福松治疗儿童便秘的多中心 随机对照临床研究

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

摘要:

目的：儿童便秘的药物治疗至今尚未形成方案，该研究拟通过观察福松（聚乙二醇4000）治疗8岁以上儿童便秘的疗效及安全性，为儿科临床医师提供儿童便秘治疗的药物选择依据。方法：采用多中心、随机、开放、阳性药物（乳果糖）对照方法研究，在国内7家医院按入选标准纳入患儿216例，福松组105例（男43，女62，年龄11.29±2.80岁），乳果糖组111例（男47，女64，年龄11.20±2.75岁）。设福松组（口服福松）及乳果糖组（口服乳果糖）分别按20 g/d及15 mL/d口服，疗程2周。观察主要疗效指标（每周排便次数、每周主要大便性状、大便性状正常率）、次要疗效指标（临床完全缓解率、腹痛情况）及安全性评价（不良事件、实验室检查、体格检查）。结果：①福松组及乳果糖组服药第1、2周后每周排便次数分别增加4次、5次（中位数）和3次、4次，差异有统计学意义。②两组患儿治疗后大便性状均有明显改善，1周后大便性状评分分别为3.41±1.11及3.64±1.33；2周后为4.26±0.89及3.63±1.33，差异有统计学意义。③两组临床完全缓解率分别为第1周70％及40％，第2周为72％及41％；在123例治疗前伴有腹痛患儿中，治疗14 d时福松组75％腹痛消失，乳果糖组为57％，差异有统计学意义。④两组患儿均未发生严重不良事件，实验室及体格检查均未发现异常。结论：福松治疗8岁以上儿童便秘安全有效。［中国当代儿科杂志，2007，9（5）：429-432］

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.