新型Th2细胞因子抑制剂甲磺司特治疗支气管哮喘的临床研究

Clinical study on a new Th2 cytokine inhibitor suplatast tosilate for treating bronchial asthma

目的评价甲磺司特治疗支气管哮喘的临床疗效和安全性。方法采用随机、双盲、双模拟、阳性药平行对照的研究方法,观察39例哮喘患者,经过2周洗脱期后,19例随机接受甲磺司特治疗,20例随机接受曲尼司特治疗(疗程均为8周)的临床疗效和安全性。结果在治疗结束时两组患者日间及夜间症状评分均显著降低,日间和夜间为缓解症状万托林的使用次数也明显减少。8周治疗结束时,两组患者的平均日间、夜间呼气峰流速(peak expiratory flow,PEF)值、第一秒用力呼气量(forced expiratory volume in 1s,FEV1)值较治疗前均有显著改善,但两组的改善情况差异无统计学意义。两组患者试验期间未发生不良事件,治疗后呼吸系统体格检查显著改善,仅有个别患者出现一过性实验室检查异常。结论甲磺司特与曲尼司特均能减轻哮喘患者症状、减少急救使用短效β2受体激动剂用量和改善肺功能,用于治疗轻、中度哮喘临床疗效确切,不良反应少,是安全、有效的哮喘控制药物。

Objective To evaluate the clinical efficacy and safety of suplatast tosilate for treating bronchial asthma. Methods A double-blind randomized clinical study was carried out to compare the effects of suplatast tosilate on asthma with tranilast. The study consisted of two groups. Totally 19 cases in group A were treated with 100 mg of suplatast tosilate and a capsule of placebo three times a day, while 20 cases in group B were given 100 mg of tranilast and one bag of placebo three times a day. Treatment in both groups lasted for eight weeks. Results The average scores of asthma symptoms showed obvious improvement after treatment in both groups but no significant differences between the two groups. The two groups had significantly improved peak expiratory flow and forced expiratory volume in 1 s following 8-week treatment, but there was no significant difference between the two groups. No adverse events occurred during the experiments. The respiratory system was obviously improved upon physical examination after treatment, but transient abnormality of laboratory examination occurred in a few patients. Conclusion Both suplatast tosilate and tranilast can relieve symptoms of asthmatic patients, reduce the dose of short-acting f12-receptor stimulant for emergency use, and improve pulmonary function. Suplatast tosilate is an effective and safe drug in treating asthma for its ascertained efficacy and less adverse effects on mild and moderate asthma.