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首页> 外文期刊>Indian journal of dermatology, venereology and leprology >Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial
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Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial

机译：左西替利嗪10毫克与左西替利嗪5毫克和孟鲁司特10毫克联合治疗对耐左西替利嗪5毫克的慢性荨麻疹的有效性和安全性：一项双盲，随机，对照试验

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Background: Chronic urticaria is a vexing problem for patients and treating physicians alike. The EAACI/GA[2]LEN/EDF/WAO guidelines advocate an increased antihistamine dosage up to four times the standard, before adding leukotriene receptor antagonists. Patients are frequently intolerant of these higher dosages. We conducted this study to determine whether the addition of leukotriene receptor antagonists to the standard antihistamine dose was comparable to higher dosages of antihistamines alone, in terms of efficacy, safety and quality of life changes. We compared levocetirizine 10 mg (double dose of standard) versus a combination of levocetirizine 5 mg and montelukast 10 mg in cases of chronic urticaria not responding to single daily dose of 5 mg levocetirizine. Methods: A single-center, double-blind, randomized, active-controlled, parallel group phase IV trial (CTRI/2014/12/005261) was conducted on 120 patients of chronic urticaria of either sex not responding to 5 mg levocetirizine. Patients were randomized into receiving either levocetirizine 10 mg or levocetirizine 5 mg + montelukast 10 mg for 4 weeks. Primary outcome measures were Urticaria Activity Score (UAS) and Urticaria Total Severity Score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety. Results: Fifty-two patients on levocetirizine 10 mg group and 51 patients on levocetirizine 5 mg + montelukast 10 mg group were analyzed. UAS and TSS reduced significantly in both treatment groups and reduction of score were comparable in between the groups (P = 0.628, P = 0.824, respectively). Among adverse effects, sedation was noted significantly more (P = 0.013) in levocetirizine 10 mg group. Quality of life was significantly improved in levocetirizine 5 mg + montelukast 10 mg group (P = 0.031). Limitations: The limitation of the study was that the follow-up period was 4 weeks. Conclusion: EAACI/GA[2]LEN/EDF/WAO guidelines need to be more flexible in allowing usage of montelukast before escalation of anti-histamine dosage.
机译：背景：慢性荨麻疹对于患者和治疗医师而言都是一个烦人的问题。 EAACI / GA [2] LEN / EDF / WAO指南主张在添加白三烯受体拮抗剂之前，将抗组胺药剂量增加至标准剂量的四倍。患者经常不能耐受这些较高剂量。我们进行了这项研究，以确定在功效，安全性和生活质量改变方面，将白三烯受体拮抗剂添加至标准抗组胺药的剂量是否可与单独使用较高剂量的抗组胺药相媲美。我们比较了10 mg左西替利嗪（标准剂量的两倍）与5 mg左西替利嗪和10 mg孟鲁司特的组合对慢性荨麻疹的每日单剂量5 mg左西替利嗪无反应。方法：对120例对5 mg左西替利嗪无反应的慢性荨麻疹患者进行了单中心，双盲，随机，主动控制，平行分组IV期试验（CTRI / 2014/12/005261）。患者被随机分为两组，分别接受10 mg左西替利嗪或5 mg左西替利嗪+ 10 mg孟鲁司特。主要结局指标为荨麻疹活动评分（UAS）和荨麻疹总严重程度评分（TSS）。为了安全起见，对常规血液学和生化测试以及紧急治疗不良事件进行了监测。结果：分析了左西替利嗪10 mg组的52例患者和左西替利嗪5 mg +孟鲁司特10 mg组的51例患者。在两个治疗组中，UAS和TSS均显着降低，并且两组之间的评分降低相当（分别为P = 0.628，P = 0.824）。在不良反应中，左西替利嗪10 mg组的镇静作用明显增加（P = 0.013）。左西替利嗪5 mg +孟鲁司特10 mg组的生活质量得到显着改善（P = 0.031）。局限性：该研究的局限性是随访期为4周。结论：EAACI / GA [2] LEN / EDF / WAO指南在提高抗组胺剂量之前，应在允许孟鲁司特的使用方面更加灵活。

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