|
虽然脂肪移植已被证明为乳房重建用于治疗乳房外形不规则和体积缩小的有用辅助方法，但是根据美国食品药品管理局（FDA）最新拟定的指导意见，由于脂肪移植物不能模仿天然乳房组织的“基本功能”，应该按照《联邦食品、药品和化妆品法案》和《公共卫生服务法案》第351条将自体脂肪作为药品、器械、生物制品进行管控，故可能严重限制整形外科医生在该临床情况下继续使用脂肪移植。那么，脂肪移植能否改善接受乳房重建女性患者报告的结局？ 2017年6月28日，《美国医学会杂志外科学分册》在线发表密歇根大学、纪念斯隆凯特林癌症中心的乳房切除重建结局联盟研究报告，调查了乳房切除术后接受脂肪移植重建乳房女性的满意度和生活质量。 该多中心纵向前瞻队列研究于2012年2月1日～2016年7月31日在乳房切除重建结局联盟研究11个中心入组年龄≥18岁（平均年龄49.4±10岁）的乳房切除重建术后随访≥2年女性患者2048例，所有主要手术类型（植入、皮瓣）均符合条件。若重建开始1年后未完成乳房重建，则该患者被排除。主要终点为通过BREAST-Q问卷评定的患者报告结局指标，该量表（范围0～100分）评分越高，表明健康相关生活质量越好。问卷子表包括乳房满意度以及心理、生理、性舒适度。对接受与未接受脂肪移植的患者报告结局进行比较。 结果发现，共有165例（8.1%）在2年内接受了脂肪移植，接受与未接受脂肪移植的女性相比：
因此，脂肪移植可以改善乳房重建患者的乳房满意度、心理和性舒适度。 JAMA Surg. 2017 Jun 28. [Epub ahead of print] Association of Fat Grafting With Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. Bennett KG, Qi J, Kim HM, Hamill JB, Wilkins EG, Mehrara BJ, Kozlow JH. University of Michigan Health System, Ann Arbor; University of Michigan, Ann Arbor; Memorial Sloan-Kettering Cancer Center, New York, New York. This cohort study examines satisfaction and quality-of life in women who undergo fat grafting for breast reconstruction after mastectomy. QUESTION: Does fat grafting improve patient-reported outcomes in women undergoing breast reconstruction? FINDINGS: In this cohort study that included 2048 patients, women who later underwent fat grafting reported significantly lower breast satisfaction, psychosocial well-being, and sexual well-being 1 year postoperatively, compared with those who did not receive subsequent fat grafting. However, following fat grafting, both cohorts had similar scores 2 years postoperatively. MEANING: Women who needed fat grafting for contour irregularities or volume deficits and had initially lower scores later reported scores comparable to those of women who did not require fat grafting, once they had undergone fat transfer. IMPORTANCE: Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context. OBJECTIVE: To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction. DESIGN, SETTING, AND PARTICIPANTS: A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction. INTERVENTIONS: Fat grafting as an adjunct to breast mound reconstruction. MAIN OUTCOMES AND MEASURES: Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting. RESULTS: A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], -4.74; 95% CI, -8.21 to -1.28; P=.008), psychosocial well-being (AMD, -3.87; 95% CI, -7.33 to -0.40; P=.03), and sexual well-being (AMD, -5.59; 95% CI, -9.70 to -1.47; P=.008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, -0.68; 95% CI, -4.42 to 3.06; P=.72), psychosocial well-being (AMD, -0.59; 95% CI, -3.92 to 2.74; P=.73), and sexual well-being (AMD, -2.94; 95% CI, -7.01 to 1.12; P=.15) 2 years postoperatively. CONCLUSIONS AND RELEVANCE: Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction. PMID: 28658472 DOI: 10.1001/jamasurg.2017.1716 |
|
|
