Tenenbaum S A, Rice J C, Espinoza L R, Cuéllar M L, Plymale D R, Sander D M, Williamson L L, Haislip A M, Gluck O S, Tesser J R
Department of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA 70112, USA.
Lancet. 1997 Feb 15;349(9050):449-54. doi: 10.1016/s0140-6736(96)07131-0.
Local complications (encapsulation, rashes, rupture, and leakage) can occur after placement of silicone gel-containing breast implants (SBI). Whether SBI exposure results in systemic manifestations in some recipients is controversial. We have carried out a blinded study to assess whether there is any difference between SBI recipients and non-exposed controls in the proportions positive for serum antibodies directed against polymeric substances.
We recruited female SBI recipients (including those without symptoms) who presented to a single rheumatology clinic. A physician global assessment was used to classify SBI recipients who did not meet criteria for specific autoimmune diseases according to the severity of local and systemic signs and symptoms. Controls were recruited from among clinic staff and their acquaintances. Results of the antipolymer antibody (APA) assay were compared with those of an assay for antinuclear antibodies (ANA) and with the severity of the signs and symptoms.
Positive APA results were found in one (3%) of 34 SBI recipients with limited symptoms, two (8%) of 26 with mild symptoms, seven (44%) of 16 with moderate symptoms, and 13 (68%) of 19 with advanced symptoms. Four (17%) of 23 healthy non-SBI-exposed controls and two (10%) of 20 non-exposed women with classic autoimmune diseases were positive for APA. Thus, women with moderate or advanced symptoms were significantly more likely than those with limited or mild symptoms, or non-exposed controls to have APA (p < 0.001). The proportion with positive ANA results was higher for women with classic autoimmune diseases 14 (70%) of 20 than for any SBI-exposed subgroup (0-33%).
The APA assay can objectively contribute to distinguishing between SBI recipients with limited or mild signs and symptoms. SBI recipients with more severe manifestations, and patients with specific autoimmune diseases. Further studies will be needed to define the signs and symptoms associated with exposure to SBI.
含硅凝胶乳房植入物（SBI）植入后可能会出现局部并发症（包膜形成、皮疹、破裂和渗漏）。SBI暴露是否会在某些接受者中导致全身表现存在争议。我们进行了一项盲法研究，以评估SBI接受者与未暴露对照组在针对聚合物物质的血清抗体阳性比例上是否存在差异。
我们招募了到单一风湿病诊所就诊的女性SBI接受者（包括无症状者）。根据局部和全身体征及症状的严重程度，使用医生整体评估对不符合特定自身免疫性疾病标准的SBI接受者进行分类。对照组从诊所工作人员及其熟人中招募。将抗聚合物抗体（APA）检测结果与抗核抗体（ANA）检测结果以及体征和症状的严重程度进行比较。
34例症状有限的SBI接受者中有1例（3%）APA检测结果为阳性，26例症状轻微的接受者中有2例（8%），16例症状中等的接受者中有7例（44%），19例症状严重的接受者中有13例（68%）。23名未暴露于SBI的健康对照组中有4例（17%）APA检测结果为阳性，20名未暴露且患有经典自身免疫性疾病的女性中有2例（10%）。因此，症状中等或严重的女性比症状有限或轻微的女性或未暴露对照组更有可能出现APA阳性（p<0.001）。患有经典自身免疫性疾病的女性ANA检测结果阳性比例（20例中的14例，70%）高于任何SBI暴露亚组（0-33%）。
APA检测有助于客观区分症状有限或轻微的SBI接受者、表现更严重的SBI接受者以及患有特定自身免疫性疾病的患者。需要进一步研究来确定与SBI暴露相关的体征和症状。
