Callaghan B, Teo N C, Clancy L
Peamount Hospital, Newcastle, County Dublin, Ireland.
Chest. 1992 Mar;101(3):787-92. doi: 10.1378/chest.101.3.787.
To assess the efficacy and safety of nedocromil sodium metered dose aerosol as an adjunct to sustained-released theophylline therapy in adult theophylline-dependent asthma patients and to examine the ability of nedocromil sodium to substitute for theophylline.
Randomized double-blind placebo-controlled parallel group study. Two-week baseline, eight-week treatment period.
Out-Patient Clinic.
Sequential sample of 35 adult chronic asthmatic patients maintained on a regimen of sustained-release theophylline (dose range, 400 to 800 mg daily) and on-demand inhaled beta 2-bronchodilators. All patients completed the study.
2 x 2-mg nedocromil sodium metered dose aerosol twice daily or matching placebo randomly allocated after two-week baseline. Theophylline dose reduced by half or one third after four weeks of test treatments, then stopped for final two weeks. Use of inhaled beta 2-bronchodilators permitted throughout trial period.
The following results were in favor (statistically significant findings, p less than 0.05) of nedocromil sodium compared with placebo: all diary card efficacy variables (nighttime asthma, morning tightness, daytime asthma, cough, twice daily peak expiratory flow [PEF], inhaled beta 2 use) during all periods of assessment (weeks 1 to 2, 3 to 4, 5 to 6, and 7 to 8) with the exception of cough and nighttime beta 2 use during weeks 1 to 2; patient and clinician opinion of treatment efficacy (end of weeks 4 and 8); ability to reduce the theophylline dose; clinician assessment of asthma severity at the end of the study, and clinic FEV1 at weeks 4, 5, 6, and 8. One placebo-treated patient reported transient moderately severe nausea and taste loss. No clinically significant changes were seen in the laboratory data.
Nedocromil sodium, 4 mg twice daily, conferred significant benefit when added to sustained-release theophylline therapy. The results suggest that nedocromil sodium may permit a reduction in theophylline dosage and possibly substitute for theophylline in previously dependent patients.
评估奈多罗米钠定量气雾剂作为成人茶碱依赖型哮喘患者缓释茶碱治疗辅助药物的疗效和安全性，并研究奈多罗米钠替代茶碱的能力。
随机双盲安慰剂对照平行组研究。两周基线期，八周治疗期。
门诊诊所。
连续抽取35例成年慢性哮喘患者，这些患者维持缓释茶碱（剂量范围为每日400至800毫克）治疗方案，并按需吸入β2支气管扩张剂。所有患者均完成研究。
在两周基线期后，随机分配每日两次使用2×2毫克奈多罗米钠定量气雾剂或匹配的安慰剂。试验治疗四周后，茶碱剂量减半或减至三分之一，然后在最后两周停药。在整个试验期间允许使用吸入性β2支气管扩张剂。
与安慰剂相比，以下结果支持奈多罗米钠（具有统计学意义的发现，p<0.05）：在所有评估期（第1至2周、第3至4周、第5至6周和第7至8周）的所有日记卡疗效变量（夜间哮喘、晨起气促、日间哮喘、咳嗽、每日两次呼气峰值流速[PEF]、吸入β2使用情况），第1至2周期间的咳嗽和夜间β2使用情况除外；患者和临床医生对治疗疗效的评价（第4周和第8周结束时）；降低茶碱剂量的能力；研究结束时临床医生对哮喘严重程度的评估，以及第4、5、6和8周时的门诊FEV1。一名接受安慰剂治疗的患者报告有短暂的中度严重恶心和味觉丧失。实验室数据未见临床显著变化。
每日两次服用4毫克奈多罗米钠，添加到缓释茶碱治疗中可带来显著益处。结果表明，奈多罗米钠可能允许减少茶碱剂量，并可能替代先前依赖患者的茶碱。
