酪酸梭菌二联活菌散剂预防肺炎儿童抗生素相关性腹泻的多中心随机对照临床试验

A Multicenter Randomized Controlled Clinical Trial of Combined Clostridium Butyricum and Bifidobacterium Powders in Prevention of Antibiotic Associated Diarrhea in Children with Pneumonia

目的:观察酪酸梭菌二联活菌散剂预防肺炎儿童抗生素相关性腹泻的效果,探讨疗效和作用。方法:采用多中心随机对照临床试验方法,以116例因肺炎于河南省中牟县人民医院以及河南省中牟县妇幼保健院住院治疗的患儿为研究对象,将其分为常规组与对照组。常规组给与常规抗生素治疗;研究组治疗方法为常规组治疗基础上联用酪酸梭菌二联活菌散剂进行治疗。每组患儿各58例,两处研究中心各29例,对两组患儿的预防治疗效果进行对比分析。结果:研究组患儿抗生素相关性腹泻的发生率低于常规组,治疗效果好于常规组,差异明显,对比结果有统计学意义(P<0.05)。结论:酪酸梭菌二联活菌散剂预防肺炎儿童抗生素相关性腹泻有显著效果,降低了抗生素相关性腹泻发生的几率,治疗效果明显。

Objective：To observe the effect of Combined Clostridium Butyricum and Bifidobacterium Powders on antibiotic-related diarrhea in children with pneumonia,and to explore the effect.Methods：A multicenter randomized controlled clinical trial was conducted in 116 children with pneumonia in Zhongmu County People＇s Hospital of Henan Province and Zhongmu Maternal and Child Health Hospital of Henan Province.The patients were divided into two groups.The conventional group was given conventional antibiotic treatment and the study group was given Combined Clostridium Butyricum andBifidobacterium Powders based on the conventional treatment.There were 58 cases in each group and 29 cases in each research center.The preventive and therapeutic effects of the two groups were compared and analyzed.Results：The incidence of antibiotic-associated diarrhea in the study group was lower than that in the conventional group,and the therapeutic effect was better than that in the conventional group,and the difference was statistically significant（P〈0.05）.Conclusion：Combined Clostridium Butyricum and Bifidobacterium Powders has a significant effect on antibiotic-associated diarrhea in children with pneumonia and reduces the risk of antibiotic-associated diarrhea.,with obvious treatment effect.