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多西环素与碘附经肋间管行胸膜固定术治疗恶性胸腔积液的疗效和安全性:一项随机试验。

Efficacy and safety of doxycycline versus iodopovidone for pleurodesis through an intercostal tube in malignant pleural effusions: a randomized trial.

机构信息

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Sector-12, 160012, Chandigarh, India.

出版信息

Support Care Cancer. 2023 Jul 10;31(8):454. doi: 10.1007/s00520-023-07932-y.

DOI:10.1007/s00520-023-07932-y
PMID:37428348
Abstract

PURPOSE

The search for an inexpensive agent for chemical pleurodesis in malignant pleural effusion (MPE) continues. We aimed to compare the efficacy and safety of iodopovidone versus doxycycline for pleurodesis in MPE.

METHODS

We randomized consecutive subjects with recurrent symptomatic MPE (1:1) to undergo pleurodesis with either doxycycline or iodopovidone administered through an intercostal tube. The primary outcome was the success rate of pleurodesis at 30 days. The secondary outcomes were the time to pleurodesis, chest pain (assessed using visual analog scale [VAS]) after pleurodesis, and complications (hypotension, acute respiratory failure, empyema).

RESULTS

We randomized 52 and 58 subjects to receive either doxycycline or iodopovidone. The mean (standard deviation [SD]) age of the study population (51% women) was 54.1 (13.6) years. Lung cancer (≥ 60%) was the most common underlying cause of MPE. We observed a similar frequency of success in the doxycycline vs. the iodopovidone group (complete response: 43 (82.7%) vs. 46 (79.3%) subjects; partial response: 7 (13.5%) vs. 10 (17.2%) subjects; p = 0.3). The mean (SD) time to pleurodesis was 1.5 (1.9) days and 1.9 (5.4) days in the doxycycline and iodopovidone groups, respectively. While the VAS for chest pain was significantly higher with iodopovidone (mean [SD] VAS: doxycycline, 31.9 [20.9]; iodopovidone, 41.3 [21.8]; p = 0.017), it did not reach the minimal clinically important difference. The complication rates were similar between the two groups.

CONCLUSION

Iodopovidone was not superior to doxycycline for pleurodesis in MPE. TRIAL REGISTRATION NUMBER/DATE: clinicaltrials.gov (NCT02583282) / October 22, 2015.

摘要

目的

在恶性胸腔积液(MPE)中寻找一种廉价的化学胸膜固定术药物仍在继续。我们旨在比较聚维酮碘与多西环素用于 MPE 胸膜固定术的疗效和安全性。

方法

我们连续将患有复发性有症状 MPE 的受试者(1:1)随机分为两组,通过肋间管接受多西环素或聚维酮碘胸膜固定术。主要结局为 30 天胸膜固定术成功率。次要结局为胸膜固定术时间、胸膜固定术后胸痛(采用视觉模拟量表[VAS]评估)和并发症(低血压、急性呼吸衰竭、脓胸)。

结果

我们将 52 名和 58 名受试者随机分为多西环素组和聚维酮碘组。研究人群(51%为女性)的平均(标准差[SD])年龄为 54.1(13.6)岁。肺癌(≥60%)是 MPE 最常见的基础病因。我们观察到多西环素组和聚维酮碘组的成功率相似(完全缓解:43(82.7%)例与 46(79.3%)例;部分缓解:7(13.5%)例与 10(17.2%)例;p=0.3)。多西环素组和聚维酮碘组的胸膜固定术时间分别为 1.5(1.9)天和 1.9(5.4)天。虽然聚维酮碘的胸痛视觉模拟量表(VAS)评分明显更高(多西环素组的平均[SD]VAS:31.9[20.9];聚维酮碘组:41.3[21.8];p=0.017),但未达到最小临床重要差异。两组的并发症发生率相似。

结论

聚维酮碘在 MPE 胸膜固定术中并不优于多西环素。

试验注册号/日期:clinicaltrials.gov(NCT02583282)/2015 年 10 月 22 日。

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