本研究评估了高强度聚焦超声（HIFU）消融疗法在治疗原发乳腺癌中的作用。根据PRISMA准则，我们在PubMed和Scopus数据库中搜索了2002年至2022年11月的研究。根据一些标准，如实验研究类型、使用HIFU疗法作为局限性乳腺癌治疗的客观临床评估（例如临床、放射学和病理学结果），选择了符合条件的研究。本研究纳入了9项研究，其中包括两项随机对照试验和七项非随机临床试验。在所有研究中，达到完全（100%）凝固性坏死的患者比例在17%至100%之间变化。九项研究中有八项遵循了治疗-切除方案，即对经HIFU消融的肿瘤进行手术切除以进行病理评估。大多数乳腺癌是单发、孤立的可触及肿瘤。用于组织病理学评估的苏木精-伊红染色显示了凝固性坏死的证据。磁共振成像（MRI）的放射学评估显示，HIFU治疗后的肿瘤和1.5至2厘米的正常乳腺组织均无对比增强，而有一个薄的外周增强环，提示凝固性坏死。所有研究都没有报告严重并发症，如出血和感染。与HIFU消融相关的常见并发症包括局部乳腺水肿、疼痛、触痛和轻度至中度烧伤。仅有一例三度烧伤的报道。总体而言，整体美容效果较好。两项随机对照试验中报道的五年无病生存率为95%。HIFU消融可以诱导局限性乳腺癌的肿瘤凝固性坏死，具有良好的安全性和美容效果。然而，关于HIFU治疗后肿瘤完全凝固性坏死的证据不一致。病理学证据的凝固性坏死结果也不一致，且没有可靠的放射学方法来确切评估凝固性坏死。需要进一步探索以确定可靠的放射学方法来治疗和随访时的消融边缘。目前HIFU疗法仅限于单发的可触及性乳腺肿瘤。需要进行更广泛和随机的临床试验来评估HIFU疗法在乳腺癌治疗中的应用，尤其是在原位肿瘤的情况下。

This study evaluates the role of high-intensity focused ultrasound (HIFU) ablative therapy in treating primary breast cancer.PubMed and Scopus databases were searched according to the PRISMA guidelines to identify studies from 2002 to November 2022. Eligible studies were selected based on criteria such as experimental study type, the use of HIFU therapy as a treatment for localised breast cancer with objective clinical evaluation, i.e., clinical, radiological, and pathological outcomes. Nine studies were included in this study.Two randomised controlled trials and seven non-randomised clinical trials fulfilled the inclusion criteria. The percentage of patients who achieved complete (100%) coagulation necrosis varied from 17% to 100% across all studies. Eight of the nine studies followed the treat-and-resect protocol in which HIFU-ablated tumours were surgically resected for pathological evaluation. Most breast cancers were single, solitary, and palpable breast tumours. Haematoxylin and eosin stains used for histopathological evaluation showed evidence of coagulation necrosis. Radiological evaluation by MRI showed an absence of contrast enhancement in the HIFU-treated tumour and 1.5 to 2 cm of normal breast tissue, with a thin peripheral rim of enhancement indicative of coagulation necrosis. All studies did not report severe complications, i.e., haemorrhage and infection. Common complications related to HIFU ablation were local mammary oedema, pain, tenderness, and mild to moderate burns. Only one third-degree burn was reported. Generally, the cosmetic outcome was good. The five-year disease-free survival rate was 95%, as reported in two RCTs.HIFU ablation can induce tumour coagulation necrosis in localised breast cancer, with a favourable safety profile and cosmetic outcome. However, there is variable evidence of complete coagulation necrosis in the HIFU-treated tumour. Histopathological evidence of coagulation necrosis has been inconsistent, and there is no reliable radiological modality to assess coagulation necrosis confidently. Further exploration is needed to establish the accurate ablation margin with a reliable radiological modality for treatment and follow-up. HIFU therapy is currently limited to single, palpable breast tumours. More extensive and randomised clinical trials are needed to evaluate HIFU therapy for breast cancer, especially where the tumour is left in situ.