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应对免疫球蛋白短缺:基于循证和数据收集的合理化计划。

Dealing With Immunoglobulin Shortages: A Rationalization Plan From Evidence-Based and Data Collection.

机构信息

Gerència del Medicament, Servei Català de la Salut, Generalitat de Catalunya, Barcelona, Spain.

Departament de Farmacologia, de Terapèutica i de Toxicologia, Unitat Docent Parc Taulí, Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

Front Public Health. 2022 May 19;10:893770. doi: 10.3389/fpubh.2022.893770. eCollection 2022.

Abstract

BACKGROUND

The demand and consumption of immunoglobulins (IgGs) are growing, and there are many difficulties in obtaining supplies. The aim of the study was to analyze the evolution of IgG consumption and cost over a decade, describe the measures implemented for clinical management in the context of regional public health system, and evaluate the initial impact of these measures.

METHODS

We performed a retrospective longitudinal study including patients of all public health systems in Catalonia. First, we analyzed data on consumption and cost of IgGs during a period between 1 January, 2010 and 31 December 2021. Second, we analyzed the impact of a set of regional measures in terms of annual consumption and cost of IgGs. Regional measures were based on rational evidence-based measures and computer registries. We compared the data of year before applying intervention measures (1 January and 31 December 2020) with data of year after applying clinical management interventions (1 January and 31 December 2021). In addition, detailed information on clinical indications of IgG use between 1 January and 31 December 2021 was collected.

RESULTS

Overall, in terms of population, the consumption of IgGs (g/1,000 inhabitants) increased from 40.4 in 2010 to 94.6 in 2021. The mean cost per patient increased from €10,930 in 2010 to €15,595 in 2021. After implementing the measures, the mean annual estimated consumption per patient in 2021 was statistically lower than the mean annual estimated consumption per patient in 2020 (mean difference -47 g, 95% CI -62.28 g, -31.72 g, = 0.03). The mean annual estimated cost per patient in 2021 was also lower than the mean annual estimated cost per patient in 2020 (the mean difference was -€1,492, 95% CI -€2,132.12, -€851.88; = 0.027). In 2021, according to evidence-based classification, 75.66% treatments were prescribed for a demonstrated therapeutic evidence-based indication, 12.17% for a developed therapeutic evidence-based indication, 4.66% for non-evidence-based therapeutic role indication, and 8.1% could not be classified because of lack of information.

CONCLUSION

The annual consumption and cost of IgGs have grown steadily over the last decade in our regional public health system. After implementing a set of regional measures, the annual consumption of IgGs per patient and annual cost per patient decreased. However, the decrease has occurred in the context of the coronavirus disease 2019 (COVID-19) pandemic, which may have influenced their clinical use. Managing the use of IgGs through a rational plan with strategies including evidence-based and data collection may be useful in a shortage situation with growing demand. Registries play a key role in collection of systematic data to analyze, synthesize, and obtain valuable information for decision support. The action developed needs close monitoring in order to verify its effectiveness.

摘要

背景

免疫球蛋白(IgG)的需求和消耗不断增长,供应方面存在诸多困难。本研究旨在分析十年来 IgG 消耗和成本的演变,描述在地区公共卫生系统背景下为临床管理实施的措施,并评估这些措施的初步影响。

方法

我们进行了一项回顾性纵向研究,纳入了加泰罗尼亚所有公共卫生系统的患者。首先,我们分析了 2010 年 1 月 1 日至 2021 年 12 月 31 日期间 IgG 消耗和成本的数据。其次,我们分析了一组区域措施对 IgG 消耗和成本的影响。区域措施基于合理的循证措施和计算机登记处。我们将干预措施实施前一年(2020 年 1 月 1 日和 12 月 31 日)的数据与干预措施实施后一年(2021 年 1 月 1 日和 12 月 31 日)的数据进行了比较。此外,还收集了 2021 年 1 月 1 日至 12 月 31 日期间 IgG 使用的临床指征的详细信息。

结果

总体而言,就人口而言,IgG 消耗(每 1000 人用量,g)从 2010 年的 40.4 增加到 2021 年的 94.6。每位患者的平均成本从 2010 年的€10930 增加到 2021 年的€15595。实施措施后,2021 年每位患者的年估计消耗量明显低于 2020 年(平均差异-47g,95%CI-62.28g,-31.72g,=0.03)。2021 年每位患者的年估计成本也低于 2020 年(平均差异为€1492,95%CI-€2132.12,-€851.88;=0.027)。2021 年,根据循证分类,75.66%的治疗是基于已证明的治疗循证指征开具的,12.17%是基于已开发的治疗循证指征开具的,4.66%是基于非循证治疗作用指征开具的,8.1%因信息不足无法分类。

结论

在过去十年中,我们地区的公共卫生系统中 IgG 的年消耗和成本稳步增长。实施一系列区域措施后,每位患者的 IgG 年消耗和年成本均有所下降。然而,这种下降发生在 2019 年冠状病毒病(COVID-19)大流行的背景下,这可能影响了它们的临床使用。通过包括循证和数据收集在内的策略,通过合理计划管理 IgG 的使用,在需求不断增长的情况下应对短缺可能是有用的。登记处在收集系统数据以进行分析、综合和获取决策支持的有价值信息方面发挥着关键作用。需要密切监测所开展的行动,以验证其有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fc8/9160570/255362b2ed5a/fpubh-10-893770-g0001.jpg

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