HTA Unit, ESTAR, Regional Health Service, Firenze, Italy.
Regional Health Agency, Toscana, Firenze, Italy.
Int J Surg. 2018 Apr;52:278-284. doi: 10.1016/j.ijsu.2018.02.046. Epub 2018 Mar 2.
In the clinical literature on abdominal hernia repair, no sound criteria have been established to support the use of biological meshes as opposed to synthetic ones. Furthermore, the information on biological meshes is quite scarce, and so their place in therapy has not yet been defined.
The treatment of primary and incisional ventral hernia was the target intervention evaluated in our analysis. Our study consisted of the following phases: a) Identification of the biologic meshes available on the market; b) Literature search focused on efficacy and safety of these meshes; c) Analysis of the findings derived from the literature search. The information collected this way was reviewed narratively, and presented according to standard meta-analysis. The main end-points of our analysis included infection of surgical wound at 1 month and recurrence at 12 months.
Our clinical literature comprised 11 trials that evaluated 5 biological meshes: Permacol (706 patients), Strattice (324 patients), Surgisis (44 patients), Tutomesh (38 patients) and Xenmatrix (22 patients). These studies generally showed a poor methodological quality. Surgical wound infection showed a wide between-study variability (95%CI: from 12.0% to 22.9%). Also the 12-month relapse rate demonstrated a wide 95%CI (from 5.0% to 19.9%). A significantly lower rate of recurrence at 12 months was found for Permacol compared with Strattice (rate difference: -14.2%; 95%CI: -22.1% to -6.2%).
Our analysis provided an overview of 5 biological meshes currently available on the market. The different types of meshes showed a marked statistical variability in the clinical outcomes. Hence, nearly all comparisons between different meshes in the two clinical end-points did not reach statistical significance. One exception was represented by the finding that cross-linked meshes had a significantly lower recurrence rate at 12 months than non-cross-linked meshes.
在腹部疝修补的临床文献中，没有确定的标准可以支持使用生物补片而不是合成补片。此外，关于生物补片的信息相当匮乏，因此其在治疗中的地位尚未确定。
我们的分析评估了原发性和切口疝的治疗方法。我们的研究包括以下几个阶段：a）确定市场上可用的生物补片；b）针对这些补片的疗效和安全性进行文献检索；c）分析文献检索结果。以叙述性方式回顾收集到的信息，并按照标准的荟萃分析进行呈现。我们分析的主要终点包括术后 1 个月的手术部位感染和术后 12 个月的复发。
我们的临床文献包括 11 项试验，评估了 5 种生物补片：Permacol（706 例患者）、Strattice（324 例患者）、Surgisis（44 例患者）、Tutomesh（38 例患者）和 Xenmatrix（22 例患者）。这些研究普遍存在方法学质量较差的问题。手术部位感染的研究间差异较大（95%CI：12.0%至 22.9%）。12 个月的复发率也有较大的 95%CI（5.0%至 19.9%）。Permacol 组的 12 个月复发率明显低于 Strattice 组（差异率：-14.2%；95%CI：-22.1%至-6.2%）。
我们的分析提供了目前市场上 5 种生物补片的概述。不同类型的补片在临床结果方面表现出明显的统计学差异。因此，几乎所有不同补片在这两个临床终点的比较都没有达到统计学意义。一个例外是交联补片在 12 个月时的复发率明显低于非交联补片。
