目的 以盐酸西替利嗪片为对照，探索荆防合剂治疗荨麻疹的有效性和安全性。方法 将符合研究方案纳排标准的72例临床确诊的自发性荨麻疹患者，按照1∶1比例采用区组随机分为治疗组和对照组，每组36例，治疗组服用荆防合剂，口服，2支/次，3次/d。对照组服用盐酸西替利嗪片，口服，1片/次，1次/d或每日早晚各1次，每次半片。疗程14 d，患者分别在治疗第7、14天接受随访。比较两组治疗后，7日荨麻疹活动度评分（urticaria activity score over 7 days，UAS7）、UAS7＜7的受试者比例、荨麻疹症状消失时间、皮肤科生活质量指数（dermatology life quality index，DLQI）、症状积分下降指数（symptom score reduction index，SSRI），评价荆防合剂治疗荨麻疹的疗效和安全性。结果 治疗后，两组愈显率和总有效率无明显差异（P＞0.05）。治疗后，两组UAS7差异无统计学意义（P＞0.05）。治疗第7天，治疗组和对照组UAS7＜7的受试者比例分别为15.63%和48.57%，组间比较差异有统计学意义（P＜0.05）；治疗第14天，组间比较差异无统计学意义（P＞0.05）。治疗组和对照组治疗第14天荨麻疹症状（瘙痒、风团）消失时间分别为（10.20±3.62）d和（10.60±4.83）d，消失率分别为64.00%和53.33%，组间比较差异无统计学意义（P＞0.05）。治疗第7、14天，与治疗前比较，两组DLQI差异均有统计学意义（P＜0.05），组间比较差异无统计学意义（P＞0.05）。治疗第14天，两组SSRI分别为84.27±26.00和68.68±40.68，组间比较差异无统计学意义（P＞0.05）。治疗期间未发生严重不良事件。结论 荆防合剂治疗荨麻疹的总体疗效与盐酸西替利嗪片相当，且该药安全性良好，值得临床推广应用。

Objective To explore the efficacy and safety of Jingfang Mixture (荆防合剂) in treatment of urticaria, with cetirizine hydrochloride tablets as the control. Method A total of 72 patients with clinically diagnosed spontaneous urticaria who met the inclusion criteria outlined in the study protocol, were randomly assigned to either the treatment group or the control group at a 1∶1 ratio, with 36 participants in each group. The treatment group received Jingfang Mixture orally, two vials three times daily, while the control group took cetirizine hydrochloride tablets orally at one tablet once daily or half tablet twice daily in the morning and evening. The treatment course lasted 14 days, with follow-ups conducted on the 7th and 14th days of the treatment respectively. After the treatment of the two groups, efficacy and safety were evaluated by comparing the urticaria activity score over 7 days (UAS7), proportion of subjects with UAS7 < 7, urticaria symptom disappearance time, dermatology life quality index (DLQI), and symptom score reduction index (SSRI) between the groups. Result After the treatment, there was no significant difference in the cure rate and total effective rate between the two groups (P > 0.05). There was no statistically significant difference in the 7-day urticaria activity score between the two groups (P > 0.05). on the 7th day, the proportion of subjects with UAS7 < 7 in the experimental group and the control group was 15.63% and 48.57%, respectively, and the difference between the groups was statistically significant (P < 0.05); On the 14th day, with no statistically significant difference between the groups (P > 0.05). The disappearance time of urticaria symptoms (itching, wheals) in the experimental group and control group within 14 days of medication was (10.2 ± 3.62) d and (10.6 ± 4.83) d, respectively, with no statistically significant difference between the groups (P > 0.05). On the 14th day after taking the medication, the number of subjects in the experimental group and the control group whose urticaria symptoms (itching, wheals) disappeared (disappearance rate) were 16 cases (64.00%) and 16 cases (53.33%), respectively, with no statistically significant difference between the groups (P > 0.05). On the 7th and 14th day after medication, there were statistically significant differences (P < 0.05) in the dermatology quality of life index (DLQI) between the experimental group and the control group compared to baseline, while there was no statistically significant difference (P > 0.05) between the groups. the SSRI of the experimental group and the control group were 84.27 ± 26.00 and 68.68 ± 40.68, respectively, with no statistically significant difference between the groups (P > 0.05). No serious adverse events occurred in this study. Conclusion The overall efficacy of Jingfang Mixture is comparable to that of cetirizine hydrochloride tablets. Moreover, the drug has good safety and is worthy of clinical promotion and application.

R285.64

国家重点研发计划“中医药现代化”重点专项（2022YFC3502100）