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围手术期吸入噻托溴铵对食管癌手术合并慢性阻塞性肺疾病患者的影响(EPITOPE):一项开放标签、随机、平行组试点研究。

Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study.

作者信息

Okamura Akihiko, Watanabe Masayuki, Miyazaki Naoki, Matsui Yoshiko, Manoshiro Haruka, Furukawa Emi, Tai Yasuhiro, Kanamori Jun, Imamura Yu, Kitazono Satoru

机构信息

Department of Esophageal Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

Center for Development of Advanced Cancer Therapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

出版信息

Gen Thorac Cardiovasc Surg. 2025 Jan;73(1):58-65. doi: 10.1007/s11748-024-02083-1. Epub 2024 Sep 18.

DOI:10.1007/s11748-024-02083-1
PMID:39294550
Abstract

OBJECTIVE

Chronic obstructive pulmonary disease (COPD) is a risk factor for pneumonia following esophagectomy. This study aimed to investigate the efficacy of perioperative inhaled tiotropium in patients with COPD undergoing esophagectomy.

METHODS

This open-label, randomized controlled trial randomly assigned 32 patients with COPD undergoing esophagectomy to conventional management or addition of tiotropium inhalation. The intervention group received tiotropium from two weeks before esophagectomy until the final evaluation one month after esophagectomy. The primary outcome was the incidence of pneumonia within 30 postoperative days. We also assessed the changes and the percentages from baseline in pulmonary function and walking distance of the incremental shuttle walking test to just before esophagectomy and final evaluation.

RESULTS

Enrolled patients were randomly assigned to the control group (n = 18) and the intervention group (n = 14). Pneumonia was recorded in 4 (28.6%) and 5 (27.8%) patients in the intervention and control groups, respectively (risk difference: 0.8%, 95% confidence interval: - 30.6 to 32.2). The intervention group demonstrated a significant improvement in pulmonary function and walking distance preoperatively. Further, the pulmonary function test was significantly better preoperatively in the intervention group than in the control group. Postoperatively, pulmonary function deterioration was more significant in the control group than in the intervention group.

CONCLUSIONS

Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.

摘要

目的

慢性阻塞性肺疾病(COPD)是食管切除术后发生肺炎的一个危险因素。本研究旨在探讨围手术期吸入噻托溴铵对接受食管切除术的COPD患者的疗效。

方法

这项开放标签的随机对照试验将32例接受食管切除术的COPD患者随机分配至常规治疗组或加用噻托溴铵吸入组。干预组在食管切除术前两周开始使用噻托溴铵,直至食管切除术后1个月的最终评估。主要结局是术后30天内肺炎的发生率。我们还评估了肺功能以及递增往返步行试验步行距离从基线至食管切除术前及最终评估时的变化及百分比。

结果

入组患者被随机分配至对照组(n = 18)和干预组(n = 14)。干预组和对照组分别有4例(28.6%)和5例(27.8%)患者发生肺炎(风险差异:0.8%,95%置信区间:-30.6至32.2)。干预组术前肺功能和步行距离有显著改善。此外,干预组术前肺功能测试明显优于对照组。术后,对照组肺功能恶化比干预组更显著。

结论

术前吸入噻托溴铵可显著改善接受食管切除术的COPD患者的肺功能和运动耐量。围手术期使用噻托溴铵并未降低食管切除术后肺炎的发生率,但可能通过减少术后肺功能恶化促进患者恢复。

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本文引用的文献

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Analysis of the short-term outcomes after esophagectomy for esophageal cancer during the COVID-19 pandemic using data from a nationwide Japanese database.分析使用全国性日本数据库中的数据,了解 COVID-19 大流行期间食管癌患者接受食管切除术的短期预后。
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Association Between Preoperative HbA1c Levels and Complications after Esophagectomy: Analysis of 15,801 Esophagectomies From the National Clinical Database in Japan.术前糖化血红蛋白水平与食管癌切除术后并发症之间的关联:对日本国家临床数据库中15801例食管癌切除术的分析
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Prevention of postoperative pulmonary complication is desired to reduce mortality and improve long-term survival after esophagectomy for esophageal cancer.预防术后肺部并发症对于降低食管癌食管切除术后的死亡率和提高长期生存率是有必要的。
Ann Gastroenterol Surg. 2020 Sep 23;4(5):478-479. doi: 10.1002/ags3.12391. eCollection 2020 Sep.
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The Design of and Rationale for the Effect of Perioperative Inhaled Tiotropium for Patients with Chronic Obstructive Pulmonary Disease in Esophageal Cancer Surgery (EPITOPE): an Open-Label, Randomized, Parallel-Group Study.围手术期吸入噻托溴铵对食管癌手术合并慢性阻塞性肺疾病患者的影响的设计和原理(EPITOPE):一项开放标签、随机、平行组研究。
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