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乙琥胺作为缓解肠易激综合征相关腹痛辅助疗法的开放标签试点研究。

Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome.

作者信息

El-Haggar Sahar M, Hegazy Sahar K, M Abd-Elsalam Sherief, Bahaa Mostafa M

机构信息

Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, Egypt.

Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

出版信息

J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2.

Abstract

WHAT IS KNOWN AND OBJECTIVES

There is clear evidence for an association between irritable bowel syndrome (IBS) and visceral hypersensitivity. This clinical study aimed to assess the adjunct role of ethosuximide, an antiepileptic drug with T-type calcium channel blocking activity, in the relieving of IBS-related abdominal pain.

METHODS

This is a prospective, 3-month, randomized and controlled study of parallel groups. Fifty outpatients who met the inclusion criteria participated in the trial. Patients were allocated randomly: 25 received mebeverine 135 mg three times daily (t.i.d), whereas the other 25 received mebeverine 135 mg t.i.d and ethosuximide 500 mg t.i.d. At baseline and 12 weeks after starting the drug, patients were evaluated by a gastroenterologist. Serum tumour necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), interleukin-8 (IL-8), faecal myeloperoxidase and faecal neutrophile gelatinase-associated lipocalin (NGAL) levels were tested before and after treatment. The Numeric Pain Rating Scale (NRS) was assessed before and after three months of therapy.

RESULTS AND DISCUSSION

After 12 weeks, the ethosuximide group showed a statistically and significantly greater reduction in the serum levels of TNF-α, IL-6, IL-8, faecal myeloperoxidase and faecal NGAL in comparison with the control group after the treatment. Moreover, the ethosuximide group showed a statistically significant decrease in NRS compared with the mebeverine group.

WHAT IS NEW AND CONCLUSION

Ethosuximide could be a promising adjunct to antispasmodics in the treatment of IBS patients. Trial registration identifier: NCT04217733.

摘要

已知信息与研究目的

有明确证据表明肠易激综合征(IBS)与内脏高敏感性之间存在关联。本临床研究旨在评估具有T型钙通道阻滞活性的抗癫痫药物乙琥胺在缓解IBS相关腹痛中的辅助作用。

方法

这是一项为期3个月的前瞻性平行组随机对照研究。50名符合纳入标准的门诊患者参与了试验。患者被随机分配:25名患者每日三次服用135毫克美贝维林,而另外25名患者每日三次服用135毫克美贝维林及每日三次服用500毫克乙琥胺。在基线期及开始用药12周后,由胃肠病学家对患者进行评估。在治疗前后检测血清肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、白细胞介素-8(IL-8)、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。在治疗三个月前后评估数字疼痛评分量表(NRS)。

结果与讨论

治疗12周后,与对照组相比,乙琥胺组治疗后血清TNF-α、IL-6、IL-8、粪便髓过氧化物酶和粪便NGAL水平在统计学上有显著降低。此外,与美贝维林组相比,乙琥胺组NRS有统计学显著下降。

新发现与结论

乙琥胺可能是治疗IBS患者时抗痉挛药物的一种有前景的辅助药物。试验注册标识符:NCT04217733。

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