JAMA:短期使用泼尼松可治疗COPD加重者

2013-06-06 青楚 医学论坛网

  瑞士和英国学者的一项联合研究表明,对于因慢性阻塞性肺疾病(COPD)急性加重而就诊于急诊的患者,在180天随访期内疾病再次加重方面,全身糖皮质激素治疗5天的效果不亚于治疗14天,且显著减少体内糖皮质激素累积量。相关论文2013年5月21日在线发表于《美国医学会杂志》(JAMA)。   该临床研究在2006年3月到2011年2月期间随机纳入瑞士5所医院既往或现在吸烟(每年≥20包) 

  瑞士和英国学者的一项联合研究表明,对于因慢性阻塞性肺疾病(COPD)急性加重而就诊于急诊的患者,在180天随访期内疾病再次加重方面,全身糖皮质激素治疗5天的效果不亚于治疗14天,且显著减少体内糖皮质激素累积量。相关论文2013年5月21日在线发表于《美国医学会杂志》(JAMA)。

  该临床研究在2006年3月到2011年2月期间随机纳入瑞士5所医院既往或现在吸烟(每年≥20包)  的COPD急性加重且没有哮喘史的患者314例,随机分入泼尼松(40 mg/d)治疗5天组和14天组。

  结果显示,5天组和14天组患者中,180天内病情再次加重率在分别为37.2%和38.4%。两组中出现病情再次加重者,两次病情加重的平均间隔时间分别为43.5天和29天。两组间在至死亡时间、病情加重复合终点、死亡和肺功能恢复方面无显著差异。14天组泼尼松平均累积剂量(793 mg)显著高于5天组(379 mg)。

Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial.
IMPORTANCE
International guidelines advocate a 7- to 14-day course of systemic glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease (COPD). However, the optimal dose and duration are unknown.
OBJECTIVE
To investigate whether a short-term (5 days) systemic glucocorticoid treatment in patients with COPD exacerbation is noninferior to conventional (14 days) treatment in clinical outcome and whether it decreases the exposure to steroids. DESIGN, SETTING, AND PATIENTS REDUCE: (Reduction in the Use of Corticosteroids in Exacerbated COPD), a randomized, noninferiority multicenter trial in 5 Swiss teaching hospitals, enrolling 314 patients presenting to the emergency department with acute COPD exacerbation, past or present smokers (≥20 pack-years) without a history of asthma, from March 2006 through February 2011.
INTERVENTIONS
Treatment with 40 mg of prednisone daily for either 5 or 14 days in a placebo-controlled, double-blind fashion. The predefined noninferiority criterion was an absolute increase in exacerbations of at most 15%, translating to a critical hazard ratio of 1.515 for a reference event rate of 50%. MAIN OUTCOME AND MEASURE: Time to next exacerbation within 180 days.
RESULTS
Of 314 randomized patients, 289 (92%) of whom were admitted to the hospital, 311 were included in the intention-to-treat analysis and 296 in the per-protocol analysis. Hazard ratios for the short-term vs conventional treatment group were 0.95 (90% CI, 0.70 to 1.29; P = .006 for noninferiority) in the intention-to-treat analysis and 0.93 (90% CI, 0.68 to 1.26; P = .005 for noninferiority) in the per-protocol analysis, meeting our noninferiority criterion. In the short-term group, 56 patients (35.9%) reached the primary end point; 57 (36.8%) in the conventional group. Estimates of reexacerbation rates within 180 days were 37.2% (95% CI, 29.5% to 44.9%) in the short-term; 38.4% (95% CI, 30.6% to 46.3%) in the conventional, with a difference of -1.2% (95% CI, -12.2% to 9.8%) between the short-term and the conventional. Among patients with a reexacerbation, the median time to event was 43.5 days (interquartile range [IQR], 13 to 118) in the short-term and 29 days (IQR, 16 to 85) in the conventional. There was no difference between groups in time to death, the combined end point of exacerbation, death, or both and recovery of lung function. In the conventional group, mean cumulative prednisone dose was significantly higher (793 mg [95% CI, 710 to 876 mg] vs 379 mg [95% CI, 311 to 446 mg], P < .001), but treatment-associated adverse reactions, including hyperglycemia and hypertension, did not occur more frequently.
CONCLUSIONS AND RELEVANCE
In patients presenting to the emergency department with acute exacerbations of COPD, 5-day treatment with systemic glucocorticoids was noninferior to 14-day treatment with regard to reexacerbation within 6 months of follow-up but significantly reduced glucocorticoid exposure. These findings support the use of a 5-day glucocorticoid treatment in acute exacerbations of COPD.

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