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-Schönlein purpura:a prospective randomized controlled trial

目的探讨阿法骨化醇对过敏性紫癜(Henoch-Schönlein purpura,HSP)患儿血清25羟基维生素D_(3)[25-(OH)D_(3)]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0.25μg/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)D_(3)水平、T淋巴细胞亚群指标(CD_(3)^(^(+))、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)D_(3)水平高于对照组(P<0.05);观察组CD_(3)^(+)、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)D_(3)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。

Objective To study the effects of alfacalcidol on serum 25-(OH)D_(3) level,cellular immune function,and inflammatory factors in children with Henoch-Schönlein 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(0.25μg/d)orally before bed for 4 weeks.The two groups were compared in terms of the level of 25-(OH)D_(3),the percentages of T lymphocyte subsets(CD_(3)^(+),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)D_(3) level,significantly higher percentages of CD_(3)^(+)T cells,CD4^(+)T cells,and NK cells,and significantly lower levels of IL-6,IL-17,IL-21,and TNF-αcompared 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)D_(3) level,improve cellular immune function,decrease inflammatory factor levels,and reduce recurrence and renal damage in children with HSP.