Beijing Friendship Hospital, Beijing, People’s Republic of China.
Clin Drug Investig. 2004;24(10):569-76. doi: 10.2165/00044011-200424100-00002.
To compare the efficacy and safety of polyethylene glycol (PEG) 3350 plus electrolytes (PEG+E; Movicol((R))) with that of ispaghula husk (psyllium; Konsyl((R))) in the treatment of constipation.
Male or female adults with chronic functional constipation.
This was a randomised, controlled, open-label, parallel-group trial. Study treatment was either PEG+E 13.8g/sachet dissolved in water twice daily or ispaghula husk 3.5g/sachet dissolved in water twice daily for a period of 2 weeks. Assessments were at baseline and after 1 and 2 weeks' therapy and by patient daily diary card. The primary outcome measures were weekly defaecation rate, stool consistency according to the Bristol Stool Form scale, time to first defaecation, and overall efficacy, which combined defaecation rate, stool consistency and difficulty on defaecation. Adverse effects were recorded and laboratory assessments were performed before and at the end of the treatment period.
Sixty-three patients were randomised to each treatment group. Treatment was highly effective in 50/63 patients in the PEG+E group compared with 26/63 in the ispaghula husk group, and the overall efficacy rates were 92% and 73%, respectively (p = 0.005). PEG+E increased the mean weekly defaecation rate from 1.18 (SD 0.77) at baseline to 7.95 (SD 3.49) after 1 week and 8.48 (SD 3.55) after 2 weeks. In the ispaghula husk group the mean weekly defaecation rate increased from 1.33 (SD 0.68) at baseline to 5.33 (SD 2.81) after 1 week and to 5.71 (SD 2.49) after 2 weeks. The treatment differences for defaecation rates were all statistically significant (p < 0.001). Two weeks of treatment with PEG+E or ispaghula husk normalised stools in 55/63 (87.3%) and 42/63 (66.7%) of patients (p < 0.001). The incidence of adverse effects did not differ between groups and none were serious or required any treatment. Laboratory evaluations found no adverse effect from either treatment.
The present study demonstrated that low-dose PEG 3350 plus electrolytes is more effective and more rapid in its onset of action than ispaghula husk, and is equally well tolerated.
比较聚乙二醇 3350 加电解质（PEG+E； Movicol((R)))与车前子壳（psyllium；Konsyl((R)))治疗便秘的疗效和安全性。
慢性功能性便秘的成年男性或女性。
这是一项随机、对照、开放标签、平行组试验。研究治疗为每天两次口服 PEG+E 13.8g/袋，溶于水，或每天两次口服车前子壳 3.5g/袋，溶于水，治疗时间为 2 周。评估在基线时、治疗后 1 周和 2 周进行，并通过患者每日日记卡进行评估。主要结局指标为每周排便频率、根据布里斯托粪便形状量表评估的粪便稠度、首次排便时间和整体疗效，整体疗效综合了排便频率、粪便稠度和排便困难程度。记录不良反应，并在治疗前和治疗结束时进行实验室评估。
63 名患者随机分为每组各 63 名。PEG+E 组 63 名患者中有 50 名治疗效果显著，而车前子壳组中只有 26 名，总有效率分别为 92%和 73%（p = 0.005）。PEG+E 使每周排便频率从基线时的 1.18（SD 0.77）增加到治疗 1 周后的 7.95（SD 3.49）和治疗 2 周后的 8.48（SD 3.55）。车前子壳组每周排便频率从基线时的 1.33（SD 0.68）增加到治疗 1 周后的 5.33（SD 2.81）和治疗 2 周后的 5.71（SD 2.49）。治疗后排便频率的差异均有统计学意义（p<0.001）。2 周治疗后，PEG+E 或车前子壳使 55/63（87.3%）和 42/63（66.7%）名患者的粪便正常化（p<0.001）。两组不良反应发生率无差异，均无严重不良反应或需要治疗。实验室评估未发现任何治疗相关的不良反应。
本研究表明，低剂量聚乙二醇 3350 加电解质比车前子壳起效更快，疗效更显著，且耐受性相当。
