CAJ | 학술논문

目的探讨枯草杆菌二联活菌制剂联合乳果糖的通便效果及停服乳果糖后对便秘的远期疗效.方法 2010年12月至2012年8月选择北京地区9家医院符合入选标准的患者216例,以随机表方式,将受试者分配到治疗组(104例,口服乳果糖+枯草杆菌二联活菌制剂,14d治疗后停用乳果糖,继续口服枯草杆菌二联活菌制剂直至28 d),对照组(112例,口服乳果糖和安慰剂,14 d治疗后停用乳果糖,继续服用安慰剂至28 d).比较两组治疗效果.结果按方案完成试验198例(治疗组96例、对照组102例).7d治疗后,两组有效率分别为88.46％(92例)和84.82％(95例)；28 d后,两组有效率分别为87.50％(91例)和81.25％(91例)；差异均无统计学意义(均P＞0.05).两组患者治疗后粪便性状,排便频率,排便困难及排便不尽程度,腹痛、腹胀和治疗后钡条排出率差异均无统计学意义(均P＞0.05).治疗组28与14 d比较,有效率差异无统计学意义(S=0.5,P=0.4795),而对照组28 d有效率比14d明显下降(S=11,P=0.0009).结论枯草杆菌二联活菌制剂与乳果糖合用,可能对提高乳果糖近期有效率和停服乳果糖后继续维持其通便效果有一定作用.
목적 탐토고초간균이련활균제제연합유과당적통편효과급정복유과당후대편비적원기료효.방법 2010년12월지2012년8월선택북경지구9가의원부합입선표준적환자216례,이수궤표방식,장수시자분배도치료조(104례,구복유과당+고초간균이련활균제제,14d치료후정용유과당,계속구복고초간균이련활균제제직지28 d),대조조(112례,구복유과당화안위제,14 d치료후정용유과당,계속복용안위제지28 d).비교량조치료효과.결과 안방안완성시험198례(치료조96례、대조조102례).7d치료후,량조유효솔분별위88.46％(92례)화84.82％(95례)；28 d후,량조유효솔분별위87.50％(91례)화81.25％(91례)；차이균무통계학의의(균P＞0.05).량조환자치료후분편성상,배편빈솔,배편곤난급배편불진정도,복통、복창화치료후패조배출솔차이균무통계학의의(균P＞0.05).치료조28여14 d비교,유효솔차이무통계학의의(S=0.5,P=0.4795),이대조조28 d유효솔비14d명현하강(S=11,P=0.0009).결론 고초간균이련활균제제여유과당합용,가능대제고유과당근기유효솔화정복유과당후계속유지기통편효과유일정작용.
Objective To explore the efficacies of live combined Bacillus Subtilis (B.Subtilis) and Enterococcus Faecium (E.Faecium) Capsules plus lactulose in the treatment of functional constipation.Methods A total of 216 patients fulfilling the diagnostic criteria of functional constipation (slow transit pattern) were randomly enrolled from 9 participating hospitals and allocated into treatment group and control group.The patients of treatment group received lactulose plus live combined B.Subtilis and E.Faecium Capsules for 14 days and only took the latter during the following 14 days.The patients of control group received lactulose plus placebo for 2 weeks and then only took placebo continually for the following 2 weeks.Results A total of 216 patients were analyzed (treatment group n =104,control group n =112).The effective rates of 7-day treatment were 88.46％ (n =92) and 84.82％ (n =95) for treatment and control groups respectively.And those of 28-day treatment were 87.50％ (n =91) and 81.25％ (n =91)respectively.And the inter-group differences were not statistically significant (all P ＞ 0.05).Fecal form,frequency,difficulty,urgency,distension,abdominal pain and expelling rates of barium enema were not statistically significant (all P ＞ 0.05).Comparing the effective rates of 28-day with that of 14-day,differences were not statistically significant in A group (S =0.5,P =0.4795),but in B group the effective rates of 28-day were lower than that of 14-day statistically (S =11,P =0.0009).Conclusion The regiment of live combined B.Subtilis and E.Faecium Capsules plus lactulose offers better efficacies in the treatment of functional constipation.