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双歧杆菌四联活菌片治疗迁延性、慢性腹泻的随机对照临床研究 被引量:31

Efficacy and safety of Bifidobacterium tetravaccine tablets in the treatment of persistent and chronic diarrhea:a randomized controlled clinical study
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摘要 目的对比双歧杆菌四联活菌片与双歧杆菌三联活菌胶囊、地衣芽孢杆菌活菌胶囊联用治疗迁延性及慢性腹泻的疗效差异。方法纳入2015年9月至2016年6月以迁延性及慢性腹泻症状为主诉的门诊患者484例,分为观察组(双歧杆菌四联活菌片治疗)和对照组(双歧杆菌三联活菌胶囊联合地衣芽孢杆菌活菌胶囊治疗),观察治疗前后两组患者排便次数、粪便性状和疗效差异。同组治疗前后比较采用配对t检验,组间比较采用独立样本t检验。率的比较采用卡方检验。结果观察组260例,脱落4例,完成256例;对照组258例,脱落30例,完成228例。观察组治疗后日排便次数为(2.13±1.06)次,低于治疗前的(3.83±0.95)次,差异有统计学意义(t=29.149,P〈0.01)。对照组治疗后日排便次数为(2.19±1.06)次,低于治疗前的(3.87±0.98)次,差异有统计学意义(t=27.800,P〈0.01)。两组治疗前及治疗后排便次数差异均无统计学意义(t=-0.460、-0.662,P均〉0.05)。观察组和对照组治疗后两组排便正常率[50.8%(130/256)比57.9%(132/228)]比较差异无统计学意义(χ2=2.458,P=0.117)。观察组和对照组有效率[64.8%(166/256)比69.7%(159/228)]和显效率[47.7%(122/256)比51.3%(117/228)]差异均无统计学意义(P=0.253、0.422)。两组均无严重不良反应发生。结论在改善腹泻患者的排便次数及粪便性状方面,多菌种单药制剂双歧杆菌四联活菌片与双歧杆菌三联活菌胶囊、地衣芽孢杆菌活菌胶囊联用具有同样令人满意的疗效及良好的安全性。 ObjectiveTo compare the differences in the efficacy of Bifidobacterium tetravaccine tablets. Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule in the treatment of persistent and chronic diarrhea.MethodsFrom September 2015 to June 2016, a total of 484 outpatients with persistent and chronic diarrhea were enrolled and divided into observation group (treated with Bifidobacterium tetravaccine tablets) and control group (treated with the combination of Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule). Before and after treatment, the frequency of defecation and the characters of stool were observed and the differences in the treatment efficacy in persistent and chronic diarrhea between two groups were compared. Paired t test and Chi square test were used to compare the difference before and after treatment in each group, and independent sample t test was used for comparison between groups.ResultsThere were a total of 256 patients in the observation group (four cases lost and 256 cases were completed). Meanwhile there were 228 patients in the control group (30 cases lost and 228 cases completed). In the observation group, after treatment the frequency of defecation was (2.13±1.06) times, which was less than that before treatment ((3.83±0.95) times), and the difference was statistically significant (t=29.149, P〈0.01). In the control group, after treatment the frequency of defecation was (2.19±1.06) times, which was less than that before treatment ((3.87±0.98)times), and the difference was statistically significant(t=27.800, P〈0.01). There was no statistically significant difference in the frequency of defecation before and after treatment between two groups ( t=-0.460 and -0.662, both P〉0.05). Furthermore there was also no statistically significant difference in the rate of normal bowel movements between observation group and treatment group after treatment (50.8%(130/256) vs 57.9%(132/228; χ2=2.458, P=0.117). There was no significant difference in effective rate (64.8%(166/256) vs 69.7%(159/228) and excellence rate (47.7%(122/256) vs 51.3%(117/228)) between two groups (P=0.253 and 0.422); besides, no severe adverse events were reported.ConclusionIn the aspect of improving of times of defecation and characters of stool in patients with persistent and chronic diarrhea, single medication of multi bacteria strains Bifidobacterium tetravaccine tablets has the same satisfied efficacy and good safety as the combination of Bifidobacterium triple viable capsules and live Bacillus licheniformis capsule.
作者 刘方旭 许乐
出处 《中华消化杂志》 CAS CSCD 北大核心 2016年第12期822-825,共4页 Chinese Journal of Digestion
关键词 有益菌种 迁延性及慢性腹泻 双歧杆菌四联活菌片 双歧杆菌三联活菌胶囊 地衣芽孢杆菌活菌胶囊 Probiotics Persistent and chronic diarrhea Bifidobacterium tetravaccine tablets Bifidobacterium triple viable capsules live Bacillus licheniformis capsule
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