A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)
A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)
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DOI：
10.1016/j.lungcan.2017.01.019
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发表时间：
2017-06-01
期刊：
影响因子：
5.3
通讯作者：
van den Heuvel, M. M.
中科院分区：
文献类型：
--
作者：
Boshuizen, R. C.;Vander Noort, V.;van den Heuvel, M. M.
背景：症状性恶性胸腔积液（MPE）常见于转移性癌症患者。相关预后差，滑石粉胸膜固定术（TP）的成功率低。留置胸膜导管（IPC）通常插入时TP一直successful.Methods：我们比较滑石胸膜固定术与使用留置胸膜导管在一个多中心随机对照试验（优效性设计）复发MPE患者。主要终点是随机治疗后6周改良博格评分（MBS）较基线的改善。结果：两种治疗后呼吸困难明显改善（p < 0.01），但两组之间改善的幅度没有显著差异（TP：IPC的中位数分别为3和1，在休息时，p = 0.16，（TP 13：IPC 16）和3和1，在运动时，p = 0.72（TP 13：IPC 17））。治疗后第6周，TP和IPC之间运动期间的呼吸困难没有差异，而休息时TP患者（n = 13）报告的呼吸困难少于IPC患者（n = 18）（中位数0 vs 1，p = 0.002）。与TP相比，IPC患者在随机治疗期间的住院天数（中位数：0 vs 5，p < 0.0001）和所有原因的总住院天数（中位数：1.6 vs 1.0，p = 0.0035）显著减少。较少的IPC患者接受了一次以上的再介入（7/45 vs 15/43，p = 0.09）。IPC后再次干预的平均次数较低（0.21 vs 0.53，p = 0.05）。结论：IPC在主要终点，改良博格量表（MBS）的改善方面并不上级。然而，IPC患者的住院时间较短，住院次数较少，再次干预次数较少。IPC是有症状的恶性胸腔积液患者的有效治疗方式。(C)2017爱思唯尔B. V.保留所有权利。
Background: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful.Methods: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6 weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events.Results: Dyspnea improved significantly (p < 0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p = 0.16,(TP 13:IPC 16)and 3 and 1 during exercise, p = 0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n = 13) reported less dyspnea than IPC patients (n = 18) (median 0 vs 1, p = 0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p < 0.0001), and total hospitalizations for all causes (median: 1.6 vs 1.0, p = 0.0035). Fewer IPC patients underwent more than one re-intervention (7/45 vs 15/43, p = 0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p = 0.05). Equal number of adverse events occurred.Conclusions: IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion. (C) 2017 Elsevier B.V. All rights reserved.