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对乙酰氨基酚对成人哮喘严重程度影响的随机安慰剂对照研究

2014/04/15

   摘要
   目的:
旨在探究规律使用对乙酰氨基酚对成人哮喘气道高反应性(BHR)以及哮喘控制的影响。
   机构:单一科研型门诊诊所。
   受试者:94例轻中度哮喘成人患者接受随机治疗;其中85例完成研究。主要的入选标准为年龄18~65岁,第1秒用力呼气量(FEV1) >70%预测值,乙酰甲胆碱的激发浓度在0.125-16mg/ml间引起FEV1下降20% (PC20)。主要排除标准包括前2个月内哮喘急性发作,目前规律服用对乙酰氨基酚,使用高剂量阿司匹林或非甾体抗炎药物,目前或既往吸烟>10包年。
   干预:在为期12周的随机、双盲、安慰剂对照、平行组研究中,给予受试者1g对乙酰氨基酚或安慰剂,每日2次共12周。
   主要和次要结果评价:主要结果变量为BHR,通过12周时测定PC20进行评估。次要结果变量包括FEV1、呼出气一氧化氮(FeNO)以及哮喘控制问卷(ACQ)评分。
   结果:12周时,对照组(N=54)以2为底的PC20对数平均(标准差)值为1.07(2.36),对乙酰氨基酚组(N=31)为0.62 (2.09)。在控制了基线PC20后,对乙酰氨基酚组加倍剂量BHR恶化平均差异(对乙酰氨基酚组减对照组)为-0.48(95% CI -1.28 to 0.32), p=0.24。而log FeNO(0.09 (95% CI -0.097 to 0.27)), FEV1(-0.07 L (95% CI -0.15 to 0.01))或ACQ评分(-0.04 (95% CI -0.27 to 0.18))无显著统计学差异(对乙酰氨基酚组减对照组)。
   结论:对乙酰氨基酚对成人轻中度哮喘的BHR以及哮喘控制无显著的影响。然而,研究结果受低效度的限制,且置信区间上限不排除临床相关不良反应。

 

(林江涛 审校)
BMJ Open. 2014 Feb 12;4(2):e004324. doi: 10.1136/bmjopen-2013-004324.


 

 

Randomised placebo-controlled study of the effect of paracetamol on asthma severity in adults.
 

Ioannides SJ, Williams M, Jefferies S, Perrin K, Weatherall M, Siebers R, Crane J, Patel M, Travers J, Shirtcliffe P, Beasley R.
 

Abstract
OBJECTIVE:
To investigate the effect of regular paracetamol on bronchial hyper-responsiveness (BHR) and asthma control in adult asthma.
SETTING: Single research-based outpatient clinic.
PARTICIPANTS: 94 adults with mild-to-moderate asthma received randomised treatment; 85 completed the study. Key inclusion criteria were age 18-65 years, forced expiratory volume in 1 s (FEV1) >70% predicted, provocation concentration of methacholine causing a 20% reduction in FEV1 (PC20) between 0.125 and 16 mg/mL. Key exclusion criteria included an asthma exacerbation within the previous 2 months, current regular use of paracetamol, use of high-dose aspirin or non-steroidal anti-inflammatory drugs, current or past cigarette smoking >10 pack-years.
INTERVENTIONS: In a 12-week randomised, double-blind, placebo-controlled, parallel-group study, participants received 12 weeks of 1 g paracetamol twice daily or placebo twice daily.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome variable was BHR, measured as the PC20 at week 12. Secondary outcome variables included FEV1, fractional exhaled nitric oxide (FeNO) and asthma control questionnaire (ACQ) score.
RESULTS: At 12 weeks, the mean (SD) logarithm base two PC20 was 1.07 (2.36) in the control group (N=54) and 0.62 (2.09) in the paracetamol group (N=31). After controlling for baseline PC20, the mean difference (paracetamol minus placebo) was -0.48 doubling dose worsening in BHR in the paracetamol group (95% CI -1.28 to 0.32), p=0.24. There were no statistically significant differences (paracetamol minus placebo) in log FeNO (0.09 (95% CI -0.097 to 0.27)), FEV1 (-0.07 L (95% CI -0.15 to 0.01)) or ACQ score (-0.04 (95% CI -0.27 to 0.18)).
CONCLUSIONS: There was no significant effect of paracetamol on BHR and asthma control in adults with mild-to-moderate asthma. However, the study findings are limited by low power and the upper confidence limits did not rule out clinically relevant adverse effects.

 

BMJ Open. 2014 Feb 12;4(2):e004324. doi: 10.1136/bmjopen-2013-004324.


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