study that investigated the effects of two TB treatments, prednisolone and immunotherapy in patients with TBP in Africa. This study used a sample size of 587 TBP and HIV-positive patients randomized into prednisolone and its corresponding placebo arm. We used the extended Cox-proportional hazard model to evaluate the effects of the covariates on the hazard of the survival outcomes. Models fitting and parameter estimation were carried out using R version 4.3.1.
Prednisolone reduces the hazard of composite outcome (hazrad ratio [HR] = 0.32, 95% confidence interval [CI] = , < 0.001), cardiac tamponade (HR = 0.14, 95% CI = 0.05, 0.42, < 0.001) and constriction (HR = 0.81, 95% CI = 0.41, 1.61, = 0.55). However, prednisolone increases the hazard of death (HR = 1.58, 95% CI = 1.11, 2.24, = 0.01). Consistent usage of ART reduces the hazard of composite outcome, death, and constriction but insignificantly increased the hazard of cardiac tamponade.
The study offers valuable insights into how prednisolone impact the hazard of different outcomes in patients with TBP and HIV. The findings hold potential clinical significance, particularly in guiding treatment decisions and devising strategies to enhance outcomes in this specific patient group. However, there are concerns about prednisolone potentially increasing the risk of death due to HIV-related death.
结核性心包炎（TBP）是一种心脏结核，与显著的发病率和死亡率相关。对TBP患者使用糖皮质激素治疗可能会改善总体疗效并降低死亡风险。然而，补充糖皮质激素的实际临床效果仍不确定。本研究特别评估了泼尼松龙、泼尼松龙与抗逆转录病毒疗法（ART）的相互作用以及其他潜在风险因素对降低TBP和人类免疫缺陷病毒（HIV）患者复合结局（死亡、心脏压塞和缩窄）风险的影响。
本研究使用的数据来自心包炎管理试验的调查，这是一项多中心国际随机双盲安慰剂对照析因研究，调查了两种结核病治疗方法（泼尼松龙和免疫疗法）对非洲TBP患者的影响。本研究纳入了587名TBP和HIV阳性患者，随机分为泼尼松龙组及其相应的安慰剂组。我们使用扩展的Cox比例风险模型来评估协变量对生存结局风险的影响。使用R版本4.3.1进行模型拟合和参数估计。
泼尼松龙降低了复合结局（风险比[HR]=0.32，95%置信区间[CI]= ，<0.001）、心脏压塞（HR=0.14，95%CI=0.05，0.42，<0.001）和缩窄（HR=0.81，95%CI=0.41，1.61，=0.55）的风险。然而，泼尼松龙增加了死亡风险（HR=1.58，95%CI=1.11，2.24，=0.01）。持续使用ART降低了复合结局、死亡和缩窄的风险，但显著增加了心脏压塞的风险。
该研究为泼尼松龙如何影响TBP和HIV患者不同结局的风险提供了有价值的见解。这些发现具有潜在的临床意义，特别是在指导治疗决策和制定策略以改善这一特定患者群体的结局方面。然而，人们担心泼尼松龙可能会增加因HIV相关死亡导致的死亡风险。
