Azovudine is a widely used antiviral drug for COVID-19 in China, but published trials on its effect on hepaticand renal function are extremely scarce.

To explore the changes of in hepatic and renal function in patients with COVID-19 infection after using Azovudine, so as to provide a reference for thesafe use of Azovudine in patients with renal insufficiency.

Inpatients ina tertiary general hospitalwho used Azovudine for COVID-19 from December 26, 2022 to December 31, 2022 were consecutively included in the retrospective study and divided into the normal group, mild injury group, moderate injury group, severe injury group, and end-stage groupaccording to estimated glomerularrate (eGFR) levels. The changes of biochemical parametersof liver and kidney including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin (ALB), total bilirubin (TB), serum creatinine (Scr), eGFR were observed in each group; the formula D_FR=D_NL×[1-F_k (1-K_f) ] was used to correct the maintenance dose of Azivudine in patients with eGFR<60 mL·min^-1· (1.73 m²) ^-1. The patients were divided into the corrected group and uncorrected group according to whether they were administered according to this formula, the biochemical parameters of liver and kidney were compared between the two groups.

Among 322 patients who used Azovudine, 190 patients met the inclusion and exclusion criteria. After grouping by the level of eGFR, there were statistically significant differences in the distribution of age, COVID-19 severity, peak procalcitonin (PCT) values, antihypertensive drugs, loop diuretics and Azovudine maintenance dose in each group (P<0.05) ; there were 73 cases (38.4%) with elevated ALT level after Azovudine treatment, and 68 cases (93.2%) with elevated ALT level within one time of the upper normal limit; eGFR decreased in 58 cases (30.5%), of which 7 cases (12.1%) dropped to the next renal function grade; regardless of the grade of renal injury, there were no deterioration in eGFR, ALT, AST, TB, ALP and albumin after the use of conventional dose or corrected dose of Azivudine (P>0.05) ; because the patients with moderate and severe renal injury were dose-corrected with Azivudine, the safety of this population was not compared if the dose was not corrected.

The use of Azivudine is prone to cause the elevation of ALT level and the decrease of eGFR, but the injury with clinical significance is 2.6% and 3.7%, respectively; there was no aggravation of liver and kidney injury in patients with moderate and severe kidney injury after using the corrected dose of Azivudine, however, this conclusion needs to be confirmed in a multicenter randomized controlled study with a large sample.

阿兹夫定是中国新型冠状病毒感染常用抗病毒药物，但其对肝肾功能影响的研究极为匮乏。

探讨新型冠状病毒感染患者使用阿兹夫定后肝肾功能的变化，为肾功能不全患者安全使用阿兹夫定提供用药参考。

回顾性连续纳入某三甲综合医院2022 - 12- 26—31使用阿兹夫定治疗新型冠状病毒感染的住院患者，按估算肾小球滤过率（eGFR）水平将其分为正常组、轻度损伤组、中度损伤组、重度损伤组、终末期组，观察各组患者使用阿兹夫定后肝肾生化指标〔丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、白蛋白、总胆红素（TB），血肌酐（Scr）、eGFR〕变化；对eGFR<60 mL·min^-1·（1.73 m²）^-1的患者应用D_FR =D_NL ×[1-F_k（1-K_f）]公式校正阿兹夫定维持剂量，按是否遵循此公式给药将其分为校正组和未校正组，比较两组患者肝肾功能生化指标变化。

336例使用阿兹夫定的患者中190例符合纳入、排除标准，按eGFR水平分组后各组年龄、新型冠状病毒感染严重程度、降钙素原峰值、降压药、襻利尿药及阿兹夫定维持剂量比较，差异有统计学意义（P<0.05）；用药后发生ALT升高有73例（38.4%），其中升高1倍正常上限值以内的有68例（93.2%）；eGFR降低有58例（30.5%），其中下降至下一肾功能分级的有7例（12.1%）；无论肾损伤分级如何，使用常规剂量或校正剂量阿兹夫定后eGFR、ALT、AST、TB、ALP、白蛋白未见恶化（P>0.05）；因中重度肾损伤患者使用阿兹夫定均进行剂量校正，未能比较此类人群若不校正剂量的安全性。

使用阿兹夫定易引起ALT升高、eGFR降低，但具有临床意义的损伤分别为2.6%、3.7%；中重度肾损伤患者使用校正阿兹夫定剂量后，未见肝肾功能损伤加重，但此结论还需大样本、多中心随机对照研究确认。