Kossovsky N, Gornbein J A, Zeidler M, Stassi J, Chun G, Papasian N, Nguyen R, Ly K, Rajguru S
Department of Pathology and Laboratory Medicine, UCLA Medical Center 90024-1732, USA.
J Appl Biomater. 1995 Fall;6(3):153-60. doi: 10.1002/jab.770060302.
In research animals, the immune adjuvant activity of silicone in eliciting antibodies to associated protein antigens is now well established. In humans, the immune adjuvant activity of silicone remains controversial. Clusters of data from various research groups are beginning to define the boundary conditions for future large epidemiological studies. In that spirit, this manuscript reports pilot clinical data from a serological study conducted 3 years ago and reported previously in this journal. Sera from a self-selected symptomatic population of patients with breast implants were assayed for elevated concentrations of antibodies showing binding avidity to silicone surface associated antigens [anti-SSAA(x)]. In that study of 249 patients, two distinct statistically significant subgroups were identified on the basis of the serological assay alone: patients without any elevated anti-SSAA(x) (negative) and patients with elevated anti-SSAA(x) (positive) (p < 0.001). In this study, a clinical survey returned by 226 of those patients was correlated with the previously acquired serological findings. The 11 most common clinical complaints reported by the 199 anti-SSAA(x) negative patients and by the 27 anti-SSAA(x) positive were compared and their frequencies analyzed. The 199 anti-SSAA(x) negative patients, as a group, showed a lower frequency of a variety of signs and symptoms compared to the 27 anti-SSAA(x) positive patients. Statistically significant differences were seen in three of the symptoms: fever, foot pain, and sleep disturbance (p < 0.05). In addition, the syndrome of fever in the absence of local chest pain was a significantly associated with anti-SSAA(x) positivity (p < 0.001).
在实验动物中，硅胶引发针对相关蛋白质抗原的抗体的免疫佐剂活性现已得到充分证实。在人类中，硅胶的免疫佐剂活性仍存在争议。来自各个研究小组的大量数据开始为未来的大型流行病学研究界定边界条件。本着这种精神，本手稿报告了3年前进行并曾在本杂志上发表过的一项血清学研究的初步临床数据。对一组自我选择的有症状的隆胸患者血清进行检测，以确定与硅胶表面相关抗原[抗SSAA(x)]结合亲和力升高的抗体浓度。在这项对249名患者的研究中，仅根据血清学检测就确定了两个具有统计学显著差异的亚组：抗SSAA(x)未升高的患者（阴性）和抗SSAA(x)升高的患者（阳性）（p<0.001）。在本研究中，226名患者返回的临床调查问卷与之前获得的血清学结果相关联。比较了199名抗SSAA(x)阴性患者和27名抗SSAA(x)阳性患者报告的11种最常见临床症状，并分析了它们的频率。与27名抗SSAA(x)阳性患者相比，199名抗SSAA(x)阴性患者作为一个群体，各种体征和症状的发生率较低。在三种症状中观察到统计学显著差异：发热、足部疼痛和睡眠障碍（p<0.05）。此外，无局部胸痛的发热综合征与抗SSAA(x)阳性显著相关（p<0.001）。
