Erbland M L, Deupree R H, Niewoehner D E
Department of Medicine, Veterans Affairs Medical Center and University of Arkansas, Little Rock, USA.
Control Clin Trials. 1998 Aug;19(4):404-17. doi: 10.1016/s0197-2456(98)00011-7.
The Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations Trial (SCCOPE) was a randomized, double-blind, placebo-controlled, multicenter trial sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program. Its principal purpose was to determine whether withholding systemic corticosteroids in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD) who were treated with other usual therapy resulted in a clinically significant increase in the rate of treatment failure. Because placebo was compared to a standard therapy, the study was designed as an equivalence trial. If corticosteroids proved effective, the study would also determine whether a short course was as effective as a long one. SCCOPE was to enroll up to 1100 subjects from more than 20 Veterans Administration Medical Centers over 3 years. Patients were screened shortly after hospital admission for acute exacerbation of COPD. Principal criteria for eligibility were age of 50 years or older, smoking history of 30 pack-years or more, clinical diagnosis of COPD as opposed to asthma, nonuse of systemic corticosteroids in the previous 30 days, and forced expiratory volume in 1 sec (FEV1) of 1500 ml or less. Eligible subjects were randomized to one of three treatment arms: (1) short course (2 weeks) of systemic corticosteroids, (2) long course (8 weeks) of systemic corticosteroids, or (3) placebo. We standardized most other aspects of care. We followed patients for 6 months. The primary endpoint of the study was treatment failure, defined as death, intubation with mechanical ventilation, hospital readmission for COPD, or intensification of pharmacologic therapy. Secondary endpoints included length of hospital stay, changes in FEV1, and changes in dyspnea score. We also evaluated possible adverse effects from systemic corticosteroids.
慢性阻塞性肺疾病急性加重期全身用糖皮质激素试验（SCCOPE）是一项由美国退伍军人事务部合作研究项目赞助的随机、双盲、安慰剂对照、多中心试验。其主要目的是确定，对于因慢性阻塞性肺疾病（COPD）急性加重而住院且接受其他常规治疗的患者，不给予全身用糖皮质激素是否会导致治疗失败率在临床上显著增加。由于将安慰剂与标准治疗进行比较，该研究被设计为等效性试验。如果糖皮质激素被证明有效，该研究还将确定短疗程是否与长疗程一样有效。SCCOPE计划在3年内从20多个退伍军人管理局医疗中心招募多达1100名受试者。患者在因COPD急性加重入院后不久接受筛查。入选的主要标准为年龄50岁及以上、吸烟史30包年及以上、临床诊断为COPD而非哮喘、在过去30天内未使用全身用糖皮质激素、第1秒用力呼气量（FEV1）为1500 ml或更低。符合条件的受试者被随机分配到三个治疗组之一：（1）全身用糖皮质激素短疗程（2周），（2）全身用糖皮质激素长疗程（8周），或（3）安慰剂。我们对护理的大多数其他方面进行了标准化。我们对患者进行了6个月的随访。该研究的主要终点是治疗失败，定义为死亡、机械通气插管、因COPD再次住院或强化药物治疗。次要终点包括住院时间、FEV1的变化和呼吸困难评分的变化。我们还评估了全身用糖皮质激素可能产生的不良反应。
