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米多君治疗难治性胃食管疾病的初步报告:随机双盲对照试验。

A preliminary report on the use of Midodrine in treating refractory gastroesophageal disease: Randomized Double-Blind Controlled Trial.

机构信息

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Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences.

出版信息

Acta Biomed. 2020 Mar 19;91(1):70-78. doi: 10.23750/abm.v91i1.8486.

Abstract

BACKGROUND

Gastroesophageal reflux disease (GERD) is a common disease with various clinical presentations. Acid suppression with proton pump inhibitors and lifestyle modification may not lead to satisfactory response in a substantial portion of patients. We investigated the possible effect of midodrine in patients with refractory GERD.

METHODS

Patients suffering from GERD and were refractory to one-month course of pantoprazole 40mg twice daily entered the study. This was a pilot, randomized, double-blind, and placebo-controlled study. After randomization, one group received Midodrine 5mg before meals for one month, and the other group received placebo for the same period. Meanwhile, pantoprazole was continued 40mg twice daily in both arms. The severity of symptoms was evaluated by the visual scoring system. Quality of life (QoL) in both groups was measured using a standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD).

RESULTS

A total of twenty patients were enrolled in this study. There was a significant interaction between the groups and time on all measured scores based on QOLRAD questionnaire. All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement. Both visual severity score and total QoL score in Midodrine arm showed a U shape change during  6 weeks.

CONCLUSIONS

Midodrine before a meal could be useful in alleviating symptoms and improving QoL in the patients with refractory gastroesophageal disease.

摘要

背景

胃食管反流病(GERD)是一种常见疾病,具有多种临床表现。质子泵抑制剂抑制胃酸和生活方式改变可能无法使相当一部分患者得到满意的疗效。我们研究了米多君对难治性 GERD 患者的可能影响。

方法

患有 GERD 且对泮托拉唑 40mg 每日两次治疗一个月无反应的患者入组本研究。这是一项前瞻性、随机、双盲、安慰剂对照研究。随机分组后,一组患者餐前服用米多君 5mg 治疗一个月,另一组患者同期服用安慰剂。同时,两组患者均继续每日服用泮托拉唑 40mg。采用视觉评分系统评估症状严重程度。采用反流和消化不良问卷(QOLRAD)的标准化版本评估两组患者的生活质量(QoL)。

结果

本研究共纳入 20 例患者。基于 QOLRAD 问卷,所有测量评分的组间和时间交互均具有统计学意义。米多君组的所有标志物均随时间显著改善,但安慰剂组无明显改善。米多君组的视觉严重程度评分和总 QoL 评分在 6 周内呈 U 型变化。

结论

餐前服用米多君可能有助于缓解难治性胃食管疾病患者的症状和提高生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9e2/7569571/31b278949807/ACTA-91-70-g001.jpg

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