不同剂量双歧杆菌四联活菌片对轻、中度活动期溃疡性结肠炎患者肠道菌群失调的影响

doi:10.3877/cma.j.issn.2095-2015.2022.05.002

目的

研究不同剂量双歧杆菌四联活菌片对轻、中度活动期溃疡性结肠炎患者肠道菌群失调的影响。

方法

采用前瞻性、随机、开放、对照研究的试验方法，选择2018年6月至2022年2月山东中医药大学第二附属医院消化中心就诊，明确诊断为伴有Ⅱ度肠道菌群失调的溃疡性结肠炎患者，随机分为A、B两组，A组应用常规剂量双歧杆菌四联活菌片联合美沙拉嗪治疗，B组应用双倍剂量双歧杆菌四联活菌片联合美沙拉嗪疗，主要观察终点为治疗4周后2组肠道菌群失调变化，次要观察终点为治疗4周后2组腹泻症状缓解情况、临床总疗效、内镜下黏膜愈合率及不良反应。

结果

66例患者纳入研究，直肠炎22例，左半结肠炎有44例，轻度27例，中度39例，两组患者基线期临床特征基本相似。主要观察终点肠道菌群失调改善情况：B组(正常菌群25例，Ⅰ度菌群失调6例，Ⅱ度菌群失调2例)显著优于A组(正常菌群16例，Ⅰ度菌群失调12例，Ⅱ度菌群失调5例，P<0.05)。次要观察终点：腹泻症状缓解情况，与A组比较，B组患者腹泻症状恢复正常时间[(7.5±4.9)d比(11.8±4.8)d]及黏液脓血便消失时间[(8.8±5.8)d比(13.3±4.7)d]明显缩短(P<0.05)。临床总疗效：B组(临床缓解25例，临床应答6例，无效2例)显著优于A组(临床缓解16例，临床应答12例，无效5例，P<0.05)。内镜下黏膜愈合率：A组48.6%，B组76.7%(P<0.05)。不良反应：A组上腹部不适、大便次数增多1例，B组胃灼热、肠鸣音亢进1例，未见其他不良反应。两组肝肾功能正常。

结论

双倍剂量的双歧杆菌四联活菌片治疗4周对轻、中度活动期溃疡性结肠炎肠道菌群失调的改善情况优于常规剂量双歧杆菌四联活菌片。

关键词: 溃疡性结肠炎, 菌群失调, 双歧杆菌四联活菌片, 美沙拉嗪

Objective

To study the effects of different doses of bifidobacterium tetralogy viable tablets on intestinal flora imbalance in patients with mild and moderate active ulcerative colitis.

Methods

A prospective, randomized, open and controlled study was used. Patients with ulcerative colitis with grade Ⅱ intestinal flora imbalance were selected from the Digestive Center of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from June 2018 to February 2022. They were randomly divided into group A and group B. Group A was treated with conventional dose bifidobacterium tetralogy viable tablets combined with mesalazine, and group B was treated with double dose bifidobacterium tetralogy viable tablets combined with mesalazine. The primary end point was the imbalance of intestinal flora in the two groups after 4 weeks of treatment, and the secondary end points were the relief of diarrhea symptoms, total clinical efficacy, endoscopic mucosal healing rate and adverse reactions in the two groups after 4 weeks of treatment.

Results

A total of 66 patients were included in the study, including 22 cases of proctitis, 44 cases of left colitis, 27 cases of mild colitis and 39 cases of moderate colitis. The clinical characteristics of the two groups at baseline were basically similar. The improvement of intestinal flora imbalance: group B(25 cases of normal flora, 6 cases of grade Ⅰ flora imbalance and 2 cases of grade Ⅱ flora imbalance)was significantly better than group A(16 cases of normal flora, 12 cases of grade Ⅰ flora imbalance and 5 cases of grade Ⅱ flora imbalance, P<0.05). Secondary end points: relief of diarrhea symptoms: compared with group A, the recovery time of diarrhea symptoms in group B[(7.5±4.9)d vs.(11.8±4.8)d] and the disappearance time of mucus purulent and bloody stool(8.8±5.8)d vs.(13.3±4.7)d] were significantly shorter(P<0.05). Total clinical efficacy: group B(25 cases of clinical remission, 6 cases of clinical response and 2 cases of ineffective)was significantly better than group A(16 cases of clinical remission, 12 cases of clinical response and 5 cases of ineffective, P<0.05). Endoscopic mucosal healing rate: it was 48.6% in group A and 76.7% in group B(P<0.05). Adverse reactions: there was 1 case of upper abdominal discomfort and increased stool frequency in group A, and 1 case of heartburn and hyperactive bowel sounds in group B. No other adverse reactions were found. The liver and kidney functions of the two groups were normal.

Conclusion

The improvement of intestinal flora imbalance in mild and moderate active ulcerative colitis treated with double dose bifidobacterium tetralogy viable tablets for 4 weeks is better than that of conventional dose bifidobacterium tetralogy viable tablets.

Key words: Ulcerative colitis, Intestinal flora imbalance, Bifidobacterium tetralogy viable tablets, Mesalazine

表1 两组患者基线期基本特征(±s)

组别	例数	男/女(例)	年龄(岁)	病程(月)	Mayo评分(分)	C-反应蛋白(mg/L)	大便次数(次/d)	红细胞沉降率(mm/1 h)
A组	33	18/15	34.6±14.3	14.6±6.7	5.9±2.3	22.5±17.3	4.4±2.5	31.6±12.3
B组	33	16/17	34.5±15.6	14.7±5.6	5.7±2.6	21.6±11.7	4.5±2.8	32.4±11.5
P值		0.90	0.96	0.83	0.77	0.86	0.87	0.49

表1 两组患者基线期基本特征(±s)

组别	例数	男/女(例)	年龄(岁)	病程(月)	Mayo评分(分)	C-反应蛋白(mg/L)	大便次数(次/d)	红细胞沉降率(mm/1 h)
A组	33	18/15	34.6±14.3	14.6±6.7	5.9±2.3	22.5±17.3	4.4±2.5	31.6±12.3
B组	33	16/17	34.5±15.6	14.7±5.6	5.7±2.6	21.6±11.7	4.5±2.8	32.4±11.5
P值		0.90	0.96	0.83	0.77	0.86	0.87	0.49

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Effects of different doses of bifidobacterium tetralogy viable tablets on intestinal flora imbalance in patients with mild and moderate active ulcerative colitis

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Effects of different doses of bifidobacterium tetralogy viable tablets on intestinal flora imbalance in patients with mild and moderate active ulcerative colitis