两种β-1,3-1,6葡聚糖变体联合使用对COVID-19患者白细胞介素-6、C反应蛋白和铁蛋白的有效控制：一项开放标签、前瞻性、随机临床试验
Efficient Control of IL-6, CRP and Ferritin in COVID-19 Patients With Two Variants of Beta-1,3-1,6 Glucans in Combination: An Open-Label, Prospective, Randomised Clinical Trial.
作者信息
Pushkala Subramanian, Seshayyan Sudha, Theranirajan Ethirajan, Sudhakar Doraisamy, Raghavan Kadalraja, Dedeepiya Vidyasagar Devaprasad, Ikewaki Nobunao, Iwasaki Masaru, Preethy Senthilkumar, Abraham Samuel Jk
机构信息
Department of Immunology, The Tamil Nadu Dr. M.G.R. Medical University, Chennai, India.
Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai, India.
出版信息
Glob Adv Integr Med Health. 2025 Mar 14;14:27536130251327134. doi: 10.1177/27536130251327134. eCollection 2025 Jan-Dec.
BACKGROUND
Several biomarkers, including C-reactive protein (CRP), ferritin, D-dimer, and Interleukin-6 (IL-6), are established predictors of disease severity and respiratory failure in patients with COVID-19.
OBJECTIVE
In this randomised clinical study, we evaluated the efficiency of the combination of 2 variants' AFO-202 and N-163 strains of produced 1,3-1,6 β-glucans in comparison with the control arm on these biomarkers in COVID-19 patients.
METHODS
Forty RT-PCR positive COVID-19 patients were divided into 2 groups: control (n = 22) and standard treatment; ii. (n = 18) - Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days.
RESULTS
IL-6 levels significantly decreased in the treatment group on day 7 ( = 0.03) but not by day 15 ( = 0.30). CRP levels in the treatment group decreased at day 7 (5.53 ± 8.21 mg/L) compared to baseline but showed no significant difference from the control group (4.91 ± 12.54 mg/L, = 0.98). At day 15, CRP levels remained lower in the treatment group (5.42 ± 10.41 mg/L) but increased in the control group (14.0 ± 37.16 mg/L), with no significant difference ( = 0.52). Ferritin levels dropped significantly in the treatment group by day 15 (from 560.58 ± 537.30 ng/mL to 127.51 ± 215.91 ng/mL) but increased in the control ( = 0.98). D-dimer levels decreased in the treatment group by day 15 but were not significantly different from controls ( = 0.56).
CONCLUSION
These results indicate that while co-supplementation with AFO-202 and N-163 beta-glucans led to improvement in CRP, ferritin, and IL-6 levels in COVID-19 patients, only the reduction in IL-6 levels on day 7 reached statistical significance. Further long-term multicentric clinical research is warranted to validate the potential of these supplements as treatment adjuncts, for addressing inflammation in COVID-19, especially in vulnerable populations infected with emerging SARS-CoV-2 variants.
背景
包括C反应蛋白（CRP）、铁蛋白、D-二聚体和白细胞介素-6（IL-6）在内的几种生物标志物是新冠病毒病（COVID-19）患者疾病严重程度和呼吸衰竭的既定预测指标。
目的
在这项随机临床研究中，我们评估了AFO-202和N-163两种菌株产生的1,3-1,6β-葡聚糖组合与对照组相比，对COVID-19患者这些生物标志物的影响。
方法
40例RT-PCR阳性的COVID-19患者分为两组：i. 对照组（n = 22），接受标准治疗；ii. 治疗组（n = 18），接受标准治疗 + AFO-202和N-163β-葡聚糖组合治疗15天。
结果
治疗组IL-6水平在第7天显著下降（P = 0.03），但在第15天未下降（P = 0.30）。治疗组CRP水平在第7天（5.53±8.21mg/L）较基线下降，但与对照组（4.91±12.54mg/L，P = 0.98）无显著差异。在第15天，治疗组CRP水平仍较低（5.42±10.41mg/L），而对照组升高（14.0±37.16mg/L），差异无统计学意义（P = 0.52）。治疗组铁蛋白水平在第15天显著下降（从560.58±537.30ng/mL降至127.51±215.91ng/mL），而对照组升高（P = 0.98）。治疗组D-二聚体水平在第15天下降，但与对照组无显著差异（P = 0.56）。
结论
这些结果表明，虽然联合补充AFO-202和N-163β-葡聚糖可改善COVID-19患者的CRP、铁蛋白和IL-6水平，但仅第7天IL-6水平的降低具有统计学意义。有必要进行进一步的长期多中心临床研究，以验证这些补充剂作为治疗辅助手段在应对COVID-19炎症方面的潜力，特别是在感染新型严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变体的脆弱人群中。
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