阿法骨化醇治疗儿童过敏性紫癜的前瞻性随机对照研究

Clinical effect of alfacalcidol in children with Henoch-Sch?nlein purpura: a prospective randomized controlled trial

摘要:

目的 探讨阿法骨化醇对过敏性紫癜（Henoch-Sch?nlein purpura，HSP）患儿血清25羟基维生素D₃［25-(OH)D₃］水平、细胞免疫功能及炎性因子的影响。 方法 前瞻性选取2018年6月至2020年6月诊断为HSP的患儿200例为研究对象，按照随机数字表法分为观察组及对照组各100例。对照组给予维生素C、芦丁片、双嘧达莫、西咪替丁、钙剂、糖皮质激素等治疗，观察组在对照组的基础上加用阿法骨化醇软胶囊0.25 μg/d，睡前口服，疗程4周。于治疗前及治疗4周后检测并比较患儿25-(OH)D₃水平、T淋巴细胞亚群指标（CD3⁺、CD4⁺、CD8⁺）、NK细胞百分率和炎性因子指标（IL-6、IL-17、IL-21、肿瘤坏死因子-α）；随访6个月，统计患儿复发率及肾损害发生率。 结果 治疗后，观察组血清25-(OH)D₃水平高于对照组（P<0.05）；观察组CD3⁺、CD4⁺和NK细胞水平高于对照组（P<0.05）；观察组IL-6、IL-17、IL-21、肿瘤坏死因子-α水平低于对照组（P<0.05）。随访6个月，观察组复发率及肾损害发生率低于对照组（P<0.05）。 结论 对HSP患儿加用阿法骨化醇，能提高血清25-(OH)D₃水平，并改善细胞免疫功能及炎性因子水平，降低患儿HSP复发率及肾损害发生率。

Abstract:

Objective To study the effects of alfacalcidol on serum 25-(OH)D3 level, cellular immune function, and inflammatory factors in children with Henoch-Sch?nlein purpura (HSP). Methods A total of 200 children with HSP were prospectively enrolled from June 2018 to June 2020. According to the random number table method, they were divided into an observation group and a control group (n=100 each). The control group was treated with vitamin C, rutin tablets, dipyridamole, cimetidine, calcium supplements, and glucocorticoids. In addition to the treatment for the control group, the observation group received alfacalcidol capsules (0.25 μg/d) orally before bed for 4 weeks. The two groups were compared in terms of the level of 25-(OH)D3, the percentages of T lymphocyte subsets (CD3+, CD4+, and CD8+) and NK cells, and the levels of inflammatory factors, interleukin-6 (IL-6), interleukin-17 (IL-17), interleukin-21 (IL-21), and tumor necrosis factor-α (TNF-α), before treatment and after 4 weeks of treatment. The children were followed up for 6 months to determine the recurrence rate and the incidence of renal damage. Results After treatment, the observation group showed a significantly higher serum 25-(OH)D3 level, significantly higher percentages of CD3+T cells, CD4+T cells, and NK cells, and significantly lower levels of IL-6, IL-17, IL-21, and TNF-α compared with the control group (P<0.05). After 6 months of follow-up, the recurrence rate and the incidence of renal damage in the observation group were significantly lower than those in the control group (P<0.05). Conclusions Alfacalcidol can increase the serum 25-(OH)D3 level, improve cellular immune function, decrease inflammatory factor levels, and reduce recurrence and renal damage in children with HSP.