目的 探讨不同剂量雷公藤颗粒联合紫癜I号方治疗儿童反复发作性过敏性紫癜（recurrent Henoch-Schönlein purpura，RHSP）的疗效及近期安全性。方法 筛选2020年4～12月河南中医药大学第一附属医院儿科肾脏病区RHSP患儿144例，随机分为试验1组、试验2组、中医对照组和西医对照组。试验1组给予0.025 g/（kg·d）雷公藤颗粒[雷公藤饮片0.5 g/（kg·d）]＋紫癜I号方，试验2组给予0.035 g/（kg·d）雷公藤颗粒[雷公藤饮片0.7 g/（kg·d）]＋紫癜I号方，中医对照组给予紫癜I号方，西医对照组给予氯雷他定＋维生素C＋泼尼松片。治疗4周，随访8周，比较4组疗效及不良反应。结果 试验1组、试验2组皮疹疗效、临床疗效均优于中医对照组和西医对照组，差异有统计学意义（P<0.05）。治疗后试验2组中医症状总积分、皮疹（主症）积分、次症积分均优于试验1组、中医对照组、西医对照组，差异有统计学意义（P<0.05）。4组患儿不良反应发生率、皮疹复发率、肾脏损伤发生率差异均无统计学意义（P>0.05）。结论 0.025、0.035 g/（kg·d）剂量雷公藤颗粒联合紫癜I号方可促进RHSP患儿皮疹消退，以0.035 g/（kg·d）雷公藤颗粒总有效率更高，短期临床应用未发现明显不良反应。

Objective To explore the efficacy and short-term safety of different doses of Tripterygium wilfordii Granules (雷公藤颗粒) combined with Purpura No. I prescription (紫癜I号方) for children with recurrent Henoch-Schönlein purpura. Methods A total of 144 children with RHSP were screened from the pediatric kidney disease area of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from April to December 2020. They were randomly divided into test 1 group, test 2 group, Chinese medicine control group and western medicine control group. Test 1 group was given 0.025 g/(kg·d) Tripterygium wilfordii Granules[0.5 g/(kg·d) of Tripterygium wilfordii decoction]+Purpura No. I prescription, test 2 group was given 0.035 g/(kg·d) Tripterygium wilfordii granules[0.7 g/(kg·d) of Tripterygium wilfordii decoction]+Purpura No. I prescription, Chinese medicine control group was given Purpura No. I prescription, and western medicine control group was given loratadine+vitamin C+Prednisone Tablets. All children were treated for 4 weeks and followed up for 8 weeks to comparative efficacy and adverse effects. Results The curative effect of skin rash and clinical efficacy in test 1 group and test 2 group were better than that of Chinese medicine control group and the western medicine control group, the differences were statistically significant (P < 0.05). The total scores of Traditional Chinese medicine (TCM) symptoms, rash (primary symptom) scores, and secondary symptom scores of test 2 group after treatment were better than those of test 1 group, Chinese medicine control group, and western medicine control group, the differences also were statistically significant (P < 0.05). There were no significant differences in the incidence of adverse reactions, rash recurrence, and renal injury in the four groups (P > 0.05). Conclusion 0.025 g/(kg·d) and 0.035 g/(kg·d)Tripterygium wilfordii Granules combined with Purpura No. I prescription both can promote the regression of rash in children, and the total effective rate of 0.035 g/(kg·d) Tripterygium wilfordii Granules were higher, no obvious adverse reactions were found on short-term clinical application.

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河南省特色骨干学科中医学学科建设项目（STG-ZYXKY-2020010）；河南省中医药科学研究专项课题（20-21ZY2031）；中国民族医药学会科研项目（2020ZY265-400603）；全国名中医工作室建设项目（2100601-CZ0138）；国家自然基金面上项目（81873343）；河南省中医药科学研究专项课题（2019ZY1010）