拉克替醇治疗便秘的多中心随机单盲平行对照试验  

A Multicenter,Randomized,Single-blinded,Parallel-controlled Trial on Lactitol in Treatment of Constipation

作　　者：徐中南[1] 戴峻[1] 施瑞华[2] 孙士其[3] 陈隆典[4] 杨力[5] 陆伦根[6] 

机构地区：[1]江苏正大天晴药业股份有限公司,210046 [2]南京医科大学第一附属医院消化科 [3]南京市第一医院消化科 [4]南京大学医学院附属鼓楼医院消化科 [5]东南大学附属中大医院消化科 [6]上海交通大学附属第一人民医院消化科

出　　处：《胃肠病学》2012年第3期168-172,共5页Chinese Journal of Gastroenterology

摘　　要：拉克替醇在国外已作为治疗肝性脑病和便秘的药物上市，但在国内尚未被推荐用于治疗便秘。目的：评价拉克替醇治疗便秘的疗效和安全性。方法：从4个临床医学中心随机纳入符合便秘诊断标准和研究要求的患者．随机分为试验组和对照组。试验组起始剂量（第1d）为拉克替醇20g，维持剂量（第2．7d）为每天10g：对照组起始剂量（第1d）为乳果糖20g，维持剂量（第2～7d）为每天10g。每天早餐时一次服完，疗程7d。排便次数≥3次，d或粪便性状呈Bristol6、7型时，可减半用量。结果：纳入疗效分析的病例数为129例，试验组63例．对照组66例。试验组与对照组治疗前一般情况无明显差异，便秘病情严重程度分布均衡。试验组和对照组用药3d后有效排便次数转正常率分别为77．8％和77．3％，粪便性状转正常率分别为62．2％和56．5％，用药7d后分别为95．2％和95．5％、60．4％和60．8％，两组间差异均无统计学意义。两组不良反应发生率分别为4．8％和4．5％，差异亦无统计学意义。结论：拉克替醇治疗便秘有效、安全．可在临床上推广使用。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.

关 键 词：拉克替醇 乳果糖 便秘 治疗 临床试验 

分 类 号：R747.9[医药卫生—神经病学与精神病学]