摘要
研究背景： 慢性便秘是小兒科門診常見的案例，傳統上治療是長期使用軟便劑及促進腸胃蠕動藥劑(例如：cisapride)，但是近年來cisapride因為合併其他藥物或食物所引起的嚴重副作用而遭禁用。一種安全、有效而且為病人及家長更容易接受的治療方法是需要的。益生菌（probiotics）是人體內正常且有益健康的微生物，已有許多研究證明其具有促進腸胃道蠕動的功能。本研究的目的就是要探討利用益生菌來治療兒童慢性便秘之效用，特別與安慰劑及目前使用的軟便劑magnesium oxide （MgO）做比較。 研究方法： 這是一個隨機、雙盲及有安慰劑控制的試驗，在父母親同意及人體試驗委員會核可之下，選取45位年齡小於10歲的慢性便秘兒童，病人以隨機方式分為三組，其中A組使用益生菌Lactobacillus casei rhamnosus (Lcr35)，劑量為8x108 CFU/day (Antibiophilus 250mg, 2 capsules, Bid)，B組使用軟便劑MgO（50mg/kg/day, bid），C組使用安慰劑，治療時間為4週。在試驗期間若有超過3天以上未排便，才可使用軟便劑lactulose (1-2 cc/kg/day)，直到有排便時則停藥，若有超過5天以上未排便或有因積便而造成腹痛時，才可使用甘油灌腸 (glycerin enema)。觀察三組病人在治療期間便秘症狀的改變，包括：排便的頻率、糞便的硬度及性狀、滲便(soiling)、腹痛等現象，以及使用軟便劑或灌腸的次數。並分別在投藥前及治療結束後做糞便細菌培養，觀察病人在治療前及治療後糞便內大腸桿菌佔所有嗜氧菌之比率及乳酸菌佔所有厭氧菌之比率變化。 研究結果： 益生菌組及MgO組的病童比安慰劑組之病童有較高的排便頻率（p=0.03）、較少的灌腸劑使用數（p=0.04）及較少的硬便或血便產生（p=0.01）。以上三項比較在益生菌組及MgO組之間則無差異。益生菌組比MgO組或安慰劑組之病童較少產生腹痛症狀（p=0.03）。三組病童在lactulose使用數、滲便（fecal soiling）次數及食慾改變上都沒有明顯差異（p=0.66, 0.95 和0.81）。益生菌組和安慰劑組都沒有副作用之報告，MgO組有一位病童有輕微腹瀉症狀產生。在治療之前，三組病童之糞便菌叢並無明顯差異。在治療之後，乳酸菌佔所有厭氧菌之比率在益生菌組比MgO組及安慰劑組高（P < 0.05）；大腸桿菌佔所有嗜氧菌之比率在三組都沒有差異。若以同一組治療後和治療前做比較，乳酸菌佔所有厭氧菌之比率在益生菌組有明顯增加（p=0.03），在MgO組及安慰劑組則無改變。 結論： 益生菌（Lactobacillus casei rhamnosus, Lcr35）可有效治療兒童之慢性便秘，其效果與傳統之軟便劑MgO並無明顯差異，但是較少產生腹痛症狀。
並列摘要
Purpose: To evaluate the efficacy of probiotics (Lactobacillus casei rhamnosus, Lcr35) for treating children with chronic constipation and to compare its effect with magnesium oxide (MgO) and placebo. Methods: This double-blind placebo-controlled, randomized study enrolled forty-five children under 10 years old with chronic constipation. Children with organic causes of constipation were excluded. They were randomly assigned to receive Lcr35 (8x108 CFU/day)(n=18), MgO (50mg/kg/day)(n=18) or placebo (n=9) orally twice daily for 4 weeks. Lactulose (1 cc/kg/day) was allowed to use when no stool passage was noted for 3 days. Glycerin enema was used only when no defecation was noted for above 5 days or abdominal pain was suffered due to stool impaction. Bacterial cultures of stool were performed before and after treatment to evaluate the change of intestinal flora. Comparisons of the frequency of defecation, consistence of stool and the use of lactulose or enema were made among the three groups. Results: The patients who received MgO or probiotics had a higher defecation frequency (p=0.03), less use of glycerin enema (p=0.04) and less hard stool or bloody stool (p=0.01) than placebo group. There was no difference between MgO and probiotics groups in the above three comparisons. Abdominal pain was less occurred in probiotics group than in both the MgO and the placebo groups (p=0.03). There was no significant difference among the three groups in the use of lactulose, episodes of fecal soiling, and change of appetite. Conculsion: Lcr35 was effective to treat children with chronic constipation. There is no difference in efficacy between MgO and Lcr35, but less abdominal pain occurs when using Lcr35.