复方仙鹤颗粒治疗儿童难治性过敏性紫癜的临床研究

Clinical Study on Refractory Allergic Purpura in Children Treated with Compound Xianhe Granules(复方仙鹤颗粒)

目的:观察复方仙鹤颗粒治疗难治性过敏性紫癜的临床疗效及其对免疫、炎症、凝血相关指标的影响。方法:将120例过敏性紫癜患儿,按照随机数字表法分为观察组和对照组,每组60例,两组患儿均给予西医常规治疗,在此基础上对照组口服槐杞黄颗粒,观察组加用复方仙鹤颗粒口服,连续治疗8周后评价两组患儿的疗效,观察两组患儿皮疹消退时间,复发次数,复发间隔时间,每2周检测尿常规;治疗前后两组患儿分别进行安全性指标(血常规、肝肾功能、电解质)、免疫相关指标(细胞因子、免疫球蛋白IgA、IgE)、炎性和凝血相关指标[C反应蛋白(CRP)、抗链球菌溶血素O(ASO)、D二聚体(D-D)]检测;并在6个月内进行随访,比较两组复发率。结果:观察组总有效率为86.7%,对照组为63.3%,观察组总有效率显著高于对照组(P<0.05)。与对照组相比,观察组治疗后皮疹持续时间缩短,复发次数减少、复发间隔时间更长(P<0.05);但两组患儿治疗后肾脏损伤改善比较无统计学意义(P>0.05)。治疗后,两组患者IL-2水平均高于治疗前,IL-4、IL-6、IL-10水平均低于治疗前(P<0.05),且治疗后观察组IL-2水平高于对照组,IL-4、IL-6、IL-10水平显著低于对照组(P<0.05),TNF-α水平两组之间差异无统计学意义(P>0.05);治疗后两组IgA水平均低于治疗前(P<0.05),且观察组IgA水平显著低于对照组(P<0.05),IgE水平两组之间差异无统计学意义(P>0.05);治疗后两组ASO、CRP、D-D水平均低于治疗前(P<0.05),且观察组ASO、CRP、D-D水平显著低于对照组(P<0.05);观察组复发率低于对照组(P<0.05)。结论:对于难治性过敏性紫癜,应用复方仙鹤颗粒联合西药治疗,临床疗效显著而且安全性好,特别是在治疗皮肤型过敏性紫癜较有优势,可缩短过敏性紫癜患者的皮疹持续时间,有效降低复发率,改善长期预后。作用机制可能与调节Th1/Th2免疫平衡,控制炎症反应,改善血液高凝状态有关。

Objective:To observe the curative effect of Compound Xianhe Granules in the treatment of refractory allergic purpura in children and its effects on immune,inflammatory and coagulation related indexes.Methods:120 children with allergic purpura were divided into observation group and control group according to random number table method with 60 cases each,both groups were given conventional Western medicine treatment,on the basis of which the control group was given oral Huaiqihuang Granules,and the observation group was given oral Compound Xianhe Granules,after 8 weeks of continuous treatment,the curative effect was evaluated,the time of rash remission,the number of recurrence,the interval of recurrence were observed in both groups,and urine routine was tested every 2 weeks;before and after treatment,patients in both groups the safety indexes(blood routine,liver and kidney function,electrolytes),immune-related indexes(cytokine,immunoglobulin IgA,IgE),inflammatory and coagulation-related indexes(C-reactive protein,anti-streptococcal hemolysin(ASO),D-dimer)were tested respectively;and follow-up was performed within 6 months to compare the recurrence rate of the two groups.Results:The total effective rate was 86.7%in the observation group and 63.3%in the control group,and the total effective rate of the observation group was significantly higher than that of the control group(P<0.05).Compared with the control group,the duration of rash was shortened,and the number of recurrences was reduced and the interval between recurrences was prolonged more significantly in the observation group(P<0.05).However,there was no statistically significant on improvement of renal injury compared between the two groups after treatment(P>0.05);After treatment,the levels of IL-2 in both groups were higher than those before treatment,and the levels of IL-4,IL-6 and IL-10 were lower than those before treatment(P<0.05),and the levels of IL-2 in the observation group were higher than that in the control group,and the levels of IL-4,IL-6 and IL-10 were significantly lower than those in the control group after treatment(P<0.05),and the differences in the level of TNF-αwere not statistically significant between the two groups(P>0.05);IgA was lower than before treatment in both groups(P<0.05),and IgA in the observation group was significantly lower than that in the control group(P<0.05),and there was no statistically significant difference between the two groups in IgE(P>0.05);ASO,CRP,and D-D levels were lower than those before treatment in both groups(P<0.05),and the ASO,CRP,and D-D levels in observation group were significantly lower than those in the control group(P<0.05);the relapse rate of the observation group was lower than that of the control group(P<0.05).Conclusion:For refractory allergic purpura,the application of Compound Xianhe Granules combined with Western medicine is clinically effective and safe,especially in the treatment of cutaneous allergic purpura,which can shorten the duration of rash,effectively reduce the recurrence rate and improve the long-term prognosis of patients with allergic purpura.The mechanism may be related to the regulation of Th1/Th2 immune balance,control of inflammatory response,and improvement of blood hypercoagulability.