Clinical trial of montelukast sodium combined with desloratadine citrate disodium in the treatment of patients with chronic urticaria
Objective To observe the clinical efficacy and safety of montelukast sodium chewable tablets combined with desloratadine citrate disodium tablets in the treatment of patients with chronic urticaria.Methods Patients with chronic urticaria were divided into control group and treatment group according to cohort method.Control group was treated with montelukast sodium chewable tablets 10 mg per night,orally chewed.On the basis of control group,the treatment group was treated with desloratadine citrate disodium tablets 8.8 mg each time,qd,orally.Two groups of patients were treated for 4 weeks.The clinical efficacy,serum levels of immunoglobulin E(IgE),interleukin-4(IL-4)and interferon-γ(INF-γ),and adverse drug reactions were compared between two groups.Results The treatment group and control group were enrolled with 68 and 66 cases,respectively.After treatment,the total effective rates of treatment and control groups were 95.59％(65 cases/68 cases)and 83.33％(55 cases/66 cases)with significant difference(P＜0.05).After treatment,the IgE levels of treatment and control groups were(70.55±8.50)and(92.57±9.65)U·mL-1;the IL-4 levels were(6.87±1.35)and(8.49±1.23)pg·mL-1;the INF-γ levels were(23.24±6.87)and(19.83±6.75)pg·mL-1;the differences were statistically significant(all P＜0.05).The adverse drug reactions of treatment group were drowsiness and fatigue,while those in the control group were drowsiness and fatigue.The total incidences of adverse drug reactions in the treatment and control groups were 8.82％and 4.55％without significant difference(P＞0.05).Conclusion Montelukast sodium chewable tablets combined with desloratadine citrate disodium tablets have a definitive clinical efficacy in the treatment of patients with chronic urticaria,which can effectively regulate the serum levels of IgE,IL-4 and INF-γ,without increasing the incidence of adverse reactions.
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