Wang Kaige, Yang Linhui, Tian Panwen, Tan Fen, Liu Dan, Li Weimin
Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
State Key Laboratory of Respiratory Health and Multimorbidity, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Respir Res. 2025 Jan 18;26(1):21. doi: 10.1186/s12931-025-03106-y.
Pleural diseases is a common respiratory disorder, mainly characterized as pleural effusion and patients with pleural effusion caused by pneumonia and empyema constituted 29% of the cohort, which suggests pleural infection as the predominant etiology of pleural effusion in China. Medical thoracoscopy (MT) combined with intrapleural injection of Urokinase holds significant therapeutic value for patients with early to moderate-stage empyema. However, there remains a lack of high-quality evidence regarding the efficacy and safety of combining MT with intrapleural injection of Urokinase administration in patients with pleural infections.
This study is a prospective, multicenter, randomized controlled clinical trial involving patients with pleural infections. The intervention involves medical thoracoscopy. The control group receives conventional treatment involving intrapleural urokinase injection followed by chest tube placement for drainage. The study outcomes include efficacy and health economic benefits. The estimated minimum sample size for each group is 64 cases, totaling 128 cases. The study groups are delineated as follows: patients in group A receives intrapleural urokinase injection followed by chest tube placement for drainage, while patients in group B undergoes MT to remove multiple septa and necrotic tissue followed by chest tube placement for drainage, and then intrapleural urokinase injection the day after MT. It is recommended that the diameter of the chest tube be 12-14 F, with three daily flushes of 30 ml normal saline to ensure optimal drainage. Subsequently, comprehensive statistical analyses will be conducted to compare treatment effects and complications across all groups, ultimately leading to conclusive findings.
The study is the first prospective, multicenter clinical trial on the efficacy and safety of medical thoracoscopy combined with intrapleural urokinase injection for the treatment of pleural infection. This study aims to offer clinical guidance for the management of pleural infection.
ChiCTR2300078352 (Registration Date: 2023/12/06).
胸膜疾病是一种常见的呼吸系统疾病，主要表现为胸腔积液，由肺炎和脓胸引起的胸腔积液患者占队列的29%，这表明胸膜感染是中国胸腔积液的主要病因。内科胸腔镜检查（MT）联合胸腔内注射尿激酶对早中期脓胸患者具有显著的治疗价值。然而，关于MT联合胸腔内注射尿激酶治疗胸膜感染患者的疗效和安全性，仍然缺乏高质量的证据。
本研究是一项前瞻性、多中心、随机对照临床试验，纳入胸膜感染患者。干预措施包括内科胸腔镜检查。对照组接受常规治疗，包括胸腔内注射尿激酶，然后放置胸腔引流管进行引流。研究结果包括疗效和健康经济效益。每组估计的最小样本量为64例，共计128例。研究组划分如下：A组患者胸腔内注射尿激酶，然后放置胸腔引流管进行引流，而B组患者接受MT以清除多个分隔和坏死组织，然后放置胸腔引流管进行引流，并在MT后第二天进行胸腔内注射尿激酶。建议胸腔引流管直径为12 - 14F，每天用30ml生理盐水冲洗3次以确保最佳引流效果。随后，将进行全面的统计分析，比较所有组的治疗效果和并发症，最终得出结论性结果。
本研究是第一项关于内科胸腔镜检查联合胸腔内注射尿激酶治疗胸膜感染的疗效和安全性的前瞻性、多中心临床试验。本研究旨在为胸膜感染的管理提供临床指导。
ChiCTR2300078352（注册日期：2023/12/06）。
