摘要
目的观察聚乙二醇4 000治疗4～14岁儿童功能性便秘(FC)的疗效及安全性,探讨治疗前后患儿结肠传输功能的改变。方法选择在本院儿科就诊的FC患儿81例,随机分为聚乙二醇4 000组(n=40例)和乳果糖组(n=41例)。对二组患儿治疗前后进行结肠传输试验和FC分型。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;安全性评价:不良事件、实验室检查、体格检查。结果 1.治疗2周,聚乙二醇4 000组16例[慢传输型(STC)亚组7例,出口梗阻型(OOC)亚组9例]、乳果糖组18例[STC亚组10例,OOC亚组8例]复查结肠传输试验恢复正常。20例未恢复正常的患儿,继续原治疗2周,其中7例(聚乙二醇4 000组3例,乳果糖组4例)患儿复查结肠传输试验恢复正常。2.聚乙二醇4 000组及乳果糖组服药第1、2周每周排便次数分别增加4次、5次(中位数)和3次、4次(中位数),二组比较差异有统计学意义(P=0.017,0.000)。3.聚乙二醇4 000组和乳果糖组治疗2周后大便性状恢复正常患儿分别为35例(87.5%)及26例(63.4%),二组比较差异有统计学意义(P=0.012)。4.聚乙二醇4 000组和乳果糖组治疗2周后临床完全缓解率分别为72.5%及43.9%,二组比较差异有统计学意义(P=0.009)。聚乙二醇4 000组和乳果糖组治疗2周后分别有60.9%及54.5%腹痛消失,二组比较差异无统计学意义。5.二组患儿均未发生不良事件,实验室及体格检查均未发现异常。结论聚乙二醇4 000治疗4～14岁FC患儿安全有效,且聚乙二醇4 000优于乳果糖;少数患儿治疗2周后疗效欠佳,可适当增加疗程至4周;聚乙二醇4 000能有效改善STC及OOC FC患儿的结肠传输功能。.
Objective To investigate the therapeutic effect and safety of polyethylene glycol 4 000 in the treatment of functional constipation（FC） in 4-14 years old children by positive drug-control study,and observe the changes of the function of colonic transit before and after treatment.Methods In Tangdu Hospital,a total of 81 children with FC were enrolled in this study who were randomly divided into pol-yethylene glycol 4 000 group（n=40） and lactulose group（n=41）.The colon transit test checks were observed to decide the type of FC,and differences before and after treatment were compared.The main observed outcome measures included the median,and the quartile number of bowel movements per week,the main weekly stool bristol type of median and quartile and stool normal rate.The secondary observed outcome measures included clinical complete remission rate,abdominal pain situation.The safety evaluation included harmful event,laboratory examination and physical inspection.Results 1.After 2 weeks of treatment,16 cases of polyethylene glycol 4 000 group included slow transit constipation（STC） subgroup（n=7）and outletobstruction constipation（OOC）subgroup（n=9） reviewed colonic transit experiment,they all returned to normal;while in lactulose group,18 patients[10 cases in STC subgroup,8 cases in OOC subgroup]reviewed colonic transit experiment,they also returned to normal.Those children who were reviewed colonic transit experiment not returned to normal,continued the original treatment for 2 weeks,of which 7 cases（3 cases in polyethylene glycol 4 000 group,4 cases in lactulose group） were reviewed colonic transit test and they were returned to normal.2.Polyethylene glycol 4 000 lactulose group and lactulose group,1 week,2 weeks after the first defecation frequency per week increased by 4 times,5 times（median）,and 3 times,4 times（median）,the differences were statistically significant（P=0.017,0.000）.3.The stool consistency of the 2 groups returned to normal were 35 cases（87.5%） and 26 cases（63.4%）,there was significant difference between the 2 groups（P=0.012）.4.The clinical complete remission rate of constipation in the forlax and lactulose groups was 72.5% and 43.9%respectively by 2 weeks of treatment,there was significant difference between the 2 groups（P=0.009）.Abdominal pain disappeared in 60.9% of patients in the forlax group but in only 54.5% in the lactulose group by 2 weeks of treatment,the difference was not statistically significant.5.No serious adverse events happened and no abnormalities were found in laboratory tests and physical examinations in the 2 groups after medication.Conclusions Polyethylene glycol 4 000 is safe and effective in the treatment of constipation in children 4-14 years old,and polyethylene glycol 4 000 better than lactulose.A small number of children with poor efficacy after 2 weeks of treatment can increase the treatment to 4 weeks.polyethylene glycol 4 000 can effectively improve the colon transfer functions of STC and OCC children with FC.
出处
《实用儿科临床杂志》
CAS
CSCD
北大核心
2010年第10期764-766,784,共4页
Journal of Applied Clinical Pediatrics
基金
陕西省科技攻关计划项目[2006k08-G3(3)]
