Background: Lactitol is used for treatment of hepatic encephalopathy and constipation in abroad, however, it has not been recommended for treatment of constipation in domestic guidelines. Aims: To assess the efficacy and safety of lactitol in treatment of constipation. Methods: Patients fulfilling the diagnostic criteria of constipation and inclusion and exclusion criteria of the study were randomly enrolled from 4 clinical medical centers and allocated into treatment group and control group. Patients in treatment group received lactitol 20 g on day 1 and 10 g/d on day 2-7, while patients in control group received lactulose 20 g on day 1 and 10 g/d on day 2-7. Drugs were taken orally with breakfast once a day for 7 days. If the frequency of defecation was beyond 3 times per day or the stool form presented as Bristol type 6 or 7, half dosage was recommended. Results: A total of 129 patients were included for efficacy analysis, 63 in treatment group and 66 in control group. General conditions and severity of constipation were comparable between these two groups before treatment. Normalization rates of defecation times were 77.8% and 77.3% for 3-day treatment, and 95.2% and 95.5% for 7-day treatment in treatment group and control group, respectively. Normalization rates of stool form were 62.2% and 56.5% for 3-day treatment, and 60.4% and 60.8% for 7-day treatment in these two groups, respectively. Differences between these two groups were not statistically significant. Rates of adverse effects in these two groups were similar (4.8% vs. 4.5%). Conclusions: Lactitol is safe and effective in treatment of constipation and may be used clinically.%背景:炎症性肠病(IBD)是一种病因尚未明确的非特异性肠道炎症性疾病,传统治疗方法疗程长,疗效欠佳,容易反复发作.目的:观察并比较英夫利昔、沙利度胺对TNBS灌肠诱发的大鼠结肠炎治疗效果,并初步探讨两者治疗IBD的作用机制.方法:46只Sprague-Dawley大鼠随机分成正常对照组(n=10)、结肠炎组(n=12)、英夫利昔组(n=12)、沙利度胺组(n=12),后三组给予TNBS/乙醇灌肠诱导大鼠结肠炎模型.造模后第1d,英夫利昔组、沙利度胺组分别给予英夫利昔腹腔注射5 mg·kg-1·d-1、沙利度胺管喂200 mg·kg-1·d-1,连续7d后处死.行疾病活动指数(DAI)、大体形态损伤指数(CMDI)和组织损伤指数(TDI)评分；以Real-time PCR、蛋白质印迹法和免疫组化分别检测结肠组织TNF-α、VEGF、caspase-3 mRNA和蛋白表达；TUNEL法检测结肠上皮细胞凋亡情况.结果:结肠炎组大鼠DAI、CMDI、TDI评分均显著高于正常对照组(P＜0.05),TNF-α、VEGF、caspase-3 mRNA和蛋白表达显著升高(P＜0.05),结肠上皮细胞凋亡显著增加;给予英夫利昔或沙利度胺治疗后,上述指标均显著改善(P＜0.05).结论:本实验成功构建了TNBS大鼠结肠炎模型,英夫利昔、沙利度胺对大鼠结肠炎均有明显的治疗效果,两者通过抑制TNF-α、VEGF、caspase-3的表达,对IBD免疫、血管生成、凋亡过程起调节作用.
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