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目的评价紫丹颗粒对过敏性紫癜患儿的临床疗效及对肾损害的影响。方法将256例过敏性紫癜患儿随机分为观察组与对照组各128例,均给予常规治疗,观察组加用紫丹颗粒,对照组加用紫丹颗粒安慰剂,疗程均为4周,疗程结束后,进行西医疗效及中医证候疗效评定,均随访1年,记录患儿肾损害出现时间及发生情况。结果观察组肾损伤发病率为6.25%(8/128),对照组为14.84%(19/128),均表现为血尿、蛋白尿及孤立性血尿或蛋白尿,二组比较差异具有统计学意义(P<0.05);二组肾损伤发病时间是主要以0~3个月多见,二组肾损伤出现时间差异无统计学意义(P>0.05)。观察组西医总有效率为96.09%,对照组为85.94%;观察组中医证候总有效率为96.09%,对照组为79.81%,二组西医及中医证疗候疗效比较,差异具有统计学意义(P<0.05)。治疗期间均无明显不良反应发生。结论紫丹颗粒治疗过敏性紫癜患儿可提高临床疗效,并可有效降低肾损害的发生。
Objective To evaluate the clinical effect of Zidan Granules on children with Henoch-Schonlein purpura and its effect on renal damage. Methods A total of 256 children with Henoch-Schonlein purpura were randomly divided into two groups: observation group (128 cases) and control group (128 cases). The patients in the observation group were treated with Zidan granules and the control group with Zidan granule placebo. The courses of treatment were 4 weeks, After the end of treatment, the curative effect of Western medicine and TCM syndromes were evaluated. All patients were followed up for 1 year. The occurrence time and occurrence of renal damage in children were recorded. Results The incidence of renal injury was 6.25% (8/128) in the observation group and 14.84% (19/128) in the control group, all of which showed hematuria, proteinuria and isolated hematuria or proteinuria. The difference between the two groups was statistically significant (P <0.05). The incidence of renal injury in the two groups was mainly 0 to 3 months, and there was no significant difference in the time of renal injury between the two groups (P> 0.05). The total effective rate of Western medicine was 96.09% in observation group and 85.94% in control group. The total effective rate of TCM syndrome in observation group was 96.09% and that in control group was 79.81%. There was significant difference in curative effect between the two groups (P <0.05). No significant adverse reactions occurred during the treatment. Conclusion Zidan granules in children with Henoch-Schonlein purpura can improve clinical efficacy, and can effectively reduce the incidence of renal damage.