紫癜康方干预儿童过敏性紫癜复发的前瞻性随机对照研究

Prospective Randomized Controlled Study of Zidiankang Intervention in Children with Recurrence of Henoch-Schonlein Purpura

目的观察紫癜康方对儿童过敏性紫癜复发的干预作用并探讨其作用机制。方法118例患儿采用前瞻性随机对照研究的方法,分为治疗组79例与对照组39例。治疗组予口服紫癜康方4周,对照组不予药物治疗,均随访24周,分别于0、4、8、12、24周评估两组患儿的症状改善及复发情况。结果两组治疗前血清白细胞介素-1(IL-1)、白细胞介素-6(IL-6)、免疫球蛋白A(IgA)、免疫球蛋白G(IgG)、免疫球蛋白M(IgM)、免疫球蛋白E(IgE)水平比较,差异均无统计学意义(均P>0.05)。两组治疗4周后两组血清IL-6、IgA、IgE水平与治疗前比较,均降低(P<0.05),且治疗组均低于对照组(P<0.05);两组血清IL-1、IgG、IgM水平与治疗前及组间比较,差异均无统计学意义(均P>0.05)。治疗组在4周、8周、12周、24周时复发率均低于对照组,但仅在24周时差异具有统计学意义(P<0.05)。治疗组治疗24周后复发率25.32%,低于对照组的46.15%(P<0.05)。治疗组皮疹平均反复次数在4周、8周、12周、24周时均少于对照组,但仅在24周时差异具有统计学意义(P<0.05)。治疗组在4周、8周、12周、24周时肾脏损害发生率比较,差异均无统计学意义(均P>0.05)。两组患者治疗前后血常规、肝功能、肾功能等安全性检测指标均未见明显异常,亦无不良反应及不良事件发生。结论紫癜康方可降低过敏性紫癜患儿的复发率,减少皮疹复发次数,促进机体免疫功能改善。

Objective:To observe the intervention effect of Zidiankang on the recurrence of Henoch-Schonlein purpura(HSP)in children.Methods:A total of 118 children with HSP were enrolled and studied in a prospective randomized controlled study.They were divided into the treatment group of 79 cases and the control group of 39 cases.The observation group was given oral Zidiankang for 4 weeks,and the control group was not treated with drugs.They were followed for 24 weeks,and the symptom improvement and recurrence of the two groups were assessed at 0,4,8,12 and 24 weeks,respectively.Results:There were no significant differences in serum IL-1,IL-6,IgG,IgA,IgM and IgE levels before treatment between the two groups(all P>0.05).After 4 weeks o£treatment,serum IL-6,IgA and IgE levels in both groups decreased compared with before treatment(P<0.05),and the treatment group was lower than that in the control group(P<0.05),while the serum IL-1,IgG and IgM levels in the two groups were not significantly compared with before treatment and serum IL-1,IgG and IgM levels between the two groups(all P>0.05).The recurrence rates in the treatment group at 4,8,12 and 24 weeks were lower than those in the control group,but the difference was statistically significant only at 24 weeks(P<0.05).The recurrence rate after treatment in the treatment group was 25.32%,which was lower than 25.32%of the control group(P<0.05).The average number of rash recurrences in the treatment group was lower than that in the control group at 4,8,12 and 24 weeks,but the difiference was statistically significant only at 24 weeks(P<0.05).The incidence of renal impairment in the treatment group at 4,8,12 and 24 weeks was not significantly different(all P>0.05).There were no obvious abnormalities in the safety teatindicators such as blood routine,liver function and kidney function before and after treatment in the two groups,and there were no adverse reactions or adverse events.Conclusion:Zidiankang can significantly reduce the recurrence rate of children with HSP,reduce the number of rash recurrences,and promote the improvement of the body's immune function.