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慢性阻塞性肺疾病的开放三联疗法:来自意大利大型索赔数据库的处方模式、急性加重情况及医疗费用

Open triple therapy for chronic obstructive pulmonary disease: Patterns of prescription, exacerbations and healthcare costs from a large Italian claims database.

作者信息

Calabria Silvia, Ronconi Giulia, Dondi Letizia, Piccinni Carlo, Pedrini Antonella, Esposito Immacolata, Pistelli Riccardo, Martini Nello

机构信息

Fondazione ReS (Ricerca e Salute) - Research and Health Foundation, Via Magnanelli 6/3, 40033, Casalecchio di Reno, Bologna, Italy.

Drugs & Health Srl, Via Angelo Brunetti 54, 00186, Rome, Italy.

出版信息

Pulm Pharmacol Ther. 2020 Apr;61:101904. doi: 10.1016/j.pupt.2020.101904. Epub 2020 Feb 21.

Abstract

BACKGROUND

The combination of two long acting bronchodilators with an inhaled corticosteroid, known as Triple Therapy (TT), is a usual clinical practice for patients affected by chronic obstructive pulmonary disease (COPD). This analysis aimed to identify subjects with COPD treated with extemporaneous combination of ICS/LABA and LAMA (namely open TT) and to describe the pharmacological strategy, the spirometry use, the exacerbations occurrence and the costs, in the perspective of the Italian National Health System (NHS).

METHODS

Through record linkage of administrative data (ReS database) of about 12 million inhabitants in 2014, a cohort of patients aged ≥45, without asthma and treated with open TT (index date) was selected. Specific drugs, oxygen supply and exacerbations were described in one year before the index date, while spirometry tests over two years before the index date. All these resources utilization, the persistence to the open TT, and integrated costs of the above healthcare services were analysed for 1-year follow-up.

RESULTS

In 2014, 10,352 patients (mean age 74 ± 9; males 66.0%) with COPD and treated with open TT were identified (prevalence 160.6 per 100,000 inhabitants aged ≥45). During the previous year, the 44.0% of this cohort was already treated with open TT, 7.0% did not received any drugs for obstructive airway diseases, 11.1% needed home oxygen therapy, and 28.7% experienced at least an exacerbation. In the follow-up year, the 37.5% of the cohort was found persistent to the open TT, 17.0% needed oxygen therapy, and the 30.9% underwent an exacerbation. Spirometry was performed on 45.7% of patients in the two previous years, while on 33.3% in the subsequent year. In the follow-up, on average, every patient of the cohort costed to the NHS €5,295: 48.2% for hospitalizations, 41.2% for drugs and 10.6% for outpatient services.

CONCLUSIONS

This large observational study based on claims data reliably identified subjects with COPD treated with open TT and their burden on the NHS. Moreover, it could describe the real clinical management of the open TT, before the marketing of the fixed one. These findings are useful for health policymakers in order to promote the appropriate utilization of both currently marketed and future therapies.

摘要

背景

两种长效支气管扩张剂与吸入性糖皮质激素联合使用,即三联疗法(TT),是慢性阻塞性肺疾病(COPD)患者常见的临床治疗方法。本分析旨在识别接受吸入性糖皮质激素/长效β2受体激动剂(ICS/LABA)和长效抗胆碱能药物(LAMA)临时联合治疗(即开放三联疗法)的COPD患者,并从意大利国家卫生系统(NHS)的角度描述其药物治疗策略、肺活量测定的使用情况、急性加重的发生情况及成本。

方法

通过对2014年约1200万居民的行政数据(ReS数据库)进行记录链接,选取了年龄≥45岁、无哮喘且接受开放三联疗法(索引日期)治疗的患者队列。在索引日期前一年描述特定药物、氧气供应和急性加重情况,而在索引日期前两年描述肺活量测定测试情况。对所有这些资源利用情况、开放三联疗法的持续使用情况以及上述医疗服务的综合成本进行了为期1年的随访分析。

结果

2014年,共识别出10352例接受开放三联疗法治疗的COPD患者(平均年龄74±9岁;男性占66.0%)(每10万名≥45岁居民中的患病率为160.6例)。在前一年,该队列中44.0%的患者已接受开放三联疗法治疗,7.0%的患者未接受任何阻塞性气道疾病药物治疗,11.1%的患者需要家庭氧疗,28.7%的患者至少经历过一次急性加重。在随访年中,该队列中37.5%的患者持续接受开放三联疗法治疗,17.0%的患者需要氧疗,30.9%的患者经历了急性加重。在前两年中,45.7%的患者进行了肺活量测定,而在随后一年中这一比例为33.3%。在随访中,该队列中每位患者平均给NHS带来的成本为5295欧元:住院费用占48.2%,药物费用占41.2%,门诊服务费用占10.6%。

结论

这项基于索赔数据的大型观察性研究可靠地识别了接受开放三联疗法治疗的COPD患者及其给NHS带来的负担。此外,它可以描述在固定三联疗法上市之前开放三联疗法的实际临床管理情况。这些发现对卫生政策制定者促进当前已上市和未来疗法的合理使用很有用。

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