口服双歧杆菌活菌散剂治疗急慢性腹泻的随机对照双盲双模拟多中心临床研究  

Live Bifidobacterium oral powder in treatment of acute and chronic diarrhea:a randomized,controlled,double-blind double-dummy,multicenter clinical study

作　　者：秦湘红[1] 胡海棠[1] 刘思德[2] 袁耀宗[3] 黄乃侠[4] 许军[2] 

机构地区：[1]丽珠集团医学临床研究中心,广东珠海519020 [2]南方医科大学附属南方医院,广东广州510515 [3]上海交通大学医学院附属瑞金医院,上海200025 [4]天津医科大学总医院,天津300052

出　　处：《中国微生态学杂志》2009年第9期844-847,共4页Chinese Journal of Microecology

摘　　要：目的评价口服双歧杆菌活菌散剂治疗肠道菌群失调所致的急慢性腹泻的疗效和安全性。方法采用阳性药物平行对照、分层区组随机、双盲双模拟、多中心临床试验设计方法。其中急性腹泻136例，慢性腹泻125例；每次口服双歧杆菌活菌散剂1包（1．0g，含双歧杆菌活菌1．0亿个）或丽珠肠乐胶囊2粒，每日2次；急性腹泻疗程3d，慢性腹泻疗程14d，观察治疗后临床症状和大便常规的恢复情况，慢性腹泻中39例进行肠道菌群分析。结果疗程结束时急性腹泻总有效率：口服双歧杆菌活菌散剂组为89．6％，丽珠肠乐胶囊组为91．2％，2组疗效相似，差异无显著性（P〉0．05）；慢性腹泻总有效率：口服双歧杆菌活菌散剂组为88．1％，丽珠肠乐胶囊组为79．O％，2组疗效相似，差异无显著性（P〉0．05）；慢性腹泻组中39例治疗前后进行的肠道菌群分析表明，2组双歧杆菌、拟杆菌和真杆菌治疗后比治疗前均有显著增加（P=0．00-0．02），但治疗前后增加值2组间比较差异无显著性（P〉0．05）。安全性研究未发现不良反应。结论口服双歧杆菌活菌散剂能有效治疗急慢性腹泻，疗效和安全性与丽珠肠乐胶囊相当。Objective To evaluate the efficacy and safety of live bifidobacterium oral powder in treatment of acute and chronic diarrhea caused by imbalance of intestinal flora. Method A positive controlled, randomized, double-blind double-dummy, multicenter clinical trim was carried out. 136 acute diarrhea patients and 125 chronic diarrhea patients were randomized into the test group and the control group. The course of treatment was 3 days in acute diarrhea and 14 days in chronic diarrhea. The improvement of clinical symptoms and the recovery of stool routine were evaluated after treatment. In- testinal flora of 39 chronic diarrhea patients were analysed. Result For treatment of acute and chronic diarrhea, the effec- tive rates of live bifidobacterium oral powder were 89.6% and 88.1% respectively, and those of Lizhuchangle capsule were 91.2% and 79.0%, respectively. Bifidobacterium , Bacteroides and Eubacterium were significantly increased after treat- ment than before treatment. No significant differences （ P 〉 0.05） were observed between live bifidobacterium oral powder and the control drug. Conclusion Live bifidobacterium oral powder is an effective agent in treatment of acute and chronic diarrhea. The efficacy and safety of live bifidobacterium oral powder are similar to those of Lizhuehangle capsule.

关 键 词：口服双歧杆菌活菌散剂 急慢性腹泻 临床研究 疗效 安全性 

分 类 号：R378.992[医药卫生—病原生物学]