吸入性糖皮质激素对慢性阻塞性肺疾病的长期影响：一项荟萃分析。
Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis.
作者信息
van Grunsven P M, van Schayck C P, Derenne J P, Kerstjens H A, Renkema T E, Postma D S, Similowski T, Akkermans R P, Pasker-de Jong P C, Dekhuijzen P N, van Herwaarden C L, van Weel C
机构信息
Department of General Practice and Social Medicine, University of Nijmegen, The Netherlands.
出版信息
Thorax. 1999 Jan;54(1):7-14. doi: 10.1136/thx.54.1.7.
BACKGROUND
The role of inhaled corticosteroids in the long term management of chronic obstructive pulmonary disease (COPD) is still unclear. A meta-analysis of the original data sets of the randomised controlled trials published thus far was therefore performed. The main question was: "Are inhaled corticosteroids able to slow down the decline in lung function (FEV1) in COPD?"
METHODS
A Medline search of papers published between 1983 and 1996 was performed and three studies were selected, two of which were published in full and one in abstract form. Patients with "asthmatic features" were excluded from the original data. Ninety five of the original 140 patients treated with inhaled corticosteroids (81 with 1500 micrograms beclomethasone daily, six with 1600 micrograms budesonide daily, and eight with 800 micrograms beclomethasone daily) and 88 patients treated with placebo (of the initial 144 patients) were included in the analysis. The effect on FEV1 was assessed by a multiple repeated measurement technique in which points of time in the study and treatment effects (inhaled corticosteroids compared with placebo) were investigated.
RESULTS
No baseline differences were observed (mean age 61 years, mean FEV1 45% predicted). The estimated two year difference in prebronchodilator FEV1 was +0.034 l/year (95% confidence interval (CI) 0.005 to 0.063) in the inhaled corticosteroid group compared with placebo. The postbronchodilator FEV1 showed a difference of +0.039 l/year (95% CI -0.006 to 0.084). No beneficial effect was observed on the exacerbation rate. Worsening of the disease was the reason for drop out in four patients in the treatment group compared with nine in the placebo group. In the treatment group six of the 95 subjects dropped out because of an adverse effect which may have been related to the treatment compared with two of the 88 patients in the placebo group.
CONCLUSIONS
This meta-analysis in patients with clearly defined moderately severe COPD showed a beneficial course of FEV1 during two years of treatment with relatively high daily dosages of inhaled corticosteroids.
背景
吸入性糖皮质激素在慢性阻塞性肺疾病（COPD）长期管理中的作用仍不明确。因此，对迄今为止发表的随机对照试验的原始数据集进行了一项荟萃分析。主要问题是：“吸入性糖皮质激素能否减缓COPD患者肺功能（FEV1）的下降？”
方法
对1983年至1996年间发表的论文进行了Medline检索，选择了三项研究，其中两项全文发表，一项以摘要形式发表。原始数据中排除了具有“哮喘特征”的患者。分析纳入了最初接受吸入性糖皮质激素治疗的140例患者中的95例（81例每日使用1500微克倍氯米松，6例每日使用1600微克布地奈德，8例每日使用800微克倍氯米松）以及最初接受安慰剂治疗的144例患者中的88例。通过多重重复测量技术评估对FEV1的影响，该技术研究了研究中的时间点和治疗效果（吸入性糖皮质激素与安慰剂对比）。
结果
未观察到基线差异（平均年龄61岁，平均FEV1为预测值的45%）。与安慰剂相比，吸入性糖皮质激素组支气管扩张剂使用前FEV1的两年估计差异为+0.034升/年（95%置信区间（CI）0.005至0.063）。支气管扩张剂使用后FEV1的差异为+0.039升/年（95%CI -0.006至0.084）。未观察到对急性加重率的有益影响。治疗组有4例患者因疾病恶化退出，而安慰剂组有9例。治疗组95名受试者中有6例因可能与治疗相关的不良反应退出，而安慰剂组88例患者中有2例。
结论
这项针对明确界定的中度重度COPD患者的荟萃分析表明，在使用相对高剂量每日吸入性糖皮质激素治疗的两年期间，FEV1呈有益的病程。
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