随机、双盲、安慰剂对照研究评价福莫特罗在急性哮喘控制中的作用
2007/08/01
研究的目的是评价急诊室采用胶囊吸入器(Aerolizer)吸入福莫特罗(formoterol)治疗哮喘急性发作的有效性和耐受性。因哮喘急性发作入院的患者进行单中心、双盲、随机、安慰剂对照、平行分组研究。患者被随机分为以下两组：
1、舒喘灵(salbutamol)组，剂量为600mg，将刻度吸入器置入间隔设备，分两喷给药，间隔20m分钟；
2、福莫特罗组，剂量为24mg，以两粒胶囊，每粒含12mg福莫特罗干粉，通过Aerolizer给药，间隔20m分钟。给药前（基础状态）和第2次以及第3次给药后5分钟测定最大呼气流速（peak expiratory flow rate ，PEFR）。共60例患者完成研究，其中舒喘灵组28例，福莫特罗组32例。两组间年龄、性别、基础PEFR、哮喘患者和以前的用药情况给予平衡处理。两组的给药后PEFR较基础状态均有显著升高（舒喘灵组63%，p = 0.001；福莫特罗组55%，p = 0.001），升高的程度在两组间无显著性差异(p = 0.99)，副作用的发生率相似。
作者认为在处理哮喘急性发作中患者对福莫特罗有很好的耐受性，和舒喘灵的疗效相当，然而需要进一步随访研究以比较离开急诊室后福莫特罗长期疗效的稳定性。
1、舒喘灵(salbutamol)组，剂量为600mg，将刻度吸入器置入间隔设备，分两喷给药，间隔20m分钟；
2、福莫特罗组，剂量为24mg，以两粒胶囊，每粒含12mg福莫特罗干粉，通过Aerolizer给药，间隔20m分钟。给药前（基础状态）和第2次以及第3次给药后5分钟测定最大呼气流速（peak expiratory flow rate ，PEFR）。共60例患者完成研究，其中舒喘灵组28例，福莫特罗组32例。两组间年龄、性别、基础PEFR、哮喘患者和以前的用药情况给予平衡处理。两组的给药后PEFR较基础状态均有显著升高（舒喘灵组63%，p = 0.001；福莫特罗组55%，p = 0.001），升高的程度在两组间无显著性差异(p = 0.99)，副作用的发生率相似。
作者认为在处理哮喘急性发作中患者对福莫特罗有很好的耐受性，和舒喘灵的疗效相当，然而需要进一步随访研究以比较离开急诊室后福莫特罗长期疗效的稳定性。
（韩福军 广州医学院第一附属医院 广州呼吸疾病研究所 510120 摘译）
(Emerg Med J. 2007 ;24:317-321)
Najafizadeh K, Sohrab Pour H, Ghadyanee M, Shiehmorteza M, Jamali M, Majdzadeh S.
A randomised, double-blind, placebo-controlled study to evaluate the role of formoterol in the management of acute asthma.
Emerg Med J. 2007 May;24(5):317-21.
A randomised, double-blind, placebo-controlled study to evaluate the role of formoterol in the management of acute asthma.
Emerg Med J. 2007 May;24(5):317-21.
AIM: To evaluate the efficacy and tolerability of formoterol delivered by Aerolizer in the emergency department.
METHODS: A single-centre, double-blind, randomised, placebo-controlled, parallel group study was conducted in patients seeking emergent care for an acute exacerbation of asthma. Patients were randomly assigned to one of two groups: group 1 (salbutamol), receiving a total dose of 600 microg salbutamol (200+200+200) delivered by a meter-dose inhaler into a spacer device as two puffs at 20 min intervals; and group 2 (formoterol), receiving formoterol 24 microg (12+12) as two dry powder capsules each containing 12 microg of formoterol via Aerolizer at 20 min intervals. The peak expiratory flow rate (PEFR) was measured at baseline and 5 min after the second and third doses.
RESULTS: 60 subjects receiving salbutamol (n = 28) or formoterol (n = 32) completed the study. Age, gender, baseline PEFR, duration of asthma and previous medication were balanced between the two groups. Mean PEFR increased significantly over baseline values in both the salbutamol and formoterol groups (63% in the salbutamol group, p = 0.001, and 55% in the formoterol group, p = 0.001). No significant difference was observed in the increase in PEFR between the groups (p = 0.99, 95% CI -29.62 to 29.59). The proportion of patients reporting adverse events was similar in the two groups.
CONCLUSION: Formoterol was found to be well tolerated and as effective as salbutamol in the management of acute asthma. Further studies are needed to follow the patients after discharge from the emergency room to compare the long-term effect of formoterol on patients’ stability.
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