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[辣椒素皮肤贴片:法国一家大学医院的成本后果研究]

[Capsaicin Cutaneous Patch: a Cost-consequences Study in a French University Hospital].

作者信息

Schweitzer Maud, Caillet Jean-Bernard, Paillet Carole, Baude Christian, Fagnoni Philippe, Aulagner Gilles, Armoiry Xavier

机构信息

Hospices Civils de Lyon, Groupement Hospitalier Est, Service Pharmaceutique, Lyon, France.

Hospices Civils de Lyon, Groupement Hospitalier Est, Centre d'Évaluation et de Traitement de la Douleur, Lyon, France.

出版信息

Therapie. 2015 Jul-Aug;70(4):359-68. doi: 10.2515/therapie/2015022. Epub 2015 Apr 21.

Abstract

INTRODUCTION

The capsaïcine 8% cutaneous patch (Qutenza®) was recently approved for the management of patients with peripheral neuropathic pain (PNP). Considering its limited clinical efficacy data, its improvement of medical benefit was determined to be 5 which was insufficient to support its reimbursement in addition to diagnosis related groups'tarifs. Nevertheless its commercialization was associated with a marked interest considering the unmet therapeutic needs for patients with PNP.

OBJECTIVES

Our objectives were to assess the effectiveness, the safety, and the economic impact of Qutenza® in real-life conditions.

METHODS

An observational cost-consequences study was launched under the aegis of the Drug Committee of our hospital. Medical charts and prescriptions of all patients who received at least one patch application were analyzed. Effectiveness and safety were assessed after 12-week and 24-week of follow-up. The economic impact was measured within the Hospital and Health Insurance perspective and with limitation to direct costs.

RESULTS

From March 2012 to October 2013, 91 patients (54.3 ± 14.1 years; 52.7% of male) received at least one application. The average follow- up duration was 188.3 ± 86.4 days. The PNP etiologies were mainly post-surgery (42.9%) and post-traumatology (20.8%). A therapeutic response (decrease of ENS score of least 30%) after 12 weeks and 24 weeks was observed in 27.9% and 37.1% of patients respectively. The SF-36 mental score was significantly improved. The safety profile was good. The application of the patch resulted in incremental costs of 154 euros per hospital stay without impact on outpatient-prescription drug expenditures.

CONCLUSION

This study confirms the interest of Qutenza® for heavily pretreated, refractory patients with PNP. The clinical profile of responders has to be further investigated in large observational studies.

摘要

引言

8%辣椒素皮肤贴片(Qutenza®)最近被批准用于治疗周围神经性疼痛(PNP)患者。鉴于其临床疗效数据有限,其医疗效益改善值为5,除诊断相关组费用外,这一数值不足以支持其报销。然而,考虑到PNP患者未满足的治疗需求,其商业化仍引起了显著关注。

目的

我们的目的是评估Qutenza®在实际临床中的有效性、安全性和经济影响。

方法

在我院药物委员会的支持下开展了一项观察性成本-效果研究。分析了所有接受至少一次贴片治疗的患者的病历和处方。在随访12周和24周后评估有效性和安全性。从医院和医疗保险角度衡量经济影响,且仅限于直接成本。

结果

2012年3月至2013年10月,91例患者(年龄54.3±14.1岁;男性占52.7%)接受了至少一次贴片治疗。平均随访时间为188.3±86.4天。PNP的病因主要是术后(42.9%)和创伤后(20.8%)。分别有27.9%和37.1%的患者在12周和24周后出现治疗反应(ENS评分至少降低30%)。SF-36心理评分显著改善。安全性良好。每次住院使用贴片导致成本增加154欧元,对门诊处方药支出无影响。

结论

本研究证实了Qutenza®对经过大量预处理且难治的PNP患者具有治疗价值。应答者的临床特征有待在大型观察性研究中进一步探究。

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