凝结芽胞杆菌(TBC169)片治疗便秘的实验研究和临床疗效

目的观察凝结芽胞杆菌片（BC1）对便秘的药理作用和I临床疗效。方法昆明种雄性小鼠随机分为6组（每组10只）。BC1片（3个剂量）和BCz片治疗组小鼠口服BC。片和BC2片，空白对照组小鼠和模型对照组小鼠口服自来水，每天1次，共7d。之后，两治疗组和模型对照组小鼠在禁食12h后．均口服复方地芬诺酯（CDX）片，引发便秘。成人慢性便秘38例患者随机分为治疗组（20例）和对照组（18例），分别口服BC1片和金双歧片（BG），每天3次，共14～21d。结果BC1片能明显地减少便秘小鼠的首次排便时间（P〈0．05）和显著地增加大便粒数及重量（P〈0．05）。在临床试验中，治疗成人慢性便秘，BC1片的治愈率为45％，总有效率为70％，而相对的BG片分别为44％和72％，两药均未见不良反应或副作用。结论BC1片对小鼠实验性便秘和成人慢性便秘均有明显的治疗作用，在临床试验中未见不良反应或副作用。

The experimental study and clinic efficacy of Bacillus coagulans tablets in the treatment of constipation

To observe the pharmacological effects and clinic efficacy of Bacillus coagulans(BC_1) tablets on the constipation.Methods Sixty Kunming mice were randomly divided into six groups (each group n=10): blank control,model control,positive drug control(BC_2 tablets) and BC_1 tablets(three doses) groups.BC_1 and BC_2 tablets treated groups in mice received orally BC_2 tablets and BC_1 tablets,the blank control as well as model control groups in mice received orally clean water,once daily for 7days,respectively.Then,all treated groups in mice were administrated orally compound diphenoxylate(CDX) tablets 12 h after fasting the induction of constipation except for blank control group.In clinic trial,eligible thirty-eight patients with chronic constipation in adults were randomly allocated to two groups.There were 20 patients in the BC_1 tablets treated group and 18 patients in the golden Bifidobacterium(GB) tablets controlled group.Two groups in patients were received orally BC_1 tablets or golden bifidobacterium tablets,three times daily for 14~21 days,respectively.Administration of these probiotic preparations was randomized,double blind and double dummy in clinic trial.Results BC_1 tablets could obviously decrease(P<0.05) first defecation time,BC_1 tablets and BC_2 tablets all could significantly increase the stool grain number and stool weight in mice with constipation,there were significant difference(P<0.05) in those results of the BC_1 tablets and BC_2 tablets comparing to model control group,however,no significant difference(P>0.05) between the BC_1 tablets and BC_2 tablets.In clinic trial,the results showed that the cure effectiveness rate of BC_1 tablets was 45.0%and total effectiveness rate was 70.0%,while the corresponding rate of GB tablets was 44.0% and was 72.0% in chronic constipation in adults,respectively.Moreover, no adverse reactions or side effect were found in either drug.Conclusion BC_1 tablets all had obvious pharmacological effects or therapeutic effects on the experimental constipation in mice or the chronic constipation in adults,and no adverse reactions or side effects were found in clinic trial.