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

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20g/d及15mL/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14d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。

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.