胸腔镜下滑石粉灌注治疗恶性胸腔积液并不优于经胸导管注入滑石浆
作者：
小柯机器人 发布时间：2019/12/17 16:16:21
英国布里斯托尔大学Nick A. Maskell研究团队在研究中取得进展。他们比较了胸腔镜下滑石粉灌注与经胸导管注入滑石浆对恶性胸腔积液患者胸膜固定失败率的影响。2019年12月5日，国际知名学术期刊《美国医学会杂志》发表了这一成果。
恶性胸腔积液（MPE）的治疗是一大挑战。滑石粉胸膜固定术是一种常见而有效的治疗方案。然而关于滑石粉的最佳输注方法尚未确定，因此实践和建议存在差别。
2012年8月至2018年4月，研究组在英国的17家医院进行了一项开放标签的随机临床试验，共招募了330名确诊为MPE的成人患者，均可在局部麻醉下进行胸腔镜检查。将患者按1：1随机分组，其中166名在适度镇静下，经胸腔镜进行4g滑石粉灌注（滑石粉灌注组）；164名在局部麻醉下，床边胸部插管，注入4g无菌滑石浆（对照组）。
330例参与者的平均年龄为68岁，女性占55%，最终有320例纳入主要结果分析。术后90天，滑石粉灌注组161例患者中有36例（22%）胸膜固定失败，对照组159例患者中有38例（24%）失败，差异不显著。在其他24个临床观察指标中，两组亦未有统计学上的差异。
总之，胸腔镜下滑石粉灌注治疗MPE，与经胸导管注入滑石浆相比，未能降低90天内的胸膜固定失败率。
附：英文原文
Title: Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial
Author: Rahul Bhatnagar, Hania E. G. Piotrowska, Magda Laskawiec-Szkonter, Brennan C. Kahan, Ramon Luengo-Fernandez, Justin C. T. Pepperell, Matthew D. Evison, Jayne Holme, Mohamed Al-Aloul, Ioannis Psallidas, Wei Shen Lim, Kevin G. Blyth, Mark E. Roberts, Giles Cox, Nicola J. Downer, Jurgen Herre, Pasupathy Sivasothy, Daniel Menzies, Mohammed Munavvar, Moe M. Kyi, Liju Ahmed, Alex G. West, Richard N. Harrison, Benjamin Prudon, Gihan Hettiarachchi, Biswajit Chakrabarti, Ajikumar Kavidasan, Benjamin P. Sutton, Natalie J. Zahan-Evans, Jack L. Quaddy, Anthony J. Edey, Amelia O. Clive, Steven P. Walker, Matthew H. R. Little, Xue W. Mei, John E. Harvey, Clare E. Hooper, Helen E. Davies, Mark Slade, Merle Sivier, Robert F. Miller, Najib M. Rahman, Nick A. Maskell
Issue&Volume: December 5, 2019
Abstract:
Importance Malignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations.
Objective To test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.
Design, Setting, and Participants Open-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung.
Interventions Patients randomized to the talc poudrage group (n?=?166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n?=?164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.
Main Outcomes and Measures The primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.
Results Among 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P?=?.74; difference, –1.8% [95% CI, –10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes.
Conclusions and Relevance Among patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences.
DOI: 10.1001/jama.2019.19997
Source: https://jamanetwork.com/journals/jama/fullarticle/2757281
