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丹麦硅胶隆胸女性体内的抗聚合物抗体。

Antipolymer antibodies in Danish women with silicone breast implants.

作者信息

Jensen Bente, Wittrup Irene Hechmann, Wiik Allan, Friis Søren, Bliddal Henning, Thomsen Birthe, McLaughlin Joseph K, Danneskiold-Samsøe Bente, Olsen Jørgen H

机构信息

Parker Institute, Frederiksberg Hospital, P.G. Ramms Allé 1,3th, 2000 Frederiksberg, Denmark.

出版信息

J Long Term Eff Med Implants. 2004;14(2):73-80. doi: 10.1615/jlongtermeffmedimplants.v14.i2.10.

Abstract

OBJECTIVE

To use a new immunologic assay to evaluate antipolymer antibody (APA) levels among women with silicone breast implants (SBIs).

METHODS

Women (n = 186) were identified through Danish population-based registers and categorized into six groups defined by prior breast surgery (silicone breast implantation/breast reduction/no breast surgery) and by the presence or absence of a prior hospital diagnosis of soft-tissue rheumatism (muscular rheumatism, ICD-8 codes 717.90 and 717.99). The women underwent blood tests, including an APA test, a clinical examination, and an interview focusing on rheumatic complaints. Blood samples were tested blindly. The severity of rheumatic symptoms/signs was scored from 1 (none) to 5 (severe) based on the clinical examination and interview.

RESULTS

Women with SBIs did not have higher levels of APA than women without SBIs. The majority of women with SBIs had mild rheumatic complaints, and the severity of their symptoms was not related to APA levels. Among women who had previously been hospitalized because of soft-tissue rheumatism, there were more fibromyalgia cases, and their symptoms were more severe compared with those women without prior soft-tissue rheumatism; however, APA levels were not higher among these women. There was a significant difference in APA measurements resulting from between-kit variation (p less 0.01).

CONCLUSIONS

Our data did not demonstrate higher APA levels among women with SBIs compared with controls. The large variation observed between the individual plates in the APA test should be evaluated in future studies.

摘要

目的

使用一种新的免疫测定法评估硅胶乳房植入物(SBI)女性体内的抗聚合物抗体(APA)水平。

方法

通过丹麦基于人群的登记册识别出186名女性,并根据既往乳房手术情况(硅胶乳房植入/乳房缩小术/未进行乳房手术)以及是否有既往医院诊断的软组织风湿病(肌肉风湿病,ICD - 8编码717.90和717.99)将她们分为六组。这些女性接受了血液检查,包括APA检测、临床检查以及针对风湿性症状的访谈。血液样本进行盲测。根据临床检查和访谈,将风湿症状/体征的严重程度从1(无)到5(严重)进行评分。

结果

有SBI的女性的APA水平并不高于没有SBI的女性。大多数有SBI的女性有轻度风湿性症状,且她们症状的严重程度与APA水平无关。在先前因软组织风湿病住院的女性中,纤维肌痛病例更多,与没有既往软组织风湿病的女性相比,她们的症状更严重;然而,这些女性的APA水平并没有更高。试剂盒间差异导致APA测量结果存在显著差异(p小于0.01)。

结论

我们的数据并未表明有SBI的女性与对照组相比APA水平更高。APA检测中各单独检测板之间观察到的较大差异应在未来研究中进行评估。

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