富马酸卢帕他定片治疗慢性特发性荨麻疹的有效性及安全性

Efficacy and safety of rupatadine tablets against chronic idiopathic urticaria

目的:评价富马酸卢帕他定片治疗慢性特发性荨麻疹的有效性及安全性。方法:采用多中心、随机双盲、平行阳性对照的试验方法,观察组采用富马酸卢帕他定片,对照组采用盐酸西替利嗪片,两组用药方案均为每日晚服用一次,每次10 mg,连续用药28 d。疗程结束时以临床症状总积分下降值、临床疗效评估其有效性;以不良事件、不良反应及实验室检查评估其安全性。结果:共有144例患者纳入全分析集(FAS):观察组(n=72)及对照组(n=72),两组病人用药前与用药后4周临床症状总积分下降值分别为(7.60±3.56)、(7.65±3.42)分,组内前后比较差异存在统计学意义(P<0.000 1),组间比较差异无统计学意义(P=0.917 5);临床疗效有效率分别为80.56%,83.33%(P=0.656 6)。两组病人用药后4周临床症状体征总积分下降值的非劣效性检验,观察组非劣于对照组。两组间发生一般不良事件及不良反应,发生率分别为11.11%、16.67%和6.94%、13.89%,未发生严重不良事件或不良反应,组间比较差异均无统计学意义(P=0.470 5、0.275 0)。结论:富马酸卢帕他定片能够安全、有效控制慢性特发性荨麻疹患者的症状。

OBJECTIVE To evaluate the efficacy and safety of rupatadine tablets against chronic idiopathic urticaria.METHODS Totally 144 patients with chronic idiopathic urticaria were enrolled and divided into 2 groups equally in a randomized,double blind,multicenter,parallel active controlled study.Patients in test group received rupatadine tablets,10 mg per day for 28 days consecutively.Patients in control group were given cetirizine dihydrochloride tablets,10 mg per day for 28 days consecutively.Mean value of reduced symptom score,effective rate,adverse events and findings of laboratory investigation were used to evaluate the efficacy and safety of rupatadine tablets.RESULTS All patients were eligible for efficacy analysis（72 each in test and control groups）.The mean value of reduced symptom score was（7.60±3.56）points in test group and（7.65±3.42）points in control group before and 4 weeks after treatment,the intergroup difference was statistically significant before and after treatment（P0.000 1）,while intragroup difference showed no statistical significance（P=0.917 5）.The clinical efficacy rate was 80.56%in test group and 83.33%in control group（P=0.656 6）.The non inferiority test on decrease of total score of clinical symptoms and signs after 4 weeks of treatment showed that,the test group was not inferior to the control group.The incidence rates of general adverse events and adverse reactions occurred were 11.11%vs.16.67% and 6.94%vs.13.89%in two groups（P=0.470 5,0.275 0）.No serious adverse event or adverse reaction occurred.CONCLUSION The study indicates that rupatadine tablets can control the symptoms of chronic idiopathic urticaria effectively and safely.