体外肺修复计划

F. Stanzel
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引用次数: 0

摘要

背景:目前对引流不良的复杂积液的治疗倾向于微创图像引导下放置更小的导管和辅助胸膜内纤溶治疗(IPFT)。在MIST-2试验中,使用10 mg阿替普酶(t-PA)联合5 mg肺酶(DNase),每日2次,连续72 h。我们的目的是评估改良方案16mg t-PA加5mg DNase 24小时治疗复杂胸膜感染的有效性和安全性。方法:这是一项单中心前瞻性研究,涉及引流不良的胸膜感染患者。主要结果是第7天胸片胸膜混浊与基线相比的变化。次要结局包括排液量、炎症标志物改善、手术转诊、住院时间和不良事件。结果:共纳入30例患者。大多数27例(90%)患者成功治疗。胸片胸膜混浊改善的比例为36.9%[四分位间距(IQR) 21.8 ~ 54.9%] ~ 18.1% (IQR 8.8 ~ 32.7%),差异有统计学意义(P < 0.05)。T-PA/DNase使胸腔内治疗前24小时的液体引流中位数从45毫升(IQR 0-100)增加到72小时后的1442毫升(IQR 905-2360);(P < 0.05), c反应蛋白降低(P < 0.05)。20%的患者出现了需要加重镇痛的疼痛,9.9%的患者出现了严重的不良事件。没有人需要手术干预。结论:本研究提示改良方案16mg t-PA加5mg DNase治疗引流不良的复杂胸膜感染是安全有效的。试验注册:该研究于07/06/2021回顾性注册,临床试验号为NCT04915586 (https://clinicaltrials.gov/ct2/show/NCT04915586)。
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Management der pleuralen Infektion: Modifiziertes Therapie-Regime mit intrapleuraler Alteplase und Pulmozyme
Background: Current management of poorly draining complex effusions favours less invasive image-guided placement of smaller tubes and adjunctive intrapleural fibrinolysis therapy (IPFT). In MIST-2 trial, intrapleural 10 mg alteplase (t-PA) with 5 mg of pulmozyme (DNase) twice daily for 72 h were used. We aimed to assess the effectiveness and safety of a modified regimen 16 mg t-PA with 5 mg of DNase administered over 24 h in the management of complex pleural infection. Methods: This was a single centre, prospective study involving patients with poorly drained pleural infection. Primary outcome was the change of pleural opacity on chest radiograph at day 7 compared to baseline. Secondary outcomes include volume of fluid drained, inflammatory markers improvement, surgical referral, length of hospitalisation, and adverse events. Results: Thirty patients were recruited. Majority, 27 (90%) patients were successfully treated. Improvement of pleural opacity on chest radiograph was observed from 36.9% [Interquartile range (IQR 21.8–54.9%)] to 18.1% (IQR 8.8–32.7%) of hemithorax (P < 0.05). T-PA/DNase increased fluid drainage from median of 45 mls (IQR 0–100) 24 h prior to intrapleural treatment to 1442 mls (IQR 905–2360) after 72 h; (P < 0.05) and reduction of C-reactive protein (P < 0.05). Pain requiring escalation of analgesia affected 20% patients and 9.9% experienced major adverse events. None required surgical intervention. Conclusion: This study suggests that a modified regimen 16 mg t-PA with 5 mg DNase can be safe and effective for patients with poorly drained complex pleural infection. Trial registration: The study was registered retrospectively on 07/06/2021 with ClinicalTrials number NCT04915586 (https://clinicaltrials.gov/ct2/show/NCT04915586).
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