孟鲁司特片联合玉屏风颗粒治疗过敏性紫癜的临床研究

Clinical trial of montelukast tablets combined with Yupingfeng granules in the treatment of allergic purpura

目的观察孟鲁司特片联合玉屏风颗粒治疗儿童过敏性紫癜的临床疗效及安全性。方法将130例过敏性紫癜患儿随机分为对照组65例和试验组65例。对照组予以口服孟鲁司特,3~4岁4 mg·d^(-1),6岁以上5 mg·d^(-1),每晚睡前给药一次;试验组在对照组治疗的基础上,予以口服玉屏风颗粒,3~7岁每次2.5 g,7~14岁每次5 g,tid。2组患者均治疗3个月。比较2组患儿的临床疗效、复发率,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.84%(61/65例)和75.38%(49/65例),复发率分别为0(0/65例)和15.38%(10/65例),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有头晕、腹泻、发热,对照组发生的药物不良反应主要有发热、恶心、头晕、胸闷。试验组和对照组的药物不良反应发生率分别为6.15%和7.69%,差异无统计学意义(P>0.05)。结论孟鲁司特片联合玉屏风颗粒治疗儿童过敏性紫癜的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of montelukast tablets combined with Yupingfeng granules in the treatment of allergic purpura. Methods A total of 130 children with allergic purpura were randomly divided into control group and treatment group with 65 cases per group. Control group was treated with montelukast, 4 mg·d-1 for 3 -4 years old, 5 mg· d- 1 for 〉 6 years old, every night, oral. Treatment group was given Yupingfeng granules, 2. 5 g each time for 3 -7 years old,5 g each time for 7 -14 years old, tid, oral, on the basis of the control group. Two groups were treated for 3 months. The clinical efficacy, recurrence rate and adverse drug reactions were com- pared between two groups. Results After treatment, the total effective rates in treatment and control groups were 93.84% （61/65 cases） and 75.38% （49/65 eases）,the recurrence rates in treatment and control groups were 0 （ 0/65 cases ） and 15.38% （ 10/65 cases ）, the differences were statistically significant （ all P 〈 0. 05 ）. The adverse drug reactions in treatment group were dizziness, diarrhea and fever, which in control group were fever, nausea, dizziness and chest tightness. The incidences of adverse drug reactions in treatment and control groups were 6. 15% and 7.69% without significant difference （ P 〉 0.05 ）.Conclusion Montelukast tablets combined with Yupingfeng granules have a definitive clinical efficacy in the treatment of allergic purpura, without increasing the incidence of adverse drug reactions.