隨機、雙盲、以安慰劑為對照之人體研究評估補充刺五加萃取物對紅血球生成素反應不良之腎臟透析病人抗發炎及效益評估:先期試驗

A randomized, double-blind, placebo-controlled trial to evaluate the anti-inflammatory efficacy and health benefits of Eleutherococcus senticosus for subjects under renal dialysis with erythropoietin hyporesponsiveness: A pilot study

張育瑛

刺五加 ； 腎臟透析 ； 紅血球生成素反應不良 ； 貧血 ； 發炎 ； Eleutherococcus senticosus ； renal dialysis ； erythropoietin hyporesponsiveness ； anemia ； inflammation

中山醫學大學營養學系碩士班學位論文

2016年

碩士

楊乃成

繁體中文

發炎和腎臟透析病人死亡率具有高度的相關性，也是腎臟透析病人產生紅血球生成素反應不良的主因。許多的體外和動物試驗證實刺五加具有抗發炎的活性，但刺五加對於紅血球生成素反應不良之腎臟透析病人的保健功效目前並不清楚？本前導性研究主要探討口服刺五加萃取物對紅血球生成素反應不良之腎臟透析病人之發炎指標、貧血指標和健康指標的影響，並進行安全性評估。本研究預計名募30名紅血球生成素反應不良之腎臟透析病人，隨機分配成三組，包括口服刺五加單方、刺五加複方及安慰劑組。在口服產品三個月前後，採血檢測各指標的變化。本研究目前召募16名個案，但僅9個受測者完成三個月的刺五加補充，故本論文僅就9個受測者進行分析，因樣本數較少，除了三組比較外，亦將刺五加單方與複方組個案合併進行分析。本研究以Wilcoxon符號等級檢定比較食用前與食用後的變化情形，以Kruskal-Wallis檢定進行三組間的比較，以Mann-Whitney U檢定進行二組間的比較。在食用前後比較的結果發現，網狀紅血球(Reticulocyte)在服用刺五加後有顯著地上升。安全性指標的分析皆顯示無差異。本研究的結果顯示補充刺五加可以增加病人網狀紅血球數目，說明刺五加可能具有提升病人紅血球造血能力。由於目前個案數太少，所有結果須再進一步確認。

The main cause for the subjects under renal dialysis with erythropoietin hyporesponsiveness is inflammation which is highly correlated with mortality rates of renal dialysis patients. The Eleutherococcus senticosus (ES) has anti-inflammatory activity confirmed by in vitro and in vivo experiments; however, it’s health benefits is not clear for the subjects under renal dialysis with erythropoietin hyporesponsiveness. This pilot study focused on inflammatory indicators, anemia indicators, health indicators and safety assessments on the subjects with oral administration of ES. The study is expected to recruit 30 renal dialysis patients with erythropoietin hyporesponsivenes and the subjects were randomly assigned into three groups, including mono-ES formula, combined-ES formula and placebo groups. Before and after three months of oral administration, subject’s blood specimens were taken and all indices were tested. The study has currently recruited 16 cases, but only 9 subjects completed three months of ES supplement, and their data were analyzed. Due to the small sample size, in addition to the three groups, the mono- ES and combined- ES groups were combined as experimental ES group for analysis. The Wilcoxon signed rank test compared data obtained pre- and post-treatment. The Kruskal-Wallis test was used to compare the continuous variables among the three groups, and the the Mann-Whitney U test was performed to compare the difference between the two groups. After taking ES for three months, we found that reticulocyte have significantly elevated. The safety indicators all showed no difference when comparing with placebo. The results of this study show that the supplements increase reticulocyte count for the subjects, indicating ES might have the ability to enhance patient’s erythropoiesis. Due to the current number of cases is too small, all the results should be further confirmed.

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