Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
G.Re.T.A. Group for Reconstructive and Therapeutic Advancements, Naples, Italy.
Cochrane Database Syst Rev. 2024 Oct 31;10(10):CD013821. doi: 10.1002/14651858.CD013821.pub2.
BACKGROUND: Women who have a mastectomy for breast cancer treatment or risk reduction may be offered different options for breast reconstruction, including use of implants or the woman's own tissue (autologous tissue flaps). The choice of technique depends on factors such as the woman's preferences, breast characteristics, preoperative imaging, comorbidities, smoking habits, prior chest or breast irradiation, and planned adjuvant therapies. OBJECTIVES: To assess the effects of implants versus autologous tissue flaps for postmastectomy breast reconstruction on women's quality of life, satisfaction, and short- and long-term surgical complications. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registries in July 2022. SELECTION CRITERIA: We included studies that compared implant-based reconstruction with autologous tissue-based reconstruction following mastectomy for breast cancer treatment or risk reduction. The minimum eligible sample size was 100 participants. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data using standard Cochrane procedures. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: Thirty-five non-randomised studies with 57,555 participants met our inclusion criteria. There were nine prospective cohort studies and 26 retrospective cohort studies. We judged 26 studies at serious overall risk of bias and the remaining studies at moderate overall risk of bias. Some studies measured quality of life and satisfaction using the BREAST-Q (scale of 0 to 100, higher is better). Implants may reduce postoperative psychosocial well-being compared with autologous tissue flaps (mean difference (MD) -4.26 points, 95% confidence interval (CI) -4.91 to -3.61; I² = 0%; 6 studies, 3335 participants; low-certainty evidence). Implants may reduce or have little to no effect on postoperative physical well-being compared with autologous tissue flaps, but the evidence is very uncertain (MD -1.92 points, 95% CI -4.44 to 0.60; I² = 87%; 6 studies, 3335 participants; very low-certainty evidence). Implants may reduce postoperative sexual well-being compared with autologous reconstruction (MD -6.63 points, 95% CI -7.55 to -5.72; I² = 0; 6 studies, 3335 participants; low-certainty evidence). Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the breast, but the evidence is very uncertain (MD -8.17 points, 95% CI -11.41 to -4.92; I² = 90%; 6 studies, 3335 participants; very low-certainty evidence). This outcome refers to a woman's satisfaction with breast size, bra fit, appearance in the mirror (clothed or unclothed), and how the breast feels to touch. Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the reconstruction (MD -5.96 points, 95% CI -10.24 to -1.68; I² = 62%; 4 studies, 1196 participants; low-certainty evidence). This outcome refers to whether the aesthetic outcome has met the woman's expectations, the impact surgery has had on her life, and whether she thinks she made the right decision to have the reconstruction. Implants may reduce or have little to no effect on the risk of short-term complications compared with autologous tissue flaps, but the evidence is very uncertain (risk ratio (RR) 0.80, 95% CI 0.63 to 1.03; I² = 91%; 22 studies, 34,244 participants; very low-certainty evidence). Implants may increase long-term complications compared with autologous tissue flaps, but the evidence is very uncertain (RR 1.56, 95% CI 1.09 to 2.22; I² = 94%; 17 studies, 26,930 participants; very low-certainty evidence). Implants may have little to no effect on the need for reintervention compared with autologous tissue flaps, but the evidence is very uncertain (RR 1.23, 95% CI 0.91 to 1.68; I² = 93%; 15 studies, 14,171 participants; very low-certainty evidence). Implants may reduce the duration of surgery compared with autologous tissue flaps, but the evidence is very uncertain (MD -125.04 minutes, 95% CI -131.41 to -118.67; I² = 0; 2 studies, 836 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: The findings of this review show that autologous tissue-based reconstruction compared with implant-based reconstruction may improve participant-reported outcomes such as psychosocial well-being, sexual well-being, and satisfaction with the reconstruction. There is also very uncertain evidence to suggest that autologous tissue-based reconstruction increases satisfaction with the breast and reduces the risk of long-term complications compared with implants. Implant-based reconstruction may be a shorter procedure, but the evidence is very uncertain. Despite the growing demand for breast reconstruction, the best technique has not been adequately studied in randomised controlled trials (RCTs), and the evidence provided by non-randomised studies is often unsatisfactory. There is no superior breast reconstruction technique for all women. Future research should focus on the definition of decisional drivers to guide an evidence-based shared decision-making process in reconstructive breast surgery.
