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

发布时间：2019-02-22 13:33

【摘要】：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(P0.000 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。
[Abstract]:Objective: to evaluate the efficacy and safety of Lupatadine fumarate in the treatment of chronic idiopathic urticaria. Methods: a multicenter, randomized, double-blind, parallel positive control trial was used. The observation group was treated with Lupatadine fumarate and the control group with cetirizine hydrochloride. Continuous administration for 28 days. At the end of the course, the clinical efficacy was evaluated by the decrease of the total score of clinical symptoms, and the safety was evaluated by adverse events, adverse reactions and laboratory tests. Results: a total of 144 patients were included in the (FAS): observation group and the control group. The total scores of the clinical symptom scores of the two groups were (7.60 卤3.56), (7.65 卤3.42) before and 4 weeks after treatment. There was significant difference between the two groups (P0. 000 1), but there was no significant difference between the two groups (P0. 917 5). The effective rate was 83.33% (P 0.656 6). Four weeks after treatment, the patients in the two groups were tested for the non-inferior effect of the total score of clinical symptoms and signs, and the observation group was not inferior to the control group. The incidence of general adverse events and adverse reactions between the two groups was 11.11% and 6.94%, respectively. No serious adverse events or adverse reactions occurred. There was no significant difference between the two groups (P < 0. 4705 卤0. 275 0). Conclusion: Lupatadine fumarate is safe and effective in controlling the symptoms of patients with chronic idiopathic urticaria.
【作者单位】：南京医科大学附属南京医院(南京市第一医院);扬子江药业集团南京海陵药业有限公司;
【分类号】：R758.24

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