近期,日本在PloS ONE杂志上发表的一项研究"Safety of Postoperative Administration of Human Urinary Trypsin Inhibitor in Lung Cancer Patients with Idiopathic Pulmonary Fibrosis"表明,肺癌伴特发性肺纤维化(IPF)患者行肺切除术后应用乌司他丁安全、可行。
该研究纳入了高分辨率CT和组织学检测诊断为可切除、肺癌伴IPF的患者,评估了术后3天内逐步增加剂量(3×105、6×105和 9×105 U/日)给予其乌司他丁的效果。研究终点为用药安全性和可行性。
结果,共有9例患者入选本研究。术后随访时间为3~12个月(中位值为9个月)。研究未发现归因于乌司他丁的主观和客观不良事件。仅1例患者在术后3个月时出现IPF急性加重,但这种情况发生于给予化疗药物不久,因此被认为是归因于化疗而非手术。(生物谷Bioon.com)
鍥炲埌椤堕儴鍥炲埌椤堕儴
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.