Giuseppe
Emeritus
[Source: The Lancet, full text: (LINK). Abstract, edited.]
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The Lancet, Early Online Publication, 18 February 2013
doi:10.1016/S0140-6736(12)62170-9
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
Original Text
Jin-Shing Chen MD a, Wing-Kai Chan MD d, Kung-Tsao Tsai MD e, Hsao-Hsun Hsu MD a, Chien-Yu Lin MS f, Ang Yuan MD b, Prof Wen-Jone Chen MD c, Prof Hong-Shiee Lai MD a, Prof Pan-Chyr Yang MD g
Summary
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.
Funding
Department of Health and National Science Council, Taiwan.
a Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; b Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; c Department of Emergency Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; d Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan; e Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan; f Institute of Statistical Science, Academia Sinica, and Microarray Core Facility, Center for Genomic Medicine, National Taiwan University, Taipei, Taiwan; g National Taiwan University College of Medicine, Taipei, Taiwan
Correspondence to: Prof Pan-Chyr Yang, National Taiwan University College of Medicine, No 1, Section 1, Ren-Ai Road, Taipei 100, Taiwan
-doi:10.1016/S0140-6736(12)62170-9
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
Original Text
Jin-Shing Chen MD a, Wing-Kai Chan MD d, Kung-Tsao Tsai MD e, Hsao-Hsun Hsu MD a, Chien-Yu Lin MS f, Ang Yuan MD b, Prof Wen-Jone Chen MD c, Prof Hong-Shiee Lai MD a, Prof Pan-Chyr Yang MD g
Summary
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.
Funding
Department of Health and National Science Council, Taiwan.
a Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; b Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; c Department of Emergency Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; d Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan; e Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan; f Institute of Statistical Science, Academia Sinica, and Microarray Core Facility, Center for Genomic Medicine, National Taiwan University, Taipei, Taiwan; g National Taiwan University College of Medicine, Taipei, Taiwan
Correspondence to: Prof Pan-Chyr Yang, National Taiwan University College of Medicine, No 1, Section 1, Ren-Ai Road, Taipei 100, Taiwan
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