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乳果糖联合枯草芽孢杆菌和屎肠球菌活菌胶囊治疗功能性便秘的疗效:一项多中心、随机、双盲、对照试验

[Efficacies of lactulose plus live combined Bacillus subtilis and Enterococcus faecium capsules in the treatment of functional constipation: a multicenter, randomized, double blind, controlled trial].

作者信息

Li Shi-Rong, Wang Hua-Hong, Wu Zuo-Yan, Liu Reng-Hai, Tong Mu-Hong, Wang Cang-Hai, Wang Rui-Ling, Zhao Hong-Chuan, Wei Wei

机构信息

Department of Gastroenterology, General Hospital of Beijing Military Region, Beijing, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2012 Nov 13;92(42):2955-60. doi: 10.3760/cma.j.issn.0376-2491.2012.42.002.

DOI:10.3760/cma.j.issn.0376-2491.2012.42.002
PMID:23328283
Abstract

OBJECTIVE

To explore the efficacies of live combined Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium) capsules plus lactulose in the treatment of functional constipation.

METHODS

A total of 216 patients fulfilling the diagnostic criteria of functional constipation (slow transit pattern) were randomly enrolled from 9 participating hospitals and allocated into treatment group and control group. The patients of treatment group received lactulose plus live combined B. subtilis and E. faecium capsules for 14 days and only took the latter during the following 14 days. The patients of control group received lactulose plus placebo for 2 weeks and then only took placebo continually for the following 2 weeks.

RESULTS

A total of 216 patients were analyzed (treatment group n = 104, control group n = 112). The effective rates of 7-day treatment were 88.46% (n = 92) and 84.82% (n = 95) for treatment and control groups respectively. And those of 28-day treatment were 87.50% (n = 91) and 81.25% (n = 91)respectively. And the inter-group differences were not statistically significant (all P > 0.05). Fecal form, frequency, difficulty, urgency, distension, abdominal pain and expelling rates of barium enema were not statistically significant (all P > 0.05). Comparing the effective rates of 28-day with that of 14-day, differences were not statistically significant in A group (S = 0.5, P = 0.4795), but in B group the effective rates of 28-day were lower than that of 14-day statistically(S = 11, P = 0.0009).

CONCLUSION

The regiment of live combined B. subtilis and E. faecium capsules plus lactulose offers better efficacies in the treatment of functional constipation.

摘要

目的

探讨枯草芽孢杆菌和屎肠球菌联合活菌胶囊联合乳果糖治疗功能性便秘的疗效。

方法

从9家参与研究的医院中随机纳入216例符合功能性便秘(慢传输型)诊断标准的患者,分为治疗组和对照组。治疗组患者接受乳果糖联合枯草芽孢杆菌和屎肠球菌联合活菌胶囊治疗14天,随后14天仅服用后者。对照组患者接受乳果糖联合安慰剂治疗2周,随后2周继续仅服用安慰剂。

结果

共分析216例患者(治疗组n = 104,对照组n = 112)。治疗组和对照组7天治疗的有效率分别为88.46%(n = 92)和84.82%(n = 95)。28天治疗的有效率分别为87.50%(n = 91)和81.25%(n = 91)。组间差异无统计学意义(均P > 0.05)。粪便形态、频率、排便困难、便急、腹胀、腹痛及钡剂灌肠排出率差异均无统计学意义(均P > 0.05)。比较28天与14天的有效率,A组差异无统计学意义(S = 0.5,P = 0.4795),但B组28天的有效率低于14天,差异有统计学意义(S = 11,P = 0.0009)。

结论

枯草芽孢杆菌和屎肠球菌联合活菌胶囊联合乳果糖方案治疗功能性便秘疗效更佳。

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