目的 观察蜕紫颗粒治疗儿童过敏性紫癜皮疹反复发作和预防肾损害的临床疗效及对免疫功能的影响。方法 选取2018年1月-2019年10月在湖北省中医院门诊及住院部首次就诊的过敏性紫癜皮疹反复发作的70例患儿，按照随机数字表法分为观察组和对照组，各35例。观察组给予蜕紫颗粒加常规治疗，对照组给予安慰剂加常规治疗。治疗4周后观察两组患儿皮疹、肾损害情况及淋巴细胞亚群变化，并随访半年，观察两组皮疹的复发率及肾损害发生率。结果 观察组最终各纳入35例，对照组最终各纳入33例。两组治疗后紫癜范围、皮疹发作次数、肾脏损害积分较治疗前显著降低，有显著性差异（P < 0.05），且观察组治疗后较对照组有显著性差异（P < 0.05）。两组治疗后CD3⁺、CD4⁺、CD4⁺/CD8⁺水平较治疗前显著增高（P < 0.05），且观察组治疗后较对照组有显著性差异（P < 0.05）。两组治疗后CD8⁺水平较治疗前显著降低（P < 0.05），且观察组治疗后较对照组有显著性差异（P < 0.05）。随访6个月，观察组皮疹复发率明显低于对照组，且有显著性差异（P < 0.05）。观察组新增肾脏损害率明显低于对照组，且有显著性差异（P < 0.05）。治疗过程中未见不良反应。结论 蜕紫颗粒对过敏性紫癜皮疹反复发作疗效确切，可以有效减轻皮疹症状、肾脏损害，减少发作次数，并减少过敏性紫癜半年的复发率，且疗效持续稳定、安全性良好；蜕紫颗粒疗效机制可能与提高CD3⁺、CD4⁺细胞、CD4⁺/CD8⁺水平，抑制CD⁸⁺水平相关。

Objective To observe the clinical efficacy of Tuizi granule in the treatment of children with Henoch Schonlein purpura and the prevention of renal damage and its influence on immune function.Methods From January 2018 to October 2019, 70 children with Henoch Schonlein purpura recurrent attacks were selected from the outpatient department and inpatient department of Hubei Hospital of traditional Chinese medicine for the first time. They were randomly divided into observation group and control group with 35 cases in each group. The observation group was given Tuizi Granule and conventional treatment, while the control group was given placebo plus conventional treatment. After 4 weeks of treatment, the rash, renal damage and lymphocyte subsets were observed in the two groups, and the recurrence rate of skin rash and the incidence of renal damage in the two groups were observed.Results The observation group were finally included in 35 cases,and the control group were finally included in 33 cases. After treatment,the purpura range, rash attack times and kidney damage score of the two groups were significantly lower than those before treatment (P < 0.05), and the observation group was significantly different from the control group after treatment (P < 0.05). After treatment, the levels of CD3⁺, CD4⁺, CD4⁺/CD8⁺ in the two groups were significantly higher than those before treatment, with significant difference (P < 0.05), and there was significant difference between the observation group and the control group after treatment (P < 0.05). After treatment, the level of CD8 ⁺ in the two groups was significantly lower than that before treatment, with significant difference (P < 0.05), and there was significant difference between the observation group and the control group after treatment (P < 0.05). After 6 months, the recurrence rate of skin rash in the observation group was significantly lower than that in the control group (P < 0.05). The new renal damage rate of the observation group was significantly lower than that of the control group,and there was a significant difference (P < 0.05). There was no adverse reaction during the treatment. Conclusion Tuizi granule has a definite curative effect on repeated attacks of Henoch Schonlein purpura. It can effectively reduce the rash symptoms and attack times, improve kidney damage,and reduce the recurrence rate of Henoch Schonlein purpura for half a year, the curative effect is stable, and its safety were good. The therapeutic mechanism may be related to the increase of CD3⁺, CD4⁺ cells, CD4⁺/CD8⁺ levels and inhibition of CD8⁺ levels.

湖北省中医院院级项目（2021YJKT-17）：基于“风热湿瘀”理论中医内外合治儿童过敏性紫癜的临床研究（2021YJKT-17），；负责人：王林群；。国家中医药管理局2010年全国名老中医药专家传承工作室建设项目（国中医药人教发[2010]59号）：“倪珠英名老中医药专家传承工作室”项目（国中医药人教发[2010]59号），；负责人：刘晓鹰；。湖北省中医院“五专”建设项目—过敏性紫癜，；负责人：刘晓鹰。湖北中医药大学“十四五”优秀学科团队建设项目，负责人：刘建忠。