快樂小藥師 Im pharmacist nichts glücklich

作者：Deborah Brauser  

出處：WebMD醫學新聞

　　October 8, 2008（佛州奧蘭多訊）－一項小型研究結果指出，益生菌可能改善罹患大腸激躁症（IBS）兒童的生活品質與多重症狀。
　　
　　因為少有研究針對罹患IBS兒童治療的安全性及療效數據進行探討，最近一項研究針對59位年齡介於4至18歲病患，使用益生菌VSL #3的效果，這些病患來自美國、義大利與印度的7個兒童腸胃醫學中心。這項研究由主要作者、伊利諾州芝加哥大學兒科教授Stefano Guandalini發表於美國腸胃科醫學會（ACG）2008年會與畢業後學程。
　　
　　根據他的發表，這項研究的主要試驗終點是改善受試者的兒童緩解整體評估[SGARC]，次級試驗終點為改善腹部疼痛／不適、腹脹／脹氣、排便以及家人評估的生活品質。在發表會時，Guandalini解釋，IBS學齡兒童的盛行率可以高達15%，即使這並不會危及生命，或即使是危及健康的，但對這些病患確實是個問題。
　　
　　之後，Guandalini向Medscape腸胃學表示，在兒童身上，我們沒有太多藥物選擇像益生菌一樣安全，益生菌是一個引起科學研究興趣的熱門領域，這個結合VSL #3的特別配方已經在其他臨床狀況下被證實是有效的，因此，期待它們對於兒童同樣有效的概念是有道理的。
　　
　　在這項雙盲性、交叉臨床研究中，Guandalini博士與其研究團隊針對35位男性病患與24位女性病患，在隨機分派兩個星期前以問卷方式調查，之後使用益生菌（VSL #3，每天450萬凍乾粉細菌），或是外觀與味道相同的安慰劑，為期六週。4至11歲的兒童每天接受一次治療；12至18歲的兒童每天接受兩次治療。在兩個星期的洗去期後，病患被交換到另外一組，並接受額外六個星期的治療。12歲以下兒童的父母每天填寫問卷，以評估孩童治療前後的症狀與生活品質。年齡12歲以上的兒童在父母的監督下，自行填寫問卷。分數從0（最好）分到5（最差）分，每兩個星期收集一次這些填寫的資料。
　　
　　在試驗結束時，Guandalini博士的團隊發現，益生菌不但是安全的，且相較於安慰劑，也可以達到統計上顯著差異的SGARC分數改善，且改善4個次級試驗終點中的3個。Guandalini博士表示，改善的斜率是相當戲劇化的。雖然糞便狀態顯示有改善，但並未達到統計上顯著差異。在交叉測試後沒有顯著差異。
　　
　　相較於安慰劑，使用VLS #3 SGARC分數在六週從2.3分增加到4.0分，而安慰劑組從3.3分增加到4.0分。腹痛／不適在使用VLS #3，六週後從2.6分降低到1.2分，而安慰劑組從2.1降到1.6分。使用VLS #3六週後腹脹／脹氣從2.9分降到1.1分，安慰劑組從2.2分降到1.5分。家庭成員評估的生活品質中，沒有發現任何不良反應。
　　
　　座談會引言人、Cork愛爾蘭國立大學的醫學與人類生理學教授，同時也是ACG新當選的總裁，Eamonn Quigley醫師表示，Guandalini博士的研究是非常有趣的；雖然他說在我們對於這些結果具有信心前，應該進行更大型的研究。Quigley博士向Medscape腸胃學表示，這是一個很小型的研究，且是交叉試驗設計，這在IBS的研究上是有點問題的。顯然的，我希望看到更多研究數據，例如根據糞便型態的分析。
　　
　　他繼續說，不幸的，我們在罹患IBS成人的治療上處於一個很可怕的態勢，而在兒童身上，這個情況更嚴重。這項研究提供更多益生菌療效更多的證據，這是很好的第一步。
　　
　　這項研究並未接受商業贊助。Guandalini博士表示無相關資金上的往來。Quigley博士領取Proctor與Gamble公司的研究經費。 

Probiotics Appear Safe and Effective in Treating Children With IBS 

By Deborah Brauser
Medscape Medical News 

October 8, 2008 (Orlando, Florida) - Probiotics might improve quality of life and multiple symptoms in children with irritable bowel syndrome (IBS), according to results from a small new study.

