Clinical trial of Saccharomyces boulardii capsule combined with mesalazine enteric-coated tablet in the treatment of patients with ulcerative colitis
10.13699/j.cnki.1001-6821.2024.24.006
- VernacularTitle:布拉氏酵母菌胶囊联合美沙拉秦肠溶片治疗溃疡性结肠炎患者的临床研究
- Author:
Hai-shui SU
1
;
Song-lin FANG
1
;
Jia-ding CAI
1
;
Yu-qin SU
1
Author Information
1. 厦门市第五医院消化内科,福建厦门 361101
- Publication Type:Journal Article
- Keywords:
Saccharomyces boulardii capsule;
mesalazine enteric-coated tablet;
ulcerative colitis;
clinical effect;
intestinal microecology;
mucosal inflammation
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(24):3548-3552
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the clinical efficacy of Saccharomyces boulardii capsules combined with mesalazine enteric-coated in the treatment of patients with ulcerative colitis(UC)and its influence on intestinal microecology and mucosal inflammation.Methods Patients with UC were randomly divided into control group and treatment group.The control group took mesalazine enteric-coated(0.5 g,tid),while the treatment group was given Saccharomyces boulardii capsule orally(0.5 g,bid)on the basis of the control group,and both groups were treated for 2 months.The clinical efficacy,mucosal healing status(modified Mayo score,Geboes index score),intestinal mucosal inflammatory indicators and intestinal microecology were compared between groups of patients,and the safety evaluation was performed.Results 45 cases were included in control group and treatment group,respectively.After 2 months of treatment,the total effective rates of treatment in treatment group and control group were 86.67％(39 cases/45 cases)and 66.67％(30 cases/45 cases),the difference was statistically significant(P＜0.05).After treatment,the modified Mayo scores were(3.02±0.85)and(3.88±1.01)points,the Geboes index scores were(0.63±0.15)and(0.91±0.20)points,the levels of interleukin-6(IL-6)were(39.27±8.89)and(67.94±11.02)pg·mL-1,the levels of interleukin-10(IL-10)were(61.44±7.76)and(50.28±6.74)ng·L-1,the levels of interleukin-23(IL-23)were(452.19±80.01)and(514.68±95.93)ng·mL-1,the levels of tumor necrosis factor-α(TNF-α)were(30.93±4.68)and(46.75±8.31)ng·L-1,the Bifidobacteria counts were(10.49±1.87)and(9.57±1.73)lgCFU·g-1,the Lactobacillus counts were(9.43±1.66)and(7.94±1.39)lgCFU·g-1,the Colibacillus counts were(7.15±1.29)and(8.03±1.47)lgCFU·g-1,the Enterococci counts were(6.59±1.02)and(7.81±1.14)lgCFU·g-1,respectively(all P＜0.05).The adverse reactions in treatment group included nausea,the adverse drug reactions in control group included nausea and dizziness.The incidence rates of adverse drug reactions in treatment group and control group were 4.44％(2 cases/45 cases)and 4.44％(2 cases/45 cases),respectively(P＞0.05).Conclusion Saccharomyces boulardii capsule combined with mesalazine enteric-coated tablet has significant effect in the treatment of UC,which can effectively inhibit the intestinal mucosal inflammation,improve the intestinal microecology and promote the intestinal mucosal healing,and it has good safety.
