聚乙二醇4000治疗成人慢性功能性便秘的多中心随机对照临床试验研究

A Randomized Controlled Multicenter Clinical Trial on the Treatment of Chronic Functional Constipation with PEG4000

目的：评价聚乙二醇４０００治疗成人慢性功能性便秘的有效性及安全性。方法：多中心临床试验以欧车前亲水胶体为对照，采用随机、平行对照的试验方法，试验共入选病例１２４例，其中入选聚乙二醇４０００治疗组６４例，临床治疗评价病例６３例，安全性评价６４例；入选欧车前亲水胶体对照６０例，临床疗效评价病例５９例，安全性评价６０例。聚乙二醇４０００和欧车前亲水胶体的剂量分别为１０ｇ和６ｇ，每日２次口服，疗程两周。结果：聚乙二醇４０００与欧车前亲水胶体均可使大部分慢性功能性便秘患者的大便形状、次数恢复正常，主要消化道症状消失，其总有效率相近，分别为８５．７％和８６．４％，但显效率不同，分别为８１．０％及６２．７％，差异有显著性（Ｐ＜０．０５）。药物不良反应发生率分别为７．８１％和１１．７％，二者比较差异无显著性（Ｐ＞０．０５）。结论：聚乙二醇４０００是治疗慢性功能性便秘的安全、有效药物。

OBJECTIVE: To compare the clinical efficacy and safety of PEG4000 for functional constipation. METHODS: A total of 124 patients with chronic functional constipation entered a multi-center, randomized, comparative trial. Patients were divided into two groups treated with PEG4000(10g bid)as a treated group and psyllium hydrophilic mucilloid(6g bid) as a control for two weeks respectively. 64 patients were enrolled in PEG4000 group, all of them were assessable for safty and among of them 63 patients were assassable for efficacy, 60 patients were enrolled in psyllium hydrophilic mucilloid group, all of them were assessable for safty and among of them 59 patients were assessable for efficacy. RESULTS: The normalization of the stool form, frequncy of defecation and main digestive synptoms in the patients with chronic functional constipation was similar in the two groups. The total efficacy rates were 85.7% and 86.4% in the treatment group and controlled group respectively, there was no significant difference between the two groups; but in the rate of excellent efficacy there was significant difference they were 81 .0% and 62.7% in the treatment and controlled groups respectively (P <0.05%). The incidence of adverse reaction were 7.8% and 11 .7% in the two groups respectively, there was no difference (P>0.05%). CONCLUSION: PEG4000 is a safe and effective agent in the treatment of chronic functional constipation.