Br Med J. 1972 Nov 18;4(5837):383-8.
The results are reported here of a long-term double-blind controlled clinical trial of disodium cromoglycate (D.S.C.G.) and isoprenaline, D.S.C.G. alone, isoprenaline alone, and a placebo given as a powder for inhalation in the treatment of severe bronchial asthma.At the end of one year 16 out of 20 patients on D.S.C.G.-isoprenaline remained on the allocated capsules, compared with 10 out of 15 on D.S.C.G., 5 out of 20 on isoprenaline, and 3 out of 19 taking the placebo. The differences between each of the D.S.C.G.-isoprenaline and D.S.C.G. regimens compared with the isoprenaline and placebo regimens were statistically significant. After eight weeks on four capsules a day the patients in each group were allocated at random so that half continued on full dosage and half on a reducing regimen. At the end of the year there was no significant difference in the failure rate between patients allocated the full dosage and the patients on the reducing dosage. The capsules were well tolerated and toxicity to D.S.C.G. was not observed.
本文报告了色甘酸钠(D.S.C.G.)与异丙肾上腺素、单独使用D.S.C.G.、单独使用异丙肾上腺素以及使用安慰剂粉末吸入治疗重度支气管哮喘的长期双盲对照临床试验结果。一年后,20名接受D.S.C.G.-异丙肾上腺素治疗的患者中有16人继续服用分配的胶囊,相比之下,15名接受D.S.C.G.治疗的患者中有10人、20名接受异丙肾上腺素治疗的患者中有5人以及19名服用安慰剂的患者中有3人继续用药。与异丙肾上腺素和安慰剂治疗方案相比,D.S.C.G.-异丙肾上腺素和D.S.C.G.各治疗方案之间的差异具有统计学意义。在每天服用四粒胶囊八周后,每组患者被随机分配,以便一半患者继续全剂量服用,另一半患者采用递减剂量方案。一年结束时,分配到全剂量的患者与采用递减剂量的患者的失败率没有显著差异。这些胶囊耐受性良好,未观察到对D.S.C.G.的毒性。