槐杞黄颗粒治疗儿童原发性肾病综合征的前瞻性随机对照临床研究

A prospective, randomized, controlled clinical study of Huai Qi Huang granules in treatment of childhood primary nephrotic syndrome

摘要:

目的 观察槐杞黄颗粒对儿童原发性肾病综合征的治疗作用.方法 采用前瞻性研究法,2009年7 月至2011 年12 月住院并初诊为原发性肾病综合征的患儿随机分为糖皮质激素联用槐杞黄颗粒治疗组(观察组,n=23)和单用糖皮质激素治疗组(对照组,n=19),比较两组患儿浮肿消退时间、尿蛋白阴转时间、感染发生率、复发率、糖皮质激素用量及细胞、体液免疫功能.结果 观察组与对照组浮肿消退时间、尿蛋白阴转时间、复发率差异无统计学意义(P>0.05).观察组感染发生率低于对照组(P<0.05),6 个月时每日糖皮质激素用量小于对照组(P<0.05).两组体液、细胞免疫学指标检测差异无统计学意义(P>0.05).未观察到槐杞黄相关不良反应的发生.结论 槐杞黄可减少肾病综合征患儿糖皮质激素用量及感染合并症的发生,且显示了其治疗的安全性.

Abstract:

Objective To study the efficacy of Huai Qi Huang granules in the treatment of childhood primary nephrotic syndrome. Methods Between July 2009 and December 2011, patients who were admitted and diagnosed for the first time as childhood primary nephrotic syndrome were randomized into a treatment group (Huai Qi Huang granules plus glucocorticoid; n=23) and a control group (glucocorticoid alone; n=19) for a prospective study. The two groups were compared for regression time of edema, time to urinary protein clearance, relapse rate, incidence of infection, dosage of glucocorticoid, and humoral and cellular immunological indicators. Results There were no significant differences in regression time of edema, time to urinary protein clearance, and relapse rate between the treatment and control groups (P>0.05). The treatment group had significantly lower incidence of infection and daily dose of glucocorticoid (at month 6) than the control group (P<0.05). Humoral and cellular immunological indicators showed no significant differences between the two groups (P>0.05). No Huai Qi Huang-related adverse events were observed in this study. Conclusions Huai Qi Huang granules treatment can reduce the dose of glucocorticoid and the incidence of infection in children with primary nephrotic syndrome and has a favourable safety.