Carrasco E, Sepulveda R
Instituto Nacional de Enfermedades, Respiratorias y Cirugia Toracica, Dr. Enrique Laval M, Santiago, Chile.
Curr Med Res Opin. 1989;11(6):341-53. doi: 10.1185/03007998909110134.
A double-blind, parallel group trial of a 1 mg sodium cromoglycate metered dose inhaler, a 5 mg formulation and a placebo aerosol was undertaken in 139 asthmatic patients with extrinsic allergic asthma. None of the patients had previously been treated with sodium cromoglycate and few (15%) were familiar with the use of a pressurized aerosol device. Each test treatment was taken at a dose of 2 'puffs' 4-times per day for a period of 12 weeks. Response to treatment was assessed by analysis of symptom scores, medication usage and 3-times daily home measurements of PEFR recorded on diary cards, and by assessment of asthma severity and lung function in the clinic at the beginning and end of a 2-week baseline period and at intervals of 3 weeks throughout the trial. Analysis of patient-generated data (symptom scores and PEFR) demonstrated statistically significant differences in favour of each active treatment compared with placebo treatment. Clinic assessments of asthma severity and the investigator's opinion of treatment also showed the superiority of each sodium cromoglycate treatment regimen over placebo. These differences were statistically significant after 9 weeks (high dose) and 12 weeks (both doses). No statistically significant differences were demonstrated between the two active treatment groups in the clinic assessments of asthma severity, or in the home or clinic measurements of PEFR. There was, however, a consistent trend in favour of the higher dose formulation with respect to diary card symptom scores. In general, improvement in the low-dose sodium cromoglycate treatment group was slower than in the high-dose group suggesting an advantage for the 5 mg sodium cromoglycate inhaler in terms of onset of therapeutic response. The results indicate that sodium cromoglycate administered by pressurized aerosol at a dose of 2 x 1 mg or 2 x 5 mg 4-times daily is effective in the treatment of asthma and suggest that the higher dose formulation may provide more rapid control of symptoms.
对139例患有外源性过敏性哮喘的患者进行了一项双盲、平行组试验，比较1毫克色甘酸钠定量气雾剂、5毫克制剂和气雾剂安慰剂。此前所有患者均未接受过色甘酸钠治疗，且很少有患者（15%）熟悉使用压力气雾剂装置。每种试验治疗均以每次2“喷”、每天4次的剂量服用，持续12周。通过分析症状评分、药物使用情况以及每日3次在家中记录在日记卡上的呼气峰流速（PEFR）测量值来评估治疗反应，并在为期2周的基线期开始和结束时以及整个试验期间每3周在诊所评估哮喘严重程度和肺功能。对患者生成的数据（症状评分和PEFR）进行分析表明，与安慰剂治疗相比，每种活性治疗在统计学上均有显著差异。哮喘严重程度的临床评估以及研究者对治疗的看法也显示，每种色甘酸钠治疗方案均优于安慰剂。这些差异在9周（高剂量）和12周（两种剂量）后具有统计学意义。在哮喘严重程度的临床评估中，或在PEFR的家庭或临床测量中，两个活性治疗组之间未显示出统计学上的显著差异。然而，就日记卡症状评分而言，一直存在有利于高剂量制剂的趋势。一般来说，低剂量色甘酸钠治疗组的改善比高剂量组慢，这表明5毫克色甘酸钠气雾剂在治疗反应起效方面具有优势。结果表明，通过压力气雾剂每天4次给予2×1毫克或2×5毫克剂量的色甘酸钠对哮喘治疗有效，并表明高剂量制剂可能能更快地控制症状。
