Department of Emergency and Critical Care Medicine, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Department of Emergency and Critical Care Medicine, Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing, China.
Gut Liver. 2024 Sep 15;18(5):906-914. doi: 10.5009/gnl230326. Epub 2024 Feb 15.
BACKGROUND/AIMS: Metabolic syndrome is common in patients with acute pancreatitis and its components have been reported to be associated with infectious complications. In this analysis, we aimed to evaluate whether metabolic abnormalities impact the effect of immune-enhancing thymosin alpha-1 (Tα1) therapy in acute necrotizing pancreatitis (ANP) patients.
All data were obtained from the database for a multicenter randomized clinical trial that evaluated the efficacy of Tα1 in ANP patients. Patients who discontinued the Tα1 treatment prematurely were excluded. The primary outcome was 90-day infected pancreatic necrosis (IPN) after randomization. Three subgroups were defined based on the presence of hyperglycemia, hypertriglyceridemia, or both at the time of randomization. In each subgroup, the correlation between Tα1 and 90-day IPN was assessed using the Cox proportional-hazards regression model. Multivariable propensity-score methods were used to control potential bias.
Overall, 502 participants were included in this analysis (248 received Tα1 treatment and 254 received matching placebo treatment). Among them, 271 (54.0%) had hyperglycemia, 371 (73.9%) had hypertriglyceridemia and 229 (45.6%) had both. Tα1 therapy was associated with reduced incidence of IPN among patients with hyperglycemia (18.8% vs 29.7%: hazard ratio, 0.80; 95% confidence interval, 0.37 to 0.97; p=0.03), but not in the other subgroups. Additional multivariate regression models using three propensity-score methods yielded similar results.
Among ANP patients with hyperglycemia, immune-enhancing Tα1 treatment was associated with a reduced risk of IPN (ClinicalTrials.gov, Registry number: NCT02473406).
背景/目的：代谢综合征在急性胰腺炎患者中很常见，其成分已被报道与感染并发症有关。在本分析中，我们旨在评估代谢异常是否会影响免疫增强胸腺素α-1（Tα1）治疗在急性坏死性胰腺炎（ANP）患者中的疗效。
所有数据均来自多中心随机临床试验数据库，该试验评估了 Tα1 在 ANP 患者中的疗效。提前停止 Tα1 治疗的患者被排除在外。主要结局是随机分组后 90 天感染性胰腺坏死（IPN）。根据随机分组时是否存在高血糖、高三酰甘油血症或两者，将患者分为三个亚组。在每个亚组中，使用 Cox 比例风险回归模型评估 Tα1 与 90 天 IPN 的相关性。使用多变量倾向评分方法控制潜在偏倚。
总体而言，本分析共纳入 502 名参与者（248 名接受 Tα1 治疗，254 名接受匹配的安慰剂治疗）。其中，271 名（54.0%）有高血糖，371 名（73.9%）有高三酰甘油血症，229 名（45.6%）两者兼有。在高血糖患者中，Tα1 治疗与 IPN 发生率降低相关（18.8%比 29.7%：风险比，0.80；95%置信区间，0.37 至 0.97；p=0.03），但在其他亚组中则不然。使用三种倾向评分方法的附加多变量回归模型得出了相似的结果。
在有高血糖的 ANP 患者中，免疫增强 Tα1 治疗与 IPN 风险降低相关（ClinicalTrials.gov，注册号：NCT02473406）。
