OBJECTIVE: To observe the efficacy and safety of alprostadil combined with tanshinone ⅡA in the treatment of patients with early chronic kidney disease (ECKD). METHODS: 138 ECKD patients were randomly divided into group A, group B and group C, 46 cases in each group. On the basis of conventional treatment, group A received 40 mg Tanshinone ⅡA sodium sulfonate injection, adding into 250 ml 0.9% Sodium chloride solution, ivgtt, qd+10 μg Alprostadil injection, adding into 100 ml 0.9% Sodium chloride solution, ivgtt, qd; group B received the same dose with Alprostadil injection; group C received the same dose with Tanshinone ⅡA sodium sulfonate injection. All patients were treated for 14 d. Clinical efficacy, laboratory indexes [24 h urine protein, serum creatinine (SCr), total cholesterol (TC), triglyceride (TG), blood urea nitrogen (BUN), uric acid (UA)] in 3 groups before and after treatment were observed, and the incidence of adverse reactions was compared. RESULTS: The total effective rate in group A was 97.83%, which was significantly higher than group B (80.43%) and group C (76.09%), the differences were statistically significant (P<0.05). Before treatment, there were no significant differences in 24 h urine protein, SCr, TC, TG, BUN and UA among 3 groups (P>0.05); after treatment, all above-mentioned indexes significantly reduced, and group A was lower than group B and group C, the differences were statistically significant (P<0.05). There was no significant difference in the incidence of adverse reactions among group A (10.87%), group B (6.52%) and group C (8.70%) (P>0.05). CONCLUSIONS: Alprostadil combined with tanshinone ⅡA shows good efficacy in the treatment of ECKD, it can improve renal function in patients with good safety.