某复合低聚果糖纤维颗粒对功能性便秘的通便功效和安全性评估:一项平行、随机、对照、双盲研究  

Efficacy and Safety of A Compound Fructose-oligosaccharide Fiber Granule for Functional Constipation:A Parallel,Randomized,Controlled,Double-blind Study

作　　者：陈明骏 寇秋爱[2] 钱妍 林子君 夏立营[2] 佟娜 刘秋霞 王欢 臧倩 林明雄 CHEN Mingjun;KOU Qiuai;QIAN Yan;LIN Zijun;XIA Liying;TONG Na;LIU Qiuxia;WANG Huan;ZANG Qian;LIN Mingxiong(Department of Traditional Chinese Medicine,the Second Medical Center&National Clinical Research Center for Geriatric Diseases,Chinese PLA General Hospital,Beijing 100853;Department of TCM Health Research Center,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing;Food Review Center of State Administration for Market Regulation,Beijing)

机构地区：[1]中国人民解放军总医院第二医学中心中医(针灸)科国家老年疾病临床研究中心,100853 [2]中国中医科学院西苑医院中医药保健研究中心 [3]国家市场监督管理总局食品审评中心

出　　处：《胃肠病学》2021年第11期671-675,共5页Chinese Journal of Gastroenterology

基　　金：国家市场监督管理总局(原国家食品药品监督管理总局)保健食品审评中心保健食品功能目录研究专项课题(ZBW-2017-BJSP-03)。

摘　　要：背景:国内外指南推荐将增加膳食纤维摄入作为功能性便秘的基础治疗措施。但对于通便功能食品的评价方法,国内仍欠缺完善的指标体系。目的:通过评价某复合低聚果糖纤维颗粒通便功能的功效和安全性,为通便功能食品的评价方法提供循证医学依据。方法:采用以安慰剂为对照的随机、双盲、平行、对照试验方式,在北京市2个临床研究中心纳入120例功能性便秘患者,随机分为试验组和对照组,每组60例。试验组口服某复合低聚果糖纤维颗粒2周,每日1袋(9 g/袋),溶于50 mL水中;对照组口服安慰剂,外观、规格、服用方法与试验组相同。记录受试者试验前后的每周排便次数、排便状况和粪便性状,同时完成安全性检测。结果:试验组治疗2周后每周排便次数增加(1.63±1.57)次,粪便变软,排便状况改善,与试验前相比差异均有统计学意义(P均<0.05),且改善程度(试验前后差值)均优于对照组(P均<0.05)。试验过程中所有受试者均未报告过敏和其他不良反应,试验前后血、尿、粪常规和血生化指标无明显变化。结论:某复合低聚果糖纤维颗粒对功能性便秘具有显著通便功效,安全性良好。本研究采用的试验方案具有科学性和可行性,为通便功能食品人体试食试验提供了方法学依据。Background: Dietary fiber is strongly recommended as the basic treatment for functional constipation according to global guidelines. However, a complete evaluation standard for the laxative functional food remains to be improved in China. Aims: To evaluate the efficacy and safety of the laxative function of a compound fructose-oligosaccharide fiber granule, so as to provide evidence-based medical basis for the evaluation of laxative functional food. Methods: In a randomized, double-blind, parallel and controlled trial with placebo as control, 120 subjects with functional constipation were enrolled in 2 clinical research centers in Beijing, and randomly divided into experimental group and control group(60 cases in each group). Subjects in experimental group were given a compound fructose-oligosaccharide fiber granule dissolved in 50 mL water orally, 1 bag(9 g) per day for 2 weeks;while those in control group were given a placebo granule with the same appearance, specification and dosage as the experimental group. The bowel movement frequency per week, defecation status and stool consistency were recorded before and after the test, and the safety tests were completed. Results: After 2 weeks of treatment, the bowel movement frequency in experimental group increased by(1.63±1.57) times per week, the stool consistency assessed by Bristol stool form scale and the difficulty in defecation were also improved as compared with the baseline(all P<0.05). Furthermore, improvements in experimental group were superior to those in control group(all P<0.05). No allergic and other adverse events were reported during the test, and there were no significant changes in blood, urine, stool routine and blood biochemical indices before and after the test. Conclusions: The compound fructose-oligosaccharide fiber granule tested in this study is proved to have laxative effect and is safety for functional constipation. The testing program is scientific and of feasibility, and may provide a methodology basis for human oral administration tr

关 键 词：功能性便秘 复合低聚果糖纤维颗粒 功能食品 方案评价 功效 安全 

分 类 号：R574.62[医药卫生—消化系统]