不同品牌腹膜透析液变更对透析充分性的短期影响

Short-term effects of switching in different brands of peritoneal dialysis solution on dialysis adequacy

目的探讨国产腹膜透析液(商品名:依达维)与进口腹膜透析液(商品名:百特)变更前后对于腹膜透析患者透析充分性的短期影响。方法收集51例行腹膜透析治疗的终末期肾病(ESRD)患者的临床资料,根据腹膜透析治疗时间的长短分为A组[规律使用百特腹膜透析液进行持续性非卧床腹膜透析(CAPD)≥1个月的患者,30例]和B组(新开始CAPD的患者,21例)。A组患者入组后第1、2个月使用依达维腹膜透析液;B组患者入组后第1、2个月使用依达维腹膜透析液,第3个月使用百特腹膜透析液。比较全部患者和两组患者使用不同腹膜透析液期间透析充分性和残肾功能指标[尿素清除指数(Kt/V)、总肌酐清除率(Ccr)、残肾肾小球滤过率(eGFR)、超滤量、尿量和4 h透析液肌酐浓度与血浆肌酐浓度的比值(D/Pcr值)],评估治疗安全性。结果51例患者使用依达维腹膜透析液期间的Kt/V达标率为78.43%(40/51),使用百特腹膜透析液期间的Kt/V达标率为82.35%(42/51),比较差异无统计学意义(P>0.05);使用依达维腹膜透析液期间的总Ccr、残肾eGFR与使用百特腹膜透析液期间比较差异无统计学意义(P>0.05);但使用依达维腹膜透析液期间的超滤量显著高于使用百特腹膜透析液期间,尿量低于使用百特腹膜透析液期间,差异具有统计学意义(P<0.05)。A组患者使用依达维腹膜透析液期间的超滤量显著高于使用百特腹膜透析液期间,尿量显著低于使用百特腹膜透析液期间,差异具有统计学意义(P<0.05);使用依达维腹膜透析液期间的总Ccr、残肾eGFR、Kt/V与使用百特腹膜透析液期间比较差异无统计学意义(P>0.05)。B组患者使用依达维腹膜透析液期间与使用百特腹膜透析液期间的超滤量、尿量、Kt/V、总Ccr、残肾eGFR比较差异均无统计学意义(P>0.05)。所有患者均行标准腹膜平衡试验检查以评估腹膜转运功能,结果发现所有患者D/Pcr值均以低平均转运为主,但使用依达维腹膜透析液期间的D/Pcr值低于使用百特腹膜透析液期间,差异具有统计学意义(P<0.05);A组患者使用依达维腹膜透析液期间D/Pcr值明显低于使用百特腹膜透析液期间,差异具有统计学意义(P<0.05);B组患者使用依达维腹膜透析液期间的D/Pcr值与使用百特腹膜透析液期间比较差异无统计学意义(P>0.05)。研究期间,两组患者均未发生与药物相关的严重不良事件。结论对于行腹膜透析治疗的ESRD患者,依达维腹膜透析液的疗效及安全性不劣于百特腹膜透析液,不同品牌腹膜透析液的变更对于腹透患者短期内的透析充分性、残余肾功能等指标无明显影响。

Objective To discuss the short-term effect of domestic peritoneal dialysate solution(trade name:Edavide)and imported peritoneal dialysate solution(trade name:Baxter)on dialysis adequacy in patients treated with peritoneal dialysis.Methods The clinical data of 51 patients with end-stage renal disease(ESRD)treated with peritoneal dialysis were collected.According to the length of peritoneal dialysis treatment,patients were divided into Group A[30 patients who received continuous ambulate peritoneal dialysis(CAPD)≥1 month,using Baxter peritoneal dialysis solution]and Group B(21 patients who newly started CAPD).Patients of Group A were treated with Edavide peritoneal dialysate in the 2nd and 3rd month after enrollment;and patients of Group B were treated with Edavide peritoneal dialysate as needed in the 1st and 2nd month after enrollment,and treated with Baxter peritoneal dialysate in the 3rd month.The dialysis adequacy and residual kidney function indicators[ratio of urea clearance to volume(Kt/V),creatinine clearance(Ccr),estimated glomerular filtration rate(eGFR),ultrafiltration volume,urine volume and ratio of 4-h dialysate creatinine concentration to plasma creatinine concentration(D/Pcr value)]during the use of different peritoneal dialysis solutions were compared between the two groups.The treatment safety was evaluated.Results The standard-achieving rate of Kt/V in 51 patients was 78.43%(40/51)during the period of being treated with Edavide peritoneal dialysate and 82.35%(42/51)during the period of being treated with Baxter peritoneal dialysate,and the difference was not statistically significant(P>0.05).In addition,the differences in total Ccr and residual renal eGFR between using Edavide peritoneal dialysate and using Baxter peritoneal dialysate were statistically significant(P<0.05).However,the ultrafiltration during the period of being treated with Edavide peritoneal dialysate was significantly higher than that during the period of being treated with Baxter peritoneal dialysate;and the urine volume during the period of being treated with Edavide peritoneal dialysate was lower than that during the period of being treated with Baxter peritoneal dialysate;and the differences were statistically significant(P<0.05).In Group A,the ultrafiltration during the period of being treated with Edavide peritoneal dialysate was significantly higher than that during the period of being treated with Baxter peritoneal dialysate;the urine volume during the period of being treated with Edavide peritoneal dialysate was significantly lower than that during the period of being treated with Baxter peritoneal dialysate;and the differences were statistically significant(P<0.05);and the differences in total Ccr,residual renal eGFR,Kt/V between using Edavide peritoneal dialysate and using Baxter peritoneal dialysate were not statistically significant(P>0.05).In Group B,the differences in ultrafiltration,urine volume,Kt/V,total Ccr,residual renal eGFR between using Edavide peritoneal dialysate and using Baxter peritoneal dialysate were not statistically significant(P>0.05).All patients received standard peritoneal balance test to evaluate peritoneal transport function.The results showed that the D/Pcr value of all patients was mainly at low average transport,but the D/Pcr value during the period of being treated with Edavide peritoneal dialysate was lower than that during the period of being treated with Baxter peritoneal dialysate,and the difference was statistically significant(P<0.05).In Group A,the D/Pcr value during the period of being treated with Edavide peritoneal dialysate was significantly lower than that during the period of being treated with Baxter peritoneal dialysate,and the difference was statistically significant(P<0.05).In Group B,the difference in D/Pcr value between using Edavide peritoneal dialysate and using Baxter peritoneal dialysate was not statistically significant(P>0.05).During the study,the incidence of drug-related serious adverse events was zero of the two groups.Conclusion For patients with end-stage renal disease being treated with peritoneal dialysis,the efficacy and safety of Edavide peritoneal dialysate are not worse than those of Baxter peritoneal dialysate,so switching in different brands of peritoneal dialysate solution shows no significant short-term impact on indicators,such as dialysis adequacy,residual renal function,in patients treated with peritoneal dialysis.