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西班牙医院中非特异性静脉用人免疫球蛋白的使用;需要制定医院方案。

Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol.

机构信息

Clinical Pharmacology Department, Puerta de Hierro Majadahonda University Hospital, C/ Manuel de Falla 1, 28222, Majadahonda, Madrid, Spain.

出版信息

Eur J Clin Pharmacol. 2010 Jun;66(6):633-41. doi: 10.1007/s00228-010-0800-y. Epub 2010 Mar 5.

DOI:10.1007/s00228-010-0800-y
PMID:20204337
Abstract

UNLABELLED

Intravenous immunoglobulin (IVIG) use in non-approved indications, the increase in consumption and its high cost recommend rationalisation in its utilisation.

AIMS

To assess the use of IVIG in Spanish hospitals.

METHODS

An observational, prospective and multicentre drug utilisation study was conducted in 13 tertiary Spanish hospitals. Data were collected for 3 months in patients receiving any IVIG. Patient demographics, indication for IVIG use, dosage regimen and cost of treatment were collected.

RESULTS

Five hundred and fifty-four patients (mean age of 52 years) were included in the study. A total of 1,287 prescriptions were administered, and the average number of prescriptions per patient was 2.3. The mean daily dose was 24 g (range 0.6-90 g). Overall, IVIG was prescribed for authorised indications in 335 patients (60%) with 953 prescriptions (74%), for non-authorised indications with scientific evidentiary support in 86 patients (16%) with 137 prescriptions (11%), and non-authorised and non-accepted indications in 133 patients (24%) with 197 prescriptions (15%). The most frequent authorised indications were primary and secondary immunodeficiencies, and the most frequent non-authorised and non-accepted indications were multiple sclerosis and bullous dermatosis. The mean cost of IVIG per patient for authorised indications was 2,636.2 , non-authorised indications with scientific support 5,262.1 and non-accepted indications 3,555.8 .

CONCLUSIONS

IVIG is prescribed for a significant number of non-authorised and non-accepted indications with a notable cost. There is an important variability in IVIG prescriptions between hospitals, indicating room for improvement in IVIG use and the need for a consensus of protocol use.

摘要

目的

评估西班牙医院中静脉注射免疫球蛋白(IVIG)的使用情况。

方法

在西班牙的 13 所三级医院中进行了一项观察性、前瞻性和多中心药物使用研究。在接受任何 IVIG 治疗的患者中,连续 3 个月收集患者的人口统计学数据、IVIG 使用的适应症、剂量方案和治疗费用。

结果

本研究共纳入 554 名(平均年龄 52 岁)患者。共开出了 1287 张处方,每位患者的平均处方数为 2.3 张。平均日剂量为 24g(范围 0.6-90g)。总体而言,IVIG 是在有科学证据支持的情况下被开给有适应证的患者(335 例,953 张处方,占 74%),开给无适应证但有科学依据的患者(86 例,137 张处方,占 11%),以及开给无适应证且不被接受的患者(133 例,197 张处方,占 15%)。最常见的适应证为原发性和继发性免疫缺陷,最常见的无适应证且不被接受的适应症为多发性硬化症和大疱性皮肤病。有适应证的患者每例 IVIG 的平均费用为 2636.2 欧元,有科学依据的无适应证的患者为 5262.1 欧元,无适应证且不被接受的患者为 3555.8 欧元。

结论

IVIG 被大量开给无适应证和不被接受的患者,费用不菲。各医院之间 IVIG 处方的差异很大,这表明在 IVIG 的使用方面有改进的空间,需要就使用方案达成共识。

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Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature.静脉注射免疫球蛋白的当前应用情况及其背后的原理:麻省总医院的数据及文献综述
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香港中文人群免疫球蛋白使用、成人抗体缺陷负担的十年变化趋势和皮下免疫球蛋白(SCIg)替代治疗的可行性。
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Prescribing Practices of Intravenous Immunoglobulin in Tertiary Care Hospitals in Malaysia: A Need for a National Guideline for Immunoglobulin Use.马来西亚三级护理医院静脉注射免疫球蛋白的处方实践:需要制定免疫球蛋白使用的国家指南。
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Dealing With Immunoglobulin Shortages: A Rationalization Plan From Evidence-Based and Data Collection.应对免疫球蛋白短缺:基于循证和数据收集的合理化计划。
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Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study.自采用最新欧洲法规以来西班牙儿科人群中药物标签外处方的影响:一项前后对照研究
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The product: All intravenous immunoglobulins are not equivalent.
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Changes in intravenous immunoglobulin prescribing patterns during a period of severe product shortages, 1995-2000.1995 - 2000年严重产品短缺期间静脉注射免疫球蛋白处方模式的变化
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The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence-based indications and safety profile.静脉注射免疫球蛋白在自身免疫性神经肌肉疾病治疗中的应用:循证医学指征及安全性概况。
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