Lal S, Dorow P D, Venho K K, Chatterjee S S
Bury General Hospital, England.
Chest. 1993 Aug;104(2):438-47. doi: 10.1378/chest.104.2.438.
In a multicenter, double-blind, group comparative trial, the efficacy of nedocromil sodium (nedocromil, 4 mg, four times daily [qid]), cromolyn sodium (2 mg, qid), and placebo was compared in patients receiving inhaled beta 2-agonists and inhaled corticosteroids for the treatment of chronic reversible obstructive airway disease. After a 2-week baseline period, 132 patients (8 centers) between the ages of 20 and 75 years entered a 4-week run-in period in which the dose of inhaled corticosteroid was reduced by 50 percent. During the run-in phase, deterioration of symptoms (total symptom score) by ten points qualified patients to enter the 6-week drug trial period. Patients in the nedocromil treatment group showed the most robust and consistent improvements over placebo and cromolyn sodium for all daily dairy variables. Statistically significant improvements over placebo were noted for both active treatment groups for daytime, nighttime, and total symptom score. Symptom scores for nedocromil were statistically significantly improved over both cromolyn sodium and placebo for both daytime and nighttime asthma. Patients treated with nedocromil also demonstrated a significant reduction in the use of nighttime as needed (prn) beta 2-agonists as compared with either the placebo- or cromolyn sodium-treated groups. Only nedocromil-treated patients demonstrated a statistically significant improvement in morning peak expiratory flow rate (PEFR) as compared with placebo. Both nedocromil and cromolyn sodium groups demonstrated statistically significant improvements in afternoon and evening PEFRs. Collectively, the improvements in nighttime symptoms, decreased bronchodilator use, and improved morning PEFR show that patients treated with nedocromil had improved nocturnal symptoms. Pulmonary function tests (FEV1, FVC, PEFR) demonstrated no statistically significant differences between the two active treatments, although trends favored nedocromil for both FEV1 and PEFR. Although symptoms improved in patients treated with cromolyn sodium, the level of symptom control was less than that achieved by nedocromil. As compared with baseline control (regular dose of inhaled steroids), patients treated with nedocromil plus the 50 percent reduced dosage of inhaled corticosteroid consistently demonstrated comparable or better symptom control. Although both active drugs reduced symptoms, nedocromil proved to be more effective than cromolyn sodium for treatment of reversible obstructive airway disease in patients normally well maintained on regimens of low to moderate doses of inhaled corticosteroids.
在一项多中心、双盲、分组对照试验中，比较了奈多罗米钠（奈多罗米，4毫克，每日四次[qid]）、色甘酸钠（2毫克，qid）和安慰剂在接受吸入性β2激动剂和吸入性皮质类固醇治疗慢性可逆性阻塞性气道疾病患者中的疗效。经过2周的基线期后，132名年龄在20至75岁之间的患者（8个中心）进入为期4周的导入期，在此期间吸入性皮质类固醇的剂量减少50%。在导入阶段，症状恶化（总症状评分）达10分的患者有资格进入为期6周的药物试验期。在所有日常症状变量方面，奈多罗米治疗组患者相对于安慰剂和色甘酸钠组表现出最显著且持续的改善。两个活性治疗组在白天、夜间和总症状评分方面相对于安慰剂均有统计学显著改善。奈多罗米的症状评分在白天和夜间哮喘方面相对于色甘酸钠和安慰剂均有统计学显著改善。与安慰剂组或色甘酸钠治疗组相比，接受奈多罗米治疗的患者在按需（prn）使用夜间β2激动剂方面也有显著减少。与安慰剂相比，只有接受奈多罗米治疗的患者在早晨呼气峰值流速（PEFR）方面有统计学显著改善。奈多罗米组和色甘酸钠组在下午和晚上的PEFR方面均有统计学显著改善。总体而言，夜间症状的改善、支气管扩张剂使用的减少以及早晨PEFR的改善表明接受奈多罗米治疗的患者夜间症状得到改善。肺功能测试（FEV1、FVC、PEFR）显示两种活性治疗之间无统计学显著差异，尽管在FEV1和PEFR方面趋势有利于奈多罗米。尽管接受色甘酸钠治疗的患者症状有所改善，但其症状控制水平低于奈多罗米所达到的水平。与基线对照（吸入性类固醇常规剂量）相比，接受奈多罗米加50%减量吸入性皮质类固醇治疗的患者始终表现出相当或更好的症状控制。尽管两种活性药物都减轻了症状，但在通常以低至中等剂量吸入性皮质类固醇方案维持良好状态的患者中，奈多罗米在治疗可逆性阻塞性气道疾病方面被证明比色甘酸钠更有效。
