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巴西人群中甲灭酸(安乃近)使用的真实世界证据。一项超过 38 万名患者的回顾性队列研究。

Real world evidence of the use of metamizole (dipyrone) by the Brazilian population. A retrospective cohort with over 380,000 patients.

机构信息

UnitedHealth Group, São Paulo, SP, Brazil.

Sanofi Pharmaceuticals, Paris, France.

出版信息

Einstein (Sao Paulo). 2022 May 6;20:eAO6353. doi: 10.31744/einstein_journal/2022AO6353. eCollection 2022.

Abstract

OBJECTIVE

To determine under which health conditions metamizole (dipyrone) is used as a single drug or as fixed-dose combination.

METHODS

Two retrospective cohorts of Brazilian patients treated with metamizole between January 2015 and December 2017 were analyzed: a metamizole-based cohort (Cohort 1) and a symptoms-based cohort (Cohort 2). Anonymized patient data was obtained from Amil Clinical Data Warehouse. The number of patients with symptoms was described by age and sex.

RESULTS

The sample size of the two cohorts consisted of 384,668 patients. In patients using metamizole (Cohort 1), the most common reason for medication was the treatment of some form of pain (81%), followed by fever (19%). Headache was the most common (19%) specified pain class, followed by sore throat (8%), muscular pain (6%), and abdominal pain (5%). In adult patients (n=276,279; 71.8%), metamizole was used as a monotherapy or associated with another drug, for any sort of pain, in over 88% of the patients. General pain was the main reason for metamizole use in children (61%).

CONCLUSION

Real world evidence to evaluate Brazilian patients' therapeutic options is unusual and yet to be more explored using digital tools enabling better data registration. The present study confirmed that metamizole is widely used as a non-anti-inflammatory drug, and also showed the management of pain and fever as the most frequent indications in all age groups studied.Registry in Clinical Trials Database: REBEC Database: 10507.

摘要

目的

确定在何种健康状况下使用麦角胺(安痛定)作为单一药物或固定剂量组合。

方法

分析了 2015 年 1 月至 2017 年 12 月期间使用麦角胺的巴西患者的两个回顾性队列:基于麦角胺的队列(队列 1)和基于症状的队列(队列 2)。从 Amil 临床数据仓库中获取匿名患者数据。按年龄和性别描述有症状患者的数量。

结果

两个队列的样本量由 384668 名患者组成。在使用麦角胺的患者中(队列 1),用药的最常见原因是治疗某种形式的疼痛(81%),其次是发热(19%)。头痛是最常见的(19%)特定疼痛类别,其次是咽痛(8%)、肌肉疼痛(6%)和腹痛(5%)。在成年患者(n=276279;71.8%)中,超过 88%的患者使用麦角胺作为单一药物或与另一种药物联合用于任何类型的疼痛。对于儿童(61%),全身疼痛是使用麦角胺的主要原因。

结论

评估巴西患者治疗选择的真实世界证据很少见,并且尚未使用更好的数据登记数字工具进行更深入的研究。本研究证实麦角胺广泛用作非抗炎药物,还显示出在所有研究年龄组中疼痛和发热管理是最常见的适应症。

临床试验注册数据库

REBEC 数据库:10507。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f123/9060643/bff896d828f7/2317-6385-eins-20-eAO6353-gf01.jpg

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