Englert H, Morris D, March L
Department of Rheumatology, Royal North Shore Hospital, Sydney, NSW.
Aust N Z J Med. 1996 Jun;26(3):349-55. doi: 10.1111/j.1445-5994.1996.tb01921.x.
Silicone augmentation mammoplasty has been postulated as a cause of environmentally-induced scleroderma. While representing a small proportion of all alleged causes of scleroderma, the issue has huge social, ethical and medicolegal ramifications. The hypothesis, however, has been recently questioned in results of comparative studies. We have previously reported no association between augmentation mammoplasty and scleroderma. However, all information was self-reported including augmentation mammoplasty status, and the prosthesis type was not identified. In addition, data were not available from untraceable cases. The current study addresses these issues.
To validate self-reported augmentation mammoplasty status, re-analyse rates of exposure to silicone gel breast prostheses in 556 scleroderma patients and 289 general practice controls and evaluate whether silicone gel breast prostheses are causally linked to scleroderma.
Study design-population-based case-control study; Cases-scleroderma patients resident in Sydney for at least six consecutive months between 1974-1988; Controls-patients from 29 randomly selected Sydney general practices, age- and gender-group-matched with cases. Validation of augmentation mammoplasty exposure was ascertained from the general medical practitioner of each interviewed case and control, or from the medical records of each deceased or untraceable case. Validation of the date of surgery and prosthesis type was from the relevant plastic surgeon. For each augmentation mammoplasty-positive case, validation of both the date and nature of the scleroderma onset was from the patient's medical records. Controls were given a "control date' for disease onset to adjust for duration of potential exposure.
Validation of augmentation mammoplasty status was possible in 252 (87.2%) living controls, and 532 (95.7%) cases, of whom 287 were living. Self-reported augmentation mammoplasty status was highly reliable in living non-senile cases (kappa = 1), and living validated controls (kappa = 0.86). No association was identified between silicone gel augmentation mammoplasty and scleroderma with unadjusted odds ratios of 1.33 (95% CI: 0.26-6.71), and 1.00 (95% CI: 0.16-6.16) following adjustment for potential confounders of age, socioeconomic status and ethnicity.
This validates the self-reported augmentation mammoplasty status previously reported and does not support the hypothesis that silicone gel augmentation mammoplasty is an environmental inducer of scleroderma in females.
硅胶隆乳术被认为是环境诱发硬皮病的一个原因。虽然在所有硬皮病的假定病因中只占一小部分，但这个问题却有着巨大的社会、伦理和法医学影响。然而，这一假设最近在比较研究的结果中受到了质疑。我们之前曾报道隆乳术与硬皮病之间没有关联。然而，所有信息都是自我报告的，包括隆乳术状态，且未明确假体类型。此外，无法从无法追踪的病例中获取数据。本研究解决了这些问题。
验证自我报告的隆乳术状态，重新分析556例硬皮病患者和289例全科医疗对照者接触硅胶凝胶乳房假体的比例，并评估硅胶凝胶乳房假体与硬皮病之间是否存在因果关系。
研究设计——基于人群的病例对照研究；病例——1974年至1988年期间在悉尼连续居住至少6个月的硬皮病患者；对照——从悉尼29个随机选择的全科医疗诊所中选取的患者，年龄和性别与病例匹配。通过每位接受访谈的病例和对照的全科医生，或每位已故或无法追踪病例的病历，确定隆乳术暴露情况的验证。手术日期和假体类型的验证来自相关整形外科医生。对于每例隆乳术阳性病例，硬皮病发病日期和性质的验证均来自患者病历。给对照设定一个疾病发病的“对照日期”，以调整潜在暴露的持续时间。
252例（87.2%）在世对照和532例（95.7%）病例（其中287例在世）的隆乳术状态得以验证。自我报告的隆乳术状态在在世的非老年病例（kappa = 1）和在世的经验证的对照（kappa = 0.86）中高度可靠。未发现硅胶凝胶隆乳术与硬皮病之间存在关联，未调整的优势比为1.33（95%可信区间：0.26 - 6.71），在对年龄、社会经济地位和种族等潜在混杂因素进行调整后为1.00（95%可信区间：0.16 - 6.16）。
这验证了之前报道的自我报告的隆乳术状态，并不支持硅胶凝胶隆乳术是女性硬皮病环境诱发因素这一假设。
