Simple aspiration and drainage and intrapleural minocycline pleurodesis versus simple aspiration and drainage for the initial treatment of primary spontaneous pneumothorax: An open-label, parallel-group, prospective, randomised, controlled trial
Journal
The Lancet
Journal Volume
381
Journal Issue
9874
Pages
1277-1282
Date Issued
2013
Author(s)
Chan W.-K.
Tsai K.-T.
Lin C.-Y.
Abstract
Background Simple aspiration and drainage is a standard initial treatment for primary spontaneous pneumothorax, but the rate of pneumothorax recurrence is substantial. We investigated whether additional minocycline pleurodesis after simple aspiration and drainage reduces the rate of recurrence. Methods In our open-label, parallel-group, prospective, randomised, controlled trial at two hospitals in Taiwan, patients were aged 15-40 years and had a first episode of primary spontaneous pneumothorax with a rim of air greater than 2 cm on chest radiographs, complete lung expansion without air leakage after pigtail catheter drainage, adequate haematological function, and normal renal and hepatic function. After simple aspiration and drainage via a pigtail catheter, patients were randomly assigned (1:1) to receive 300 mg of minocycline pleurodesis or no further treatment (control group). Randomisation was by computer-generated random numbers in sealed envelopes. Our primary endpoint was rate of pneumothorax recurrence at 1 year. This trial is registered with ClinicalTrials.gov (NCT00418392). Findings Between Dec 31, 2006, and June 30, 2012, 214 patients were randomly assigned-106 to the minocycline group and 108 to the control group (intention-to-treat population). Treatment was unsuccessful within 7 days of randomisation in 14 patients in the minocycline group and 20 patients in the control group. At 1 year, pneumothoraces had recurred in 31 of 106 (29?2%) patients in the minocycline group compared with 53 of 108 (49?1%) in the control group (p=0?003). We noted no procedure-related complications in either group. Interpretation Simple aspiration and drainage followed by minocycline pleurodesis is a safe and more effective treatment for primary spontaneous pneumothorax than is simple aspiration and drainage only. Minocycline pleurodesis should be an adjunct to standard treatment for primary spontaneous pneumothorax.
SDGs
Other Subjects
minocycline; adolescent; adult; article; catheter; controlled study; double blind procedure; drug efficacy; drug safety; drug treatment failure; female; human; major clinical study; male; open study; pleurodesis; priority journal; prospective study; randomized controlled trial; recurrent disease; spontaneous pneumothorax; Taiwan; thoracocentesis; thorax drainage; thorax pain; thorax radiography
Publisher
Lancet Publishing Group
Type
journal article