芒硝用于结肠镜检查前肠道准备的随机双盲对照临床研究  

Randomized Double-blind Controlled Clinical Study on Natrii Sulfas for Colonoscopy Preparation

作　　者：佘世锋[1] 吴海滨[2] 兰绍阳[1] 陈斌[1] 汪双双[1] 刘凤斌[1] 雍建国 龙旭 

机构地区：[1]广州中医药大学第一附属医院脾胃病科,广东广州510405 [2]深圳市中医院,广东深圳518033 [3]四川省川眉芒硝责任有限公司,四川成都610041

出　　处：《中药新药与临床药理》2014年第4期508-511,共4页Traditional Chinese Drug Research and Clinical Pharmacology

摘　　要：目的评价芒硝用于结肠镜检查清洗肠道的临床效果和安全性。方法采用单中心、随机、双盲、平行对照方法,将48例患者按随机编码表方法分为芒硝组和复方聚乙二醇电解质散(和爽)组。以肠道残余粪水量和肠道泡沫量为主要评价指标,由内窥镜医师进行评价;以问卷调查患者服用药物后的伴随症状为次要指标。结果芒硝组肠道残余粪水量明显少于和爽组,差异有统计学意义(P=0.010);肠道泡沫明显少于和爽组,差异有统计学意义(P=0.022)。服用芒硝后伴随症状以腹痛为主,未发现明显的不良反应,但给药后至排便的时间较和爽组明显延长(P=0.0007)。结论芒硝清洗肠道效果优于和爽,且有良好的耐受性和安全性,但给药后至排便的时间较长。Objective To evaluate the clinical effects and safety of Natrii Sulfas for bowel cleansing before colonoscopy measurement. Methods A single-center, randomized, double-blind, paralleled-control trial was carried out in 48 patients. The patients were randomized to Natrii Sulfas group and polyethylene glycol （PEG） group. With the amount of intestinal residue fluid and intestinal foam as the primary outcomes, colonoscopy physicians who were blinded to the protocol evaluated the quality of bowel preparation. The accompanied symptoms of patients showed by the questionnaires were used as the secondary outcomes. Results Natrii Sulfas group had lower amount of intestinal residue fluid （P= 0.010） and intestinal foam amount （P=0.022） than those in PEG group. The accompanied symptoms in Natrii Sulfas group were mainly shown as abdominal pain, and the time from medication to defecation was significantly longer than that in PEG group. Conclusion Natrii Sulfas is more effective and safer than PEG in bowel cleansing, and has good tolerability, but the time from medication to defecation is longer than PEG.

关 键 词：芒硝 复方聚乙二醇电解质散 肠道准备 随机对照 临床研究 

分 类 号：R285.6[医药卫生—中药学]