乙琥胺和己酮可可碱在缓解用美贝维林治疗的肠易激综合征患者腹痛中的潜在作用：一项随机、双盲、安慰剂对照试验
A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial.
作者信息
El-Haggar Sahar M, Hegazy Sahar K, Abd-Elsalam Sherief M, Elkaeed Eslam B, Al-Karmalawy Ahmed A, Bahaa Mostafa M
机构信息
Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, 31527, Egypt.
Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, 315274, Egypt.
出版信息
J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022.
BACKGROUND AND PURPOSE
Irritable bowel syndrome (IBS) is defined as an association of chronic abdominal pain with bowel habit abnormalities, without clear organic dysfunction. T-type calcium channels and low-grade mucosal inflammation are linked to abdominal pain; however, medical treatments for IBS abdominal pain are largely ineffective. In this study, we investigated if pentoxifylline (PTX) and ethosuximide could potentially alleviate abdominal pain in patients with IBS treated with mebeverine.
METHODS
We recruited 150 patients from Tanta University Hospital to this randomized, prospective, and double blinded study. Patients were randomly allocated to three groups (n = 50). Group 1 (mebeverine) received 135 mg mebeverine three times/day (t.i.d). Group 2 (ethosuximide group) received 135 mg mebeverine t.i.d plus 250 mg ethosuximide twice daily (b.i.d) and group 3 (PTX group) received 135 mg mebeverine t.i.d plus 400 mg PTX b.i.d. Patients were assessed by a gastroenterologist at baseline and 6 months after therapy. Serum interleukin-8 (IL-8), IL-6, tumor necrosis-α (TNF-α), fecal myeloperoxidase, and fecal neutrophil gelatinase associated lipocalin (NGAL) levels were measured before and after therapy. The numeric pain rating scale (NRS) was also assessed before and after therapy.
PRIMARY OUTCOMES
Reduced NRS scores and abdominal pain relief.
SECONDARY OUTCOMES
Decreased inflammatory biomarkers.
RESULTS
After 6 months, groups 2 and 3 showed a significantly greater reduction in serum IL-8, IL-6, TNF-α, fecal myeloperoxidase, and fecal NGAL levels when compared to group 1 after therapy. Both groups 2 and 3 showed significant reductions in NRS scores when compared to the group 1.
CONCLUSION
Ethosuximide and PTX may be promising, novel adjunct drugs to antispasmodics for relieving abdominal pain in patients with IBS.
TRIAL REGISTRATION
Identifier: NCT04217733.
背景与目的
肠易激综合征（IBS）被定义为慢性腹痛与排便习惯异常相关，且无明确的器质性功能障碍。T型钙通道和低度黏膜炎症与腹痛有关；然而，IBS腹痛的药物治疗大多无效。在本研究中，我们调查了己酮可可碱（PTX）和乙琥胺是否有可能减轻接受美贝维林治疗的IBS患者的腹痛。
方法
我们从坦塔大学医院招募了150名患者参与这项随机、前瞻性、双盲研究。患者被随机分为三组（n = 50）。第1组（美贝维林组）每天三次（t.i.d）服用135毫克美贝维林。第2组（乙琥胺组）每天三次服用135毫克美贝维林，外加每天两次（b.i.d）服用250毫克乙琥胺，第3组（PTX组）每天三次服用135毫克美贝维林，外加每天两次服用400毫克PTX。在基线和治疗6个月后由胃肠病学家对患者进行评估。在治疗前后测量血清白细胞介素-8（IL-8）、IL-6、肿瘤坏死-α（TNF-α）、粪便髓过氧化物酶和粪便中性粒细胞明胶酶相关脂质运载蛋白（NGAL）水平。在治疗前后还评估了数字疼痛评分量表（NRS）。
主要结局
NRS评分降低和腹痛缓解。
次要结局
炎症生物标志物降低。
结果
6个月后，与治疗后的第1组相比，第2组和第3组的血清IL-8、IL-6、TNF-α、粪便髓过氧化物酶和粪便NGAL水平显著降低。与第1组相比，第2组和第3组的NRS评分均显著降低。
结论
乙琥胺和PTX可能是有前景的新型解痉辅助药物，可缓解IBS患者的腹痛。
试验注册
标识符：NCT04217733。
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