Silverman M, Connolly N M, Balfour-Lynn L, Godfrey S
Br Med J. 1972 Aug 12;3(5823):378-81. doi: 10.1136/bmj.3.5823.378.
A year-long double-blind trial was carried out in 53 asthmatic children with severe perennial symptoms who were not receiving corticosteroids or corticotrophin. The treatment group were given disodium cromoglycate with isoprenaline (Intal Co.) while the placebo group were given lactose with isoprenaline four times daily. The groups were closely matched for clinical, physiological, and immunological features. Evaluation was based on the use of a diary and clinical and physiological investigations, including exercise tests.After one year 71% of the treatment group were still well controlled while 76% of the placebo group had dropped out because of inadequate control of symptoms. There was no rise in the rate of failure towards the end of the trial period and there were no seasonal variations in the failure rate. No important toxic effects were noted. It was impossible to predict the outcome of the trial in any given patient from his clinical, physiological, or immunological status at the beginning. However, the prevention of exercise-induced asthma by premedication with disodium cromoglycate in a laboratory exercise test did correlate well with the satisfactory clinical response to the drug.
对53名患有严重常年性症状且未接受皮质类固醇或促肾上腺皮质激素治疗的哮喘儿童进行了为期一年的双盲试验。治疗组给予色甘酸钠异丙肾上腺素（因他考特），而安慰剂组给予乳糖异丙肾上腺素，每日4次。两组在临床、生理和免疫特征方面进行了密切匹配。评估基于日记记录以及临床和生理检查，包括运动试验。一年后，71%的治疗组患者病情仍得到良好控制，而76%的安慰剂组患者因症状控制不佳而退出试验。试验期结束时失败率没有上升，且失败率没有季节性变化。未观察到重要的毒性作用。从一开始患者的临床、生理或免疫状态无法预测任何特定患者的试验结果。然而，在实验室运动试验中，色甘酸钠预处理预防运动诱发性哮喘与该药物令人满意的临床反应密切相关。
