2020 年第 5 期 第 15 卷

五酯胶囊对难治性肾病综合征患者他克莫司血药浓度及肝肾功能的影响

Effect of Wuzhi capsules on serum concentration of tacrolimus and liver and kidney function in patients with refractory nephrotic syndrome

作者：朱可庆;王莹;葛国军;王星霞

英文作者：Zhu Keqing Wang Ying Ge Guojun Wang Xingxia

单位：中国人民解放军联勤保障部队第九〇三医院肾脏病科，杭州310000

英文单位：Department of Nephrology the 903rd Hospital of Joint Logistics Support Force of Chinese People′s Liberation Army Hangzhou 310000 China

关键词：肾病综合征；五酯胶囊；他克莫司；血药浓度；肝肾功能

英文关键词：Nephroticsyndrome;Wuzhicapsules;Tacrolimus;Blooddrugconcentration;Liverandkidneyfunction

• 摘要：

• 目的 研究五酯胶囊对难治性肾病综合征（RNS）他克莫司治疗患者血药浓度及肝肾功能的影响。方法 选取2016年8月至2019年2月中国人民解放军联勤保障部队第九〇三医院收治120例RNS患者纳为研究对象。采用随机数字表法分为对照组和观察组，各60例。对照组采用泼尼松片+他克莫司治疗，观察组采用泼尼松片+他克莫司+五酯胶囊治疗，2组均连续治疗4个月。期间监测2组他克莫司用量、血药浓度、24 h蛋白定量、血浆白蛋白定量与肝肾功能。观察不良反应发生情况。结果 观察组治疗1、2、3、4个月后他克莫司用量均显著少于对照组，血药浓度均显著高于对照组［（7.6±1.2）μmol/L比（5.1±1.3）μmol/L、（7.4±1.3）μmol/L比（5.4±1.5）μmol/L、（5.8±1.1）μmol/L比（3.5±0.6）μmol/L、（5.6±1.1）μmol/L比（3.3±0.4）μmol/L］，差异均有统计学意义（均P＜0.05）。观察组治疗1、2、3、4个月后24 h尿蛋白定量显著低于对照组，血浆白蛋白定量显著高于对照组，差异均有统计学意义（均P＜0.05）。治疗前后2组血尿素氮、血肌酐、丙氨酸转氨酶和天冬氨酸转氨酶差异均无统计学意义（均P>0.05）。2组不良反应发生率差异无统计学意义（P>0.05）。结论五酯胶囊能有效提高RNS患者他克莫司血药浓度，纠正患者尿蛋白代谢异常现象，提高血浆白蛋白水平，且不影响机体肝肾功能。

• Objective To investigate the effect of Wuzhi capsules on serum concentration of tacrolimus and liver and kidney function in patients with refractory nephrotic syndrome(RNS). Methods Totally 120 RNS patients admitted in the 903rd Hospital of Joint Logistics Support Force of Chinese People′s Liberation Army  from August 2016 to February 2019 were divided into observation group and control group, with 60 cases in each group. Control group were treated with the prednisone+tacrolimus, while observation group were treated with the prednisone+tacrolimus+Wuzhi capsules. Both groups were treated for 4 months. Tacrolimus dosage, serum drug concentration, 24 h protein level, plasma albumin level and liver and kidney function were monitored. The adverse reactions were observed. Results After 1, 2, 3 and 4 months of treatment, the dosage of tacrolimus in the observation group was significantly lower than that in the control group; the blood concentration of tacrolimus was significantly higher than that in the control group［（7.6±1.2）μmol/L vs （5.1±1.3）μmol/L, （7.4±1.3）μmol/L vs （5.4±1.5）μmol/L, （5.8±1.1）μmol/L vs （3.5±0.6）μmol/L, （5.6±1.1）μmol/L vs （3.3±0.4）μmol/L］(all P＜0.05). After 1, 2, 3 and 4 months of treatment, the 24 hours urine protein quantity of the observation group was significantly lower than that of the control group; the plasma albumin quantity was significantly higher than that of the control group(all P＜0.05). There were no significant differences in levels of blood urea nitrogen, creatinine,  alanine aminotransferase (ALT) and aspartate aminotransferase (AST) between the two groups before and after treatment(all P>0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). ConclusionWuzhi capsules can effectively improve TCA blood concentration, ameliorate the urinary protein abnormality and promote plasma albumin level in RNS patients without affecting liver and kidney function.