Because few data exist on the safety and effectiveness of IBS treatment in children, a recent study was conducted to look at the effects of the probiotic VSL?#3 on 59 patients, aged 4 to 18 years, at 7 pediatric gastroenterology centers in the United States, Italy, and India. The study was presented here at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting and Postgraduate Course by lead investigator Stefano Guandalini, MD, professor of pediatrics at the University of Chicago, in Illinois.

According to his presentation, the study's primary end point was "improving the subject's global assessment of relief for children [SGARC], with secondary end points of improving abdominal pain/discomfort, abdominal bloating/gassiness, stool pattern, and the family's assessment of quality of life." During the presentation, Dr. Guandalini explained that "the prevalence of school-aged children with IBS can be up to 15%. And even though it's not life threatening or even health threatening, it's a real problem for these patients."

Later, Dr. Guandalini told Medscape Gastroenterology that, "in children, we don't have a lot of drugs or options of treatment that are as safe as probiotics." He continued: "Probiotics is a huge area of scientific interest, and this particular combination of VSL?#3 has been shown to be useful in other clinical settings. So there are conceptual reasons to expect that they should be beneficial and effective in children as well."

In this double-blind crossover trial, Dr. Guandalini and his research team assessed 35 male and 24 female patients for 2 weeks by questionnaire before randomly assigning either the probiotic agent (VSL?#3, 450?billion lyophilized bacteria/day) or an identical-looking and -tasting placebo for 6 weeks. Children aged 4 to 11 years were treated once a day; children aged 12 to 18 years received doses twice a day. After a 2-week wash-out period, patients were switched to the other group and underwent 6 more weeks of treatment. Parents filled out daily diary questionnaires for children 12 and younger to evaluate their symptoms and overall quality of life before and after each treatment. Patients older than 12 filled out their own questionnaires, with parental supervision. The ratings went from 0 (best) to 5 (worst), and all diaries were collected every 2 weeks.

At the end of the study, Dr. Guandalini's team found that not only was the probiotic agent safe, it also achieved a statistically significant improvement over placebo in SGARC and alleviated 3 of 4 secondary end points. "There was quite a dramatic slope of improvement there," said Dr. Guandalini. Although stool pattern showed improvement, it was not deemed statistically significant. There were no prevalent differences between each crossover phase.

SGARC score decreased from 4.0 at baseline to 2.3 after 6 weeks with VLS?#3, and from 4.0 at baseline to 3.3 with placebo. Abdominal pain/discomfort decreased from 2.6 to 1.2 after 6 weeks with VLS?#3, and from 2.1 to 1.6 with placebo. Abdominal bloating/gassiness decreased from 2.9 to 1.1 after 6 weeks with VLS?#3, and from 2.2 to 1.5 with the placebo. For family assessment of quality of life, no patient recorded any adverse effects.

Session moderator Eamonn Quigley, MD, professor of medicine and human physiology at the National University of Ireland, in Cork, and the newly elected president of the ACG, found Dr. Guandalini's study "very interesting," although he said a larger study is needed "before we can be convinced [about the results]". Dr. Quigley told Medscape Gastroenterology that "it's a small study and it's got a crossover design, which is slightly problematic in terms of IBS. Obviously I would like to see more data, [such as] a breakdown according to stool type."

He continued: "Unfortunately, we have a dreadful situation in terms of therapies for adults with IBS. And for children, it's even worse. [This study] provides more evidence for the efficacy of probiotics. It's an excellent first step."

The study did not receive commercial support. Dr. Guandalini disclosed no relevant financial relationships. Dr. Quigley has had research supported by Proctor and Gamble and is affiliated with Alimentary Health, which holds patents in the area of probiotics.

American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting and Postgraduate Course: Abstract 11. Presented October 6, 2008.

關鍵字： VSL VSL#3 IBS 大腸激躁症 潰瘍性結腸炎