Inhaled Lidocaine for the Treatment of Asthma: Lack of Efficacy in Two Double-Blind, Randomized, Placebo-Controlled Clinical Studies
Inhaled Lidocaine for the Treatment of Asthma: Lack of Efficacy in Two Double-Blind, Randomized, Placebo-Controlled Clinical Studies
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DOI：
10.1089/jamp.2010.0827
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发表时间：
2010-12-01
影响因子：
3.4
通讯作者：
Montgomery, A. Bruce
中科院分区：
文献类型：
--
作者：
Abuan, Tammy;Yeager, Melissa;Montgomery, A. Bruce
背景：哮喘严重或持续恶化可用慢性口服皮质类固醇(OCS)治疗，如泼尼松。虽然OCS治疗有效，但常常伴随着副作用；因此，需要非皮质类固醇治疗。方法：我们进行了两项双盲、安慰剂对照的临床研究，评估利多卡因吸入溶液(LSI；每天两次，40毫克；eFlow(R)雾化吸入)治疗哮喘。研究1-轻/中度包括154名轻-中度哮喘患者[一秒用力呼气量(FEV1)和用力呼气量(FEV1)=60%的预测，短效吸入β-激动剂后FEV1(L)改善12%；前一个月没有OCS或吸入皮质类固醇(ICS)]，并评估治疗12周后FEV1是否改善。研究2-OCS包括114名更严重的哮喘患者(FEV135%-85%的预测值，OCS治疗6个月，平均每天剂量在5-70毫克或等量的泼尼松或同等剂量，稳定-GT；=30天)，并评估20周的治疗是否具有减少对OCS的皮质类固醇的效果。结果：在研究1-轻度/中度中，LSI没有改善肺功能，在研究2-OCS中，与安慰剂相比，LSI没有减少皮质类固醇的效果。因此，没有达到主要的疗效终点。在第12周(研究1-轻度/中度)或第20周(研究2-OCS)，哮喘症状评分、早晚最大呼气流量值、预计FEV1%、哮喘不稳定患者比例和哮喘生活质量评分没有显著改善。LSI耐受性良好。结论：这些结果表明利多卡因雾化吸入治疗哮喘不是一种有效的治疗方法，它没有改善肺功能，也没有糖皮质激素的节省作用。
Background: Asthma with severe or persistent exacerbations is treated with chronic oral corticosteroids (OCS), such as prednisone. Although efficacious, OCS treatment is often associated with side effects; thus, corticosteroid- sparing treatments are needed.Methods: We conducted two double-blind, placebo-controlled, clinical studies assessing lidocaine solution for inhalation (LSI; 40 mg twice daily; eFlow (R) nebulizer) to treat asthma. Study 1-Mild/Moderate included 154 patients with mild-moderate asthma [ forced expiratory volume in one second (FEV1) >= 60% predicted, and >= 12% improvement in FEV1 (L) after short-acting, inhaled beta-agonist; no OCS or inhaled corticosteroids (ICS) in previous month] and evaluated whether FEV1 improved after 12 weeks of treatment. Study 2-OCS included 114 patients with more severe asthma (FEV1 35-85% of predicted values, treatment with OCS for >= 6 months, average daily dose between 5 and 70 mg prednisone or equivalent, stable >= 30 days) and evaluated whether 20 weeks of treatment had a corticosteroid-sparing effect, measured as reduced need for OCS.Results: LSI did not improve pulmonary function in Study 1-Mild/Moderate, and did not have a corticosteroid-sparing effect in Study 2-OCS, when compared with placebo. Thus, the primary efficacy endpoints were not met. Significant improvements were not observed for asthma symptom scores, morning and evening peak expiratory flow values, FEV1 % predicted, proportion of patients with asthma instability, and asthma quality-of-life scores at week 12 (Study 1-Mild/Moderate) or week 20 (Study 2-OCS). LSI was well tolerated.Conclusions: These results indicate that lidocaine solution for inhalation is not a useful treatment for asthma; it did not improve pulmonary function and did not have a corticosteroid-sparing effect.