盐酸奥洛他定片治疗慢性特发性荨麻疹疗效和安全性的多中心临床研究

发布时间：2018-04-30 15:18

本文选题：盐酸奥洛他定 + 氯雷他定　；参考：《中国医院药学杂志》2017年16期

【摘要】：目的:观察盐酸奥洛他定片治疗慢性特发性荨麻疹的临床疗效及安全性。方法:采用随机、双盲双模拟、阳性药物平行对照、多中心的试验方法,试验组和对照组共纳入150例。分别采用盐酸奥洛他定片,每次1片,每日2次;氯雷他定片,每次1片,每日1次,2组分别给予盐酸奥洛他定和氯雷他定模拟片,连续给药4周。疗程结束时以症状体征总积分下降指数、总有效率及疾病总体改善情况等来评估其临床疗效,以不良事件及不良反应、实验室检查来评估其安全性。结果:纳入符合方案分析集(PPS)的病例数为143例,试验组72例,对照组71例。总有效率分别为83.33%和80.28%(P0.05)。25例患者发生43例次不良事件(试验组14人20例次,对照组11人23例次),其中37例次不良事件与药物相关,主要表现为口干、头晕、嗜睡、乏力、上腹痛、谷丙转氨酶ALT升高、谷草转氨酶AST升高等。2组间不良事件及不良反应发生率差异无统计学意义(P0.05),无严重不良事件发生。结论:盐酸奥洛他定片治疗慢性特发性荨麻疹,疗效显著,安全性好。
[Abstract]:Objective: to observe the clinical efficacy and safety of oloatadine hydrochloride in the treatment of chronic idiopathic urticaria. Methods: a randomized, double-blind, double-simulated, positive drug parallel control, multicenter trial method was used. 150 cases were enrolled in the trial group and control group. Olitadine hydrochloride and loratadine hydrochloride were given for 4 weeks respectively in two groups: ollotadine hydrochloride and loratadine hydrochloride, one tablet per day, and one tablet, one tablet per day, and two groups were treated with ollotadine hydrochloride and loratadine hydrochloride respectively for 4 weeks. At the end of the course, the clinical efficacy was evaluated by the index of the total score of symptoms and signs, the total effective rate and the overall improvement of the disease, and the safety was evaluated by the adverse events and adverse reactions, and the laboratory examination. Results: 143 cases of PPS were included in the protocol analysis, 72 cases in the trial group and 71 cases in the control group. The total effective rate was 83.33% and 43 adverse events occurred in 80.28%(P0.05).25 patients (n = 14, n = 20) and control group (n = 11, n = 23). Among them, 37 cases were related to drugs, such as dry mouth, dizziness, lethargy, fatigue and upper abdominal pain. There was no significant difference in the incidence of adverse events and adverse reactions between the two groups (P 0.05), and no serious adverse events occurred. Conclusion: olitadine hydrochloride tablet is effective and safe in the treatment of chronic idiopathic urticaria.
【作者单位】：华中科技大学同济医学院附属同济医院;武汉大学人民医院;皖南医学院弋矶山医院;
【分类号】：R758.24

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