Randomized Clinical Trial: Macrogol/PEG 3350 Plus Electrolytes for Treatment of Patients With Constipation Associated With Irritable Bowel Syndrome
Randomized Clinical Trial: Macrogol/PEG 3350 Plus Electrolytes for Treatment of Patients With Constipation Associated With Irritable Bowel Syndrome
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DOI：
10.1038/ajg.2013.197
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发表时间：
2013-09-01
影响因子：
9.8
通讯作者：
Halphen, M.
中科院分区：
文献类型：
--
作者：
Chapman, R. W.;Stanghellini, V.;Halphen, M.
目的：聚乙二醇（PEG）3350+电解质（PEG 3350 + E）是一种已确立的便秘治疗方法，已被提议作为肠易激综合征（IBS-C）相关便秘的治疗选择。本研究旨在比较PEG 3350 + E与安慰剂在IBS-C成人患者中的疗效和安全性。方法：在14天的无研究药物的导入期后，确诊IBS-C的患者随机接受PEG 3350 + E（N = 68）或安慰剂（N = 71）治疗28天。主要终点是最后一个治疗周每天自发排便（SBM）的平均次数。从运行中增加。第4周两组之间的差异（PEG 3350 + E，4.40 +/- 2.581;安慰剂，3.11 +/- 1.937）具有统计学显著性（95%置信区间：1.17，1.95; P < 0.0001）。尽管与PEG 3350 + E导入期相比，腹部不适/疼痛的平均严重程度评分显著降低，但与安慰剂相比无差异。在第4周，PEG 3350 + E组的自发完全排便、应答率、粪便稠度和劳损严重程度也显示出优于安慰剂的上级改善。最常见的药物相关治疗后出现的不良事件是腹痛（PEG 3350 + E，4.5%;安慰剂，0%）和腹泻（PEG 3350 + E，4.5%;安慰剂，4.3%）。在IBS-C中，PEG 3350 + E在缓解便秘方面上级安慰剂，尽管与基线相比观察到腹部不适/疼痛的统计学显著改善，但与安慰剂相比没有相关的改善。PEG 3350 + E是一种成熟有效的治疗方法，应被视为适用于IBS-C。
OBJECTIVES: Polyethylene glycol (PEG) 3350 plus electrolytes (PEG 3350 + E) is an established treatment for constipation and has been proposed as a treatment option for constipation associated with irritable bowel syndrome (IBS-C). This study aimed to compare the efficacy and safety of PEG 3350 + E vs. placebo in adult patients with IBS-C.METHODS: Following a 14-day run-in period without study medication, patients with confirmed IBS-C were randomized to receive PEG 3350 + E (N = 68) or placebo (N = 71) for 28 days. The primary endpoint was the mean number of spontaneous bowel movements (SBMs) per day in the last treatment week.RESULTS: In both groups, mean weekly number of SBMs (+/- s.d.) increased from run-in. The difference between the groups in week 4 (PEG 3350 + E, 4.40 +/- 2.581; placebo, 3.11 +/- 1.937) was statistically significant (95% confidence interval: 1.17, 1.95; P < 0.0001). Although mean severity score for abdominal discomfort/pain was significantly reduced compared with run-in with PEG 3350 + E, there was no difference vs. placebo. Spontaneous complete bowel movements, responder rates, stool consistency, and severity of straining also showed superior improvement in the PEG 3350 + E group over placebo in week 4. The most common drug related treatment-emergent adverse events were abdominal pain (PEG 3350 + E, 4.5%; placebo, 0%) and diarrhoea (PEG 3350 + E, 4.5%; placebo, 4.3%).CONCLUSIONS: In IBS-C, PEG 3350 + E was superior to placebo for relief of constipation, and although a statistically significant improvement in abdominal discomfort/pain was observed compared with baseline, there was no associated improvement compared with placebo. PEG 3350 + E is a well-established and effective treatment that should be considered suitable for use in IBS-C.