Abstract:Objective To evaluate the efficacy of Zishen Huashi Decoction as an adjuvant therapy for complex renal calculi treated with percutaneous nephrostolithotomy combined with flexible ureteroscopy, and to explore the effects of Zishen Huashi Decoction on the immune function of erythrocytes.Methods This prospective randomized controlled trial included 108 patients with complex renal calculi who were admitted to Tangshan Workers' Hospital from October 2018 to April 2021 and were grouped according to the random number table. The control group (54 cases) received percutaneous nephrostolithotomy combined with flexible ureteroscopy, while the experimental group (54 cases) also received Zishen Huashi Decoction treatment in addition to percutaneous nephrostolithotomy combined with flexible ureteroscopy. The curative effect, the proportion of one-stage operation, indicators for kidney injury, immune function of erythrocytes, inflammatory response, and complications were compared between the two groups.Results The overall effective rate and the proportion of one-stage operation were higher in the experimental group than those in the control group (P < 0.05). There was no difference in serum levels of kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), blood urea nitrogen (BUN) and cystatin C (Cys-C) between the two groups preoperatively (P >0.05), while the levels of these indicators were lower in the experimental group 7 days following the operation (P < 0.05). The serum levels of C3bRR, ICRRR, TER, and RBC-ICR were not different between the groups before the operation (P >0.05), but were higher in the experimental group 7 days after the operation (P < 0.05). In addition, the serum levels of interleukin (IL)-1β, high-sensitivity C-reactive protein (hs-CRP), angiotensin (Ang) Ⅰ and Ang Ⅱ were also not different between the groups before the operation (P > 0.05), yet they were lower in the experimental group compared with the control group postoperatively (P < 0.05). No difference was observed in the incidence of postoperative complications between the groups (P > 0.05).Conclusions The Zishen Huashi Decoction is effective as an adjuvant treatment for complex renal calculi treated with percutaneous nephrostolithotomy combined with flexible ureteroscopy, by increasing the proportion of one-stage operation, reducing kidney injury, improving the immune function of erythrocytes, and ameliorating the inflammatory response.