Schonman Ron, Corona Roberta, Bastidas Adriana, De Cicco Carlo, Mailova Karina, Koninckx Philippe Robert
Departments of Obstetrics and Gynecology at University Hospital Leuven, Belgium.
J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):188-94. doi: 10.1016/j.jmig.2008.12.014.
To study the efficacy and safety of Intercoat gel in a laparoscopic mouse model with pneumoperitoneum-enhanced adhesion formation.
Randomized controlled trial. Evidence obtained from a properly designed, randomized, controlled trial (Canadian Task Force classification I).
University laboratory research center.
Balb\c female mice 9 to 10 weeks old.
Two laparoscopic mouse models for adhesion formation were used. In the first model, adhesions following bipolar opposing lesions in the pelvis were enhanced by 60 minutes of carbon-dioxide pneumoperitoneum. In the second model, adhesions were further enhanced by bowel manipulation. The first experiment evaluated the efficacy of Intercoat in both models. The second experiment evaluated the efficacy of Intercoat in the first model, when applied immediately on the lesion, when applied at the end of the pneumoperitoneum, and when applied in the upper abdomen. Biopsy specimens were taken after 7 days and were evaluated after hematoxylin-eosin and CD45 staining.
Qualitative and quantitative adhesion scoring. Morphology was evaluated by standard light microscopy. In both models, Intercoat decreased adhesion formation whether applied immediately on the lesion or at the end of the pneumoperitoneum (qualitative and quantitative scoring p <.0001 and p <.0001, respectively). Intercoat application is associated with tissue redness, vascular congestion, and cellular edema but without an inflammatory reaction. Applied in the upper abdomen, Intercoat does not increase adhesions, but decreases adhesions at higher doses (p =.0024). Intercoat in high doses had a toxic effect (p =.0058).
Intercoat is an effective antiadhesion product. It is associated with tissue edema and vasodilatation as observed after 7 days both macroscopically and by histology.
在腹腔镜小鼠气腹增强粘连形成模型中研究Intercoat凝胶的疗效和安全性。
随机对照试验。证据来源于设计合理的随机对照试验（加拿大工作组分类I级）。
大学实验室研究中心。
9至10周龄的Balb\c雌性小鼠。
使用两种腹腔镜小鼠粘连形成模型。在第一个模型中，通过60分钟的二氧化碳气腹增强盆腔双极相对损伤后的粘连。在第二个模型中，通过肠管操作进一步增强粘连。第一个实验评估Intercoat在两种模型中的疗效。第二个实验评估Intercoat在第一个模型中，在损伤部位立即应用、气腹结束时应用以及在上腹部应用时的疗效。7天后采集活检标本，经苏木精-伊红和CD45染色后进行评估。
粘连的定性和定量评分。通过标准光学显微镜评估形态学。在两种模型中，无论在损伤部位立即应用还是在气腹结束时应用Intercoat，均能减少粘连形成（定性和定量评分分别为p <.0001和p <.0001）。应用Intercoat与组织发红、血管充血和细胞水肿相关，但无炎症反应。在上腹部应用时，Intercoat不会增加粘连，但在高剂量时会减少粘连（p =.0024）。高剂量的Intercoat有毒性作用（p =.0058）。
Intercoat是一种有效的抗粘连产品。在7天后通过宏观和组织学观察发现，它与组织水肿和血管扩张有关。
