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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(1.0 g,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3 d,慢性腹泻疗程14 d,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79.0%,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 oral Bifidobacterium live powder in the treatment of acute and chronic diarrhea caused by imbalance of intestinal microflora. Methods The positive drug parallel control, stratified block randomized, double-blind double-dummy, multicenter clinical trial design method. One case of acute diarrhea in 136 cases, 125 cases of chronic diarrhea; each oral Bifidobacterium live powder 1 package (1.0 g, containing 100 million live bifidobacteria) or Lizhu Changle capsules 2 capsules, 2 times a day; The acute diarrhea course was 3 days and the chronic diarrhea course was 14 days. The clinical symptoms and stool routine recovery were observed after treatment. 39 cases of chronic diarrhea were analyzed for intestinal flora. Results The total effective rate of acute diarrhea at the end of the course of treatment was 89.6% in oral Bifidobacterium active group and 91.2% in Lizhu Changle Capsule group. There was no significant difference between the two groups (P> 0.05) Efficacy: Bifidobacterium oral live oral powder group was 88.1%, Lizhu Changle capsule group was 79.0%, two groups of similar efficacy, the difference was not significant (P> 0.05); 39 cases of chronic diarrhea group before and after treatment Intestinal flora analysis showed that the Bifidobacterium, Bacteroidetes and Eubacterium groups were significantly increased after treatment than before treatment (P = 0.00-0.02), but there was no significant difference between the two groups before and after treatment (P > 0.05). Safety studies found no adverse reactions. Conclusion oral Bifidobacterium active powder can effectively treat acute and chronic diarrhea, efficacy and safety and Lizhu intestinal capsule quite.