Lipworth Loren, Tarone Robert E, McLaughlin Joseph K
International Epidemiology Institute, Rockville, MD 20850, USA.
Ann Plast Surg. 2004 Jun;52(6):598-601. doi: 10.1097/01.sap.0000128087.51384.f9.
Numerous meta-analyses, weight-of-the-evidence, and critical reviews have summarized data from case-control and cohort studies, published through 1999, which have been conducted to evaluate the potential association between cosmetic silicone breast implants and the occurrence of well-defined connective tissue diseases, as well as a hypothesized new atypical disease, which does not fulfill established diagnostic criteria for any known connective tissue disease. These reviews have unanimously concluded that there is no evidence of an association between breast implants and any of the traditional connective tissue diseases evaluated individually or combined or atypical connective tissue disease. We have performed an updated review of the results of epidemiologic studies published since 1999. Two long-term follow-up studies of women with breast implants in Denmark and a retrospective cohort study in Australia found no excess of definite connective tissue disease, including rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus and Sjogren's syndrome, among women with cosmetic breast implants compared with breast reduction or other plastic surgery controls or women in the general population. No consistent evidence was observed of increased risk of definite connective tissue disease in women with extracapsular ruptures in 2 studies which evaluated risk by rupture status among women with cosmetic breast implants. The results of several studies provide no evidence of a higher frequency of undefined connective tissue disease among women with cosmetic breast implants or of a rheumatic symptom profile unique to these women and/or indicative of a specific atypical connective tissue disease. In conclusion, the most recent epidemiologic investigations have been remarkably consistent with earlier epidemiologic studies in finding no evidence of an excess of any individual connective tissue disease or all connective tissue diseases combined, including both established and atypical or undefined connective tissue disease, among women with cosmetic silicone breast implants. Thus, the conclusions reached in earlier independent reviews have not changed based on data published during the subsequent years.
众多的荟萃分析、证据权重分析和批判性综述总结了截至1999年发表的病例对照研究和队列研究的数据,这些研究旨在评估美容性硅胶乳房植入物与明确的结缔组织疾病的发生之间的潜在关联,以及一种假设的新的非典型疾病,该疾病不符合任何已知结缔组织疾病的既定诊断标准。这些综述一致得出结论,没有证据表明乳房植入物与任何单独评估或合并评估的传统结缔组织疾病或非典型结缔组织疾病之间存在关联。我们对1999年以来发表的流行病学研究结果进行了更新综述。丹麦两项对乳房植入女性的长期随访研究以及澳大利亚的一项回顾性队列研究发现,与乳房缩小术或其他整形手术对照组或普通人群中的女性相比,接受美容性乳房植入的女性中,包括类风湿性关节炎、系统性硬化症、系统性红斑狼疮和干燥综合征在内的明确结缔组织疾病并无过多发生。在两项评估美容性乳房植入女性中破裂状态风险的研究中,未观察到一致的证据表明包膜外破裂女性患明确结缔组织疾病的风险增加。几项研究的结果没有提供证据表明接受美容性乳房植入的女性中未明确的结缔组织疾病发生率更高,也没有提供证据表明这些女性具有独特的风湿症状特征和/或表明存在特定的非典型结缔组织疾病。总之,最近的流行病学调查与早期的流行病学研究非常一致,即没有证据表明接受美容性硅胶乳房植入的女性中存在任何单独的结缔组织疾病或所有结缔组织疾病合并发生过多的情况,包括已确定的、非典型的或未明确的结缔组织疾病。因此,基于随后几年发表的数据,早期独立综述得出的结论并未改变。