Supplementary Material for: Effects of Melatonin and Propolis Supplementation on Inflammation, Oxidative Stress, and Clinical Outcomes in Patients with Primary Pneumosepsis: A Randomized Controlled Clinical Trial

Background & Objective: The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis. Materials and Methods: This pilot randomized controlled trial was conducted on 55 patients with primary pneumosepsis who were randomly assigned to the intervention and control groups. In the three intervention groups, the patients received propolis alone (1,000 mg/day), propolis (1,000 mg/day) plus melatonin (20 mg/day), and melatonin alone (20 mg/day). The control group received placebo. The inflammatory and oxidative stress markers as well as clinical outcomes were evaluated before and after the intervention, and the 28-day survival rate was also recorded. Results: After the intervention, the combination of propolis and melatonin significantly reduced interleukin-6 (-55.282 pg/ml ) and C-reactive protein (-21.656 mg/l ) levels, while increasing gavage intake (326.680 ml/day ) and improving some clinical outcomes (APACHE II, SOFA and NUTRIC scores) compared to control group. However, no significant difference was observed between the groups in terms of oxidative stress and hematological indices. In addition, the 28-day survival rate had no significant difference between the groups (P=0.07). Conclusion: Supplementation with propolis and melatonin may improve clinical outcomes by reducing inflammation. Further investigations are required to confirm these findings.

背景与目的：本研究旨在探讨补充蜂胶（propolis）与褪黑素（melatonin）对原发性肺脓毒症患者炎症反应、临床结局及氧化应激指标的影响。
材料与方法：本先导性随机对照试验纳入55例原发性肺脓毒症患者，按随机分配原则分为干预组与对照组。其中3个干预亚组分别接受单纯蜂胶（1000 mg/日）、蜂胶（1000 mg/日）联合褪黑素（20 mg/日）、单纯褪黑素（20 mg/日）干预，对照组则给予安慰剂。分别于干预前后检测炎症与氧化应激指标及临床结局，并记录受试者28天生存率。
结果：干预结束后，与对照组相比，蜂胶联合褪黑素干预组可显著降低白细胞介素-6（interleukin-6）与C反应蛋白（C-reactive protein）水平（分别下降55.282 pg/ml及21.656 mg/l），同时提升管饲摄入量（326.680 ml/日），并改善多项临床结局指标，包括APACHE II评分（Acute Physiology and Chronic Health Evaluation II）、SOFA评分（Sequential Organ Failure Assessment）及NUTRIC评分（Nutritional Risk in the Critically Ill）。但各组间氧化应激及血液学指标未观察到显著差异；此外，各组28天生存率亦无统计学差异（P=0.07）。
结论：补充蜂胶与褪黑素可能通过减轻炎症反应改善临床结局，上述结论尚需进一步开展研究予以验证。