快樂小藥師 Im pharmacist nichts glücklich

作者：Mindy Hung, Medical Writer

出處：WebMD醫學新聞

審閱：Gary D. Vogin, MD

 　　Jan. 7, 2004--根據一項發表於一月份Gut期刊的隨機、雙盲研究結果顯示，每日一次高劑量的益生菌治療(VSL#3)證實能以抗生素誘導減輕迴腸囊袋炎病患的潰瘍性結腸炎。

　　英國倫敦聖馬克醫院的Toshiki Mimura博士和同事表示，與臨床、內視鏡和組織學的減輕相比，以這種療法能維持高水平的生活品質（QOL）。

　　調查人員從聖馬克醫院及義大利Bologna的一間中心招收36位復發(在前一年至少發生兩次)或難治 (需要連續使用抗生素) 的迴腸囊袋炎病患，所有病患的迴腸囊袋炎疾病活動指數(PDAI)的分數都在7以上，零分表示沒有發炎，而18則為最嚴重，研究人員以四週療程的抗生素metronidazole(400或500mg，每天兩次)及ciprofloxacin(500mg，每天兩次)誘導緩解所有病患。

　　研究人員將這二十位病患隨機分配到接受安慰劑，而16位病患接收每日一次的6g VSL#3(3-g的膠囊包含3千億菌/g，由四種乳酸菌、三種雙叉桿菌和一種嗜熱唾液鏈球菌所組成)持續一年或直到復發。

　　研究人員在隨機試驗前進行了體檢，並在12個月中每二個月進行一次或直到復發，復發被定義為與研究開始前相比，臨床PDAI分數增加2以上且內視鏡PDAI分數增加3以上，研究人員在隨機分配前、二個月及12個月時進行內視鏡和組織學的評估。

　　主要的研究終點是在12個月累計維持減輕比例，第二項結果為健康有關的QOL，在研究一開始，每二個月，和復發時使用發炎腸症問卷(IBDQ)評估。

　　研究人員在研究一開始，每兩個月和復發時評估其他第二項結果，病患治療滿意度，研究對象從下面選項選擇他們的解答：(1)非常不滿意，大部分時間都不高興；(2)大體上是不滿意，不高興；(3)普通；(4) 大體上是滿意，高興；(5)非常心滿意足，大部分時間都很高興。

　　研究人員證實經由接受有效療法或安慰劑的12位子群病患在治療一開始和60天後的糞便分析，有效組的病患糞便中存有活益生菌，參與率的中位數在VSL#3組為96%，在安慰劑組則為97%。

　　VSL#3組的十七位病患(85%)持續減輕一年，在安慰劑組中，則有一位病患(6%)維持減輕(P <.0001)，由於類似即興腸胃炎的症狀，VSL#3組的二位病患在第二個月及第八個月復發而退出，VSL#3組維持高IBDQ分數(P=.30 )但是安慰劑組(P=.0005 )在整年持續惡化。

　　在病患滿意度方面，調查人員在研究一開始並沒有找出兩組的顯著差異(中位數，4vs. 4分，P=.26)但是他們在復發時或12個月後則有顯著差異(VSLVSL#3組為4分vs. 安慰劑組2分;P<.0001 )。

　　Mimura醫師和同事表示，這項研究證實復發或難治型迴腸囊袋炎病患能以強力的抗生素治療獲得減輕，VSL#3 益生菌療法對於維持緩解是非常有效的。

Once-Daily Probiotic Treatment

By Mindy Hung, Medical Writer

Medscape Medical News

Jan. 7, 2004 - Once-daily high-dose probiotic therapy (VSL#3) sustains antibiotic-introduced remission in ulcerative colitis patients with pouchitis, according to a randomized, double-blind study published in the January issue of Gut.

"In parallel with clinical, endoscopic, and histological remission, a high level of QOL [quality of life] was maintained with this therapy," Toshiki Mimura, MD, and colleagues from St. Mark's Hospital in London, U.K., report.

Investigators drew 36 patients with recurrent (occurrence at least twice in the previous year) or refractory (requiring continuous use of antibiotics) pouchitis from St. Mark's Hospital and a center in Bologna, Italy.

All patients had a Pouchitis Disease Activity Index (PDAI) score of 7 or higher, with zero being no inflammation and 18 being the worst. Researchers induced remission in all patients with a four-week course of the antibiotics metronidazole (400 mg or 500 mg twice daily) and ciprofloxacin (500 mg twice daily).

Twenty patients were randomized to receive placebo, while 16 patients received 6g VSL#3 (3-g sachets containing 300 billion bacteria/g, made up of four strains of lactobacilli, three strains of bifidobacteria, and one strain of Streptococcus salivarius subsp thermophilus) once daily for one year or until relapse.

The researchers conducted physical examination prior to randomization and every two months for 12 months, or until relapse, which was defined as an increase in clinical PDAI score of 2 or higher together with an increase in the endoscopic PDAI score of 3 or higher compared with baseline. Researchers performed endoscopic and histological evaluations before randomization, at two months, and at 12 months.

The primary end point was a cumulative maintained remission rate at 12 months. Health-related QOL, a secondary outcome, was assessed at study entry, every two months, and at the time of relapse using the inflammatory bowel disease questionnaire (IBDQ).

Researchers evaluated the other secondary outcome, patient satisfaction with the treatment at study entry, every two months and at the time of relapse. Subjects chose their answer from the following options: (1) very dissatisfied, unhappy most of the time; (2) generally dissatisfied, unhappy; (3) neither dissatisfied nor satisfied; (4) generally satisfied, pleased; (5) very satisfied, happy most of the time.

Researchers confirmed the presence of viable probiotic bacteria in the stool of patients in the active group via stool analysis of a subgroup of 12 patients receiving active treatment or placebo at the beginning of treatment and after 60 days.

The median compliance rate was 96% in the VSL#3 group and 97% in the placebo group.

Seventeen patients (85%) in the VSL#3 group maintained remission at one year, while in the placebo group, one patient (6%) maintained remission (P < .0001). Two patients in the VSL#3 group relapsed at month two and month eight while one patient dropped out due to acute gastroenteritis-like symptoms.

The IBDQ score remained high in the VSL#3 group (P = .30) but deteriorated in the placebo group (P = .0005) over the year.

In terms of patient satisfaction, the investigators did not find a significant difference at entry between the two groups (median, 4 vs. 4 points; P = .26) but they differed significantly at the time of relapse or 12 months (4 points in the VSL#3 group vs. 2 points in the placebo group; P < .0001).

"This study has demonstrated that in patients with recurrent or refractory pouchitis who have achieved remission with intense antibiotic treatment, the probiotic therapy VSL#3 is highly effective in maintaining remission," write Dr. Mimura and colleagues.

This study was partially supported by VSL Pharmaceuticals, Inc.

Gut. 2004;53:108-114

Reviewed by Gary D. Vogin, MD

關鍵字： VSL VSL#3 IBS 迴腸囊袋炎