脂肪移植能否改善乳房切除術後重建患者的滿意度

最新 06-29

雖然脂肪移植已被證明為乳房重建用於治療乳房外形不規則和體積縮小的有用輔助方法，但是根據美國食品藥品管理局（FDA）最新擬定的指導意見，由於脂肪移植物不能模仿天然乳房組織的「基本功能」，應該按照《聯邦食品、藥品和化妝品法案》和《公共衛生服務法案》第351條將自體脂肪作為藥品、器械、生物製品進行管控，故可能嚴重限制整形外科醫生在該臨床情況下繼續使用脂肪移植。那麼，脂肪移植能否改善接受乳房重建女性患者報告的結局？

2017年6月28日，《美國醫學會雜誌外科學分冊》在線發表密歇根大學、紀念斯隆凱特林癌症中心的乳房切除重建結局聯盟研究報告，調查了乳房切除術後接受脂肪移植重建乳房女性的滿意度和生活質量。

該多中心縱向前瞻隊列研究於2012年2月1日～2016年7月31日在乳房切除重建結局聯盟研究11個中心入組年齡≥18歲（平均年齡49.4±10歲）的乳房切除重建術後隨訪≥2年女性患者2048例，所有主要手術類型（植入、皮瓣）均符合條件。若重建開始1年後未完成乳房重建，則該患者被排除。主要終點為通過BREAST-Q問卷評定的患者報告結局指標，該量表（範圍0～100分）評分越高，表明健康相關生活質量越好。問卷子表包括乳房滿意度以及心理、生理、性舒適度。對接受與未接受脂肪移植的患者報告結局進行比較。

結果發現，共有165例（8.1%）在2年內接受了脂肪移植，接受與未接受脂肪移植的女性相比：

術後1年，乳房滿意度、心理和性舒適度較低（校正平均差異：-4.74、-3.87、-5.59，95%置信區間：-8.21～-1.28、-7.33～-0.40、-9.70～-1.47，P=0.008、0.03、0.008）

術後2年，乳房滿意度、心理和性舒適度相似（校正平均差異：-0.68、-0.59、-2.94，95%置信區間：-4.42～3.06、-3.92～2.74、-7.01～1.12，P=0.72、0.73、0.15）

因此，脂肪移植可以改善乳房重建患者的乳房滿意度、心理和性舒適度。

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.

DOI: 10.1001/jamasurg.2017.1716