Pearce N, Grainger J, Atkinson M, Crane J, Burgess C, Culling C, Windom H, Beasley R
Department of Community Health, Wellington School of Medicine, New Zealand.
Thorax. 1990 Mar;45(3):170-5. doi: 10.1136/thx.45.3.170.
A previous New Zealand case-control study of asthma deaths in the 5-45 year age group during 1981-3 found that prescription of fenoterol (by metered dose inhaler) was associated with an increased risk of death in patients with severe asthma. One major criticism of this study was that drug data for the cases and controls came from different sources. A new case-control design has been used to evaluate the same hypothesis, with a different set of asthma deaths, the same source for drug information being used for both cases and controls. This depended on identifying deaths from asthma during 1977-81 from national mortality records, and ascertaining which patients from those who died had been admitted to a major hospital for asthma during the 12 months before death. The study was confined to this subgroup, which accounted for about 20% of all asthma deaths in the areas served by a major hospital. For each of the eligible patients who died four age matched controls were selected from patients admitted to hospital for asthma during the year that the death occurred who had also had an admission for asthma in the previous 12 months. For the 58 cases and 227 control subjects information on prescribed drugs was collected from the hospital records relating to the previous admission. The odds ratio of asthma death in patients prescribed inhaled fenoterol was 1.99 (95% confidence interval 1.12-3.55, p = 0.02). As in the previous study, subgroups defined by markers of chronic asthma severity were also considered. The inhaled fenoterol odds ratio was 2.98 (95% CI 1.15-7.70, p = 0.02) in patients prescribed three or more categories of asthma drugs, 3.91 (95% CI 1.79-8.54, p less than 0.01) in patients with a previous admission for asthma in the past 12 months, and 5.83 (95% CI 1.62-21.0, p = 0.01) in patients prescribed oral corticosteroids at the time of admission. In patients with the most severe asthma (defined by a previous admission for asthma during the past 12 months and prescribed oral corticosteroids at time of admission) the inhaled fenoterol odds ratio was 9.82 (95% CI 2.23-43.4, p less than 0.01). These findings add further support to the hypothesis that inhaled fenoterol increases the risk of death in patients with severe asthma.
此前一项针对1981年至1983年间5至45岁年龄组哮喘死亡病例的新西兰病例对照研究发现，（通过定量吸入器）使用非诺特罗进行治疗与重度哮喘患者死亡风险增加有关。该研究的一个主要批评意见是，病例组和对照组的药物数据来自不同来源。一项新的病例对照设计被用于评估相同的假设，此次研究的哮喘死亡病例不同，病例组和对照组的药物信息来源相同。这依赖于从国家死亡率记录中识别出1977年至1981年间的哮喘死亡病例，并确定那些死亡患者中哪些人在死亡前12个月内曾因哮喘入住一家大型医院。该研究仅限于这个亚组，该亚组约占一家大型医院服务地区所有哮喘死亡病例的20%。对于每一位符合条件的死亡患者，从死亡发生年份因哮喘入院且在过去12个月内也曾因哮喘入院的患者中选取4名年龄匹配的对照。对于58例病例和227名对照受试者，从与之前入院相关的医院记录中收集了处方药信息。使用吸入型非诺特罗的患者哮喘死亡的比值比为1.99（95%置信区间1.12 - 3.55，p = 0.02）。与之前的研究一样，还考虑了由慢性哮喘严重程度标志物定义的亚组。在使用三类或更多类哮喘药物的患者中，吸入型非诺特罗的比值比为2.98（95%置信区间1.15 - 7.70，p = 0.02）；在过去12个月内曾因哮喘入院的患者中，比值比为3.91（95%置信区间1.79 - 8.54，p < 0.01）；在入院时使用口服糖皮质激素的患者中，比值比为5.83（95%置信区间1.62 - 21.0，p = 0.01）。在哮喘最严重的患者（定义为过去12个月内曾因哮喘入院且入院时使用口服糖皮质激素）中，吸入型非诺特罗的比值比为9.82（95%置信区间2.23 - 43.4，p < 0.01）。这些发现进一步支持了吸入型非诺特罗会增加重度哮喘患者死亡风险这一假设。
