两种剂量的吡嘧司特钾片临床研究报告

目的：以曲尼司特片100mg为对照,分别评价两个单位研制的吡嘧司特钾片5mg（NTFM药业有限公司,试验1）、10mg（QDGFGKJ药业股份有限公司,试验2）治疗过敏性鼻炎的临床安全性和有效性。单剂量口服10mg吡嘧司特钾片测定血药浓度经时过程,并估算主要药代动力学参数。方法：试验1、试验2的试验组每日2次在早晚饭后分别口服吡嘧司特钾片5mg或10mg,对照组均为在早晚饭后分别口服曲尼司特片100mg,疗程均为4周。试验3为20名男性志愿受试者单剂量口服吡嘧司特钾1片（10mg/片）。结果：有效性：试验1结果显示,试验药吡嘧司特钾片5mg与对照药曲尼司特片100mg用于过敏性鼻炎治疗后症状积分疗效、总体疗效两组之间比较差异均有统计学意义（P〈0.01）,说明试验药吡嘧司特钾片5mg改善过敏性鼻炎症状积分的疗效、总体疗效均优于对照药曲尼司特片100mg。试验2结果显示,试验药吡嘧司特钾片10mg与对照药曲尼司特片100mg用于过敏性鼻炎病人治疗后症状积分疗效、总体疗效两组之间比较差异均无统计学意义（P〉0.05）,说明试验药吡嘧司特钾片10mg改善过敏性鼻炎症状积分的疗效、总体疗效均与对照药曲尼司特片100mg相似。安全性：试验1结果显示,试验药吡嘧司特钾片5mg与对照药曲尼司特片100mg用于过敏性鼻炎的受试者不良反应发生率分别为4.81%、3.21%,两组之间比较差异无统计学意义（P〉0.05）,且两组均未见发生严重不良反应。试验2结果显示,试验药吡嘧司特钾片10mg与对照药曲尼司特片100mg用于过敏性鼻炎的受试者不良反应发生率分别为2.94%、10.00%,两组之间比较差异无统计学意义（P〉0.05）,且两组均未见发生严重不良反应。试验3为单剂量口服10mg吡嘧司特钾片测定血药浓度经时过程。结论：吡嘧司特片治疗过敏性鼻炎5mg/片/次、10mg/片/次、每日2次、疗程4周,两种剂量给药均是安全、有效的。

Clinical trial report of two doses of pemirolast potassium

AIM:Using 100 mg tranilast as control,to investigate the clinical safety and effect of 5 mg or 10 mg pemirolast potassium which is for the treatment of allergic rhinitis.METHODS:Patients in the trial groups took pemirolast potassium 5 mg or 10 mg orally after breakfast and supper daily for 4 weeks.Patients in control group took tranilast 100 mg,and the usage and course of treatment were the same as trial groups.20 male volunteers took pemirolast potassium 10 mg once a day.RESULTS:Pemirolast potassium 5 mg had a better effect for treatment of allergic rhinitis than tranilast 100 mg(P<0.01).Pemirolast potassium 5 mg had a similar curative effect for allergic rhinitis to tranilast 100 mg.No serious drug reaction happened,and two doses of pemirolast potassium and tranilast 100 mg showed similar safety(P>0.05).CONCLUSION:To cure allergic rhinitis,two doses of pemirolast potassium have good efficancy and safety compared to tranilast 100 mg.