Cornell Hugh J, Macrae Finlay A, Melny Joy, Pizzey Catherine J, Cook Fiona, Mason Sandra, Bhathal Prithi S, Stelmasiak Teodor
School of Applied Sciences, RMIT University, Melbourne, Victoria, Australia.
Scand J Gastroenterol. 2005 Nov;40(11):1304-12. doi: 10.1080/00365520510023855.
Enzyme therapy based on animal digestive extracts was investigated as a means of completely digesting toxic residues from gluten in the small intestine, thus providing a means of protection of the mucosa.
A randomized, placebo-controlled, clinical trial of an encapsulated enzyme extract was conducted in 21 coeliac patients in remission who were challenged with a modest amount of gluten daily over 2 weeks. Enzyme extract (900 mg) in three divided doses was administered during this challenge to half the group and a placebo to the other half in a double-blind, crossover design. Symptoms were recorded in daily diaries; blood was taken for tissue transglutaminase antibodies (anti-tTG) at the start and at intervals up to 12 weeks. Duodenal biopsies were performed for histological assessment at the start and end of each challenge period for 6 patients chosen at random from volunteers. After a further 10 weeks, the groups were changed over, and the same assessments carried out.
Only 8 of the 21 patients (38%) had more than 5 episodes of moderate to severe symptoms during either of the gluten challenge periods, and in these, symptoms scores were ameliorated during enzyme therapy compared with the placebo period (p<0.02). Rises of 5 U/ml or more in anti-tTG occurred in only 5 patients at about 6-8 weeks after challenge, but were not correlated with symptoms.
Only 1 of the 6 patients had normal histology at entry, thus focusing attention on the need for better management of the disease. By histological criteria, enzyme therapy offered better protection than placebo during the gluten challenges. The study supports the use of enzyme supplementation as a safeguard for patients with coeliac disease because of the difficulty of ensuring a strictly gluten-free diet.
研究基于动物消化提取物的酶疗法，作为一种完全消化小肠中麸质有毒残留物的方法，从而提供一种保护黏膜的手段。
对21名处于缓解期的乳糜泻患者进行了一项关于胶囊化酶提取物的随机、安慰剂对照临床试验，这些患者在2周内每天接受适量麸质激发。在激发期间，将酶提取物（900毫克）分三次给药给一半的患者，另一半患者给予安慰剂，采用双盲、交叉设计。症状记录在每日日记中；在开始时及直至12周的间隔时间采集血液检测组织转谷氨酰胺酶抗体（抗tTG）。从志愿者中随机选择6名患者，在每个激发期开始和结束时进行十二指肠活检以进行组织学评估。再过10周后，两组进行交叉，并进行相同的评估。
21名患者中只有8名（38%）在任何一个麸质激发期出现超过5次中度至重度症状发作，在这些患者中，与安慰剂期相比，酶疗法期间症状评分有所改善（p<0.02）。激发后约6 - 8周，只有5名患者抗tTG升高5 U/ml或更多，但与症状无关。
6名患者中只有1名在入组时组织学正常，因此需要关注对该疾病进行更好管理的必要性。根据组织学标准，在麸质激发期间，酶疗法比安慰剂提供了更好的保护。由于难以确保严格的无麸质饮食，该研究支持使用酶补充剂作为乳糜泻患者的一种保障措施。
