Miyamoto Hideaki, Sakao Yukinori, Sakuraba Motoki, Oh Shiaki, Takahashi Nobumasa, Miyasaka Yoshikazu, Akaboshi Taku, Inagaki Tomoya
Department of General Thoracic Surgery, Juntendo University, Tokyo, Japan.
Ann Thorac Cardiovasc Surg. 2010 Aug;16(1):16-20.
Numerous reports have been published on the application of fibrin glues, biological adhesives used as sealants for air leaks after pulmonary resection; however, the use of blood products has been questioned from both safety and economic perspectives. Therefore we were prompted to attempt the use of Integran (method C), a sheet-type absorbable topical collagen hemostat that is neither expensive nor derived from blood.
To compare the efficacy of method C with that of method G, a combined approach in which TachoComb or a polyglycolic acid (PGA) sheet was fixed with a fibrin glue in a randomized controlled trial to prevent pulmonary fistula formation after lung surgery.
Of the patients who were scheduled to undergo pulmonary resection in 2006 at the Department of General Thoracic Surgery, Juntendo University, and who provided informed consent for the study before surgery, those who developed visible air leaks during lobectomy, segmentectomy, partial resection for lung tumor or pulmonary cyst, or intractable pneumothorax were included as the subjects of this study. The subjects were randomized for treatment with either of 2 procedures, namely, method C or method G. Pulmonary fistula was defined as an obvious air leak persisting until day 3 after surgery.
A total of 38 patients were assigned to method C and 34 to method G. Three patients (7.9%) assigned to method C (including 1 who underwent lobectomy and 2 who underwent partial resection), and 6 (17.6%) patients assigned to method G, including 3 who each underwent a lobectomy and partial resection, developed postoperative pulmonary fistula. The incidence of pulmonary fistula was significantly lower in the group assigned to method C, with a statistically significant difference of p = 0.044.
In a randomized controlled trial of sealing with a sheet-type collagen vs. a combined approach of fixing a collagen sponge, using fibrin glue for closure of air leaks, the use of Integran, a sheet-type absorbable topical collagen hemostat, is feasible to prevent pulmonary fistula after lung surgery. It is also affordable and safe because it is not a blood product.
关于纤维蛋白胶（一种用于肺切除术后漏气封堵的生物粘合剂）的应用已有大量报道；然而，从安全性和经济性角度来看，血液制品的使用受到了质疑。因此，我们尝试使用Integran（方法C），这是一种片状可吸收局部胶原蛋白止血剂，既不贵也非源自血液。
在一项随机对照试验中，比较方法C与方法G的疗效，方法G是一种联合方法，即使用速即纱或聚乙醇酸（PGA）片并用纤维蛋白胶固定，以预防肺手术后肺瘘形成。
2006年在顺天堂大学胸外科计划接受肺切除手术且在手术前提供了研究知情同意书的患者中，那些在肺叶切除术、肺段切除术、肺肿瘤或肺囊肿部分切除术或难治性气胸期间出现明显漏气的患者被纳入本研究。将受试者随机分为两种治疗方法，即方法C或方法G。肺瘘定义为术后持续至第3天的明显漏气。
共有38例患者被分配至方法C组，34例被分配至方法G组。分配至方法C组的3例患者（7.9%）（包括1例行肺叶切除术和2例行部分切除术的患者）以及分配至方法G组的6例患者（17.6%）（包括3例行肺叶切除术和部分切除术的患者）发生了术后肺瘘。方法C组的肺瘘发生率显著较低，p = 0.044，差异具有统计学意义。
在一项关于片状胶原蛋白封堵与使用纤维蛋白胶封闭漏气的胶原蛋白海绵固定联合方法的随机对照试验中，使用Integran（一种片状可吸收局部胶原蛋白止血剂）预防肺手术后肺瘘是可行的。它价格实惠且安全，因为它不是血液制品。
