- 期刊
肝硬化相關的門脈高壓症患者食用益生菌的安全性－臨床試驗
The Safety of Probiotics for Patient with Cirrhosis-related Portal Hypertension: Clinical Studies
摘要
近日之醫學研究指出，益生菌可刺激腸道之免疫力而具有多項益生功效，包括緊縮腸道腸細胞間隙，因此可以減少細菌穿透腸壁進入血流的機會，進而改善全身的發炎。康貝兒(+)乳酸菌(GK#10)為市面上保健食品，其購買者大多皆為健康者，而對患有潛在疾病的高風險族群如低免疫力的肝硬化尤其併有門脈高壓之病人，若攝取高量益生菌，是否會有安全上的疑慮，值得嚴格地加以評估。基於此安全與應用範圍的考量，本臨床研究以複合性益生菌株與高乳酸菌菌數產品應用於高風險族群患者。本臨床實驗一共蒐集高風險患者49位患者進行試驗與血液分析，追蹤受試者經八周的口服試驗物（GK#10或安慰劑組）與停用四周後，分別於第0、5、9及13周抽血檢驗血液生化值進行分析與評估。經由血液生化值統計可知，連續八周攝取康貝兒(+)乳酸菌GK#10或安慰劑組臨床試驗血液生化值分析統計顯示該乳酸菌產品安全無虞，不會對高風險患者族群造成任何併發症。
並列摘要
Recent medical studies indicate that probiotics can stimulate the intestinal immunity and have many beneficial effects. GK#10, a functional food launched by a domestic company, is popular among Taiwanese. The usual consumers are healthy. However, the safety in cirrhotic patients, especially in high risk patients, is not well evaluated. We conducted a clinical trial at National Cheng Kung University Hospital. Forty-nine cirrhotic patients were invited using probiotics, GK #10, when they were discharged from hospital. They were randomized devided into probiotics using group and non-using group (control) group. The placebo and the probiotics grups looks the same in appearance and the same taste. The dose is 4.5x10^(11) cfu/day in probiotics-using group. All patients received blood tests on entering the trial and week 5, 9, and 13, respectively. Our data showed that GK #10 is safe in the high risk cirrhotic patients, as shown in liver function tests, renal function tests, and clinical outcome. Our study has some limitations because of not so many patients are recruited, and the observation period was short. However, even in such high risk patients, GK# 10 shows safety in all patients and some beneficial effects in some disease parameters.