自适应式生物反馈疗法联合口服复方聚乙二醇4000电解质散治疗儿童出口梗阻型便秘的前瞻性随机对照研究（英文翻译）

Clinical efficacy of adaptive biofeedback training combined with oral administration of compound polyethylene glycol 4000-electrolyte powder in the treatment of children with outlet obstruction constipation: a prospective randomized controlled trial

摘要:

目的 探讨自适应式生物反馈疗法联合口服复方聚乙二醇4000电解质散在儿童出口梗阻型便秘治疗中的临床疗效，为出口梗阻型便秘患儿寻找合理而有效的治疗方法。 方法 前瞻性选取168例出口梗阻型便秘患儿为研究对象，按来院就诊次序随机分成试验组和对照组（n=84），试验组采用自适应式生物反馈疗法联合口服复方聚乙二醇4000电解质散治疗，对照组仅采用口服复方聚乙二醇4000电解质散治疗。最终因无法坚持治疗试验组退出11例，余73例；对照组退出2例，余82例。通过临床症状总积分和总有效率比较两组患儿治疗4周和8周时的疗效。 结果 治疗前和治疗4周时两组临床症状总积分比较差异无统计学意义（P>0.05），治疗8周时试验组临床症状总积分低于对照组（P<0.05）；治疗4周时两组临床总有效率比较差异无统计学意义（P>0.05），而治疗8周时试验组临床总有效率高于对照组（P<0.05）。 结论 在口服复方聚乙二醇4000电解质散的基础上加用自适应式生物反馈训练治疗儿童出口梗阻型便秘能明显提升疗效，且效果持久稳定。

Abstract:

Objective To study the clinical efficacy, advantages, and disadvantages of adaptive biofeedback training combined with oral administration of compound polyethylene glycol 4000-electrolyte powder in the treatment of children with outlet obstruction constipation (OOC). Methods A total of 168 children with OOC were enrolled in this prospective study. All the subjects were randomly divided into a test group and a control group based on the order of visiting time, 84 in each group. The test group was treated with adaptive biofeedback training combined with oral administration of compound polyethylene glycol 4000-electrolyte powder, and the control group was treated with oral administration of compound polyethylene glycol 4000-electrolyte powder alone. Eleven children in the test group and two children in the control group withdrew from the study since they could not finish the whole treatment course. Finally, 73 children in the test group and 82 children in the control group were included in this analysis. As clinical outcomes, the total score of clinical symptoms and overall response rate were compared between the two groups at weeks 4 and 8 of treatment. Results There was no significant difference in the total score of clinical symptoms between the two groups at beginning of treatment and at week 4 (P>0.05), while the test group had a significantly lower total score of clinical symptoms than the control group at week 8 (P<0.05). At week 4, there was no significant difference in overall response rate between the two groups (P>0.05), while the test group had a significantly higher overall response rate than the control group at week 8 (P<0.05). Conclusions Adaptive biofeedback training combined with oral administration of compound polyethylene glycol 4000-electrolyte powder is significantly associated with improvement of clinical outcomes in the treatment of children with OOC.