血栓素A2受体拮抗剂塞曲司特治疗支气管哮喘疗效和安全性的研究

目的评价国产二类新药塞曲司特(血栓素A2受体阻滞剂)治疗支气管哮喘的有效性和安全性.方法采用多中心、随机、双盲双模拟、阳性药平行对照的研究.232例受试者经过1周的洗脱期后,117例随机接受了A方案[每天晚饭后口服2片塞曲司特(40mg/片)和外形与孟鲁司特相同的安慰剂1片].115例接受了B方案[每天晚饭后口服1片孟鲁司特(10mg/片)和外形与塞曲司特相同的安慰剂2片],疗程均为8周.结果治疗8周后,塞曲司特组临控率为62.61%,显效率为91.31%,与孟鲁司特组的临控率(59.29%)和显效率(92.03%)之间差异均无显著性(P＞0.05);两组患者治疗后哮喘症状平均记分均比治疗前有明显改善,但两组患者之间的差异无显著性.治疗8周后,塞曲司特组早上、晚上PEF上升率(%)分别为25.87±22.05和26.01±24.53,孟鲁司特组早上、晚上PEF上升率(%)分别为25.59±31.83和25.73±24.37,两组间差异无显著性.塞曲司特组不良反应发生率为3.48%,孟鲁司特组不良反应发生率为3.54%,两组比较差异无显著性(P>0.05).结论血栓素A2受体拮抗剂塞曲司特片与对照药白三烯受体拮抗剂孟鲁司特治疗支气管哮喘的疗效相似,不良反应少而轻微,是治疗支气管哮喘的安全、有效的新药.

Effectiveness and safety of Seratrodast,a thromboxane A2 receptor antagonist,for asthma

Objective To evaluate the effectiveness and safety of Seratrodast,a thromboxane A 2 receptor antagonist,for asthma.Methods A double-blind randomized clinical study in multiple centre was carried out to compare the effectiveness of Seratrodast on asthma with Montelukast,a leukotriene-receptor antagnist.The study consisted two programes.Programe A was performed in 117 cases (group A) in whom 80mg of Seratrodast and a tablet of placebo were intaken daily following supper,while programe B was undertaken in 115 cases (group B) in whom 10mg of Montelukast and two tablets of placebo were intaken daily following supper Both programes lasted for eight weeks.Results There were no significance in the effective rates and increasing rates of PEF between group A and group B following treatment (P> 0.05).The average scores of asthma symptoms showed greatly improved after treatment in both groups and no significant difference between the two groups.The rate of side effect for Seratrodast and Montelukast were 3.48% and 3.54%,respectively(P> 0.05).Conclusions Seratrodast,a thromboxane A 2 receptor antagonist,appeared to be an effectiveness and safety in the treatment of asthma.Its ascertain efficacy and less side effects are similar to that of Montelukast.