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目的 通过随机、对照、双盲的临床实验研究低剂量甲氨碟呤 (MTX)在激素依赖型哮喘中的疗效并评价其安全性。方法 按照随机 ,对照 ,双盲的设计 ,5 0例激素依赖型哮喘患者分两组 (治疗组和安慰剂组 ) ,分别予甲氨碟呤 ( 15mg·周 -1)与安慰剂治疗 12周 ,治疗前后记录强的松日用量 ,哮喘症状评分 ,β -R兴奋剂日用频率 ,测定肺功能一秒钟用力呼气容积 (FEV1)、以及峰流速 (PEF) ,治疗过程中记录哮喘急性发作频率及监测MTX的不良反应。结果 45例完成试验。治疗组 2 4例 ,对照组 2 1例。治疗组予MTX治疗后患者的强的松日需用量明显减少 [治疗前 ( 14 3 8± 4 90 )mg·d-1;治疗后 ( 10 63± 5 77)mg·d-1,P <0 0 0 1] ,哮喘症状评分 [治疗前 ( 2 0 4± 1 0 0 )分 ;治疗后 ( 1 46± 0 88)分 ,P <0 0 1] ,β -R兴奋剂日用频率 [治疗前 ( 6 3 1± 1 45 ) ;治疗后 ( 4 5 0± 1 0 6) ,P <0 0 0 1]明显下降 ,FEV1,PEF无显著改变 (P >0 0 5 )。治疗组哮喘急性发作频率较对照组明显减少 (治疗组 :1 0 8± 0 62 ;对照组 :1 62± 0 80 ,P <0 0 5 )。治疗过程中未发现与MTX有关的严重副作用。对照组治疗前后各项指标无明显变化 (P >0 0 5 )。结论 低剂量MTX可明显减少激素依赖型哮喘患者的激素用量 ,?
Objective To investigate the efficacy and safety of low-dose methotrexate (MTX) in steroid-dependent asthma in a randomized, controlled, double-blind clinical trial. Methods Fifty patients with hormone-dependent asthma were randomized into two groups (treatment group and placebo group) according to a randomized, controlled and double-blind design. Patients were treated with methotrexate (15 mg · week -1) and placebo for 12 weeks , Prednisone daily dose, asthma symptom score, daily frequency of β -R agonist, FEV 1, and peak flow velocity (PEF) were recorded before and after treatment. The acute asthmatic The frequency of seizures and adverse reactions to MTX monitoring. Results 45 cases completed the test. 24 cases in the treatment group and 21 cases in the control group. The amount of prednisone needed was significantly reduced in the treatment group after treatment with MTX [before treatment (14 3 8 ± 4 90) mg · d -1; after treatment (10 63 ± 5 77) mg · d -1, P < 0 0 0 1], asthma symptom score [before treatment (20 4 ± 1 0 0), post treatment (1 46 ± 0 88), P 0 01], daily frequency of β -R stimulants Before treatment (6 3 1 ± 1 45); after treatment (45 0 ± 1 0 6), P 0 01 0, but no significant change in FEV 1 and PEF (P 0 05). The frequency of acute exacerbation of asthma in the treatment group was significantly lower than that in the control group (treatment group: 108 ± 0 62; control group: 162 ± 0 80, P <0 05). No serious MTX-related side effects were found during treatment. There was no significant change in the control group before and after treatment (P> 0.05). Conclusion Low-dose MTX can significantly reduce hormone-dependent asthma patients,?