福松治疗儿童便秘：一项随机对照多中心临床研究

[Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study].

作者信息

Wang Bao-Xi, Wang Mao-Gui, Jiang Mi-Zu, Xu Chun-Di, Shao Cai-Hong, Jia Li-Ying, Huang Zhi-Hua, Xu Xiao-Hua

机构信息

Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China.

出版信息

Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.

PMID:17937851

Abstract

OBJECTIVE

To determine the therapeutic effectiveness and safety of polyethylene glycol 4000 (forlax) in the treatment of constipation in children over 8 years old.

METHODS

This study was designed as a randomized, positive medicine (lactulose) controlled multicenter trial. A total of 216 children with constipation from 8-18 years old from 7 hospitals across China who were matched with a uniform entry criteria were enrolled in this study. The 216 patients were randomized to receive either oral forlax (20 g/d, n=105) or lactulose (15 mL/d, n=111) for 2 weeks. The therapeutic effects, including bowel movement frequency, stool consistency, clinical complete remission rate of constipation and abdominal symptoms, and the safety of forlax and lactulose were evaluated at 1 and 2 weeks of treatment.

RESULTS

The median weekly frequency of bowel movement in the forlax group increased by 4 and 5 times respectively after 1 and 2 weeks of treatment, and increased by 3 and 4 times in the lactulose group (P < 0.05). The stool consistency of the two groups was both improved significantly after treatment. The Bristol score of stool consistency of the forlax and lactulose groups were 3.41+/-1.11 and 3.64+/-1.33 respectively (P < 0.05) after 1 week of treatment, and were 4.26+/-0.89 and 3.63+/-1.33 respectively (P < 0.05) after 2 weeks of treatment. The clinical complete remission rate of constipation in the forlax and lactulose groups was 70% and 40% respectively (P < 0.05) by week 1 of treatment, and that was 72% and 41% respectively (P < 0.05) by week 2 of treatment. Abdominal pain disappeared in 75% of patients in the forlax group but in only 57% in the lactulose group by week 2 of treatment (P < 0.05). No serious adverse events happened and no abnormalities were found in laboratory tests and physical examinations in the two groups after medication.

CONCLUSIONS

Forlax is safe and effective in the treatment of constipation in children over 8 years old.

摘要

目的

确定聚乙二醇4000（福松）治疗8岁以上儿童便秘的疗效和安全性。

方法

本研究设计为随机、阳性药物（乳果糖）对照的多中心试验。来自中国7家医院的216例8至18岁符合统一入选标准的便秘儿童被纳入本研究。将216例患者随机分为口服福松组（20 g/d，n = 105）或乳果糖组（15 mL/d，n = 111），治疗2周。在治疗1周和2周时评估治疗效果，包括排便频率、大便性状、便秘临床完全缓解率和腹部症状，以及福松和乳果糖的安全性。

结果

治疗1周和2周后，福松组每周排便次数中位数分别增加4次和5次，乳果糖组分别增加3次和4次（P < 0.05）。两组治疗后大便性状均明显改善。治疗1周后，福松组和乳果糖组大便性状的布里斯托评分分别为3.41±1.11和3.64±1.33（P < 0.05），治疗2周后分别为4.26±0.89和3.63±1.33（P < 0.05）。治疗第1周时，福松组和乳果糖组便秘临床完全缓解率分别为70%和40%（P < 0.05），治疗第2周时分别为72%和41%（P < 0.05）。治疗第2周时，福松组75%的患者腹痛消失，而乳果糖组仅为57%（P < 0.05）。两组用药后均未发生严重不良事件，实验室检查和体格检查均未发现异常。