Sánchez-Guerrero J, Colditz G A, Karlson E W, Hunter D J, Speizer F E, Liang M H
Department of Rheumatology, Harvard Medical School, Boston, MA, USA.
N Engl J Med. 1995 Jun 22;332(25):1666-70. doi: 10.1056/NEJM199506223322502.
Silicone breast implants have been linked to a variety of illnesses, the most controversial of which are connective-tissue diseases and symptoms. To study this relation, we analyzed data from 14 years of follow-up of the Nurses' Health Study cohort.
Women who were free from connective-tissue disease in June 1976 were followed through May 31, 1990, before there was widespread media coverage of the possible association of breast implants and connective-tissue diseases. Information was collected through biennial and supplementary mailed questionnaires and blinded reviews of medical records with the use of standardized criteria. Relative risk, the measure of association, was defined as the incidence rate of connective-tissue disease among women with breast implants divided by the corresponding incidence rate among women without breast implants.
Among 87,501 women who were eligible for follow-up, 516 were confirmed as having definite connective-tissue diseases and 1183 as having breast implants (of which 876 were silicone-gel-filled, 170 saline-filled, 67 double-lumen, 14 polyurethane-coated, and 56 of unknown type). The mean (+/- SD) period of follow-up after surgery was 9.9 +/- 6.4 years (range, 1 month to 40.5 years). Three of the patients with definite connective-tissue disease--all had rheumatoid arthritis--had implants (one silicone-gel-filled, one saline-filled, and one double-lumen). The age-adjusted relative risk of a definite connective-tissue disease among women with any type of implant was 0.6 (95 percent confidence interval, 0.2 to 2.0), as compared with women without implants. For women with silicon-gel-filled implants, the comparable relative risk was 0.3 (95 percent confidence interval, 0 to 1.9). The relative risk of self-reported signs or symptoms of connective-tissue disease for women with implants was 1.5 (95 percent confidence interval, 0.9 to 2.4); the risk of having any 1 of 41 signs, symptoms, or laboratory features of connective-tissue disease was 0.7 (95 percent confidence interval, 0.3 to 1.6).
In a large cohort study, we did not find an association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria, or signs and symptoms of these diseases.
硅胶乳房植入物与多种疾病有关，其中最具争议的是结缔组织疾病及症状。为研究这种关系，我们分析了护士健康研究队列14年随访的数据。
1976年6月时无结缔组织疾病的女性被随访至1990年5月31日，当时媒体尚未广泛报道乳房植入物与结缔组织疾病可能存在的关联。通过每两年一次的补充邮寄问卷以及使用标准化标准对医疗记录进行盲法审查来收集信息。关联度量指标相对风险定义为有乳房植入物女性的结缔组织疾病发病率除以无乳房植入物女性的相应发病率。
在87501名符合随访条件的女性中，516人被确诊患有明确的结缔组织疾病，1183人有乳房植入物（其中876人植入的是硅胶凝胶，170人是盐水，67人是双腔，14人是聚氨酯涂层，56人类型不明）。手术后的平均（±标准差）随访期为9.9±6.4年（范围为1个月至40.5年）。3名确诊结缔组织疾病的患者——均患有类风湿关节炎——有植入物（1人植入硅胶凝胶，1人植入盐水，1人植入双腔）。与无植入物的女性相比，任何类型植入物女性患明确结缔组织疾病的年龄调整相对风险为0.6（95%置信区间为0.2至2.0）。对于植入硅胶凝胶的女性，可比相对风险为0.3（95%置信区间为0至1.9）。有植入物女性自我报告的结缔组织疾病体征或症状的相对风险为1.5（95%置信区间为0.9至2.4）；出现结缔组织疾病41种体征、症状或实验室特征中任何一种的风险为0.7（95%置信区间为0.3至1.6）。
在一项大型队列研究中，我们未发现硅胶乳房植入物与根据多种标准化标准定义的结缔组织疾病或这些疾病的体征及症状之间存在关联。
