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口服孟鲁司特与口服齐留通治疗急性哮喘的比较:一项随机、双盲、安慰剂对照研究。

Comparison of oral montelukast with oral zileuton in acute asthma: A randomized, double-blind, placebo-controlled study.

作者信息

Magazine Rahul, Shahul Hameed Aboobackar, Chogtu Bharti, Kamath Asha

机构信息

Department of Pulmonary Medicine, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.

Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.

出版信息

Lung India. 2016 May-Jun;33(3):281-6. doi: 10.4103/0970-2113.180805.

Abstract

BACKGROUND

Leukotriene modifiers have an established role in the management of chronic asthma but their role in acute asthma is still under evaluation.

OBJECTIVE

To study and compare the effects of oral montelukast with oral zileuton in acute asthma.

MATERIALS AND METHODS

This study included 120 asthmatics and was conducted from September 2012 to March 2014. Patients were randomized into three different groups to receive montelukast or zileuton or placebo in addition to standard treatment for asthma exacerbation. Peak expiratory flow rate (PEFR) values, details of rescue medication and vital signs were recorded at 6 h, 12 h, 24 h, and 48 h of drug or placebo administration and at discharge. Additional recording was done in the morning (8-10 am) following admission. The primary endpoint was the mean PEFR of each group at these time points; the secondary end point being the need for rescue medications.

RESULTS

The mean PEFR recordings of the three study groups - placebo, montelukast, and zileuton - respectively, at various time points were as follows: at 6 h (223.25 ± 90.40, 199.00 ± 82.52, 233.75 ± 84.05; P = 0.240); at 12 h (271.00 ± 109.38, 251.50 ± 101.44, 309.50 ± 129.63; P = 0.048); at 24 h (288.25 ± 114.26, 269.00 ± 107.51, 324.50 ± 127.88; P = 0.080); and at 48 h (295.00 ± 114.80, 293.50 ± 113.24, 344.75 ± 119.91; P = 0.015); discharge (305.00 ± 118.56, 305.25 ± 119.51, 361.25 ± 119.70; P = 0.010). The mean PEFR for the three study groups at 8-10 am on the morning following admission was 268.75 ± 111.43, 252.50 ± 99.99, 306.75 ± 114.44; P = 0.047. Total rescue doses needed were 10, 1, and 0, respectively (P = 0.049).

CONCLUSION

Zileuton is better than montelukast as an additional drug in acute asthma and results in significant improvement in lung function, and reduction in the need for rescue medications.

摘要

背景

白三烯调节剂在慢性哮喘的管理中已确立了其作用,但它们在急性哮喘中的作用仍在评估中。

目的

研究并比较口服孟鲁司特与口服齐留通在急性哮喘中的效果。

材料与方法

本研究纳入了120名哮喘患者,研究时间为2012年9月至2014年3月。患者被随机分为三组,除了接受哮喘急性发作的标准治疗外,分别接受孟鲁司特、齐留通或安慰剂治疗。在给药或给予安慰剂后的6小时、12小时、24小时、48小时以及出院时记录呼气峰值流速(PEFR)值、急救药物详情和生命体征。入院后的早晨(上午8 - 10点)进行额外记录。主要终点是这些时间点每组的平均PEFR;次要终点是对急救药物的需求。

结果

三个研究组——安慰剂组、孟鲁司特组和齐留通组——在不同时间点的平均PEFR记录分别如下:6小时时(223.25 ± 90.40,199.00 ± 82.52,233.75 ± 84.05;P = 0.240);12小时时(271.00 ± 109.38,251.50 ± 101.44,309.50 ± 129.63;P = 0.048);24小时时(288.25 ± 114.26,269.00 ± 107.51,324.50 ± 127.88;P = 0.080);48小时时(295.00 ± 114.80,293.50 ± 113.24,344.75 ± 119.91;P = 0.015);出院时(305.00 ± 118.56,305.25 ± 119.51,361.2

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4552/4857564/5829f8a83d36/LI-33-281-g002.jpg

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