Corticosteroids for pulmonary sarcoidosis

 

Abstract

Background

Pulmonary sarcoidosis is a common condition with an unpredictable course. Oral (OCS) or inhaled steroids (ICS) 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.

Objectives

To determine the randomised controlled trial (RCT) evidence for the benefit of corticosteroids (oral or inhaled) in the treatment of pulmonary sarcoidosis.

Search methods

CENTRAL, MEDLINE, and EMBASE were searched using predefined terms. 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 Pharmaceutical companies and authors of identified RCTs were contacted for other published and unpublished studies. Searches are current as of May 2008.

Selection criteria

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, treated with OCS (oral steroids) or ICS (oral steroids), compared with a control.

Data collection and analysis

Study quality was assessed and data extracted independently by two reviewers. The primary outcome was CXR (chest x-ray). Outcomes were analysed as continuous and dichotomous outcomes, using standard statistical techniques. Heterogeneity was explored where it was identified.

Main results

Thirteen RCTs of variable quality involving 1066 participants met the inclusion criteria of the review. The oral steroid dose was equivalent to prednisolone 4-40 mg/day. OCS: there was an improvement in CXR over 3-24 months (Relative Risk (RR): 1.46 [1.01 to 2.09], 3 studies), but this finding requires cautious interpretation. No other significant differences were identified on secondary outcomes. ICS: Data were inadequate to perform meaningful analysis of data on CXR. Two studies showed no improvement in lung function, In one study there was an improvement in diffusing capacity in the treated group. There were no data on side-effects. In one study symptoms improved at the end of six months of treatment.

Authors' conclusions

Oral steroids improved the chest X-ray and a global score of CXR, symptoms and spirometry over 3-24 months. However, there is little evidence of an improvement in lung function. There are limited data beyond two years to indicate whether oral steroids have any modifying effect on long-term disease progression. Oral steroids may be of benefit for patients with Stage 2 and 3 disease with moderate to severe or progressive symptoms or CXR changes.

 

Plain language summary

Corticosteroids for pulmonary sarcoidosis

Sarcoidosis is a common disease that can affect several parts of the body. The cause of the disease is unknown, and it often gets better without treatment. Sarcoidosis is more likely among some ethnic groups (including African-Americans and African-Caribbeans), for whom the disease has worse outcomes. When sarcoidosis affects the lungs, it can cause breathlessness, coughs, and lung problems, and lead to more complications and death. The review of trials found that using corticosteroids for lung sarcoidosis leads to some short-term benefit in terms of chest x-ray, but there is limited evidence that this benefit lasts or affects the long term outcomes of the disease.

 

摘要

背景

皮質類固醇對肺部類肉瘤病的效益

肺部類肉瘤病是一種無法預測的常見的狀況。口服(OCS)，或吸入式類固醇(ICS)廣泛應用於治療肺部類肉瘤病，但對何時和何種病患開始使用類固醇治療、多少劑量使用多久時間則沒有共識。使用皮質類固醇長達數個月會產生有害的副作用，所以知道對肺部類肉瘤病是否有益是很重要的。

目標

要確定隨機對照試驗(RCT)對皮質類固醇(口服或吸入)治療肺部類肉瘤病效益的證據。

搜尋策略

使用預先定義好的字詞檢索CETRNAL，MEDLINE和EMBASE。檢索到的RCTs和審查書目被檢索以找到額外的RCTs。聯繫了被確認的RCTs所屬製藥公司和作者以獲得其他發表和未發表的研究。檢索於2006年5月進行。

選擇標準

兩名審查員獨立的評估全文文章以確認收案標準為基於下列條件：該項研究是針對有組織學證據的肺部類肉瘤病成人病患的RCT或臨床對照試驗，且以OCS(口服類固醇)或ICS(吸入式類固醇)治療並與對照組比較。

資料收集與分析

兩個審查員獨立的針對研究品質進行評估並分析數據。主要的結果是CXR(胸部X光)。將結果以連續性及二分法表示，並使用標準的統計技術分析。經確認後，發現以兩種數據分析出的結果是相異的。

主要結論

共有13個總共包含了1066名受試者的品質不等的RCTs符合此次審查的收案標準。口服類固醇的劑量相當於使用prednisolon 4 – 40毫克/天。 OCS：使用超過 3 – 24個月後，CXR出現了改善的現象(相對危險度(RR)：1.46 [1.01至2.09]，3個研究)，但這一發現需要謹慎的解讀。次要結果中沒有顯著性的差異是被確定的。ICS：數據不足，無法進行有意義的CXR數據分析。有兩個研究顯示，肺功能沒有任何改善，在一個研究中，治療組出現了擴散能力的改善。沒有關於副作用的資料。在一個研究，於6個月的治療結束時，症狀有明顯改善。

作者結論

在口服類固醇使用3 – 24個月後，胸部X光和CXR的全球分數、症狀和肺功能量計有獲得改善。然而，僅有很少的證據顯示有改善肺功能的效果。只有有限的超過兩年以上的試驗數據指出口服類固醇對於長期疾病的進程會有影響。口服類固醇可能對中度至嚴重或進展性症狀或CXR變化的第2階段和第3病程病人有益。

翻譯人

本摘要由臺北醫學大學萬芳醫院劉怡敏翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

類肉瘤病是一種常見的疾病且會影響身體的許多部位造成影響。該疾病的成因不明，而且沒有治療時，往往會對症狀有改善。類肉瘤病好發於一些民族中(包括非洲裔和非洲加勒比人)發生，對他們來說，疾病會導致更形惡化的結果。當類肉瘤病感染肺部時，會導致呼吸困難、咳嗽和肺部問題，並導致更多的併發症和死亡。在試驗的審查時發現，使用皮質類固醇治療肺部類肉瘤病對會胸部X光有一些短期的效果，但僅有有限的證據顯示這種益處持續或長期的影響疾病的結果。