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一种新型天然来源疗法(NTN)在乳糖不耐受成年患者中的疗效与安全性:一项多中心、随机、交叉、双盲、安慰剂对照研究。

Efficacy and Safety of a Novel Therapeutic of Natural Origin (NTN) in Adult Patients with Lactose Intolerance: A Multicenter, Randomized, Crossover, Double-Blind, Placebo-Controlled Study.

作者信息

Pop Corina, Sporea Ioan, Santos Javier, Tudor Nicolae, Tiuca Nicoleta

机构信息

Department of Gastroenterology and Internal Medicine, Clinical Emergency University Hospital, Bucharest, Romania.

Department of Gastroenterology, Clinical Emergency University Hospital, Timisoara, Romania.

出版信息

Foods. 2022 Aug 26;11(17):2600. doi: 10.3390/foods11172600.

DOI:10.3390/foods11172600
PMID:36076786
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9455900/
Abstract

BACKGROUND

Film-forming substances, such as natural polysaccharides (NP) and pea proteins (PP), act as a protective barrier for treating various gastrointestinal conditions. We assessed the efficacy and safety of a novel therapeutic of natural origin (NTN) containing NP and PP for symptomatic treatment of lactose intolerance.

METHODS

In this multicenter, randomized, double-blind, parallel-group study, patients with lactose intolerance received NTN ( = 30) or placebo ( = 30) for 7 days, then the alternate treatment for 7 days. Patients rated their gastrointestinal symptoms using a 7-point Likert scale. The lactose hydrogen breath test was used to assess exhaled hydrogen.

RESULTS

NTN as primary or crossover treatment significantly improved patient-reported symptoms of bloating, distension, and abdominal pain. Abdominal pain also improved under primary treatment with placebo. Primary treatment with NTN, but not placebo, normalized mean exhaled hydrogen levels. In the group allocated initially to placebo, crossover to NTN attenuated the increase in hydrogen production. No treatment-related adverse effects were reported in either group.

CONCLUSIONS

Subjective improvements in bloating, distension, and abdominal pain with NTN were supported by objective evidence of hydrogen production normalization. NTN appears to be a useful alternative to lactose avoidance or enzyme replacement in patients with lactose intolerance.

摘要

背景

成膜物质,如天然多糖(NP)和豌豆蛋白(PP),可作为治疗各种胃肠道疾病的保护屏障。我们评估了一种含有NP和PP的新型天然疗法(NTN)对乳糖不耐受症状性治疗的疗效和安全性。

方法

在这项多中心、随机、双盲、平行组研究中,乳糖不耐受患者接受NTN(n = 30)或安慰剂(n = 30)治疗7天,然后交叉接受另一种治疗7天。患者使用7点李克特量表对胃肠道症状进行评分。乳糖氢呼气试验用于评估呼出氢气量。

结果

NTN作为初始治疗或交叉治疗均显著改善了患者报告的腹胀、腹部膨隆和腹痛症状。安慰剂初始治疗时腹痛也有所改善。NTN初始治疗可使呼出氢气平均水平恢复正常,而安慰剂则不能。在最初分配接受安慰剂治疗的组中,交叉接受NTN治疗可减弱氢气产生量的增加。两组均未报告与治疗相关的不良反应。

结论

NTN可使腹胀、腹部膨隆和腹痛症状主观改善,呼出氢气量恢复正常的客观证据也支持这一点。NTN似乎是乳糖不耐受患者避免摄入乳糖或使用酶替代疗法的一种有效替代方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/da8e6cf29eba/foods-11-02600-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/d22615adb24a/foods-11-02600-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/6fbcf74bd929/foods-11-02600-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/984e3b955f7c/foods-11-02600-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/da8e6cf29eba/foods-11-02600-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/d22615adb24a/foods-11-02600-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/6fbcf74bd929/foods-11-02600-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/984e3b955f7c/foods-11-02600-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/9455900/da8e6cf29eba/foods-11-02600-g004.jpg

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