枸地氯雷他定片治疗慢性特发性荨麻疹有效性与临床安全性分析  

Clinical Study on the Efficacy and Safety of Citrus Medica Ground Ioratadine Tablets in the Treatment of Chronic Idiopathic Urticaria

作　　者：毛越苹[1] 谭国珍[1] 张楚怡 赖维[2] 黄振明[3] 李其林[4] 林达[5] 林桦[6] 任虹[7] 赵建林[8] 丁敏[9] 姚煦 朱晓芳[11] 李俊杰[12] 李剑[13] 王群[14] 方锐华[15] 黄必然[16] 

机构地区：[1]中山大学附属孙逸仙纪念医院皮肤性病科,广东广州510120 [2]中山大学附属第三医院皮肤科,广东广州510630 [3]广州市皮肤病防治所,广东广州510095 [4]广州市红十字会医院,广东广州510220 [5]安徽医科大学附属第一医院,安徽合肥230022 [6]南通市第一人民医院,江苏南通226001 [7]连云港市第一人民医院,江苏连云港222002 [8]泰州市人民医院,江苏泰州225499 [9]徐州市中心医院,江苏徐州221009 [10]中国医学科学院皮肤病医院,江苏南京210042 [11]扬州市苏北人民医院,江苏扬州225001 [12]东莞市人民医院,广东东莞523059 [13]复旦大学附属华山医院,上海200040 [14]广东省人民医院,广东广州510030 [15]广州市第一人民医院,广东广州510180 [16]惠州市中心医院,广东惠州516001

出　　处：《中国皮肤性病学杂志》2014年第9期974-976,共3页The Chinese Journal of Dermatovenereology

摘　　要：目的评价枸地氯雷他定片治疗慢性特发性荨麻疹的疗效与安全性。方法采用多中心、开放、非比较性临床试验的研究方法,共有1 235例受试者进入研究,符合方案分析集(PPAS)1 210例,全分析集(FAS)1 213例,安全性分析集(SAS)1 235例,受试者均给予枸地氯雷他定片8.8mg口服,1次/d,疗程两周。观察记录受试者用药前、治疗期间、治疗结束后的症状、体征情况及不良反应,分别在治疗第1周和第2周结束时计算疗效指数,对其有效率和安全性给予评价。结果枸地氯雷他定片治疗慢性特发性荨麻疹用药后1周、2周的治愈率分别为23.08%和56.94%,有效率分别为42.10%和87.86%。对瘙痒、风团数量及大小等症状有明显改善作用;治疗过程中出现口干、嗜睡、困倦、乏力、头晕、头痛、心动过速等51例不良反应,发生率4.13%。结论枸地氯雷他定片治疗慢性特发性荨麻疹有较好的临床疗效,且安全性优良。Objective To evaluate the efficacy and safety of citrus medica ground ioratadine tablet in the treatment of chronic idiopathic urticaria. Methods A total of 1 235 patients were treated with oral citrus medica ground loratadine tablets （ 1 time/day, altogether 2 weeks）. We observe and record the symptoms, signs, adverse events, and side effects of every patient before, during, and after the treatment. The efficacy and safety of the clinical study were evaluated by calculating efficacy index at the end of the first and the second week. Results The cure rate were 23.08% and 56.94% after one and two weeks treatment. Meanwhile, the effective rate were 42. 10% and 87.86%. In the comparison with before treatment, the itch, numbers and sizes of wheals all improved. The incident rate of side effect was 4. 13 % o Conclusion The citrus medica ground loratadine tablet can effectively control the clinical signs and symptoms, and have no significant adverse reactions.

关 键 词：慢性特发性荨麻疹 枸地氯雷他定片 临床试验 

分 类 号：R758.24[医药卫生—皮肤病学与性病学]