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静脉注射免疫球蛋白:力求合理使用。

Intravenous immunoglobulin: striving for appropriate use.

作者信息

Kumar Arvind, Teuber Suzanne S, Gershwin M Eric

机构信息

Division of Rheumatology, Allergy and Clinical Immunology, Department of Internal Medicine,University of California at Davis School of Medicine, Davis, Calif. 95616, USA.

出版信息

Int Arch Allergy Immunol. 2006;140(3):185-98. doi: 10.1159/000093204. Epub 2006 May 8.

Abstract

BACKGROUND

Intravenous immunoglobulin (IVIG) is the mainstay therapy in human immune deficiency states characterized by qualitative and quantitative reductions in B cells. In addition, however, there is widespread use of IVIG in a number of other areas, including neuroimmunologic, infectious, dermatologic, hematologic, autoimmune, inflammatory and idiopathic disorders. In many of these cases, there are little objective data to support the use.

METHODS

We performed a review of more than 400 publications in PubMed using the key words 'intravenous immunoglobulin' and excluded publications that focused on immune deficiency, for which the indication for IVIG is already clear.

RESULTS

For a number of off-label indications, there is significant evidence of efficacy and IVIG has become the standard of care for many clinical syndromes other than immune deficiency. In some conditions, however, the data have not been well controlled or randomized and are often limited to case reports that are difficult to interpret. Although the critical shortage of IVIG of the last decade is no longer an issue, IVIG is expensive and not without risk. The use of IVIG should be based not only on clinical data, but also, and especially, on the biological rationale for its use.

CONCLUSIONS

The appropriate use of IVIG is an important issue that is difficult to resolve, and will continue to challenge clinicians based on expense and potentially limited supply, including the intrinsic limitations of donor plasma. The establishment of national and international voluntary registries to report use of IVIG in disorders for which evidence is lacking would be a first step toward facilitating randomized, controlled clinical trials.

摘要

背景

静脉注射免疫球蛋白(IVIG)是治疗人类免疫缺陷状态的主要疗法,其特征为B细胞在数量和质量上均减少。然而,除此之外,IVIG还广泛应用于许多其他领域,包括神经免疫、感染、皮肤、血液、自身免疫、炎症和特发性疾病。在许多此类病例中,几乎没有客观数据支持其使用。

方法

我们在PubMed上检索了400多篇使用关键词“静脉注射免疫球蛋白”的出版物,并排除了那些专注于免疫缺陷的出版物,因为IVIG在免疫缺陷方面的适应证已经明确。

结果

对于许多非适应证,有显著的疗效证据,IVIG已成为免疫缺陷以外许多临床综合征的标准治疗方法。然而,在某些情况下,数据未得到充分控制或随机化,且往往仅限于难以解释的病例报告。尽管过去十年中IVIG的严重短缺已不再是问题,但IVIG价格昂贵且并非没有风险。IVIG的使用不仅应基于临床数据,而且尤其应基于其使用的生物学原理。

结论

IVIG的合理使用是一个难以解决的重要问题,基于费用和潜在的供应有限,包括供体血浆的内在局限性,这将继续给临床医生带来挑战。建立国家和国际自愿登记处,以报告IVIG在缺乏证据的疾病中的使用情况将是促进随机对照临床试验的第一步。

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