氟哌噻醇美利曲森治疗成人嗜气症的疗效:一项单中心平行随机对照试验

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY
JGH Open Pub Date : 2025-07-28 DOI:10.1002/jgh3.70199
Sen-lin Zhu, Ping Li, Hui-wen Xu, Sheng Yao, Lin-lin Huang
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引用次数: 0

摘要

目的通过单中心平行随机对照试验,评价氟哌替索-美利曲辛短期治疗成人嗜气症的疗效和安全性。方法将符合条件的患者按受试者顺序随机分为3组。每组30例患者(15F/15M),接受2周治疗。组1、组2、组3分别给予盐酸依托必利、氟哌噻醇美利曲辛及两药合用治疗。以治疗后用视觉模拟评分法(VAS)测量的食气症状缓解的平均得分为终点。结果共有90例患者符合研究条件,其中76例完成了2周的治疗期。VAS摄气功能改善评分显示,2组较1组(6.92±2.96比4.58±4.08,p = 0.016)、3组较1组(7.34±3.12比4.58±4.08,p = 0.006)均有显著改善。2组与3组比较差异无统计学意义(6.92±2.96∶7.34±3.12,p = 0.618)。VAS评分≥5分的患者中,2组和3组食气症状改善的比例均显著高于1组(p = 0.020, p = 0.007)。三组在治疗期间具有相似的基线特征和相似的非严重不良反应。结论氟哌替索-美利曲辛短期治疗,加或不加原动力学苯甲酰胺衍生物,可能改善成人嗜气症症状,且无明显不良反应。试验注册:ClinicalTrials.gov标识符:ChiCTR-IPR-15006869
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Therapeutic Efficacy of Flupentixol-Melitracen for Treatment of Aerophagia in Adults: A Single-Center Parallel Randomized Controlled Trial

Therapeutic Efficacy of Flupentixol-Melitracen for Treatment of Aerophagia in Adults: A Single-Center Parallel Randomized Controlled Trial

Objective

This study was designed to evaluate the efficacy and safety of short-term flupentixol-melitracen in adult patients with aerophagia through a single-center parallel randomized controlled trial.

Methods

Eligible patients were randomly divided into three groups based on the order of subjects. Each group consisted of 30 patients (15F/15M) who received 2 weeks of treatment. Groups 1, 2, and 3 were treated with itopride hydrochloride, flupentixol-melitracen, and the combination of two medicines, respectively. The mean scores of aerophagia symptom relief measured by the visual analogue scale (VAS) after treatment were used as the endpoints.

Results

A total of 90 patients were eligible for the study, of which 76 completed the 2-week treatment period. The scores indicating improvement of aerophagia by VAS showed significant improvement in Group 2 compared with Group 1 (6.92 ± 2.96 vs. 4.58 ± 4.08, p = 0.016) and Group 3 compared with Group 1 (7.34 ± 3.12 vs. 4.58 ± 4.08, p = 0.006). There was no significant difference between Group 2 and Group 3 (6.92 ± 2.96 vs. 7.34 ± 3.12, p = 0.618). The percentage of patients exhibiting scores indicating improvement of aerophagia by VAS ≥ 5 in Group 2 and Group 3 was significantly higher than Group 1 (p = 0.020, p = 0.007). The three groups had similar baseline characteristics and experienced similar non-serious adverse effects during the treatment period.

Conclusion

The findings suggest that short-term treatment with flupentixol-melitracen, with or without a prokinetic benzamide derivative, is likely to improve symptoms of aerophagia in adults without significant adverse effects.

Trial Registration: ClinicalTrials.gov identifier: ChiCTR-IPR-15006869

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来源期刊
JGH Open
JGH Open GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
3.40
自引率
0.00%
发文量
143
审稿时长
7 weeks
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