Csako Gyorgy, Costello Rene, Shamim Ejaz A, O'Hanlon Terrance P, Tran Anthony, Clauw Daniel J, Williams H James, Miller Frederick W
Department of Laboratory Medicine, Clinical Center, NIH, DHHS, 9000 Rockville Pike, Bethesda, MD 20892, USA.
Arthritis Res Ther. 2007;9(5):R95. doi: 10.1186/ar2295.
Prior studies have suggested abnormalities of serum proteins, including paraproteins, in women with silicone implants but did not control for the presence of connective-tissue disease (CTD). This retrospective case-control study, performed in tertiary-care academic centers, assessed possible alterations of serum proteins, including paraproteins, in such a population. Seventy-four women with silicone implants who subsequently developed CTD, and 74 age-matched and CTD-matched women without silicone implants, were assessed in the primary study; other groups were used for additional comparisons. Routine serum protein determinations and high-sensitivity protein electrophoresis and immunofixation electrophoresis were performed for detection of paraproteins. Women with silicone implants, either with or without CTD, had significantly lower serum total protein and alpha1-globulin, alpha2-globulin, beta-globulin, gamma-globulin, and IgG levels compared with those without silicone implants. There was no significant difference, however, in the frequency of paraproteinemia between women with silicone implants and CTD (9.5%) and age-matched and CTD-matched women without silicone implants (5.4%) (odds ratio, 1.82; 95% confidence interval, 0.51-6.45). Paraprotein isotypes were similar in the two groups, and the clinical characteristics of the 13 women with paraproteinemia were comparable with an independent population of 10 women with silicone breast implants, CTD, and previously diagnosed monoclonal gammopathies. In summary, this first comprehensive study of serum proteins in women with silicone implants and CTD found no substantially increased risk of monoclonal gammopathy. Women with silicone implants, however, had unexpectedly low serum globulin and immunoglobulin levels, with or without the subsequent development of CTD. The causes and clinical implications of these findings require further investigation.
先前的研究表明，植入硅胶的女性存在血清蛋白异常，包括副蛋白，但未对结缔组织病（CTD）的存在进行控制。这项在三级医疗学术中心进行的回顾性病例对照研究，评估了该人群中血清蛋白（包括副蛋白）可能的变化。在主要研究中，对74名植入硅胶后患上CTD的女性，以及74名年龄匹配且无CTD的植入硅胶女性进行了评估；其他组用于进一步比较。进行常规血清蛋白测定、高灵敏度蛋白电泳和免疫固定电泳以检测副蛋白。与未植入硅胶的女性相比，植入硅胶的女性，无论是否患有CTD，其血清总蛋白、α1球蛋白、α2球蛋白、β球蛋白、γ球蛋白和IgG水平均显著降低。然而，植入硅胶且患有CTD的女性（9.5%）与年龄匹配且无CTD的植入硅胶女性（5.4%）之间的副蛋白血症发生率没有显著差异（优势比，1.82；95%置信区间，0.51 - 6.45）。两组的副蛋白同种型相似，13名患有副蛋白血症的女性的临床特征与10名患有硅胶乳房植入物、CTD且先前诊断为单克隆丙种球蛋白病的独立人群相当。总之，这项对植入硅胶且患有CTD的女性血清蛋白的首次综合研究发现，单克隆丙种球蛋白病的风险没有大幅增加。然而，无论是否随后发展为CTD，植入硅胶的女性血清球蛋白和免疫球蛋白水平意外地低。这些发现的原因和临床意义需要进一步研究。
