2011-11-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/658599摘要：原發型自發性氣胸病患第一次氣胸發作後，約有23-50%的病患會復發。第一次發作之最佳治療方式，目前仍有很大爭議。根據最近英國胸腔醫學會公布的治療指引，單純空氣抽除被認為是第一次發作病患的建議治療方式。但單純空氣抽除後一年內氣胸之復發機率高達25-30%，因此並不適合作為標準的治療。文獻顯示在肋膜腔內注射刺激性藥物造成肋膜沾粘〈化學式肋膜沾粘〉可以減少手術或非手術氣胸病患復發的機率，同時可以縮短漏氣的時間。Minocycline是四環黴素的衍生藥物，動物實驗顯示其效果和四環黴素類似，都能引發肋膜纖維化及沾粘。在本研究中，我們將探討第一次發作之原發型自發性氣胸病患接受空氣抽除後，追加Minocycline 肋膜沾粘之療效。試驗之主要目的為比較空氣抽除後追加Minocycline 肋膜沾粘是否可以減少氣胸發作之機率；試驗之次要目的則包含Minocycline 肋膜沾粘之安全性，短期結果，以及長期效果。為增加收案速度，這個試驗於國立台灣大學醫學院附設醫院、亞東醫院以及敏盛醫院進行，預計共邀請300 名受試者參加。前三年第一階段的研究共收案180 人，因為亞東及敏盛醫院收案人數太少且病患追蹤情況不佳，因此第二階段的研究(第四年)只於台大醫院收案。至第四年為止，共收案255 人。202 人進入隨機編組，並根據Intention to treat 方式進入分析。其中Minocycline組共有101 人，觀察組共有101 人。Minocycline 組有33 人復發或治療失敗(32.7%)，觀察組有49 人復發或治療失敗(48.5%)，p=0.031。初步成果顯示第一次發作之原發型自發性氣胸病患接受空氣抽除後，追加Minocycline 肋膜沾粘為一安全、方便之治療，並可減少日後氣胸復發之機率，同時不會影響長期肺功能。但因收案之病例數及時間尚不足，因此希望進行本延續計畫(第五年)以完成Minocycline 肋膜沾粘治療原發型自發性氣胸之臨床試驗。<br> Abstract: The estimated recurrence rate of primary spontaneous pneumothorax is23-50% after the first episode, and the optimal treatment remains unknown.In the recently published British Thoracic Society (BTS) guidelines, simpleaspiration is recommended as first line treatment for all primarypneumothoraces requiring intervention. However, the 1 year recurrence rateof this procedure was as high as 25-30%, making it inappropriate as astandard of care. Intrapleural instillation of a chemical irritant (chemicalpleurodesis) is an effective way to shorten the duration of air leaks andreduce the rates of recurrent spontaneous pneumothorax in surgical andnon-surgical patients. Minocycline, a derivative of tetracycline, is as effectiveas tetracycline in inducing pleural fibrosis in rabbits. In the previous studies,we have shown that additional minocycline pleurodesis is a safe andconvenient procedure to decrease the rates of ipsilateral recurrence afterthoracoscopic treatment of primary spontaneous pneumothorax. In thepresent study, additional minocycline pleurodesis will be randomlyadministered in patients with first episode of primary spontaneouspneumothorax after simple aspiration. The primary goal is to test ifintrapleural minocycline can reduce the rate of recurrence. The secondarygoals are to evaluate the safety profile, short-term results, and long-termeffects of minocycline pleurodesis after simple aspiration. The sites of studyincluded National Taiwan University Hospital (NTUH), Min-Sheng Hospitaland Far Eastern Memorial Hospital. A total of 300 patients will be includedfor this study. During the first three years, patient inclusion and follow-up isdifficult in Min-Sheng Hospital and Far Eastern Memorial Hospital. Therefore,we changed the study site at NTUH only since the 4th year. At the end of the4th year, 255 patients were included in this study. The mid-term analysis wasperformed using intention to treat (ITT) method. Among them, 202 patientswere randomized to undergo minocycline pleurodesis (101 patients) orobservation (101 patients). Pneumothorax recurrence or treatment failurewas noted in 33 patients (32.7%) in the minocycline group and in 49 patients(48.5%) in the observation group (p = 0.031). The initial results showed thatminocycline pleurodesis is a simple and effective therapy for first episodeprimary spontaneous pneumothorax patients undergoing simple aspiration.In addition, minocycline pleurodesis did not affect long-term pulmonaryfunction. Because the study duration of this clinical is 5-year and thefollow-up time is not sufficient, so we want to continue this trial for moreconvinced results.Minocycline肋膜沾粘原發型自發性氣胸primary spontaneous pneumothoraxminocycline pleurodesis