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一项关于奥美拉唑-多潘立酮联合使用质子泵抑制剂治疗2型糖尿病患者酸相关性疾病的真实世界回顾性研究(PRIDE-2)。

A real-world retrospective study of omeprazole-domperidone combination in managing acid peptic disease with PRoton-pump Inhibitors in patients with type 2 DiabEtes mellitus (PRIDE-2).

作者信息

Saboo Bharat, Mulwani Nimmi, Petare Anup Uttam, Veligandla Krishna Chaitanya, Pinto Colette Stephen, Mane Amey, Rathod Rahul, Kotak Bhavesh

机构信息

Department of Diabetology, Prayas Diabetes Centre, Indore, Madhya Pradesh, India.

Department of Diabetology, Dr. Nimmi's Diabetes Care, Chandkheda, Ahmedabad, Gujarat, India.

出版信息

Drugs Context. 2023 Feb 13;12. doi: 10.7573/dic.2022-10-3. eCollection 2023.

DOI:10.7573/dic.2022-10-3
PMID:36816461
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9933899/
Abstract

BACKGROUND

Proton-pump inhibitors, along with a prokinetic agent, are widely used to provide symptomatic relief amongst patients with acid peptic disease (APD). This article evaluates the effectiveness and safety of the omeprazole-domperidone combination amongst patients with type 2 diabetes mellitus for the management of APD.

METHODS

PRIDE-2 (PRoton-pump Inhibitor in patients with type 2 DiabEtes mellitus) is a retrospective study reviewing electronic medical records of patients with type 2 diabetes mellitus and APD who were receiving the omeprazole-domperidone combination and visiting multiple Indian healthcare settings between March 2018 and April 2021. The effectiveness outcome of the therapy was evaluated in terms of resolution of APD symptoms at visit 5 (120 days after baseline visit) compared with visit 1 (baseline visit). Safety was determined in terms of reported adverse events (AEs) during the treatment period (120 days).

RESULTS

A total of 174 patients were included in the study. The mean age of the patients was 51.5±9.6 years, with the majority (59.8%) being men. A significant proportion of patients reported relief from APD symptoms, including abdominal pain (91.6%), epigastric burning (68.7%), nausea (89.5%), flatulence (100.0%), loss of appetite (93.6%), and altered bowel movements (94.7%) (<0.001 for each) at visit 5 compared with visit 1. No serious AEs were reported.

CONCLUSION

Omeprazole-domperidone combination was beneficial in providing symptomatic relief to patients with diabetes and APD. The combination therapy was well tolerated, with few reports of minor AEs.

摘要

背景

质子泵抑制剂与促动力药一起,被广泛用于缓解酸相关性疾病(APD)患者的症状。本文评估了奥美拉唑 - 多潘立酮联合用药在2型糖尿病患者中治疗APD的有效性和安全性。

方法

PRIDE - 2(2型糖尿病患者中的质子泵抑制剂)是一项回顾性研究,回顾了2018年3月至2021年4月期间在多个印度医疗机构就诊、接受奥美拉唑 - 多潘立酮联合用药的2型糖尿病和APD患者的电子病历。将治疗的有效性结果评估为第5次就诊(基线就诊后120天)时APD症状的缓解情况与第1次就诊(基线就诊)时相比。安全性根据治疗期间(120天)报告的不良事件(AE)来确定。

结果

共有174名患者纳入研究。患者的平均年龄为51.5±9.6岁,大多数(59.8%)为男性。与第1次就诊相比,相当比例的患者报告APD症状得到缓解,包括腹痛(91.6%)、上腹部烧灼感(68.7%)、恶心(89.5%)、肠胃气胀(100.0%)、食欲不振(93.6%)和排便习惯改变(94.7%)(每项<0.001)。未报告严重不良事件。

结论

奥美拉唑 - 多潘立酮联合用药对糖尿病和APD患者缓解症状有益。联合治疗耐受性良好,仅有少数轻微不良事件报告。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/690b/9933899/36ca760847ea/dic-2022-10-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/690b/9933899/36ca760847ea/dic-2022-10-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/690b/9933899/36ca760847ea/dic-2022-10-3-g001.jpg

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