10毫克左西替利嗪与5毫克左西替利嗪联合10毫克孟鲁司特治疗对5毫克左西替利嗪耐药的慢性荨麻疹的有效性和安全性：一项双盲、随机、对照试验。

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.

作者信息

Sarkar Tushar Kanti, Sil Amrita, Pal Santasmita, Ghosh Chinmoy, Das Nilay Kanti

机构信息

Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.

Department of Pharmacology, Institute of Post Graduate Education and Research, Kolkata, West Bengal, India.

出版信息

Indian J Dermatol Venereol Leprol. 2017 Sep-Oct;83(5):561-568. doi: 10.4103/ijdvl.IJDVL_551_16.

DOI:10.4103/ijdvl.IJDVL_551_16

PMID:28656910

Abstract

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.

摘要

背景

慢性荨麻疹对患者和治疗医生来说都是一个棘手的问题。欧洲变态反应和临床免疫学会（EAACI）/全球变态反应和临床免疫学会（GA[2]LEN）/欧洲皮肤病学论坛（EDF）/世界变态反应组织（WAO）指南提倡在加用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。患者通常难以耐受这些更高的剂量。我们开展这项研究以确定在标准抗组胺药剂量基础上加用白三烯受体拮抗剂在疗效、安全性和生活质量改变方面是否与单独使用更高剂量的抗组胺药相当。我们比较了在对每日单剂量5mg左西替利嗪无反应的慢性荨麻疹患者中，10mg左西替利嗪（标准剂量的双倍）与5mg左西替利嗪和10mg孟鲁司特联合用药的效果。

方法

对120例对5mg左西替利嗪无反应的慢性荨麻疹患者进行了一项单中心、双盲、随机、活性药物对照、平行组IV期试验（CTRI/2014/12/005261）。患者被随机分为接受10mg左西替利嗪或5mg左西替利嗪+10mg孟鲁司特治疗4周。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）。监测血常规和生化常规检查以及治疗中出现的不良事件以评估安全性。

结果

分析了10mg左西替利嗪组的52例患者和5mg左西替利嗪+10mg孟鲁司特组的51例患者。两个治疗组的UAS和TSS均显著降低，且两组评分降低程度相当（分别为P = 0.628，P = 0.824）。在不良反应方面，10mg左西替利嗪组的镇静作用更明显（P = 0.013）。5mg左西替利嗪+10mg孟鲁司特组的生活质量显著改善（P = 0.031）。