CAJ | 학술논문

目的研究益生菌(培菲康散剂,BIFICO)对1～6岁婴幼儿腹泻发病的影响及预防作用.方法 490例要幼儿按年龄分层招募后被分为两组:试验组(n =247)和对照组(n=243).以随机、双盲、安慰剂对照为原则,给予合格的受试者口服临床研究专用培菲康散剂.受试者连续服用试验用药4天、随访观察21天为一个周期,共进5个周期.研究期内遵循“逢泻必检”原则,对受试儿童随访并采集腹泻婴幼患儿的粪便标本,进行病原学检测,评价预防效果.结果共有480名完成全部实验.对照组和实验组分别有120人次和95人次发生腹泻,腹泻发生率分别为50.85％和38.93％,差异具有统计学意义(x2 =4.175,P=0.041).以观察周期分组后,第3周期对照组婴幼儿腹泻发病率显著高于实验组(x2 =4.415,P=0.036).从腹泻要幼儿粪便中共检出轮状病毒14株、诺如病毒3株、扎如病毒3株、腺病毒2株,另外检出沙门菌5株、细菌性痢疾4株.结论口服培菲康散剂可降低1～6岁婴幼儿腹泻发病率,对腹泻具有一定的预防作用.
목적 연구익생균(배비강산제,BIFICO)대1～6세영유인복사발병적영향급예방작용.방법 490례요유인안년령분층초모후피분위량조:시험조(n =247)화대조조(n=243).이수궤、쌍맹、안위제대조위원칙,급여합격적수시자구복림상연구전용배비강산제.수시자련속복용시험용약4천、수방관찰21천위일개주기,공진5개주기.연구기내준순“봉사필검”원칙,대수시인동수방병채집복사영유환인적분편표본,진행병원학검측,평개예방효과.결과 공유480명완성전부실험.대조조화실험조분별유120인차화95인차발생복사,복사발생솔분별위50.85％화38.93％,차이구유통계학의의(x2 =4.175,P=0.041).이관찰주기분조후,제3주기대조조영유인복사발병솔현저고우실험조(x2 =4.415,P=0.036).종복사요유인분편중공검출륜상병독14주、낙여병독3주、찰여병독3주、선병독2주,령외검출사문균5주、세균성이질4주.결론 구복배비강산제가강저1～6세영유인복사발병솔,대복사구유일정적예방작용.
Objective To investigate the prevention of diarrhea by oral BIFICO for infants aged 1-6 years.Methods 490 cases of infants were randomly divided after age stratification:the experimental group (n =247) and the control group (n =243).Based on principles of randomized double-blind and placebocontrolled,the infants were given BIFICO(dedicated clinical research)therapy for 4 consecutive days,then observed for 21 days.25 days composed a cycle.They were observed total 5 cycles.During the study period,principles for "the diarrhoea patients must be detected",follow-up visited the participant infants and conducted etiology detection by way of sampling for diarrhea infants.Evaluate the prevention efficacy of diarrhea by oral BIFICO for infants aged 1-6 years.Results A total of 480 completed all study.120 and 95 infants in the control group and experimental group were detected with diarrhea.The incidence of diarrhea was 50.85％ and 38.93％ in these two guoup,respectively.The difference has statistical significance (x2 =4.175,P =0.041).In the third observation period,the infants in the control group had a higer incidence of diarrhea compared with which in the experimental grouP(x2 =4.415,P =0.036).14 strains of rotavirus,3 strains of norovirus,3 strains of sappovirus,2 strains of adenovirus,5 strains of salmonella and 4 strains of Shigella were check out in 128 samples.Conclusion Oral BIFICO can paly certain preventive role on diarrhea,and decrease the incidence of diarrhea in infants aged 1-6 years.