From the Directorate General of Medical Devices and Pharmaceutical Services, Medical Device Vigilance System and Inspections, and the Directorate General of Digitalization, Health Informative System and Statistics, Italian Ministry of Health; and the Department of Public Health and Infectious Diseases, Sapienza University of Rome.
Plast Reconstr Surg. 2020 Nov;146(5):530e-538e. doi: 10.1097/PRS.0000000000007240.
Studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) are trying to optimize medical and surgical treatments for early and advanced stages of this disease. The aim of this article is to share the experience gathered on the authors' prospectively collected 46 well-documented cases.
Italian physicians are obliged to report BIA-ALCL cases to the Italian Ministry of Health. Because of this cooperation with health care professionals, the competent authority has coordinated and centralized the collection of information for each patient in 46 cases of BIA-ALCL. Statistical analyses with cumulative incidence and corresponding 95 percent confidence interval are provided for each year, dividing the number of new cases that occurred in a defined year and the population at risk of experiencing BIA-ALCL during the same year.
The mean time to the onset of symptoms is reduced to 6.4 ± 3.77 years (range, 1 to 22 years). Increased knowledge has also shortened the average time to diagnosis, at 7.2 ± 3.71 years (range, 2 to 22 years). A late seroma appears in 91 percent of cases. The patient who died underwent limited surgery. The Italian incidence has been estimated as 2.8 per 100,000 patients receiving implants (95 percent CI, 0.88 to 4.84) in 2015; 2.1 (95 percent CI, 0.43 to 3.86) in 2016; 3.2 (95 percent CI, 1.11 to 5.31) in 2017; and 3.5 (95 percent CI, 1.36 to 5.78) in 2018.
Although the number of cases has risen slightly, BIA-ALCL is still a rare disease with a stable incidence, easily recognized and with a favorable prognosis also in advanced stages if complete surgical excision is performed.
针对乳房植入物相关间变性大细胞淋巴瘤(BIA-ALCL)的研究旨在为该病的早期和晚期阶段优化医疗和手术治疗。本文旨在分享作者前瞻性收集的 46 例记录完善的病例经验。
意大利医生有义务向意大利卫生部报告 BIA-ALCL 病例。由于与医疗保健专业人员的合作,主管当局为 46 例 BIA-ALCL 患者的每个病例协调和集中了信息收集。对每年发生的新病例数和同年发生 BIA-ALCL 的风险人群进行了累积发病率和相应 95%置信区间的统计分析。
症状出现的平均时间缩短至 6.4±3.77 年(范围 1-22 年)。知识的增加也缩短了平均诊断时间,为 7.2±3.71 年(范围 2-22 年)。91%的病例出现晚期血清肿。死亡患者接受了局限性手术。2015 年,意大利的发病率估计为每 10 万名植入患者 2.8 例(95%CI,0.88-4.84);2016 年为 2.1(95%CI,0.43-3.86);2017 年为 3.2(95%CI,1.11-5.31);2018 年为 3.5(95%CI,1.36-5.78)。
尽管病例数量略有增加,但 BIA-ALCL 仍然是一种罕见疾病,发病率稳定,易于识别,如果完全进行手术切除,即使在晚期也具有良好的预后。