Safety of postoperative administration of human urinary trypsin inhibitor in lung cancer patients with idiopathic pulmonary fibrosis |
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Authors: | Yamauchi Yoshikane Izumi Yotaro Inoue Masanori Sugiura Hiroaki Goto Taichiro Anraku Masaki Ohtsuka Takashi Kohno Mitsutomo Soejima Kenzo Nomori Hiroaki |
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Institution: | Department of Surgery, School of Medicine, Keio University, Tokyo, Japan. |
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Abstract: | BackgroundPatients 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.MethodsPatients 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.ResultsNine 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.DiscussionUlinastatin 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.Trial RegistrationUMIN.ac.jp/ctr/UMIN000002410 |
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