Ng S H, Dash C H, Savage S J
Postgrad Med J. 1977 Jun;53(620):315-20. doi: 10.1136/pgmj.53.620.315.
A double-blind, cross-over study was undertaken to compare inhalation of betamethasone valerate (BV, 800 microgram daily) with sodium cromoglycate (SCG, 80 mg daily) in twenty children requiring bronchodilators for perennial asthma. Each treatment period lasted 4 weeks but statistical comparisons were made only in respect of the last 14 days of each therapy. When the children were using BV they required not only less of the bronchodilator drugs but had fewer symptoms and higher daily peak expiratory flow rates when taking SCG. Statistically, all these differences were highly significant. For 2 weeks before the main trial each child was given a placebo aerosol (single-blind) to assess severity of asthma. In comparison with this period, SCG was associated with a significantly increased peak expiratory flow rate a lower symptom score by day but not by night, but their usage of bronchodilators followed a similar pattern. When the BV period was compared with the placebo period, patients had an even more significant rise in peak expiratory flow rate, less day and night symptoms, and took hardly any bronchodilators. The response to the two drugs did seem to depend upon which was given first. No monilial infections were found, nor any measurable defect in adrenal response from either treatment. Betamethasone valerate is considered to be superior to sodium cromoglycate as a treatment for childhood asthma insufficiently controlled on bronchodilators.
一项双盲交叉研究对20名因常年性哮喘需要使用支气管扩张剂的儿童进行了比较,比较了每日吸入800微克戊酸倍他米松(BV)和每日吸入80毫克色甘酸钠(SCG)的效果。每个治疗期持续4周,但仅对每种疗法的最后14天进行统计学比较。当儿童使用BV时,他们不仅需要较少的支气管扩张剂药物,而且在使用SCG时症状更少,每日呼气峰值流速更高。从统计学上讲,所有这些差异都非常显著。在主要试验前2周,每个儿童都接受了一种安慰剂气雾剂(单盲),以评估哮喘的严重程度。与这个时期相比,SCG与呼气峰值流速显著增加、白天症状评分降低(但夜间未降低)相关,但他们使用支气管扩张剂的情况遵循类似模式。当将BV治疗期与安慰剂期进行比较时,患者的呼气峰值流速上升更为显著,白天和夜间症状更少,并且几乎不使用支气管扩张剂。两种药物的反应似乎确实取决于哪种药物先使用。未发现念珠菌感染,也未发现任何一种治疗对肾上腺反应有可测量的缺陷。对于使用支气管扩张剂控制不佳的儿童哮喘,戊酸倍他米松被认为优于色甘酸钠。