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曲安奈德肌肉注射与泼尼松口服门诊治疗急性哮喘的比较:一项随机对照试验

Comparison of intramuscular triamcinolone and oral prednisone in the outpatient treatment of acute asthma: a randomized controlled trial.

作者信息

Schuckman H, DeJulius D P, Blanda M, Gerson L W, DeJulius A J, Rajaratnam M

机构信息

Department of Emergency Medicine, Summa Health System, Akron, OH 44304, USA.

出版信息

Ann Emerg Med. 1998 Mar;31(3):333-8. doi: 10.1016/s0196-0644(98)70343-9.

Abstract

STUDY OBJECTIVE

To determine whether a one-time dose of triamcinolone diacetate, 40 mg intramuscular (i.m.), given to adult patients treated in the emergency department for mild to moderate exacerbation of asthma would decrease the rate of relapse during the following week, compared with a nontapering course of oral prednisone, 40 mg/day over 5 days.

METHODS

A randomized, double-blind, controlled clinical trial was conducted at two university-affiliated community teaching hospitals with a combined annual census of 97,000. Patients were eligible if they were between the ages of 18 and 50 years, had an initial peak expiratory flow rate of less than 350 L/minute, and were to be discharged from the ED taking steroids. Patients were randomly assigned to receive either triamcinolone (40 mg i.m.) and placebo tablets or a placebo injection and prednisone (40 mg/day orally for 5 days). Patients were instructed to use a beta-agonist metered-dose inhaler, to continue other routine medications, to complete symptom diary cards, and to return in 7 to 10 days for follow-up. The main outcome measure was relapse, which was defined as an unscheduled visit to a physician's office or ED for worsening or persistent symptoms within 7 days of the initial ED visit.

RESULTS

A total of 168 patients were initially enrolled; 6 patients were withdrawn for protocol violations and 8 because they could not be contacted for follow-up. A total of 154 patients were available for outcome analysis, 78 in the triamcinolone group and 76 in the prednisone group. There were no differences between the two patient groups with regard to demographics, smoking history, weight, or symptom severity. Mean initial peak flows were 244+/-64 L/minute for the triamcinolone group and 245+/-83 L/minute for the prednisone group. Fifty percent of the study patients were current smokers. The relapse rates were 9.0% (7/78) in the triamcinolone group and 14.5% (11/76) in the prednisone group (P=.29). The absolute difference in relapse rates was 5.5% (95% confidence interval [CI], 4.6% to 15.6%). There was no difference in symptom frequency or severity between the two groups during the first 5 days of outpatient treatment. Analysis between the groups stratified for smoking showed no difference in relapse rate between smokers and nonsmokers.

CONCLUSION

A single dose of triamcinolone diacetate, 40 mg i.m., produced a relapse rate similar to that of prednisone, 40 mg/day orally for 5 days, after ED treatment of mild to moderate exacerbations of asthma. Intramuscular triamcinolone would appear to be an attractive alternative when compliance with a daily oral regimen is of concern.

摘要

研究目的

确定对于在急诊科接受治疗的轻至中度哮喘加重的成年患者,给予一次40毫克醋酸曲安奈德肌肉注射,与连续5天每天口服40毫克泼尼松且不逐渐减量的疗程相比,是否会降低接下来一周内的复发率。

方法

在两家大学附属社区教学医院进行了一项随机、双盲、对照临床试验,两家医院的年普查人数共计97,000人。年龄在18至50岁之间、初始呼气峰值流速低于350升/分钟且将出院并服用类固醇药物的患者符合入选条件。患者被随机分配接受曲安奈德(40毫克肌肉注射)和安慰剂片,或安慰剂注射和泼尼松(每天口服40毫克,共5天)。指导患者使用β受体激动剂定量吸入器,继续服用其他常规药物,填写症状日记卡,并在7至10天后来院进行随访。主要结局指标为复发,定义为在首次急诊科就诊后7天内因症状恶化或持续而不定期前往医生办公室或急诊科就诊。

结果

最初共纳入168例患者;6例因违反方案退出,8例因无法联系到进行随访而退出。共有154例患者可进行结局分析,曲安奈德组78例,泼尼松组76例。两组患者在人口统计学、吸烟史、体重或症状严重程度方面无差异。曲安奈德组的平均初始峰值流速为244±64升/分钟,泼尼松组为245±83升/分钟。50%的研究患者为当前吸烟者。曲安奈德组的复发率为9.0%(7/78),泼尼松组为14.5%(11/76)(P = 0.29)。复发率的绝对差异为5.5%(95%置信区间[CI],4.6%至15.6%)。在门诊治疗的前5天,两组之间的症状频率或严重程度无差异。按吸烟情况分层的组间分析显示,吸烟者和非吸烟者的复发率无差异。

结论

对于轻至中度哮喘加重患者在急诊科治疗后,一次40毫克肌肉注射醋酸曲安奈德产生的复发率与每天口服40毫克泼尼松共5天的复发率相似。当担心每日口服方案的依从性时,肌肉注射曲安奈德似乎是一个有吸引力的替代选择。

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