目的 探讨六味能消胶囊联合双歧杆菌三联活菌胶囊治疗儿童功能性便秘的临床效果。方法 选取2019年6月—2021年9月郑州市金水区总医院收治的82例功能性便秘患儿，使用随机数字表法将82例患儿随机分成对照组和治疗组，每组各41例。对照组口服双歧杆菌三联活菌胶囊，1粒/次（1～6岁），2粒/次（7～14岁），3次/d，以温牛奶或温开水冲服。治疗组在对照组基础上口服六味能消胶囊，1/3粒/次（1～3岁）、1/2粒/次（4～5岁）、2/3粒/次（6～10岁）、1粒/次（11～14岁），2次/d。两组均连续治疗2周。观察两组的临床疗效，比较治疗前后两组主要症状评分、肛门直肠动力学参数值、肠道菌群数量及血清P物质（SP）、血管活性肠肽（VIP）水平。结果 治疗后，治疗组总有效率为95.1%，显著高于对照组的80.5%（P<0.05）。治疗后，两组粪便性状评分、排便频率评分、排便时间评分、腹胀评分均较治疗前显著降低（P<0.05）；且均以治疗组下降更显著（P<0.05）。治疗后，两组直肠最低敏感量、最大耐受量和肛门括约肌最大收缩压较治疗前均显著降低（P<0.05）；但均以治疗组的改善更显著（P<0.05）。两组治疗前后肛门括约肌静息压组内及组间比较差异均无统计学意义。治疗后，两组患者粪便中双歧杆菌、乳酸杆菌数量较治疗前均显著增加，而梭杆菌、肠球菌数量则均显著减少（P<0.05）；且治疗后，治疗组肠道菌群数量改善优于对照组（P<0.05）。治疗后，两组血清SP水平均显著升高，而血清VIP水平均显著降低（P<0.05）；且治疗后，治疗组血清SP、VIP水平改善优于对照组（P<0.05）。结论 六味能消胶囊联合双歧杆菌三联活菌胶囊治疗儿童功能性便秘的整体疗效确切，能安全有效地缓解患儿症状，改善肛门直肠动力学异常，恢复肠道内环境稳态，纠正脑肠肽分泌异常，值得临床推广应用。

Objective To explore the clinical effect of Liuwei Nengxiao Capsules combined with live combined bifidobacterium, lactobacillus and enterococcus in treatment of children with functional constipation. Methods A total of 82 children with functional constipation admitted to the General Hospital of Jinshui District Zhengzhou City from June 2019 to September 2021 were selected. The 82 children were randomly divided into control group and treatment group by random number table method, with 41 cases in each group. Patients in the control group were po administered with Live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules, 1 grain/time (1 to 6 years old), two grains/time (7 to 14 years old), three times daily, with warm milk or warm water. Patients in the treatment group were po administered with Liuwei Nengxiao Capsules on the basis of the control group, 1/3 grain/time (1-3 years old), 1/2 grain/time (4-5 years old), 2/3 grain/time (6-10 years old), 1 grain/time (11-14 years old), twice daily. Both groups were treated for 2 weeks. The clinical efficacy of the two groups were observed, and the scores of main symptoms, anorectal kinetic parameters, intestinal flora number and serum substance P (SP) and vasoactive intestinal peptide (VIP) levels were compared before and after treatment. Results After treatment, the total effective rate in the treatment group was 95.1%, significantly higher than that in the control group (80.5%) (P < 0.05). After treatment, the scores of fecal traits, defecation frequency, defecation time and abdominal distension in two groups were significantly lower than those before treatment (P < 0.05). The decrease was more significant in the treatment group (P < 0.05). After treatment, the minimum sensitive volume of rectum, the maximum tolerated volume and the maximum systolic pressure of anal sphincter in two groups were significantly decreased compared with before treatment (P < 0.05). However, the improvement in treatment group was more significant (P < 0.05). There was no significant difference in the anal sphincter resting pressure between the two groups before and after treatment. After treatment, the numbers of bifidobacteriaand lactobacillus in feces in two groups were significantly increased compared with before treatment, while the numbers of Clostridium and enterococcus were significantly decreased (P < 0.05). After treatment, the number of intestinal flora in the treatment group was better than that in the control group (P < 0.05). After treatment, serum SP level was significantly increased, while serum VIP level was significantly decreased in both groups (P < 0.05). After treatment, the serum SP and VIP levels in the treatment group were better than those in the control group (P < 0.05). Conclusion Liuwei Nengxiao Capsules combined with live combined bifidobacterium,lactobacillus and enterococcus has a definite overall effect in treatment of children with functional constipation, and can safely and effectively relieve the symptoms of children, improve anorectal dynamic abnormalities, restore intestinal environmental homeostasis and correct brain-gut peptide secretion abnormalities, which is worthy of clinical application

R975

郑州市科技攻关项目（20190038）