Paramothayan N S, Jones P W
Division of Physiological Medicine, St George's Hospital Medical School, Cranmer Terrace, London, UK, SW17 0RE.
Cochrane Database Syst Rev. 2000(4):CD001114. doi: 10.1002/14651858.CD001114.
Pulmonary sarcoidosis is a common condition with an unpredictable course. Oral or inhaled steroids are widely used in its treatment, but there is no consensus about when and in whom therapy should be initiated, what dose should be given and for how long. Corticosteroids given for several months have deleterious side-effects so it is important to know whether they have any maintained benefit in pulmonary sarcoidosis.
To determine the randomised controlled trial (RCT) evidence for the benefit of corticosteroids (oral or inhaled) in the treatment of pulmonary sarcoidosis.
The Cochrane Airways Group interstitial lung disease RCT register was searched using the terms: sarcoidosis and (steroid* OR corticosteroid* OR prednisolone OR prednisone OR beclomethasone OR budesonide OR fluticasone). Bibliographies of retrieved RCTs and reviews were searched for additional RCTs. Pharmaceutical companies and authors of identified RCTs were contacted for other published and unpublished studies.
Two reviewers independently assessed full text articles for inclusion based upon the following criteria: the study had to be a RCT or controlled clinical trial in adults with histological evidence of pulmonary sarcoidosis.
Study quality was assessed and data extracted independently by two reviewers. Outcomes were analysed as continuous and dichotomous outcomes, using standard statistical techniques.
Nine RCTs were identified, two had insufficient data for any analysis. There were 516 patients in the five usable trials of oral steroids, and 66 patients in two trials of inhaled steroids. The oral steroid dose was equivalent to prednisolone 15-40 mg/day. The inhaled steroid was budesonide 0.8 - 1.2 mg/day. Outcomes were symptoms, chest X-ray (CXR) changes, lung function and global scores (a combination of all three outcomes). Oral steroids improved the CXR over 6-24 months. Two studies showed no improvement in lung function, in another there was an improvement in diffusing capacity in the treated group. Global scores improved in patients with Stage 2 and 3 disease but not with Stage 1 disease. There were no data on side-effects. Inhaled steroids had no effect on CXR. In one study diffusing capacity improved. In another, symptoms improved at the end of six months of treatment.
REVIEWER'S CONCLUSIONS: Oral steroids improved the chest X-ray and a global score of CXR, symptoms and spirometry over 6-24 months., but there is little evidence of an improvement in lung function. There are no data beyond two years to indicate whether oral steroids have any modifying effect on long-term disease progression. Oral steroids are indicated for patients with Stage 2 and 3 disease with moderate - severe or progressive symptoms or CXR changes. The available data provide no guidance for the management of this disease after two years. Short term (less than six months) of inhaled steroids may improved symptoms, perhaps in patients who mainly have cough.
肺结节病是一种常见疾病，病程难以预测。口服或吸入类固醇广泛用于其治疗，但对于何时以及对何人开始治疗、给予何种剂量以及治疗多长时间尚无共识。给予数月的皮质类固醇有有害的副作用，因此了解它们在肺结节病中是否有持续的益处很重要。
确定皮质类固醇（口服或吸入）治疗肺结节病益处的随机对照试验（RCT）证据。
使用以下术语检索Cochrane气道组间质性肺病RCT登记册：结节病和（类固醇或皮质类固醇或泼尼松龙或泼尼松或倍氯米松或布地奈德或氟替卡松）。检索检索到的RCT和综述的参考文献以获取其他RCT。联系已识别RCT的制药公司和作者以获取其他已发表和未发表的研究。
两位审阅者根据以下标准独立评估全文文章是否纳入：该研究必须是针对有肺结节病组织学证据的成年人的RCT或对照临床试验。
由两位审阅者独立评估研究质量并提取数据。使用标准统计技术将结果分析为连续和二分结果。
确定了9项RCT，其中2项数据不足无法进行任何分析。口服类固醇的5项可用试验中有516名患者，吸入类固醇的2项试验中有66名患者。口服类固醇剂量相当于泼尼松龙15 - 40毫克/天。吸入类固醇为布地奈德0.8 - 1.2毫克/天。结果包括症状、胸部X线（CXR）变化、肺功能和综合评分（所有三项结果的组合）。口服类固醇在6 - 24个月内改善了CXR。两项研究显示肺功能无改善，另一项研究中治疗组的弥散能力有所改善。2期和3期疾病患者的综合评分有所改善，但1期疾病患者没有。没有关于副作用的数据。吸入类固醇对CXR没有影响。在一项研究中弥散能力有所改善。在另一项研究中，治疗6个月结束时症状有所改善。
口服类固醇在6 - 24个月内改善了胸部X线和CXR、症状及肺活量测定的综合评分，但几乎没有证据表明肺功能有所改善。没有超过两年的数据表明口服类固醇对长期疾病进展是否有任何调节作用。口服类固醇适用于有中度 - 重度或进行性症状或CXR改变的2期和3期疾病患者。现有数据对两年后该疾病的管理没有提供指导。短期（少于6个月）吸入类固醇可能改善症状，可能适用于主要有咳嗽症状的患者。
