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目的 比较天然蒙脱石粉剂 (商品名 :思密达 )及双歧三联活菌胶囊 (商品名 :培菲康 )对慢性功能性腹泻患者日均排便次数及大便形态Bristol分型的影响。方法 采用多中心、前瞻性、开放、随机、阳性药物对照方法 ,对慢性功能性腹泻患者随机分成 2组 ,治疗组予天然蒙脱石粉剂 3g ,每日 3次 ;对照组予双歧三联活菌胶囊 4 2 0mg ,每日 3次。疗程 2 8d。 结果 本研究共纳入 4 10例患者 ,其中治疗组 2 0 8例对照组 2 0 2例。两组在 2 8d疗程中日均大便次数分别为 (2 .0 2± 0 .81)次及 (2 .2 2± 0 .82 )次 ,差异有显著性 (P =0 .0 0 7)。两组停药后 2周内大便日均 (1.82± 0 .85 )次及 (1.97± 0 .89)次 ,差异有显著性 (P =0 .0 32 )。治疗组在 2 8d疗程中Bristol分型均值为 4 .6 4± 0 .83,对照组为 4 .89± 0 .83,差异有显著性 (P =0 .0 0 1)。治疗组停药后 2周内Bristol分型均值为 4 .34± 1.2 0 ,对照组为 4 .6 3± 1.2 3,差异无显著性。结论 天然蒙脱石粉剂是治疗慢性功能性腹泻有效而安全的药物。
Objective To compare the effects of natural montmorillonite powder (trade name: Smectite) and bifidobacterium triple viable capsule (trade name: Peifeikang) on the number of defecation and stool pattern Bristol in patients with chronic functional diarrhea. Methods The patients with chronic functional diarrhea were randomly divided into 2 groups. The treatment group was treated with natural montmorillonite powder 3g 3 times a day. The control group was bidentate triple combined live Bacteria capsules 420mg, 3 times a day. Treatment 2 8d. Results A total of 410 patients were enrolled in this study, of which 208 were in the treatment group and 202 in the control group. The average number of stools in two groups during 28 days of treatment was (2.20 ± 0.81) times and (2.22 ± 0.82) times, respectively, with significant difference (P = 0.070) . The average daily stool frequency (1.82 ± 0.85) times and (1.97 ± 0.89) times in the two groups after stopping the treatment were significantly different (P = 0.322). In the treatment group, the mean Bristol classification was 4.64 ± 0.83 in 28 days of treatment and 4.89 ± 0.83 in control group, the difference was significant (P = 0.010). In the treatment group, the mean Bristol classification was 4.34 ± 1.2 0 within 2 weeks after treatment, and 4.36 ± 1.2 3 in the control group, with no significant difference. Conclusion Natural montmorillonite powder is effective and safe for the treatment of chronic functional diarrhea.