Objectives: Chronic urticaria presents a chronic process of recurrent attacks, and its first-line treatment is second-generation antihistamine with limited treatment options. The efficacy of antihistamine varies among individuals and cannot meet the needs of all patients. This study aims to explore the clinical efficacy and safety of Zhiyang Xiaozhen granules combined with antihistamine in the treatment of chronic urticaria patients.
Methods: We retrospectively analyzed the clinical data of patients with chronic urticaria who visited the Xiangya Hospital of Central South University from April 2020 to March 2021. The patients who received conventional second-generation antihistamine treatment were selected as a control group, while the patients who received combined treatment with Zhiyang Xiaozhen granules on the basis of conventional second-generation antihistamine treatment were selected as an observation group. The differences in the Weekly Urticaria Activity Score (UAS7) and Dermatology Life Quality Index (DLQI) between the 2 groups before and 4 weeks after treatment were compared. The Symptom Score Reduce Index (SSRI) was used to evaluate and compare the efficacy of the 2 treatment regimens.
Results: After 4 weeks of treatment, the UAS7 levels in both groups were significantly reduced (P=0.001 and P<0.001, respectively). The effective rates of the control group and the observation group were 61.11% and 59.38%, respectively when converting UAS7 to SSRI for efficacy evaluation, and there was no statistically significant difference in efficacy between the 2 groups (P>0.05); however, when converting DLQI to SSRI for efficacy evaluation, the effective rates of the control group and the observation group were 33.33% and 46.88%, respectively, and the difference in efficacy between the 2 groups was statistically significant (P<0.001). There were 3 patients with adverse drug reactions related to drowsiness in both groups.
Conclusions: The combination of Zhiyang Xiaozhen granules and second-generation antihistamine can effectively improve disease activity in patients with chronic urticaria, and the improvement in quality of life is better than that with the second-generation antihistamine alone.
目的: 慢性荨麻疹呈反复发作的慢性经过，其一线用药为第2代抗组胺药，治疗选择有限，且抗组胺药的疗效存在个体差异，并不能满足所有患者的需求。本研究旨在探索止痒消疹颗粒联合抗组胺药治疗慢性荨麻疹患者的临床疗效和安全性。方法: 回顾性收集2020年4月至2021年3月就诊于中南大学湘雅医院，且诊断为慢性荨麻疹的患者的临床资料。接受常规的第2代抗组胺药治疗的患者为对照组，在常规的第2代抗组胺药治疗的基础上联合使用止痒消疹颗粒治疗的患者为观察组。比较治疗前和治疗4周后2组7日荨麻疹活动度评分(Weekly Urticaria Activity Score，UAS7)及皮肤病生活质量指数(Dermatology Life Quality Index，DLQI)的差异，采用症状积分下降指数(Symptom Score Reduce Index，SSRI)评价并比较2种治疗方案的疗效。结果: 治疗4周后，2组的UAS7均明显降低(分别P=0.001，P<0.001)。尽管根据UAS7计算SSRI来评价疗效时，对照组和观察组的有效率分别为61.11%和59.38%，2组间疗效的差异无统计学意义(P>0.05)；但是在根据DLQI计算SSRI来疗效评价时，对照组和观察组的有效率分别为33.33%和46.88%，2组间疗效的差异有统计学意义(P<0.001)。2组均有3例患者存在嗜睡的药物不良反应。结论: 止痒消疹颗粒联合第2代抗组胺药可有效降低慢性荨麻疹患者的疾病活动度，且对生活质量的改善优于单用第2代抗组胺药。.
Keywords: Zhiyang Xiaozhen granules; antihistamine; chronic urticaria; clinical efficacy.