甲泼尼龙联合他克莫司治疗老年原发性肾病综合征的临床观察

Clinical Observation of Methylprednisolone Combined with Tacrolimus in the Treatment of Elderly Patients with Primary Nephrotic Syndrome

目的:探讨甲泼尼龙联合他克莫司治疗老年原发性肾病综合征的临床疗效及对自然杀伤(NK)细胞、T淋巴细胞亚群和组织相容性复合体(MHC)Ⅱ水平的影响。方法:选取88例老年原发性肾病综合征患者,根据治疗方案分为单药组和联合组,各44例。单药组患者给予甲泼尼龙片0.8 mg/kg,qd(早晨),后逐渐减至4 mg/d后。联合组患者在单药组基础上加用他克莫司胶囊0.025 mg/kg,q12 h(餐后1 h服用),根据血药浓度调整剂量。两组患者疗程均为6个月。观察两组患者临床疗效及治疗前后的24h尿蛋白定量、血清白蛋白、肾功能指标[血肌酐(SCr)、血尿素氮(BUN)]、总胆固醇(TC)、血清纤维蛋白原(FIB)、NK细胞、T淋巴亚群(CD4^+、CD8^+、CD4^+/CD8^+)和MHCⅡ水平,并记录不良反应发生情况。结果:联合组患者总有效率(72.73%)显著高于单药组(40.91%),差异有统计学意义(P=0.003)。治疗前,两组患者上述各项指标比较,差异均无统计学意义(P>0.05);治疗后,两组患者上述各项指标均显著改善,联合组患者24 h尿蛋白定量、血清白蛋白、SCr、BUN、FIB、NK细胞、T淋巴细胞亚群和MHCⅡ水平的改善程度均显著优于单药组,差异均有统计学意义(P<0.05)。单药组患者的不良反应发生率(6.82%)略低于联合组(9.09%),但差异无统计学意义(P=0.694)。结论:甲泼尼龙联合他克莫司治疗老年原发性肾病综合征疗效显著,可改善患者NK细胞、T淋巴细胞亚群水平,降低MHCⅡ表达水平,且安全性较好。

OBJECTIVE： To explore the clinical efficacy of methylprednisolone combined with tacrolimus in the treatment of elderly patients with primary nephrotic syndrome and their effects on natural killer （NK） cells, T lymphocyte subsets and histocompatibility complex （MHC） Ⅱ level. METHODS： 88 elderly patients with primary nephrotic syndrome were selected and divided in- to single drug group and drug combination group, with 44 cases in each group. Single drug group was given Methylprednisolone tablet 0.8 mg/kg, qd （morning）, gradually decreasing to 4 mg/d. Drug combination group was additionally given Tacrolimus cap- sule 0.025 mg/kg, q12 h （1 h after meal）, adjusting drug dosage according to plasma concentration. Treatment course of 2 groups lasted for 6 months. Clinical efficacies of 2 groups were observed as well as 24 h urinary protein quantitation, serum albumin, renal function indexes （SCr, BUN）, TC, FIB, the number ofNK, T lymphocytes subset （CD4^＋, CD8^＋, CD4^＋/CD8^＋）, MHC Ⅱ level before and after treatment. The occurrence of ADR was recorded. RESULTS： Total effective rate （72.73%） of drug combination group was significantly higher than that of single drug group （40.91%）, with statistical significance （P=0.003）. Before treatment, there was no statistical significance in above indexes between 2 groups （P〉0.05）. After treatment, above indexes of 2 groups were improved significantly, and the improvement of 24 h urinary protein quantitation, serum albumin, SCr, BUN, FIB, NK cells, T lymphocytes subset and MHC Ⅱ level in drug combination group were significantly better than in single drug group, with statistical significance （P〈0.05）. The incidence of ADR in single drug group （6.82%） was slightly lower than in drug combination group （9.09%）, without statistical significance （P=0.694）. CONCLUSIONS： Methylprednisolone combined with tacrolimus have significant therapeutic efficacy in the treatment of elderly primary nephrotic syndrome, can improve NK cells and T lymphocyte subsets level and decrease the expression of MHC Ⅱ with good safety.