Lazzaroni M, Petrillo M, Desideri S, Bianchi Porro G
Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.
Aliment Pharmacol Ther. 1993 Dec;7(6):655-9. doi: 10.1111/j.1365-2036.1993.tb00148.x.
This placebo-controlled study assessed the efficacy and tolerability of polyethylene glycol-electrolyte lavage solution (PEG-ELS), with and without simethicone, in the preparation of patients with inflammatory bowel disease for colonoscopy. PEG-ELS 4 L plus placebo, or PEG-ELS 4 L plus simethicone 120 mg. was administered according to a randomized double-blind protocol to 115 patients with ulcerative colitis or Crohn's disease. The parameters assessed were: presence of bubbles, degree of haziness, degree of bowel cleansing and patient acceptance. In the 105 patients completing the study, the efficacy of colonic lavage was found to be essentially comparable for the two preparations, although the addition of simethicone showed a significant reduction in the formation of bubbles. Significantly better results were reported by patients treated with the drug combination regarding reduction of general malaise (P = 0.01) and sleep disturbance (P = 0.01). The PEG-ELS solution represents an effective bowel cleansing method which can also be used for patients suffering from inflammatory bowel disease. The addition of simethicone to the traditional formulation is an acceptable development in terms of clinical efficacy and tolerability.
这项安慰剂对照研究评估了含与不含西甲硅油的聚乙二醇电解质灌洗液(PEG - ELS)在炎症性肠病患者结肠镜检查前肠道准备中的疗效和耐受性。按照随机双盲方案,将PEG - ELS 4 L加安慰剂或PEG - ELS 4 L加西甲硅油120 mg给予115例溃疡性结肠炎或克罗恩病患者。评估的参数包括:气泡的存在、浑浊程度、肠道清洁程度和患者接受度。在完成研究的105例患者中,发现两种制剂的结肠灌洗效果基本相当,不过添加西甲硅油后气泡形成显著减少。接受药物组合治疗的患者在减轻全身不适(P = 0.01)和睡眠障碍(P = 0.01)方面报告的结果明显更好。PEG - ELS溶液是一种有效的肠道清洁方法,也可用于炎症性肠病患者。在传统配方中添加西甲硅油在临床疗效和耐受性方面是一个可接受的改进。