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接受神经性疼痛治疗患者的特征、资源利用及安全性概况:一项关于欧洲全科医疗的真实世界证据研究——5%利多卡因药用贴剂的作用

Characteristics, resource utilization and safety profile of patients prescribed with neuropathic pain treatments: a real-world evidence study on general practices in Europe - the role of the lidocaine 5% medicated plaster.

作者信息

Katz Pablo, Pegoraro Valeria, Liedgens Hiltrud

机构信息

a Grunenthal GmbH , Aachen , Germany.

b QuintilesIMS , Milan , Italy.

出版信息

Curr Med Res Opin. 2017 Aug;33(8):1481-1489. doi: 10.1080/03007995.2017.1335191. Epub 2017 Jun 8.

Abstract

OBJECTIVES

To identify characteristics, resource utilization, and safety profile of patients prescribed with lidocaine 5% medicated plaster, pregabalin, gabapentin, amitriptyline and duloxetine when experiencing pain in the real-world setting of general practitioners (GPs) in Europe.

METHODS

Retrospective analysis on real world data from IMS Health Longitudinal Patient Database. Patients with at least one prescription of the drugs of interest during 2014 were selected and those with a non-neuropathic pain-related diagnosis were excluded. Patients' demographic and clinical characteristics, resource utilization data and adverse drug reactions (ADRs) as described in the leaflet were extracted. The association between treatments and ADR occurrence was evaluated applying multivariate logistic models.

RESULTS

A total of 70,515 patients were selected from Italy, Germany, the UK, Spain and Belgium. Lidocaine 5% medicated plaster patients were the oldest in Italy, the UK and Spain and the most health impaired in Italy, Spain and Belgium. No relevant differences in the number of co-prescriptions, specialist visits, examinations and hospitalizations were found. Significantly less lidocaine 5% plasters patients experienced ADRs, with odds ratios in favor of lidocaine 5% medicated plasters ranging from 3.41 (p = .036) to 52.33 (p < .001).

CONCLUSIONS

Evidence from daily clinical practice in GP settings agrees with the findings from more controlled clinical-trial settings, with lidocaine 5% medicated plaster patients showing a better safety profile, but also a comparable level of resource utilization. A possible re-evaluation of the scientific value coming from this retrospective study in building up a diagnostic as well as a therapeutic algorithm is suggested.

摘要

目的

在欧洲全科医生(GP)的实际诊疗环境中,确定使用5%利多卡因药用贴剂、普瑞巴林、加巴喷丁、阿米替林和度洛西汀治疗疼痛的患者的特征、资源利用情况和安全性。

方法

对来自艾美仕市场研究公司纵向患者数据库的真实世界数据进行回顾性分析。选取2014年期间至少有一次使用感兴趣药物处方的患者,并排除非神经性疼痛相关诊断的患者。提取患者的人口统计学和临床特征、资源利用数据以及药品说明书中描述的药物不良反应(ADR)。应用多变量逻辑模型评估治疗与ADR发生之间的关联。

结果

从意大利、德国、英国、西班牙和比利时共选取了70515名患者。在意大利、英国和西班牙,使用5%利多卡因药用贴剂的患者年龄最大,在意大利、西班牙和比利时,其健康受损程度最高。在联合处方数量、专科就诊、检查和住院次数方面未发现相关差异。使用5%利多卡因贴剂的患者发生ADR的情况明显较少,支持5%利多卡因药用贴剂的优势比范围为3.41(p = 0.036)至52.33(p < 0.001)。

结论

全科医疗环境下的日常临床实践证据与更具对照性的临床试验环境中的研究结果一致,使用5%利多卡因药用贴剂的患者安全性更好,且资源利用水平相当。建议对这项回顾性研究在建立诊断和治疗算法方面的科学价值进行重新评估。

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