1.
A prophylaxis study of acute exacerbation of interstitial pneumonia after lung cancer surgery.
Ito, H, Nakayama, H, Yokose, T, Nagashima, T, Morohoshi, T, Tajiri, M, Maehara, T, Watanabe, K, Arai, H, Yamamoto, T, et al
Japanese journal of clinical oncology. 2020;(2):198-205
Abstract
INTRODUCTION Acute exacerbation of interstitial pneumonia (AE-IP) is a lethal complication after lung surgery. We conducted a prospective, multi-institutional phase II trial to assess the efficacy and safety of prophylactic measures. METHOD Patients with lung cancer with dorsal subpleural fibrotic changes occupying three or more segments of both lower lobes and planned anatomical lung resection were enrolled. Prior to surgery, patients received a 125-mg bolus injection of methylprednisolone and continuous intravenous infusion of sivelestat sodium hydrate (sivelestat) for 2 days. RESULTS Sixty-nine patients were analysed. Preoperative high-resolution computed tomography (HRCT) showed 37 (53.6%) cases presented with usual interstitial pneumonia (UIP) and possible UIP pattern. There were 60 lobectomies and 9 segmentectomies. Thirty-eight cases were in clinical stage I. No adverse events associated with prophylaxis were observed. There were four cases of AE-IP (5.8%), higher than the expected 2.0%. Three of the four cases showed inconsistencies with the UIP pattern in preoperative HRCT and were pathologically diagnosed as UIP. All patients died of respiratory failure. Overall, 89.9% were diagnosed as idiopathic interstitial pneumonias; UIP was found in 48 patients (69.6%). Severe post-operative complications occurred in 11.6% of the cases. There were 35 deaths, 17 cases of lung cancer and 11 cases related to interstitial pneumonias. The overall survival rate at 3 years was 41.8% of the total and 47.2% of cases with clinical stage I. CONCLUSIONS Perioperative use of sivelestat and low-dose methylprednisolone in patients with anatomical lung resection was safe but did not prove to be a prophylactic effect for AE-IP.
2.
Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol for a multicentre, single-blind, randomised controlled clinical trial.
Takeuchi, M, Obara, H, Kawakubo, H, Shinoda, M, Okabayashi, K, Mayanagi, S, Irino, T, Fukuda, K, Nakamura, R, Wada, N, et al
BMJ open. 2019;(5):e028269
Abstract
INTRODUCTION The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. METHODS AND ANALYSIS We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. ETHICS AND DISSEMINATION The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER UMIN 000031560; Pre-results.
3.
Prophylaxis for acute exacerbation of interstitial pneumonia after lung resection.
Ito, H, Nakayama, H, Yokose, T, Yamada, K
Asian cardiovascular & thoracic annals. 2014;(8):948-54
Abstract
BACKGROUND AND PURPOSE Acute exacerbation of interstitial pneumonia is a life-threatening complication after lung cancer surgery. Dorsal subpleural fibrotic changes occupying 3 or more segments of both lower lobes on high-resolution computed tomography indicate a very high risk. We conducted a prospective phase II study to assess the efficacy of prophylactic treatment. METHODS Patients with lung cancer underwent high-resolution computed tomography preoperatively to assess the risk of acute exacerbations of interstitial pneumonia. Before induction of general anesthesia, high-risk patients received 125 mg of methylprednisolone as an intravenous bolus and sivelestat sodium hydrate 300 mg ·day(-1) as a continuous intravenous infusion. From January 2010 through August 2011, a total of 327 patients underwent surgery for lung cancer, and 31 (9.5%) were enrolled. RESULTS There was no case of acute exacerbation. No adverse events were associated with prophylaxis. Usual interstitial pneumonia was confirmed histopathologically in 25 (80.6%) patients. Four (12.9%) patients had major complications. Usual interstitial pneumonia was diagnosed postoperatively in 4 (1.4%) of 327 patients who did not meet the inclusion criteria, and 1 of these patients died due to acute exacerbation of occult interstitial pneumonia. CONCLUSION Perioperative use of sivelestat sodium hydrate and low-dose methylprednisolone may be useful as prophylaxis for acute exacerbation of interstitial pneumonia.