【目的】 探讨六味地黄丸联合泼尼松治疗肾病综合征患儿的疗效及其对免疫球蛋白、凝血功能及肾功能的影响。 【方法】 采用随机数字表法，将2019年1月～2024年1月期间在安徽中医药大学第一附属医院确诊为肾病综合征肝肾阴虚证 的 86例患儿随机分为对照组和观察组，每组各 43例。2组患儿均给予低盐饮食、利尿消肿、抗凝、降脂等常规对症治疗， 在此基础上，对照组给予泼尼松规范治疗，观察组在对照组基础上加用六味地黄丸中药汤剂治疗，均持续治疗3个月。观察 2组患儿治疗前后中医证候积分、免疫球蛋白（IgA、IgG、IgM）、凝血功能指标[纤维蛋白原（FBG）、活化部分凝血活酶时间 （APTT）、凝血酶原时间（PT）]、肾功能指标[血清肌酐（Scr）、血尿素氮（BUN）]的变化情况，比较 2 组患儿的临床疗效及不 良反应发生率。【结果】（1）疗效方面，治疗3个月后，观察组的总有效率为95.35%（41/43），对照组为79.07%（34/43），组间 比较（χ2 检验），观察组的疗效明显优于对照组（P＜0.05）。（2）中医证候积分方面，治疗后，2组患儿的腰膝酸软、眩晕耳鸣、 五心烦热、午后潮热积分均较治疗前降低（P＜0.05），且观察组对各项中医证候积分的降低幅度均明显优于对照组（P＜0.05 或P＜0.01）。（3）免疫球蛋白方面，治疗后，2组患儿的IgA、IgG水平均较治疗前升高（P＜0.05），而2组患儿的IgM水平均较 治疗前有升高趋势，但差异均无统计学意义（P＞0.05）；治疗后组间比较，观察组对IgA、IgG水平的升高幅度均明显优于对 照组（P＜0.05或P＜0.01）。（4）凝血功能方面，治疗后，2组患儿的PT均较治疗前延长（P＜0.05），FBG水平均较治疗前降低 （P＜0.05），APTT 均较治疗前无明显变化（P＞0.05）；治疗后组间比较，观察组对 PT 和 FBG 的改善幅度均明显优于对照组 （P＜0.01）。（5）肾功能方面，治疗后，2组患儿的Scr、BUN水平均较治疗前降低（P＜0.05），且观察组对Scr、BUN水平的降 低幅度均明显优于对照组（P＜0.01）。（6）不良反应方面，观察组与对照组的不良反应发生率分别为 6.97%（3/43）、2.32% （1/43），组间比较，差异无统计学意义（χ2 =1.049，P＞0.05）。【结论】 六味地黄丸联合泼尼松治疗肾病综合征肝肾阴虚证患儿 疗效确切，不仅能显著提升治疗总有效率，改善中医主要证候，还可调节机体免疫功能，减少血液高凝风险，改善肾功能， 且安全性高。

Objective To investigate the effects of Liuwei Dihuang Wan（LWDHW） combined with prednisone on immunoglobulin levels， coagulation function， and renal function in children with nephrotic syndrome （NS）. Methods A total of 86 children diagnosed with NS and liver-kidney yin deficiency syndrome at the First Affiliated Hospital of Anhui University of Chinese Medicine from January 2019 to January 2024 were randomly divided into a control group and an observation group，with 43 cases in each group. Both groups of children received conventional symptomatic treatment， including a low-salt diet， diuresis， anticoagulation， and lipid-lowering therapy. In addition，the control group received standard treatment with prednisone，while the observation group received the same treatment as the control group plus LWDHW in decoction for 3 months. Traditional Chinese medicine （TCM） syndrome scores， immunoglobulins （IgA， IgG， IgM）， coagulation parameters [fibrinogen （FBG）， activated partial thromboplastin time （APTT）， prothrombin time （PT）]， and renal function markers [serum creatinine （Scr），blood urea nitrogen （BUN）] were observed before and after treatment. Clinical efficacy and adverse events were compared. Results （1） After 3 months of treatment，the overall response rate in the observation group was 95.35% （41/43），while that in the control group was 79.07% （34/43）. The intergroup comparison （by chi-square test） revealed that the therapeutic efficacy of the observation group was significantly superior to that of the control group （P＜0.05）.（2） After treatment，the TCM syndrome scores for soreness/weakness of waist/knees，dizziness/ tinnitus，feverish sensation in the chest，palms and soles，and afternoon tidal fever in both groups of children were significantly lower than thsoe before treatment （P＜0.05）. Additionally，the reduction in scores for all TCM syndromes in the observation group was significantly greater than that in the control group （P＜0.05 or P＜0.01）. （3） After treatment，the IgA and IgG levels in both groups of children increased compared to before treatment （P＜0.05）. There was a trend of increased IgM levels in both groups after treatment，but the differences were not statistically significant （P＞0.05）；the post-treatment intergroup comparison showed that the increase in IgA and IgG levels in the observation group was significantly greater than that in the control group （P＜0.05 or P＜0.01）. （4） After treatment，the PT levels of both groups of children were prolonged compared to before treatment （P＜ 0.05），the FBG levels were reduced compared to before treatment （P＜0.05），and the APTT levels showed no significant changes compared to before treatment （P＞0.05）. After treatment，the improvement in PT and FBG levels in the observation group was significantly better than that in the control group （P＜0.01）. （5） After treatment，the Scr and BUN levels in both groups decreased compared to before treatment （P＜0.05），and the reduction in Scr and BUN levels in the observation group was significantly greater than that in the control group （P＜0.01）.（6） In terms of adverse reactions，the incidence rates in the observation group and control group were 6.97% （3/43） and 2.32% （1/43），respectively. There was no statistically significant difference between the two groups （χ2 =1.049， P＞0.05）. Conclusion LWDHW combined with prednisone effectively improves clinical efficacy， alleviates TCM syndromes， modulates immune function， reduces hypercoagulability， and enhances renal function in children with NS and liver-kidney yin deficiency，with good safety.

R277.5

国家中医药管理局科技计划项目（编号：2023ZYLCYJ05-05）