摘要
目的 评价国产 2类新药塞曲司特 (血栓烷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、阳性药平行对照研究。 2 2 0例受试者经过 1周的洗脱期后 ,113例随机接受了A方案 (每天早饭后口服外形与扎鲁司特相同的安慰剂 1片 ,晚饭后口服 2片塞曲司特片 40mg/片和扎鲁司特安慰剂 1片 )。 10 7例接受了B方案(每天早饭后口服 1片扎鲁司特片 2 0mg/片 ,晚饭后口服 1片扎鲁司特和 2片塞曲司特安慰剂 ) ,疗程均为 6周。 结果 治疗 6周后 ,塞曲司特组临床控制率为 71 68%,显著高于扎鲁司特组 62 62 %(P <0 0 5 ) ;塞曲司特组的显效率为 84 0 7%,与扎鲁司特组 (79 44 %)比较差异无显著性 ;2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 2组间差异无显著性。治疗 6周后 ,塞曲司特组早、晚PEF上升率分别为 (66 0 0± 3 3 3 4) %和 (62 80± 3 6 43 ) %,扎鲁司特组则分别为 (61 3 9±2 5 43 ) %和 (5 3 95± 19 77) %,2组间差异无显著性。塞曲司特组不良反应发生率为 3 5 4%,扎鲁司特组为 3 74%,2组比较差异无显著性。 113名服用塞曲司特的哮喘患者出现头痛 3例 (占 2 65 %)、心慌 1例 (占 0 88%) ,程度轻微 ,均未影响继续用药。
Objective: To evaluate the effect and safety of seratrodast,a thromboxane A_2 receptor antagonist,on asthma. Methods: A double-blind randomized clinical study in multiple-centre comparing the effect of seratrodast on asthma with zafirlukast,a leukotriene-receptor antagnist. Results: The control rate of seratrodast (71.68%) was significantly higer than that of zafirlukast (62.62%, P <0.05). There was no significance between the effective rate and increasing rate of PEF in the two groups ( P >0.05). The rates of side reactions for seratrodast and zafirlukast were 3.54% and 3.74%,respectively( P >0.05). Conclution: Seratrodast,a thromboxane A_2 receptor antagonist,appeared to be effective and safe in the treatment of asthma.Its ascertain efficacy and less side reactions are similar to those of zafirlukast.
出处
《实用临床医药杂志》
CAS
2004年第2期2-5,共4页
Journal of Clinical Medicine in Practice
