Abstract： Objective： To observe the clinical effect of modified Huanglian Yishen Decoction assisting treatment for acute kidney injury (AKI) of spleen-kidney qi deficiency and internal obstruction of stasis and toxin type. Methods：A total of 62 patients of spleen-kidney qi deficiency and internal obstruction of stasis and toxin type were divided into the treatment group and the control group，with 31 cases in each group. The control group was treated with conventional western medicine，and the treatment group was treated with modified Huanglian Yishen Decoction based on the treatment of the control group. The traditional Chinese medicine (TCM) syndrome scores，urine related indicators (24-hour total urine volume，24-hour urine protein quantity， and 24- hour urine protein excretion rate)， kidney function indexes [blood urea nitrogen (BUN)， creatinine (SCr)， cystatin C (CysC)， and estimated glomerular filtration rate (eGFR)]， kidney injury indicators [kidney injury molecule- 1 (KIM- 1)， neutrophil gelatinase- associated lipocalin (NGAL)，blood lactate (LAC)，and procalcitonin (PCT) ]，and immune stress indicators [heme oxygenase-1 (HO- 1)， malondialdehyde (MDA)， and superoxide dismutase (SOD)] levels were compared before and after treatment in two groups. The clinical effects and incidence of adverse reactions were evaluated in the two groups. Results：After treatment，the total effective rate was 93.55% in the treatment group，higher than that of 74.19% in the control group (P＜0.05). After treatment，the TCM syndrome scores，24-hour urine protein quantity， 24- hour urine protein excretion rates， BUN， SCr， CysC， and serum KIM- 1， NGAL，LAC，PCT，and MDA levels in the two groups were decreased when compared with those before treatment (P＜0.05)，the TCM syndrome score，kidney injury indicators，24-hour urine protein quantity， 24-hour urine protein excretion rate，and serum MDA level in the treatment group were lower than those in the control group (P＜0.05). After treatment，the 24-hour total urine volume，eGFR，and serum HO-1 and SOD levels in the two groups were higher than before treatment (P＜0.05)；the above indicators in the treatment group were higher than those in the control group (P＜0.05). There was no significant difference being found in the comparison of incidence of adverse reactions between the two groups (P＞0.05). Conclusion：Modified Huanglian Yishen Decoction has a definite curative effect in the auxiliary treatment of AKI of spleen-kidney qi deficiency and internal obstruction of stasis and toxin type，which can reduce the degree of kidney injury in patients， improve kidney function， reduce immune stress response， and has high safety.