甲泼尼龙片联合吗替麦考酚酯胶囊治疗急性肾损伤的临床研究

Clinical trial of methylprednisolone combined with mycophenolate mofetil capsules in the treatment of acute kidney injury

目的观察甲泼尼龙片联合吗替麦考酚酯胶囊治疗急性肾损伤的临床疗效和安全性。方法将72例急性肾损伤患者随机分为对照组36例和试验组36例。对照组予以口服吗替麦考酚酯,每次500 mg,bid,每疗程2周,连续治疗2个疗程;试验组在对照组的基础上予以口服甲泼尼龙,每次4 mg,tid,每疗程2周,连续治疗2个疗程。比较2组患者的临床疗效、治疗后3,7,15 d尿素氮(BUN)、血肌酸酐(Scr)及Notch蛋白的表达情况,以及药物不良反应发生率。结果治疗后,对照组和试验组的总有效率分别为69.44%(25/36例)和88.89%(32/36例),差异有统计学意义(P<0.05)。治疗3,7,15 d后,试验组和对照组BUN、Scr含量Notch蛋白指标明显低于治疗前;治疗后,试验组和对照组的血红蛋白指标分别为(123.46±10.36),(101.37±12.24)g·L^(-1),KIM^(-1)分别为(0.34±0.12),(0.93±0.39)ng·m L^(-1),SOD分别为(72.24±7.26),(84.86±9.71)U·m L^(-1),MDA分别为(4.05±0.51),(5.36±0.79)nmol·m L^(-1),差异有统计学意义(P<0.05)。试验组的药物不良反应主要有肝功能异常1例,感染1例,高血压1例;对照组的药物不良反应主要有肝功能异常1例,感染2例,高血压1例。试验组和对照组的药物不良反应发生率分别为8.33%(3/36例)和11.11%(4/36例),差异无统计学意义(P>0.05)。结论甲泼尼龙联合吗替麦考酚酯比单一使用吗替麦考酚酯治疗急性肾损伤临床疗效更佳,提高Notch蛋白的表达量,利于建立Notch/Hes1信号通路的,促进恢复血清细胞因子。

Objective To evaluate the efficacy and safety of methylprednisolone combined with mycophenolate mofetil in the treatment of acute kidney injury. Methods A total of 72 patients with acute kidney injury were randomly devided into the control group（ n = 36） and the treatment group（ n = 36）. The control group was orally given mycophenolate mofetil 500 mg,bid; the treatment group was given methylprednisolone 4 mg,tid,on the basis of the control group. Both groups were treated for 2 courses（ 2 weeks a course）. After treatment,the clinical efficacy,the expression of the blood urea nitrogen（ BUN）,serum creatinine（ Scr） and Notch protein at the 3,7,15 d and the incidence of adverse drug reactions（ ADR） were compared between the 2 groups.Results After treatment, the total effective rates of the controlgroup and the treatment group were 69. 44%（ 25/36） and 88. 89%（ 32/36）,the difference was statistically significant（ P〈0. 05）. After 3,7,15 d of the treatment,BUN,Scr and Notch protein content index of the treatment group and the control group were significantly lower than before treatment. After treatment,the hemoglobin index in treatment group and control group were（ 123. 46 ± 10. 36）,（ 101. 37 ± 12. 24） g · L^（-1）,KIM^（-1）（ 0. 34 ± 0. 12）,（ 0. 93 ± 0. 39） ng·m L^（-1）,SOD（ 72. 24 ± 7. 26）,（ 84. 86 ± 9. 71） U·m L^（-1）,MDA（ 4. 05 ± 0. 51）,（ 5. 36 ± 0. 79）nmol·m L^（-1）respectively,the difference was statistically significant（ P〈0. 05）. There was 1 case with abnormal liver function,1 case infection,1 case hypertension in the treatment group. There was 1 case with abnormal liver function,2 cases with infection,1 cases with hypertension in the control group. The incidence of adverse drug reactions（ ADR）in the treatment group and the control group were 8. 33%（ 3/36 cases） and 11. 11%（ 4/36 cases） respectively,the difference was not statistically significant（ P〉0. 05）. Conclusion The curative effect of the methylprednisolone combined with mycophenolate mofetil was better than that of mycophenolate mofetil in the treatment of acute kidney injury,improved the expression level of Notch protein,beneficial to the establishment of Notch/Hes1 signaling pathway and promoted the recovery of serum cytokines.