Lu Susan, Liu Nancy, Dass S Balachandra, Reiss Theodore F
Merck Research Laboratories, Rahway, New Jersey 07065, USA.
J Asthma. 2009 Jun;46(5):465-9. doi: 10.1080/02770900902846323.
Loratadine added to montelukast has been suggested to improve endpoints of asthma.
This study investigated the additive effects of concomitant montelukast and loratadine when compared with montelukast, loratadine, and inhaled beclomethasone monotherapies in asthma. Methods. Patients (N = 406) were 15 to 65 years of age with a forced expiratory volume in 1 second (FEV(1))-predicted of 50% to 85%, FEV(1) reversibility > or = 15%, and a minimal level of daytime symptoms and beta -agonist use. This three-part 2X2 crossover-study consisted of two double-blind 6-week treatment periods where patients were administered once daily oral montelukast 10 mg, loratadine 10 mg, montelukast 10 mg + loratadine 10 mg, or twice daily inhaled beclomethasone 200 mu g. A subsequent 48-week extension study compared montelukast + loratadine with beclomethasone. The primary endpoint was the percentage change from baseline in FEV(1).
Over 6 weeks of double-blind treatment, significant improvements (p < 0.05) in the primary endpoint of FEV(1) were seen for montelukast + loratadine versus loratadine (least-square mean percentage-point difference of 5.8%), beclomethasone versus montelukast + loratadine (2.35%), montelukast versus loratadine (5.94%), and beclomethasone versus montelukast (4.65%); a numerical improvement (p = 0.054) was seen for montelukast + loratadine versus montelukast (1.60%). Significant improvements for montelukast + loratadine versus montelukast were seen in some secondary endpoints (evening peak expiratory flow, nocturnal asthma symptom score, nocturnal awakenings, and asthma-specific quality of life) but not others. Significant improvements in most endpoints except daytime asthma symptoms score were seen for montelukast + loratadine versus loratadine. In the extension study, both montelukast + loratadine and beclomethasone improved several endpoints. All treatments were generally comparable in the percentage of patients with clinical and laboratory adverse experiences.
In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV(1) and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast + loratadine versus beclomethasone was seen in any endpoint.
有人提出，孟鲁司特联合氯雷他定可改善哮喘的相关指标。
本研究探讨了孟鲁司特与氯雷他定联合用药相对于孟鲁司特、氯雷他定及吸入用倍氯米松单药治疗哮喘的附加效果。方法：患者（N = 406）年龄在15至65岁之间，1秒用力呼气容积（FEV₁）预计值为50%至85%，FEV₁可逆性≥15%，且日间症状和β受体激动剂使用水平最低。这项三部分的2×2交叉研究包括两个为期6周的双盲治疗期，在此期间，患者每日口服一次孟鲁司特10毫克、氯雷他定10毫克、孟鲁司特10毫克 + 氯雷他定10毫克，或每日两次吸入倍氯米松200微克。随后的一项为期48周的延长期研究比较了孟鲁司特 + 氯雷他定与倍氯米松的疗效。主要终点是FEV₁相对于基线的变化百分比。
在为期6周的双盲治疗中，孟鲁司特 + 氯雷他定组相对于氯雷他定组（最小二乘平均百分点差异为5.8%）、倍氯米松组相对于孟鲁司特 + 氯雷他定组（2.35%）、孟鲁司特组相对于氯雷他定组（5.94%）以及倍氯米松组相对于孟鲁司特组（4.65%），FEV₁的主要终点均有显著改善（p < 0.05）；孟鲁司特 + 氯雷他定组相对于孟鲁司特组有数值上（p = 0.054）的改善（1.60%）。孟鲁司特 + 氯雷他定组相对于孟鲁司特组在一些次要终点（夜间呼气峰值流速、夜间哮喘症状评分、夜间觉醒次数及哮喘特异性生活质量）有显著改善，但在其他次要终点则不然。孟鲁司特 + 氯雷他定组相对于氯雷他定组，除日间哮喘症状评分外，在大多数终点均有显著改善。在延长期研究中，孟鲁司特 + 氯雷他定组和倍氯米松组均改善了多个终点。在有临床和实验室不良经历的患者百分比方面，所有治疗方法总体上相当。
在本研究中，孟鲁司特联合氯雷他定使FEV₁有小幅数值上的改善，但无统计学意义，总体而言，在其他哮喘终点未出现持续改善。在任何终点，孟鲁司特 + 氯雷他定组相对于倍氯米松组均未出现改善。
