双歧三联活菌治疗肠易激综合征的临床多中心研究

目的 观察双歧三联活菌对腹泻型肠易激综合征(IBS)的疗效和安全性。方法 采用多中心、随机、开放的临床试验,97例腹泻型IBS患者口服双歧三联活菌胶囊27d。记录并量化治疗前、后患者的症状和大便性状,检查血、尿、粪常规,记录治疗中的不良事件;7例患者服药前、后进行选择性粪细菌培养。结果 口服双歧三联活菌27d后,患者各项IBS症状评分明显下降,各项症状改善率为74．2％～87．6％,大便Bristol评分显著下降。粪细菌培养显示口服双歧三联活菌使乳杆菌和肠球菌在肠道定植。不良事件2例,与服药无关。结论 双歧三联活菌可明显改善腹泻型IBS的症状,且安全性高、耐受性好。

Effect of Bifico on diarrhea-predominant irritable bowel syndrome:a multicenter clinical trial

Objective To evaluate the efficacy and safety of Bifico in patients with diarrhea-predomi nant irritable bowel syndrome. Methods This is a multicenter, randomized, open clinical trial. Ninety-seven patients w ith diarrhea-predominant irritable bowel syndrome were given capsules of Bifico orally for 27day s.The clinical symptoms and the character of stool before and after treatment we re record ed and quantified. Blood, urine and stool were examined routinely. The adverse e vents were recorded. The fecal bacterias were cultured selectively before and af ter treatment. Results After treatment, all symptom scores were reduced signifi cantly. The improvement rates of symptoms were between 74.2% and 87.6%, and th e Bristol scores of stool decreased markedly. Lactobacillus and enterococci co lonized in the gut after treatment.2 adverse events occurred but with no relevance with treatment. Conclusion Bifico can improve the clinical symptoms of diarrhea-predominant irritable bowe l syndrome effectively with safety and good tolerability.