Kariv Revital, Tiomny Elisa, Grenshpon Roman, Dekel Roy, Waisman Galit, Ringel Yehuda, Halpern Zamir
Department of Gastrointestinal and Liver Diseases, 6 Weizmann Street, Tel-Aviv, 64239, Israel.
Dig Dis Sci. 2006 Dec;51(12):2128-33. doi: 10.1007/s10620-006-9289-8. Epub 2006 Nov 1.
Preclinical studies have shown that a very low dose of naltreoxone hydrochloride (NTX), an opiate antagonist, can block excitatory opioid receptors without affecting inhibitory opioid receptors, resulting in analgesic potency without side effects. The present study assessed the efficacy and safety of PTI-901 (low-dose NTX) treatment in Irritable bowel syndrome (IBS) patients. Forty-two IBS patients participated in an open-label study. Participants received 0.5 mg PTI-901/day for 4 weeks and were evaluated during baseline, during treatment, and at 4-week follow-up. Patients recorded degree of abdominal pain, stool urgency, consistency, and frequency. Primary outcomes were number of pain-free days and overall symptom relief, evaluated by a global assessment score. Data were analyzed per protocol. Global assessment improved in 76% of 42 patients. During treatment, the mean weekly number of pain-free days increased from 0.5+/-1 to 1.25+/-2.14 (P=0.011). There were no significant adverse reactions. PTI-901 improves pain and overall feeling, and is well tolerated by IBS patients. A large, randomized, double-blind, placebo-controlled study is justified.
临床前研究表明，极低剂量的盐酸纳曲酮（NTX），一种阿片类拮抗剂，可阻断兴奋性阿片受体而不影响抑制性阿片受体，从而产生无副作用的镇痛效果。本研究评估了PTI-901（低剂量NTX）治疗肠易激综合征（IBS）患者的疗效和安全性。42例IBS患者参与了一项开放标签研究。参与者每天接受0.5mg PTI-901，持续4周，并在基线期、治疗期间和4周随访时进行评估。患者记录腹痛程度、排便急迫感、大便性状和频率。主要结局为无痛天数和总体症状缓解情况，通过整体评估评分进行评估。数据按方案进行分析。42例患者中有76%的整体评估得到改善。治疗期间，每周无痛天数的平均值从0.5±1增加到1.25±2.14（P=0.011）。没有明显的不良反应。PTI-901可改善疼痛和总体感觉，且IBS患者耐受性良好。有必要进行一项大型、随机、双盲、安慰剂对照研究。
