地洛他定治疗过敏性鼻炎114例的临床疗效和安全性评价  

Evaluation of clinical effect and safety of desloratadine in treating allergic rhinitis

作　　者：王少华[1] 陈安进[1] 孟广明[2] 刘光辉[3] 张全安[4] 范文汉[5] 孟祥贵[6] 

机构地区：[1]青岛市市立医院临床药理基地,山东青岛266011 [2]青岛市市立医院耳鼻喉科,山东青岛266011 [3]华中科技大学附属同济医院变态反应科,湖北武汉430030 [4]西安交通大学第二临床医院耳鼻喉科,陕西西安710000 [5]第三军医大学西南医院耳鼻喉科,重庆400030 [6]第三军医大学附属新桥医院耳鼻喉科,重庆400040

出　　处：《中国新药与临床杂志》2004年第12期865-868,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :评价地洛他定治疗过敏性鼻炎的临床疗效和安全性。方法 :采用多中心、随机、双盲、阳性药物平行对照研究。入选过敏性鼻炎病人 2 4 0例 ,完成 2 2 4例 ,其中地洛他定组 114例 ,男性 5 5例 ,女性 5 9例 ,年龄 (4 0±s 7)a ,病程 (6 6± 9)mo ,服用地洛他定 ,5mg,po ,qd ;氯雷他定组 110例 ,男性 4 5例 ,女性 6 5例 ,年龄 (39± 7)a ,病程 (6 3± 8)mo ,予氯雷他定 ,10mg,po ,qd。 2组疗程均为2wk ,观察 2组疗效和不良反应。结果 :地洛他定用于治疗过敏性鼻炎 2wk后的显效例数和有效率分别为 4 6例和 92 .1% ,氯雷他定组的显效例数和有效率分别为 32例和 88.2 %。 2组疗效差异无显著意义 (P >0 .0 5 )。 2组均未出现严重及预料之外的不良反应 ,地洛他定组和氯雷他定组的不良反应发生率分别为 8.3%和 15 .0 % ,P >0 .0 5。结论 :地洛他定治疗过敏性鼻炎具有明显疗效 。AIM: To evaluate the effect and safety of delortadine in treating allergic rhinitis. METHODS: A multi-center randomized and double-blind clinical trial was used. Two hundred and forty patients were divided into two groups and 224 patients finished the trial in the end. The desloratadine group of 114 patients (M 55,F 59;age(40±s 7) a) took desloratadine tablet (5 mg),po,qd. The loratadinum group of 110 patients (M 45,F 65;age(39±7) a ) took loratadinum tablet 10 mg,po,qd. The period of treatment of both groups was 2 wk. RESULTS: After 2 wk treatment, the notable effective patients and the effective rate of desloratadine were 46 and (92.1 %), those of loratadine were 32 and (88.2 %). There was no difference between two groups (P>(0.05)). The adverse reaction rate was (8.3 %) and (15.0 %), respectively. There was no signficant difference between two groups (P>(0.05)). CONCLUSION: Desloratadine in treating allergic rhinitis is safe and effective with mild adverse reactions.

关 键 词：氯雷他定 鼻炎 变应性 常年性 组胺H1拮抗剂 随机对照试验 双盲法 多中心研究 地洛他定 

分 类 号：R743.3[医药卫生—神经病学与精神病学] R971[医药卫生—临床医学]