乳房重建包括自体组织乳房重建或假体植入乳房重建。目前，假体植入乳房重建已经成为患者的主要选择。传统假体植入乳房重建手术将假体植入胸大肌后间隙，由于假体体积通常较大，胸大肌难以完全覆盖假体。此外，由于术中不能实现乳房下皱襞重建，美观效果不佳。近年来，脱细胞真皮基质的出现，为解决该难题带来了希望，促进一期植入假体乳房重建并且改善美观效果，与二期植入假体乳房重建相比，理论上可以减少手术创伤、缩短术后恢复时间。不过，事实上并非如此，两年前发表的荷兰多中心随机对照研究次要结局表明，脱细胞真皮基质辅助一期假体植入乳房重建与二期假体植入乳房重建相比，不良安全事件显著较多。两年后，荷兰发表了该研究的主要结局：患者满意度和生活质量。
相关阅读
2018年8月10日，英国《柳叶刀》肿瘤学分册在线发表荷兰阿姆斯特丹自由大学医院、阿姆斯特丹公共卫生研究所、乌得勒支大学医院、亚历山大·门罗乳腺癌医院、米安德医院、鹿特丹大学医院、阿姆斯特丹大学医院、大阿姆斯特丹市医院、希尔弗瑟姆医院的研究报告，对即刻脱细胞真皮基质辅助一期假体植入乳房重建与二期假体植入乳房重建（当前治疗标准）的患者满意度和生活质量进行了比较。
该多中心非盲随机对照研究（BRIOS）于2013年4月14日～2015年5月29日从荷兰8家医院入组142例年龄超过18岁的乳腺癌或遗传倾向女性，接受保留皮肤的乳房切除术＋即刻假体植入乳房重建。其中，69例被随机分配进行脱细胞真皮基质一期假体植入乳房重建，73例被随机分配进行二期假体植入乳房重建。根据参与者的所在医院和手术类型（治疗或预防）进行分层。主要终点为患者自评生活质量，通过修正后的意向治疗人群健康相关生活质量量表和满意度量表（BREAST-Q）进行定量。该研究在荷兰临床研究注册数据库的登记编号为NTR5446，研究随访已经完成。
经过筛选，修正后的意向治疗人群包括一期60例患者和二期61例患者。其中，一期48例女性、二期44例女性假体植入后至少1年完成BREAST-Q，分别随访平均17.0±7.8、17.2±6.7个月。
结果发现，一期与二期相比，术后患者的生活质量和满意度评分相似。
生理健康：78.0±14.1比79.3±12.2（P=0.60）
心理健康：72.6±17.3比72.8±19.6（P=0.95）
性生活健康：58.0±17.0比57.1±19.5（P=0.82）
乳房满意度：63.4±15.8比60.3±15.4（P=0.35）
结局满意度：72.8±19.1比67.8±16.3（P=0.19）
因此，结合之前发表的研究结果，脱细胞真皮基质一期假体植入乳房重建与二期假体植入乳房重建相比，患者的生活质量和满意度评分相似、不良结局风险显著较高，应该根据具体情况考虑使用脱细胞真皮基质进行一期假体植入乳房重建。
对此，英国阿登布鲁克医院、剑桥大学、安格里亚鲁斯金大学的乳腺外科专家发表同期述评：脱细胞真皮基质一期直接植入乳房重建。
相关阅读
Lancet Oncol. 2018 Aug 10. [Epub ahead of print]
Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial.
Vera Lidwina Negenborn, Danny Aschwin Young-Afat, Rieky Elise Gustina Dikmans, Jan Maerten Smit, Henri Adolf Hubert Winters, Johan Peter William Don Griot, Johannes Wilhelmus Rembertus Twisk, Pieter Quinten Ruhé, Marcus Antonius Maria Mureau, Oren Lapid, Esther Moerman, Adriaan Anne William Martinus van Turnhout, Mathias Joseph Petrus Franciscus Ritt, Mark-Bram Bouman, Margriet Gezina Mullender.
Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands; Research Institute, Amsterdam Public Health, Amsterdam, Netherlands; University Medical Center, Utrecht, Netherlands; Alexander Monro Breast Cancer Hospital, Bilthoven, Netherlands; Meander Medical Centre, Amersfoort, Netherlands; Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, Netherlands; Amsterdam UMC Academic Medical Center, University of Amsterdam, Netherlands; Onze Lieve Vrouwe Gasthuis Oost, Amsterdam, Netherlands; Tergooi Hospital, Hilversum, Netherlands.
BACKGROUND: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR.
METHODS: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446.
FINDINGS: Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17.0 months [SD 7.8]) in the one-stage group and 44 women (17.2 months [SD 6.7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78.0 [SD 14.1] vs two-stage 79.3 [12.2], p=0.60), psychosocial wellbeing (72.6 [17.3] vs 72.8 [19.6], p=0.95), and sexual wellbeing (58.0 [17.0] vs 57.1 [19.5], p=0.82), or in the patient-reported satisfaction domains: satisfaction with breasts (63.4 [15.8] vs 60.3 [15.4], p=0.35) and satisfaction with outcome (72.8 [19.1] vs 67.8 [16.3], p=0.19).
INTERPRETATION: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis.
FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.
DOI: 10.1016/S1470-2045(18)30378-4
Lancet Oncol. 2018 Aug 10. [Epub ahead of print]
One-stage direct-to-implant breast reconstruction using acellular dermal matrix.
John R Benson.
Addenbrooke's Hospital, Cambridge, UK; University of Cambridge, Cambridge, UK; Anglia Ruskin University, Cambridge, UK.
In their Article published in The Lancet Oncology, Vera Lidwina Negenborn and colleagues report primary outcomes for the Breast Reconstruction in One Stage (BRIOS) trial. This is the first randomised study comparing one-stage implant-based breast reconstruction (IBBR) using acellular dermal matrix (ADM) with a conventional two-stage procedure in which a tissue expander is exchanged for a definitive implant once expansion is complete. Introduction of ADM as a surgical adjuvant was intended to offset the disadvantages of a two-stage approach, including treatment duration and complications secondary to suboptimal muscular and fascial coverage of the implant. Thus, ADM would avoid the need for a separate expansion phase by creating a compound pocket of matrix and muscle with sufficient fill-volume to allow placement of a permanent prosthesis during the initial surgery. Furthermore, superior aesthetic results were expected, such as improved shape and contour of the lower pole together with re-creation and better definition of the inframammary fold.
DOI: 10.1016/S1470-2045(18)30424-8
联系客服
