Li Tian, Liu Yan, Zhang Weihong
Breast Surgery Department, Baoshan Branch, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201900, China.
Jingjiang Hospital of Traditional Chinese Medicine, Jingjiang, China.
Aesthetic Plast Surg. 2018 Dec;42(6):1519-1530. doi: 10.1007/s00266-018-1203-1. Epub 2018 Aug 6.
Breast prosthesis implants have been safely and efficiently used in the plastic surgery department. With the increasing demand for aesthetics, these silicon implants were not only used in breast augmentation surgery but also in breast reconstruction after mastectomy. Nevertheless, breast prosthesis implantation brings a lot of complications, such as: postoperative chronic pain, capsule contracture, prosthesis displacement and prosthesis rupture and infection in severe cases. From the year 1998, botulinum toxin A (BTX-A), a neurotoxin, has been reported to be effective for pain control, capsule contracture lessening, expander enlargement and so on. However, those articles included all kinds of study types: randomized, double-blinded controlled trial (RCT), nonrandomized trial, retrospective analysis and case series, besides the outcomes were varied. To clarify how BTX-A acts at the mammaplasty field, we made this systematic review and meta-analysis.
To review how BTX-A acts in the field of mammaplasty as well as discuss the relative mechanisms of BTX-A and the related research progress.
We searched Pubmed, Embase, Cochrane, Web of science, Clinical trials, Wanfang Database and VIP from inception until March 2018 for papers reporting the use of BTX-A in the breast surgery using implants deep within the pectoralis major muscle. System review, viewpoints and case reports were excluded.
Ten articles met the criteria for inclusion including six prospective controlled (2 RCT; 4 other trails), three retrospective cohorts and one case series. These studies were all about patients using BTX-A during or after breast surgery with expanders or prostheses. A total of 682 patients were enrolled, 543 (79.61%) accepted BTX-A injection, 185 underwent mastectomies with immediate reconstruction, 13 with delayed reconstruction, 295 mastectomies with either immediate or delayed reconstruction and 189 with breast augmentation using silicone prostheses. The study time ranging from 4 months to 13 years, 15 patients (2.76%) received BTX-A injection more than two times, 9.2% received less than 75 U BTX-A, 34.3% 75-100 U, 0.18% 250 U, and in 56.4% the dosage was not stated. No complications associated with BTX-A were mentioned, almost all the studies reported efficacy for pain control. Other assessments included increased speed of expander enlargement and volume were mentioned in four papers, two articles analyzed the visual analogue scores, three suggested relief of capsular contracture, two reported lower narcotic use, three mentioned shorter hospital stays and one proved lowering the rate of unplanned expander. It seems all the studies demonstrate the valid usage of BTX-A, but the quality of this evidence still under the line.
We could try to use BTX-A as a new method in the field of mammaplasty. There are so many advantages such as postoperative pain relief, reducing the hospital stay, and increasing operation success rate, but rigorous methodological evidence is still lacking. A lot of studies were retrospective, only two studies used the RCT method. Therefore, to obtain strong evidence to clarify the usage of BTX-A, more randomized double-blinded controlled trials will be required, meanwhile the mechanism study adds to the evidence.
This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
乳房假体植入物已在整形外科中安全有效地使用。随着美学需求的增加,这些硅胶植入物不仅用于隆胸手术,还用于乳房切除术后的乳房重建。然而,乳房假体植入会带来许多并发症,如术后慢性疼痛、包膜挛缩、假体移位,严重时还会出现假体破裂和感染。自1998年以来,据报道肉毒杆菌毒素A(BTX-A)这种神经毒素在控制疼痛、减轻包膜挛缩、扩张器增大等方面有效。然而,这些文章包括了各种研究类型:随机双盲对照试验(RCT)、非随机试验、回顾性分析和病例系列,而且结果各不相同。为了阐明BTX-A在乳房整形领域的作用机制,我们进行了这项系统评价和荟萃分析。
回顾BTX-A在乳房整形领域的作用,并探讨BTX-A的相关机制及研究进展。
我们检索了从数据库建立至2018年3月的Pubmed、Embase、Cochrane、科学网、临床试验、万方数据库和维普数据库,以查找报告在胸大肌深层使用植入物的乳房手术中使用BTX-A的论文。排除系统评价、观点和病例报告。
10篇文章符合纳入标准,包括6篇前瞻性对照研究(2篇RCT;4篇其他试验)、3篇回顾性队列研究和1篇病例系列研究。这些研究均涉及在乳房手术期间或之后使用BTX-A的患者,使用的是扩张器或假体。共纳入682例患者,543例(79.61%)接受了BTX-A注射,185例行即刻乳房重建的乳房切除术,13例行延迟乳房重建,295例行即刻或延迟乳房重建的乳房切除术,189例行硅胶假体隆胸术。研究时间为4个月至13年,15例患者(2.76%)接受了超过两次的BTX-A注射,9.2%的患者接受的BTX-A剂量小于75 U,34.3%为75 - 100 U,0.18%为250 U,56.4%的患者未说明剂量。未提及与BTX-A相关的并发症,几乎所有研究都报告了其在控制疼痛方面的疗效。其他评估包括4篇论文提到扩张器增大速度加快和体积增加,2篇文章分析了视觉模拟评分,3篇表明包膜挛缩得到缓解,2篇报告使用的麻醉剂减少,3篇提到住院时间缩短,1篇证明降低了计划外扩张器的发生率。似乎所有研究都证明了BTX-A的有效应用,但该证据的质量仍未达标。
我们可以尝试将BTX-A作为乳房整形领域一种新的方法。它有很多优点,如缓解术后疼痛、缩短住院时间、提高手术成功率等,但仍缺乏严格的方法学证据。许多研究是回顾性研究,只有两项研究采用了RCT方法。因此,为了获得有力证据以阐明BTX-A的用法,将需要更多的随机双盲对照试验,同时机制研究也能增加证据。
证据水平III:本刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者指南www.springer.com/00266 。