Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Lancet. 2013 Apr 13;381(9874):1277-82. doi: 10.1016/S0140-6736(12)62170-9. Epub 2013 Mar 12.
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.
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).
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.
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.
Department of Health and National Science Council, Taiwan.
单纯抽吸引流是原发性自发性气胸的标准初始治疗方法，但气胸复发率仍然较高。我们研究了单纯抽吸引流后加用米诺环素胸膜固定术是否能降低复发率。
本研究在台湾的两家医院开展了一项开放性标签、平行组、前瞻性、随机对照临床试验，纳入年龄在 15-40 岁之间、胸部 X 线片上气胸边缘大于 2cm、猪尾导管引流后完全肺复张且无漏气、血液学功能正常、肝肾功能正常的首次发作的原发性自发性气胸患者。患者在单纯抽吸引流后通过猪尾导管随机（1:1）分配至米诺环素胸膜固定术组或不进行进一步治疗（对照组）。随机分组通过密封信封中的计算机生成的随机数字进行。主要终点为 1 年时气胸复发率。本试验在 ClinicalTrials.gov 注册（NCT00418392）。
2006 年 12 月 31 日至 2012 年 6 月 30 日，共有 214 名患者被随机分配至米诺环素组（106 名）和对照组（108 名）（意向治疗人群）。在随机分组后 7 天内，米诺环素组有 14 名患者和对照组有 20 名患者治疗失败。在 1 年时，米诺环素组有 31 名（29.2%）患者气胸复发，对照组有 53 名（49.1%）患者气胸复发（p=0.003）。两组均未出现与操作相关的并发症。
与单纯抽吸引流相比，单纯抽吸引流后加用米诺环素胸膜固定术是一种治疗原发性自发性气胸的安全且更有效的方法。米诺环素胸膜固定术应作为原发性自发性气胸标准治疗的辅助手段。
台湾卫生福利部和国家科学委员会。
