Zangaglia Roberta, Martignoni Emilia, Glorioso Margaret, Ossola Maria, Riboldazzi Giulio, Calandrella Daniela, Brunetti Gabriele, Pacchetti Claudio
Parkinson's Disease and Movement Disorders Unit, IRCCS C. Mondino Institute of Neurology Foundation, Pavia, Italy.
Mov Disord. 2007 Jul 15;22(9):1239-44. doi: 10.1002/mds.21243.
Chronic constipation is the most frequent symptom of autonomic system involvement in Parkinson's disease (PD). Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double-blind, placebo-controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC-ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC-ES group both at the first (4 weeks; P < 0.0003) and at the final evaluation (8 weeks; P < 0.0012). The frequency of bowel movements (P < 0.002) and stool consistency (P < 0.006) were significantly changed in the MC-ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC-ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ-39) did not show any significant modification in either group during the 8-week treatment period. The results of this placebo-controlled study show the efficacy of MC-ES in the treatment of constipation in PD. MC-ES was well-tolerated and did not affect the course of PD.
慢性便秘是帕金森病（PD）自主神经系统受累最常见的症状。该症状常常较为严重，会损害患者的生活质量。本研究的目的是在一项双盲、安慰剂对照研究中，确定等渗聚乙二醇溶液治疗PD患者便秘的有效性和安全性。共有57例便秘的PD患者被随机分配接受等渗聚乙二醇电解质溶液（MC-ES；29例患者）或安慰剂（28例患者）治疗8周。治疗效果定义为症状完全缓解或以下指标中的两项显著改善：排便频率、用力排便情况、大便性状、使用直肠泻药作为急救治疗。在第1次（4周；P<0.0003）和最终评估（8周；P<0.0012）时，MC-ES组的缓解率均显著更高。与安慰剂组相比，MC-ES组的排便频率（P<0.002）和大便性状（P<0.006）有显著变化。在最终评估时，安慰剂组有2例（12.5%）患者使用了直肠泻药，而MC-ES组未记录到使用情况。与安慰剂相比，使用聚乙二醇治疗的患者在用力排便方面的缓解率显示出有利趋势。在8周治疗期间，两组的统一帕金森病评定量表第三部分和帕金森病问卷（PDQ-39）均未显示出任何显著变化。这项安慰剂对照研究的结果表明，MC-ES治疗PD患者便秘有效。MC-ES耐受性良好，且不影响PD的病程。
