Rosendahl Pia, Hippler Joerg, Schmitz Oliver J, Hoffmann Oliver, Rusch Peter
Applied Analytical Chemistry, University of Duisburg-Essen, Universitaetsstr. 5, 45141, Essen, Germany.
Department of Gynecology and Obstetrics, School of Medicine, University of Duisburg-Essen, Hufelandstraße 55, 45147, Essen, Germany.
Anal Bioanal Chem. 2016 May;408(12):3309-17. doi: 10.1007/s00216-016-9401-7. Epub 2016 Mar 11.
The replacement of medical-grade silicone with industrial-grade silicone material in some silicone gel-filled breast implants (SBI) manufactured by Poly Implant Prothèse and Rofil Medical Nederland B.V., reported in 2010, which resulted in a higher rupture tendency of these SBI, demonstrates the need for non-invasive, sensitive monitoring and screening methods. Therefore a sensitive method based on large volume injection-gas chromatography coupled to mass spectrometry (LVI-GC/MS) was developed to determine octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclo-hexasiloxane (D6) in blood samples from women with intact (n = 13) and ruptured SBI (n = 11). With dichloromethane extraction, sample cooling during preparation, and analysis extraction efficiencies up to 100 % and limits of detection of 0.03-0.05 ng D4-D6/g blood were achieved. Blood samples from women with SBI were investigated. In contrast to women with intact SBI, in blood from women with ruptured SBI higher D4 and D6 concentrations up to 0.57 ng D4/g blood and 0.16 ng D6/g blood were detected. With concentrations above 0.18 D4 ng/blood and 0.10 ng D6/g blood as significant criteria for ruptured SBI, this developed analytical preoperative diagnostic method shows a significant increase of the recognition rate. Finally a higher precision (error rate 17%) than the commonly used clinical diagnostic method, mamma sonography (error rate 46%), was achieved.
2010年报道，聚植入物假体公司（Poly Implant Prothèse）和荷兰罗菲尔医疗公司（Rofil Medical Nederland B.V.）生产的一些硅胶填充乳房植入物（SBI）中，医用级硅胶被工业级硅胶材料所取代，这导致这些SBI的破裂倾向更高，这表明需要非侵入性、灵敏的监测和筛查方法。因此，开发了一种基于大体积进样-气相色谱-质谱联用（LVI-GC/MS）的灵敏方法，用于测定完整SBI（n = 13）和破裂SBI（n = 11）女性血液样本中的八甲基环四硅氧烷（D4）、十甲基环五硅氧烷（D5）和十二甲基环己硅氧烷（D6）。通过二氯甲烷萃取、样品制备过程中的冷却以及分析，萃取效率高达100%，检测限为0.03 - 0.05 ng D4 - D6/g血液。对有SBI的女性血液样本进行了研究。与有完整SBI的女性相比，在有破裂SBI的女性血液中检测到更高的D4和D6浓度，分别高达0.57 ng D4/g血液和0.16 ng D6/g血液。以高于0.18 ng D4/g血液和0.10 ng D6/g血液作为破裂SBI的显著标准，这种开发的术前诊断分析方法显示识别率有显著提高。最后，该方法比常用的临床诊断方法乳房超声检查（错误率46%）具有更高的精度（错误率17%）。
