Inhaled budesonide in pulmonary sarcoidosis: a double-blind, placebo-controlled study. Dutch Study Group on Pulmonary Sarcoidosis.
Inhaled budesonide in pulmonary sarcoidosis: a double-blind, placebo-controlled study. Dutch Study Group on Pulmonary Sarcoidosis.
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吸入布地奈德治疗肺结节病：一项双盲、安慰剂对照研究。
DOI：
10.1183/09031936.95.08050682
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发表时间：
1995
期刊：
影响因子：
--
通讯作者：
HM Jansen
中科院分区：
文献类型：
--
作者：
C. Alberts;T. van der Mark;HM Jansen
在一项双盲、安慰剂对照研究中，我们评估了吸入布地奈德对新诊断的肺结节病的疗效，以及布地奈德治疗是否可以推迟口服皮质类固醇治疗。我们评估：1）症状; 2）胸部X线摄影; 3）血清血管紧张素转换酶（ACE）; 4）肺功能。纳入组织学确诊的肺结节病患者，胸部X线片I、II或III期，肺功能异常（吸气肺活量（IVC）< 79%预测值或肺一氧化碳转移因子（TL、CO）< 77%预测值）。当支气管肺泡灌洗液（BALF）中淋巴细胞占总细胞总数的20%以上时，纳入放射学II或III期但肺功能正常的患者。47例患者通过Nebuhaler接受安慰剂或布地奈德（1.2 mg）每日一次治疗6个月，随后6个月不接受治疗。根据预先确定的标准，在盲法治疗期间排除了11名患者，因为他们需要口服泼尼松：安慰剂组7名（28%）患者（n = 25）和布地奈德组4名（18%）患者（n = 22）。患者的总体临床印象（GCI）评分显示，布地奈德组有显著性差异。在活性治疗期间，两组之间的IVC显示出7.9%的显著差异。这种差异在随访期间持续存在，当差异为9.4%时，TL，CO随时间推移几乎保持不变，组间无差异。两组胸部影像学表现的改善和血清ACE的变化相似。（250字处删节）
In a double-blind, placebo-controlled study, we assessed the efficacy of inhaled budesonide on the course of newly diagnosed pulmonary sarcoidosis and whether budesonide treatment could postpone oral corticosteroid treatment. We evaluated: 1) symptoms; 2) chest radiography; 3) angiotensin-converting enzyme (ACE) in serum; and 4) lung function. Patients with histologically confirmed pulmonary sarcoidosis with chest radiographic stages I, II or III, and with an abnormal lung function (inspiratory vital capacity (IVC) < 79% of predicted or transfer factor of the lungs for carbon monoxide (TL,CO) < 77% pred) were included. Patients with radiographic stage II or III but with normal lung function were included when more than 20% of the total cell population in bronchoalveolar lavage fluid (BALF) was lymphocytes. Forty seven patients received placebo or budesonide (1.2 mg) once daily via a Nebuhaler for 6 months, followed by 6 months without treatment. Based on predetermined criteria, 11 patients were excluded during the blind treatment period as they needed oral prednisone: seven (28%) patients in the placebo group (n = 25) and four (18%) patients in the budesonide group (n = 22). Patient's Global Clinical Impression (GCI) score showed a significant difference in favour of budesonide. IVC showed a significant difference of 7.9% predicted between the two groups during the active treatment period. This difference persisted during follow-up, when the difference was 9.4% pred. TL,CO remained nearly unchanged over time, with no difference between the groups. Improvements in chest radiographic appearance and changes in serum ACE were similar for the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)