聚乙二醇3350治疗成人慢性功能性便秘的多中心随机对照的临床研究

Efficacy and safety of polyethylene glycol 3350 in the treatment of human functional chronic constipation

目的 :观察聚乙二醇 3350 (默维可 ,Movical)治疗成人慢性功能性便秘的疗效及安全性。方法 :采用多中心随机平行对照试验 ,按照试验中心分层 ,按入选标准选择成人便秘患者 1 2 6例 ,随机进入试验组和对照组 ,2组均为 63例。选择欧车前亲水胶 (恺司尔 ,Konsyl)作为试验对照药。试验组服用聚乙二醇 3350 1 3 .7g·d-1 ,bid ;对照组服用欧车前亲水胶 3 .5g·d-1 ,bid ;疗程 2周。结果 :2组患者经治疗后便秘伴随症状如 :腹痛、腹胀、排便困难、排便疼痛等均得到缓解。均未造成服药后电解质丢失 ,2组结果近似 ,服药后试验组及对照组大便形状复常率为87.30 %和 66 .67% ,总有效率为 92 .0 7%和 73 .0 2 % ,大便性状恢复正常、总有效率及首次排便时间试验组均优于对照组 (P <0 .0 1 )。在安全性研究中 ,除对照组 1例ALT升高外 ,其余均未发现明显不良反应。结论 :聚乙二醇3350治疗成人慢性功能性便秘安全。

Objective:To evaluate the efficacy and safety of polyethylene glycol 3350 (Movical) in the treatment of human functional chronic constipation.Methods:In this multicentre,randomized, controlled, parallel group study,126 patients with confirmed functional constipation on basis of choosing standard were randomly divided into 2 groups,each group contained 63 patients,to receive 13.7g Movical twice daily (the trial group) or 3.5g psylium hydrophilic mucilloid (Konsyl) twice daily (the control group) for 2 weeks.Results:After treatment, the constipation and accompanying symptoms such as abdominal pain, abdominal bloating were relieved in both groups.No electrolyte disorder was observed during treatment in both groups. Improvements of the stool form in the first bowel movement were 87.30% in the trial group and 66.67% in the control group. The total effective rates were 92.07% in the trial group and 73.02% in the control group ( P <0.01).In this study, except one patient whose ALT became abnormal after treatment,other patients had no significant side effects.Conclusion:Polyethylene glycol 3350 (Movical) is effective and safe in the treatment of human functional chronic constipation. [