近期,，日本在PloS ONE雜志上發(fā)表的一項研究"Safety of Postoperative Administration of Human Urinary Trypsin Inhibitor in Lung Cancer Patients with Idiopathic Pulmonary Fibrosis"表明,，肺癌伴特發(fā)性肺纖維化（IPF）患者行肺切除術后應用烏司他丁安全,、可行。
該研究納入了高分辨率CT和組織學檢測診斷為可切除,、肺癌伴IPF的患者，評估了術后3天內逐步增加劑量（3×105,、6×105和 9×105 U/日）給予其烏司他丁的效果,。研究終點為用藥安全性和可行性。
結果,，共有9例患者入選本研究,。術后隨訪時間為3～12個月（中位值為9個月）。研究未發(fā)現歸因于烏司他丁的主觀和客觀不良事件,。僅1例患者在術后3個月時出現IPF急性加重,，但這種情況發(fā)生于給予化療藥物不久，因此被認為是歸因于化療而非手術,。（生物谷Bioon.com）
鍥炲埌欏墮儴鍥炲埌欏墮儴
doi:10.1371/journal.pone.0029053
PMC:
PMID:
Safety of Postoperative Administration of Human Urinary Trypsin Inhibitor in Lung Cancer Patients with Idiopathic Pulmonary Fibrosis
Yoshikane Yamauchi1, Yotaro Izumi1*, Masanori Inoue2, Hiroaki Sugiura2, Taichiro Goto1, Masaki Anraku1, Takashi Ohtsuka1, Mitsutomo Kohno1, Kenzo Soejima3, Hiroaki Nomori1
Background
Patients with idiopathic pulmonary fibrosis (IPF) undergoing pulmonary resection for lung cancer carry risks of acute exacerbations of IPF (AE) postoperatively. Currently, agents which may attenuate AE are actively sought. Urinary trypsin inhibitor, ulinastatin, is a synthetic glycoprotein which may potentially inhibit various inflammatory factors associated with the development and progression of IPF. The present study was done to evaluate the effects of administration of high dose ulinastatin in lung cancer patients with IPF immediately following lung resection.
Methods
Patients with IPFs radiologically diagnosed on high resolution CT, and histologically diagnosed resectable lung cancers, were eligible for the study. The effects of escalating doses of ulinastatin 3×105, 6×105, and 9×105 units/body/day, administered postoperatively for 3 days were evaluated. The endpoints were safety and feasibility.
Results
Nine patients were evaluated, in cohorts of 3 patients per dosage. Postoperative follow up ranged from 3 to 12 months (median 9 months). The postoperative courses were uneventful in all patients. No subjective adverse events such as abdominal symptoms or skin rashes, or objective adverse events as per serum laboratory tests, such as liver or kidney dysfunctions potentially attributable to ulinastatin administration were observed. AE was seen in one patient at 3 months after surgery, but since this occurred shortly after administration of chemotherapy, it was considered to be attributable to the chemotherapy rather than surgery.
Discussion
Ulinastatin administration after lung resection in lung cancer patients with IPF was considered to be safe and feasible. Further study is planned at the highest dose of this study to evaluate efficacy.
