Macchiarini P, Wain J, Almy S, Dartevelle P
Departments of Thoracic and Vascular Surgery and Heart-Lung Transplantation, Marie-Lannelongue Hôpital, Paris-Sud University, Le Plessis Robinson, France.
J Thorac Cardiovasc Surg. 1999 Apr;117(4):751-8. doi: 10.1016/S0022-5223(99)70296-5.
Air leaks after pulmonary resections may contribute to increased patient morbidity, delayed removal of chest drainage tubes, and prolonged hospitalization.
The purpose of this study was to investigate the effects of a new synthetic, absorbable sealant on the healing of healthy bronchial and lung tissues (experimental study) and its safety and efficacy to stop air leaks after lung resection (clinical study).
Fifteen large white pigs underwent a left upper lobectomy. All parenchymal surgical sites were sealed; the bronchial stump was either stapled, sealed, or both (n = 5 each). In the clinical study, 26 consecutive patients were prospectively randomized, intraoperatively, to standard closure of parenchymal surgical sites with (n = 15) or without (n = 11) the sealant.
In the experimental study, no postoperative air leaks occurred, with intact bronchial closures and normal tissues at death. In the clinical study, 100% of intraoperative leaks were sealed versus 18% of control patients (P =.001). Although 77% (n = 10) of treated patients remained leak-free from the end of the operation to chest tube removal versus 9% (n = 1) of control patients (P =.001), there was no statistical difference in the duration of postoperative chest tube time, hospital stay, or cost. There were no acute or late undesirable side-effects related to the sealant application.
The surgical adhesive investigated here demonstrated a compelling safety profile and significant clinical efficacy to stop air leaks after lung resections.
肺切除术后的空气泄漏可能会导致患者发病率增加、胸腔引流管拔除延迟以及住院时间延长。
本研究的目的是调查一种新型合成可吸收密封剂对健康支气管和肺组织愈合的影响（实验研究）及其在肺切除术后阻止空气泄漏的安全性和有效性（临床研究）。
15只大型白色猪接受了左上叶切除术。所有实质手术部位均进行了密封；支气管残端要么用吻合器吻合、密封，要么两者都用（每组n = 5）。在临床研究中，26例连续患者在术中被前瞻性随机分组，实质手术部位采用标准闭合方法，其中15例使用密封剂，11例不使用密封剂。
在实验研究中，术后未发生空气泄漏，死亡时支气管闭合完好且组织正常。在临床研究中，100%的术中泄漏得到密封，而对照组患者为18%（P = 0.001）。虽然77%（n = 10）的治疗患者从手术结束到胸腔引流管拔除期间无漏气，而对照组患者为9%（n = 1）（P = 0.001），但术后胸腔引流管留置时间、住院时间或费用方面无统计学差异。与密封剂应用相关的急性或晚期不良副作用均未出现。
本研究中所调查的手术粘合剂显示出令人信服的安全性和显著的临床疗效，可阻止肺切除术后的空气泄漏。