背景:患有乳腺癌的女性可能会选择乳房切除术进行治疗或降低风险,而对于这些女性,可选择不同的乳房重建方案,包括使用植入物或女性自身组织(自体组织皮瓣)。技术选择取决于女性的偏好、乳房特征、术前影像学检查、合并症、吸烟习惯、既往胸部或乳房放疗,以及计划的辅助治疗等因素。
目的:评估乳房切除术治疗或降低乳腺癌风险后的乳房重建中使用植入物与自体组织皮瓣对女性生活质量、满意度以及短期和长期手术并发症的影响。
检索方法:我们于 2022 年 7 月在 Cochrane 乳腺癌组专库、CENTRAL、MEDLINE、Embase 和两个试验注册库中进行了检索。
纳入标准:我们纳入了将基于植入物的重建与基于自体组织的重建进行比较的研究,这些研究均为乳房切除术治疗或降低乳腺癌风险后的乳腺癌治疗或降低风险的患者。合格的最小样本量为 100 名参与者。
数据收集和分析:两名综述作者独立评估了偏倚风险并使用标准 Cochrane 程序提取了数据。我们使用 GRADE 评估证据的确定性。
主要结果:35 项非随机研究共纳入 57555 名参与者,符合我们的纳入标准。其中有 9 项前瞻性队列研究和 26 项回顾性队列研究。我们判断 26 项研究存在整体高偏倚风险,其余研究存在整体中度偏倚风险。一些研究使用 BREAST-Q(评分范围为 0 至 100,分数越高表示越好)来衡量生活质量和满意度。与自体组织皮瓣相比,植入物可能会降低术后心理社会健康(平均差(MD)-4.26 分,95%置信区间(CI)-4.91 至-3.61;I²=0%;6 项研究,3335 名参与者;低质量证据)。与自体组织皮瓣相比,植入物可能会降低或对术后生理健康几乎没有影响,但证据非常不确定(MD-1.92 分,95%CI-4.44 至 0.60;I²=87%;6 项研究,3335 名参与者;极低质量证据)。与自体重建相比,植入物可能会降低术后性生活健康(MD-6.63 分,95%CI-7.55 至-5.72;I²=0;6 项研究,3335 名参与者;低质量证据)。与自体组织皮瓣相比,接受乳房植入物重建的女性对乳房的满意度可能较低,但证据非常不确定(MD-8.17 分,95%CI-11.41 至-4.92;I²=90%;6 项研究,3335 名参与者;极低质量证据)。该结果是指女性对乳房大小、胸罩贴合度、穿衣镜中乳房外观(穿衣或不穿衣)以及乳房触感的满意度。与自体组织皮瓣相比,接受乳房植入物重建的女性对重建的满意度可能较低(MD-5.96 分,95%CI-10.24 至-1.68;I²=62%;4 项研究,1196 名参与者;低质量证据)。该结果是指美学效果是否符合女性的期望、手术对她生活的影响以及她是否认为进行重建是正确的决定。与自体组织皮瓣相比,植入物可能会降低或对短期并发症的风险几乎没有影响,但证据非常不确定(风险比(RR)0.80,95%CI 0.63 至 1.03;I²=91%;22 项研究,34244 名参与者;极低质量证据)。与自体组织皮瓣相比,植入物可能会增加长期并发症,但证据非常不确定(RR 1.56,95%CI 1.09 至 2.22;I²=94%;17 项研究,26930 名参与者;极低质量证据)。与自体组织皮瓣相比,植入物对再次干预的需求可能几乎没有影响,但证据非常不确定(RR 1.23,95%CI 0.91 至 1.68;I²=93%;15 项研究,14171 名参与者;极低质量证据)。与自体组织皮瓣相比,植入物可能会缩短手术时间,但证据非常不确定(MD-125.04 分钟,95%CI-131.41 至-118.67;I²=0;2 项研究,836 名参与者;极低质量证据)。
作者结论:本综述的研究结果表明,与基于植入物的重建相比,基于自体组织的重建可能会改善参与者报告的结果,如心理社会健康、性生活健康和对重建的满意度。也有非常不确定的证据表明,与植入物相比,基于自体组织的重建会增加对乳房的满意度并降低长期并发症的风险。植入物可能是一个较短的手术过程,但证据非常不确定。尽管对乳房重建的需求不断增长,但随机对照试验(RCT)并未充分研究最佳技术,并且非随机研究提供的证据往往并不令人满意。对于所有女性来说,没有一种优越的乳房重建技术。未来的研究应重点关注决策驱动因素的定义,以指导在重建性乳房手术中进行基于证据的共同决策。
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