Hawkes N D, Rhodes J, Evans B K, Rhodes P, Hawthorne A B, Thomas G A O
Department of Gastroenterology, Prince Charles Hospital, Merthyr Tydfil, UK.
Aliment Pharmacol Ther. 2002 Sep;16(9):1649-54. doi: 10.1046/j.1365-2036.2002.01320.x.
Opioids change gut motility and secretion, causing delayed intestinal transit and constipation. Endorphins play a role in the constipation troubling some patients with irritable bowel syndrome; hence naloxone, an opioid antagonist, may have a therapeutic role.
To assess the efficacy and safety of an oral formulation of naloxone in irritable bowel syndrome patients with constipation.
A randomized, double-blind, placebo-controlled trial was performed. Patients fulfilling the Rome II criteria for irritable bowel syndrome (constipation-predominant and alternating types) were randomized to receive 8 weeks of treatment with naloxone capsules, 10 mg twice daily, or identical placebo.
Twenty-eight patients entered the study, which was completed by 25. 'Adequate symptomatic relief' was recorded in six of 14 on naloxone and three of 11 on placebo. Whilst the differences were not significant, improvements in severity gradings and mean symptom scores for pain, bloating, straining and urgency to defecate were greater with naloxone than placebo for all parameters. In addition, quality of life assessments improved to a greater extent in patients taking naloxone.
Preliminary results suggest that naloxone is well tolerated and beneficial in patients with irritable bowel syndrome and constipation. A larger clinical trial is needed to provide sufficient statistical power to assess efficacy.
阿片类药物会改变肠道蠕动和分泌，导致肠道运输延迟和便秘。内啡肽在困扰一些肠易激综合征患者的便秘中起作用；因此，阿片类拮抗剂纳洛酮可能具有治疗作用。
评估口服纳洛酮制剂对便秘型肠易激综合征患者的疗效和安全性。
进行了一项随机、双盲、安慰剂对照试验。符合罗马II标准的肠易激综合征（便秘为主型和交替型）患者被随机分配接受为期8周的治疗，分别服用纳洛酮胶囊（每日两次，每次10毫克）或相同的安慰剂。
28名患者进入研究，25名完成研究。服用纳洛酮的14名患者中有6名和服用安慰剂的11名患者中有3名记录到“症状充分缓解”。虽然差异不显著，但在所有参数上，纳洛酮组在疼痛、腹胀、用力排便和排便急迫感的严重程度分级及平均症状评分方面的改善均大于安慰剂组。此外，服用纳洛酮的患者生活质量评估改善程度更大。
初步结果表明，纳洛酮在便秘型肠易激综合征患者中耐受性良好且有益。需要进行更大规模的临床试验以提供足够的统计效力来评估疗效。
