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目的研究小剂量他克莫司(tacrolimus,TAC)联合糖皮质激素在中等量蛋白尿IgA肾病中的临床疗效和安全性。方法回顾筛选2012年1月至2015年1月在我院肾科就诊并结合临床和肾活检确诊为中等量蛋白尿(1.0~3.5 g/24 h)IgA肾病患者64例。根据治疗方案将患者分为小剂量TAC+激素组[n=34,他克莫司0.02~0.05 mg/(kg·d),分两次口服,血药谷浓度维持在3~5 ng/m L,强的松起始剂量0.5 mg/(kg·d)(最大剂量不超过40 mg/d)口服]和激素组[n=30,强的松起始剂量1 mg/(kg·d)(最大剂量不超过70 mg/d)口服]。收集分析患者治疗前及治疗后1、3、6个月时的临床资料,并记录发生的不良反应。选取24 h尿蛋白定量、血肌酐(Scr)、血白蛋白(ALB)为主要临床疗效评价指标。结果两组患者治疗前各临床指标基线值对比差异均无统计学意义(P>0.05)。两组患者在治疗6个月后24 h尿蛋白定量均显著下降,血白蛋白显著升高,与治疗前比较差异均有统计学意义(P<0.05)。小剂量TAC+激素组在治疗1、3、6个月时24 h尿蛋白定量的降低值与激素组比较差异具有统计学意义(P<0.05);但在完全缓解率和总有效率上两组间各时间点比较差异均无统计学意义(P>0.05)。不良反应比较:在对白细胞、血红蛋白及血小板的监测中未发现加用小剂量TAC出现的骨髓抑制现象,也没有明确的感染事件发生。其他不良反应:小剂量TAC+激素组新发血糖升高4例,肝功能损害3例,胃肠道反应1例,反复口腔溃疡1例,激素组新发血糖升高5例,肝功能受损4例,胃肠道反应2例,两组比较差异无统计学意义(P>0.05)。两组患者治疗6个月时血肌酐及e GFR分别与治疗前比较,差异均无统计学意义(P>0.05)。结论在中等量蛋白尿IgA肾病的治疗中,小剂量起始、低血药浓度维持的TAC+激素的治疗方案依然有效,对比单足量激素组表现出了更好的降低患者蛋白尿水平的作用,且没有增加不良反应,但并不能带来临床完全缓解率和总有效率的上升。
Objective To study the clinical efficacy and safety of low dose tacrolimus (TAC) in combination with glucocorticoid in moderate proteinuria of IgA nephropathy. Methods Sixty-four patients with IgA nephropathy diagnosed as moderate proteinuria (1.0-3.5 g / 24 h) by nephrology and clinical and renal biopsy from January 2012 to January 2015 were retrospectively reviewed. According to the treatment plan, the patients were divided into small dose of TAC + hormone group [n = 34, tacrolimus 0.02 ~ 0.05 mg / (kg · d) , The initial dose of prednisone 0.5 mg / (kg · d) (maximum dose not more than 40 mg / d)] and hormone group [n = 30, the initial dose of prednisone 1 mg / (kg · d) The maximum dose does not exceed 70 mg / d) oral]. The clinical data of patients before treatment and at 1, 3, and 6 months after treatment were collected and recorded, and the adverse reactions were recorded. 24 h proteinuria, serum creatinine (Scr), albumin (ALB) as the main clinical evaluation indicators. Results There was no significant difference in baseline value between the two groups before treatment (P> 0.05). After 6 months of treatment, urinary protein in 24 hours in both groups significantly decreased, and serum albumin increased significantly. There was significant difference between before and after treatment (P <0.05). Compared with the hormone group, the decrease of urinary protein in 24 h after treatment with low dose TAC + hormone group was statistically significant (P <0.05), but in the two groups of complete remission rate and total effective rate There was no significant difference between the time points (P> 0.05). Adverse reactions compared: in the detection of leucocytes, hemoglobin and platelets did not find the addition of small doses of TAC appear myelosuppression, there is no clear incident of infection. Other adverse reactions: low-dose TAC + hormone group, new blood sugar increased in 4 cases, liver damage in 3 cases, gastrointestinal reaction in 1 case, recurrent oral ulcer in 1 case, hormone group, new blood sugar increased in 5 cases, impaired liver function 4 cases, gastrointestinal reaction in 2 cases, no significant difference between the two groups (P> 0.05). There was no significant difference in serum creatinine and e GFR between the two groups at 6 months after treatment and before treatment (P> 0.05). Conclusions In the treatment of moderate proteinuria of IgA nephropathy, the treatment regimen of TAC + hormones maintained at low-dose initial and low plasma concentrations is still effective. Compared with single-hormonal hormone group, the effect of reducing the level of proteinuria in patients is better , And did not increase adverse reactions, but does not bring clinical complete remission rate and the total effective rate of rise.