Edwards T B, Dockhorn R J, Wagner D E, Fiddes R A, Grossman J, Menendez R, Southern D L, Cefali E A, Hassanein R S
Albany Medical College, New York, USA.
Ann Allergy Asthma Immunol. 1995 Nov;75(5):409-16.
BACKGROUND/OBJECTIVE: The purpose of this study was to determine whether the addition of extended-release theophylline to the daily treatment regimen of inhaled beta 2-agonist users would result in decreased use of beta 2-agonist while maintaining similar efficacy for treatment of asthma.
This was a single-blind, multicenter (six sites) study. Sixty-one patients with a history of mild-to-moderate asthma treated with inhaled beta 2-agonist were randomized to treatment with Theo-24 (anhydrous extended-release capsules) plus inhaled beta 2-agonist or placebo plus beta 2-agonist. Patients kept daily symptom diaries, measured peak flow rates, recorded puffs of inhaled beta 2-agonist, and adverse events during a 4-week treatment period.
Fifty-five patients were included in the efficacy analysis. The primary efficacy variable in this study was the mean number of puffs (adjusted for baseline differences) of beta 2-agonist inhaled per day. In this study, the addition of theophylline to the daily regimen of inhaled beta 2-agonist for 4 weeks significantly reduced the total daily dose of inhaled beta 2-agonist at weeks 3 and 4 of treatment compared with placebo. The differences were significant at the P < .05 level. For patients in the theophylline group, the number of puffs decreased from an unadjusted mean of 9.81 at baseline to an adjusted mean of 6.78 after 4 weeks of treatment compared with 9.91 at baseline and 8.17 for the placebo group. There were no unexpected or serious adverse events.
In this study, the addition of once daily, extended-release theophylline to the daily regimen of inhaled beta 2-agonist for 4 weeks significantly reduced the total daily dose of inhaled beta 2-agonist at weeks 3 and 4 of treatment compared with placebo, while maintaining acceptable asthma symptom scores.
背景/目的：本研究旨在确定在吸入性β2受体激动剂使用者的日常治疗方案中添加缓释型茶碱是否会减少β2受体激动剂的使用量，同时保持治疗哮喘的相似疗效。
这是一项单盲、多中心（六个地点）研究。61名有轻至中度哮喘病史且接受吸入性β2受体激动剂治疗的患者被随机分为接受Theo-24（无水缓释胶囊）加吸入性β2受体激动剂治疗组或安慰剂加β2受体激动剂治疗组。患者在4周的治疗期内记录每日症状日记、测量峰值流速、记录吸入性β2受体激动剂的吸入次数以及不良事件。
55名患者纳入疗效分析。本研究的主要疗效变量是每天吸入β2受体激动剂的平均吸入次数（根据基线差异进行调整）。在本研究中，与安慰剂相比，在吸入性β2受体激动剂的日常治疗方案中添加茶碱4周，在治疗的第3周和第4周显著降低了吸入性β2受体激动剂的每日总剂量。差异在P <.05水平具有统计学意义。对于茶碱组患者，吸入次数从未调整的基线平均值9.81降至治疗4周后的调整平均值6.78，而安慰剂组基线为9.91，4周后为8.17。未出现意外或严重不良事件。
在本研究中，与安慰剂相比，在吸入性β2受体激动剂的日常治疗方案中添加每日一次的缓释型茶碱4周，在治疗的第3周和第4周显著降低了吸入性β2受体激动剂的每日总剂量，同时保持了可接受的哮喘症状评分。
