CAJ | 학술논문

目的：评价酪酸梭菌二联活菌(常乐康)对因感染性疾病住院儿童抗生素相关性腹泻( antibiotic-associated diarrhea,AAD)的预防作用,并与布拉氏酵母菌(亿活)的疗效进行比较。方法采用前瞻性、随机病例对照研究方法,纳入2011年5月至2012年5月在中国医科大学附属盛京医院儿科病房因各种感染性疾病住院,需用抗生素治疗的患儿552例,完成480例。其中试验组又分为2个亚组：常乐康组80例：口服常乐康840 mg/次,2次/d,疗程1周；亿活组160例：口服亿活250 mg/次,2次/d,疗程1周；对照组：未给予任何益生菌制剂。两组患儿均常规给予抗生素类药物及对症治疗原发病。每日观察记录大便次数,根据Bristol粪便评估量表评价粪便性状,统计腹泻发生率和药物相关不良反应。结果观察7 d内试验组AAD发生率为4．2%(10/240),对照组为20．4%(49/240),两组比较差异有统计学意义(χ2=5．584,P=0．006)。与对照组比较,试验组发生AAD的风险下降了58．5%,其中常乐康组下降64．7%(RR=0．394,95%CI 0．183~0．875,P=0．008),亿活组下降51．6%(RR=0．484,95%CI 0．276~0．774,P =0．007),常乐康组较亿活组下降38．2%(RR =0．728,95% CI 0．257~0．784, P=0．009)。试验组较对照组AAD患儿平均便次减少,腹泻持续时间缩短,差异有统计学意义( P均<0．01)。观察期间未见药物相关不良反应。结论酪酸梭菌二联活菌和布拉氏酵母菌均能有效降低感染性疾病住院患儿发生AAD的风险,减轻腹泻症状,缩短腹泻持续时间,未发现不良反应。酪酸梭菌二联活菌和布拉氏酵母菌对中国北方儿童AAD的保护效力相当。
목적：평개락산사균이련활균(상악강)대인감염성질병주원인동항생소상관성복사( antibiotic-associated diarrhea,AAD)적예방작용,병여포랍씨효모균(억활)적료효진행비교。방법채용전첨성、수궤병례대조연구방법,납입2011년5월지2012년5월재중국의과대학부속성경의원인과병방인각충감염성질병주원,수용항생소치료적환인552례,완성480례。기중시험조우분위2개아조：상악강조80례：구복상악강840 mg/차,2차/d,료정1주；억활조160례：구복억활250 mg/차,2차/d,료정1주；대조조：미급여임하익생균제제。량조환인균상규급여항생소류약물급대증치료원발병。매일관찰기록대편차수,근거Bristol분편평고량표평개분편성상,통계복사발생솔화약물상관불량반응。결과관찰7 d내시험조AAD발생솔위4．2%(10/240),대조조위20．4%(49/240),량조비교차이유통계학의의(χ2=5．584,P=0．006)。여대조조비교,시험조발생AAD적풍험하강료58．5%,기중상악강조하강64．7%(RR=0．394,95%CI 0．183~0．875,P=0．008),억활조하강51．6%(RR=0．484,95%CI 0．276~0．774,P =0．007),상악강조교억활조하강38．2%(RR =0．728,95% CI 0．257~0．784, P=0．009)。시험조교대조조AAD환인평균편차감소,복사지속시간축단,차이유통계학의의( P균<0．01)。관찰기간미견약물상관불량반응。결론락산사균이련활균화포랍씨효모균균능유효강저감염성질병주원환인발생AAD적풍험,감경복사증상,축단복사지속시간,미발현불량반응。락산사균이련활균화포랍씨효모균대중국북방인동AAD적보호효력상당。
Objective To evaluate the protection of combined clostridium butyricum and bifidobac-terium living powders for antibiotic-associated diarrhea ( AAD ) with all kinds of infections in hospitalized children,and to compare the therapeutic effect with saccharomyces boulardii. Methods This study was a prospective,randomized case-control clinical trial which collected the data of the hospitalized children with all kinds of infections in Pediactric Department of Shengjing Hospital of China Medical University between May 2011 to May 2012. A total of 552 cases were enrolled and 480 cases completed the study. A total of 240 chil-dren were in experimental group,80 cases received combined clostridium butyricum and bifidobacterium liv-ing powders 840 mg per time,twice a day and the other 160 cases received saccharomyces boulardii 250 mg per time,twice a day,for one week; the control group took none of probiltics. Two groups received routine antibiotic therapy. Everyday′s defecate frequency was recorded, the traits of excrement according to bristol stool assessment scale were evaluated,the incidence of diarrhea and drug related adverse reactions were coun-ted. Results During the studied 7 days,the AAD incidence was 4. 2%(10/240) in experimental group and 20. 4%(49/240) in control group,there was significant difference between two groups. The risk of AAD in experimental group decreased 58. 5%. Compared to saccharomyces boulardii,combined clostridium butyricum and bifidobacterium living powders decreased 38. 2% (RR=0. 728, 95%CI 0. 257~0. 784, P=0. 009). Compared to control group,the average defecate frequency decreased in experimental group,diarrhea duration contracted,there was statistic difference between two groups ( P<0. 01 ) . No drug related adverse reactions happened during the trial. Conclusion Both combined clostridium butyricum and bifidobacterium living powders and saccharomyces boulardii could effectively reduce the risk of AAD in hospitalized children with bacterial infection,relieve diarrhea symptoms,short the duration of diarrhea,and did not find the adverse reac-tions. Combined clostridium butyricum and bifidobacterium living powders and saccharomyces boulardii had the same protective effect for AAD of northern China children.