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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 observe the efficacy and safety of polyethylene glycol 4 000 in the treatment of functional constipation (FC) in children aged 4-14 years and to explore the changes of colonic transit function in children before and after treatment. Methods Eighty-one infants with FC in our pediatric department were randomly divided into 4 000 groups (n = 40) and lactulose group (n = 41). Two groups of children before and after treatment of colon transmission test and FC typing. The main efficacy indicators: weekly bowel movements, major stool per week, stool trait normal rate; secondary efficacy indicators; clinical complete remission rate, abdominal pain; safety evaluation: adverse events, laboratory tests, physical examination. Results 1. For 2 weeks, there were 16 patients in the 4,000 polyethylene glycol groups (7 in the STC subgroup, 9 in the OOC subgroup), 18 in the lactulose group [STC subgroup 10 Cases, OOC subgroup of 8 cases] review of colon transmission test returned to normal. Twenty patients who did not return to normal were treated for another two weeks. Seven of them (3 in 4,000 in polyethylene glycol group and 4 in lactulose group) returned to normal. (2) The number of bowel movements in 4,000 and lactulose groups increased by 4 times, 5 times (median), 3 times and 4 times (median) in the first and second weeks, respectively The difference was statistically significant (P = 0.017,0.000). There were statistically significant differences between the two groups (P <0.05) .3. There were 35 cases (87.5%) and 26 cases (63.4%) in the polyethylene glycol 4000 group and the lactulose group after 2 weeks of treatment, respectively. 0.012). 4. The complete remission rate of PEG 4000 group and lactulose group after 2 weeks of treatment was 72.5% and 43.9%, respectively, with significant difference between the two groups (P = 0.009). 60.9% and 54.5% of abdominal pain disappeared in 4 000 polyethylene glycol and 2 weeks after lactulose treatment, respectively. There was no significant difference between the two groups. 5. No adverse events occurred in both groups, and no abnormalities were found in laboratory and physical examinations. Conclusions PEG 4000 is safe and effective for 4-14-year-old FC children, and PEG 4000 is better than lactulose. A small number of children have poor curative effect after 2 weeks of treatment and may be given an appropriate course of treatment up to 4 weeks. Poly Glycol 4000 can effectively improve colonic transit in children with STC and OOC FC. .