Talaromycosis is a leading cause of AIDS-associated opportunistic infections and death in Southeast Asia. We have recently shown in the Itraconazole versus Amphotericin for Talaromycosis (IVAP) trial that induction therapy with amphotericin B reduced mortality over 24 weeks, but not during the first 2 weeks. Antifungal treatment effects in real-world settings have not been rigorously evaluated. Using data obtained from patient records at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam from 2004 to 2009, we first developed a prognostic model using Bayesian logistic regression to identify predictors of death. Second, we developed a causal model using propensity score matching to assess the treatment effects of amphotericin B and itraconazole. Our prognostic model identified intravenous drug use (odds ratio [OR] = 2.01), higher respiratory rate (OR = 1.12), higher absolute lymphocyte count (OR = 1.62), a concurrent respiratory infection (OR = 1.67) or central nervous system infection (OR = 2.66) as independent predictors of death. Fever (OR = 0.56) was a protective factor. Our prognostic model exhibits good in-sample performance and out-of-sample validation, with a discrimination power of 0.85 and 0.91, respectively. Our causal model showed no significant difference in treatment outcomes between amphotericin B and itraconazole over the first 2 weeks (95% credible interval: 0.62, 2.50). Our prognostic model provides a simple tool based on routinely collected clinical data to predict individual patient outcome. Our causal model shows similar results to the IVAP trial at 2 weeks, demonstrating an agreement between real-world data and clinical trial data.

中文翻译：

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真实世界患者队列中 HIV 相关踝部真菌病的预后和治疗效果


踝部真菌病是东南亚艾滋病相关机会性感染和死亡的主要原因。我们最近在伊曲康唑与两性霉素治疗踝部真菌病 (IVAP) 试验中表明，两性霉素 B 的诱导治疗可降低 24 周内的死亡率，但在前 2 周内不会降低死亡率。现实世界中的抗真菌治疗效果尚未经过严格评估。利用从越南胡志明市热带病医院 2004 年至 2009 年的患者记录中获得的数据，我们首先使用贝叶斯逻辑回归开发了一个预后模型来识别死亡预测因素。其次，我们使用倾向评分匹配开发了一个因果模型来评估两性霉素 B 和伊曲康唑的治疗效果。我们的预后模型确定了静脉吸毒（比值比 [OR] = 2.01）、较高的呼吸频率（OR = 1.12）、较高的绝对淋巴细胞计数（OR = 1.62）、并发呼吸道感染（OR = 1.67）或中枢神经系统感染（OR = 2.66）作为死亡的独立预测因子。发烧（OR = 0.56）是一个保护因素。我们的预后模型表现出良好的样本内性能和样本外验证，辨别力分别为 0.85 和 0.91。我们的因果模型显示，两性霉素 B 和伊曲康唑在前 2 周内的治疗结果没有显着差异（95% 可信区间：0.62、2.50）。我们的预后模型提供了一个基于常规收集的临床数据的简单工具来预测个体患者的结果。我们的因果模型在两周时显示出与 IVAP 试验相似的结果，证明了真实世界数据与临床试验数据之间的一致性。