Foo A L, Lanteri C J, Burton P R, Sly P D
Division of Clinical Sciences, Western Australian Research Institute for Child Health, Perth.
J Asthma. 1993;30(5):381-90. doi: 10.3109/02770909309056742.
A double-blind, randomized, placebo-controlled, parallel-group study was undertaken in 120 clinically stable asthmatic children (aged 6-19 years) to determine the ability of 8 weeks of treatment with nedocromil sodium (4 mg, three times a day) to reduce the level of histamine responsiveness. Despite the subjects being clinically stable and reporting few asthma symptoms, approximately one-third had abnormal pulmonary function on enrollment into the study. Statistically significant increases in pulmonary function were seen in the group treated with nedocromil sodium but not in the control group (p = 0.01). Furthermore, 52% of the individuals with abnormal pulmonary function returned to normal following treatment with nedocromil sodium compared to 11% of those with abnormal pulmonary function who received placebo. However, there were no differences in the level of histamine responsiveness between the two treatment groups at baseline or after 4 or 8 weeks of treatment with nedocromil sodium or placebo. These data suggest that the level of histamine responsiveness is not intimately related to the level of asthma control in children.
对120名临床症状稳定的哮喘儿童（年龄在6至19岁之间）进行了一项双盲、随机、安慰剂对照、平行组研究，以确定奈多罗米钠（4毫克，每日三次）治疗8周降低组胺反应性水平的能力。尽管受试者临床症状稳定且报告的哮喘症状较少，但约三分之一的受试者在进入研究时肺功能异常。接受奈多罗米钠治疗的组肺功能有统计学意义的显著改善，而对照组则没有（p = 0.01）。此外，肺功能异常的个体中，52%在接受奈多罗米钠治疗后恢复正常，相比之下，接受安慰剂治疗的肺功能异常者中这一比例为11%。然而，在基线时以及在接受奈多罗米钠或安慰剂治疗4周或8周后，两个治疗组之间的组胺反应性水平没有差异。这些数据表明，组胺反应性水平与儿童哮喘控制水平没有密切关系。
