Myers Stephen P, O'Connor Joan, Fitton J Helen, Brooks Lyndon, Rolfe Margaret, Connellan Paul, Wohlmuth Hans, Cheras Phil A, Morris Carol
NatMed-Research Unit, Research Cluster for Health and Wellbeing, Southern Cross University, Lismore, NSW, Australia;
Biologics. 2011;5:45-60. doi: 10.2147/BTT.S12535. Epub 2011 Feb 15.
Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study.
Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity.
The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes.
The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration.
已证明从褐藻中分离出的岩藻聚糖具有一系列免疫调节作用。这项探索性研究旨在确定一种包含三种不同褐藻提取物与营养素混合物的海藻营养复合物给药是否安全，以及是否具有作为免疫调节剂的生物学潜力。该研究作为一项开放标签的I期和II期联合研究进行。
10名参与者被随机分为两组，在4周内分别接受100毫克（n = 5）或1000毫克（n = 5）剂量的研究药物。主要结局指标是淋巴细胞亚群的体内变化。次要结局指标是T淋巴细胞（CD4和CD8）活化的体外变化、粒细胞和单核细胞的吞噬作用、辅助性T细胞1/辅助性T细胞2细胞因子以及血清氧自由基吸收能力。
在所测试的两种剂量下，该制剂在4周内均被发现是安全的。造血、肝脏或肾脏功能的血液测量结果没有临床相关变化。免疫调节测量结果显示，两种剂量之间没有剂量反应。两种剂量的综合结果表明，细胞毒性T细胞数量和单核细胞吞噬能力显著增加，炎症细胞因子白细胞介素6水平显著降低。单独对100毫克剂量（n = 5）进行的分析显示，粒细胞和单核细胞的吞噬作用随时间有显著的线性变化（P < 0.05）。
口服4周时，海藻营养复合物使用安全。该制剂被证明具有作为免疫调节剂的潜力，这种生物活性值得进一步探索。
