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目的观察小剂量他克莫司(TAC)联合雷公藤多苷(TW)治疗激素抵抗性肾病综合征(SRNS)的临床疗效和安全性。方法经肾活检并结合临床诊断为系膜增生性肾炎(MesPGN)和局灶节段性肾小球硬化(FSGS)、经泼尼松[1 mg/(kg.d),最大60 mg/d]治疗3个月无效的患者,随机分为2组。小剂量TAC+TW组:TAC首次使用0.05 mg/(kg.d),分2次、间隔12 h于餐后2 h服用,服药3 d后检测TAC浓度,维持血药浓度1.5～4 ng/ml;同时加用TW治疗剂量60 mg/d,分3次餐前口服。TW组:单用TW,治疗剂量60 mg/d,分3次餐前口服。观察各组的疗效、不良反应以及TAC的浓度变化。结果(1)符合入组条件的SRNS患者共20例,小剂量TAC+TW组11例,TW组9例。入组基线年龄、性别分布、发病时间、血压、24h尿蛋白定量、血清白蛋白、肌酐、胆固醇、三酰甘油、空腹血糖、肾脏病理类型及服用泼尼松时间等无明显统计学差异。(2)小剂量TAC+TW组治疗1个月后尿蛋白开始下降,随访至12个月时有8例完全缓解(72.7%),2例部分缓解(18.2%),1例无效(9.1%),总有效率(90.9%)。而TW组同样治疗1个月后尿蛋白开始减少,但随访至12个月时仅有2例完全缓解(22.2%),部分缓解4例(44.5%),无效3例(33.3%),总有效率(66.7%)。随访至终点小剂量TAC+TW组完全缓解率高于TW组。(3)小剂量TAC+TW组治疗后患者血浆蛋白明显升高,治疗至6个月时血浆蛋白基本恢复至正常水平;而TW组血浆蛋白升高却不明显。两组患者血肌酐水平治疗前后无明显改变。(4)不良反应的发生率两组之间无明显差异。结论小剂量TAC+TW能有效减少SRNS患者蛋白尿,临床缓解率较高;并且患者耐受性好,是治疗SRNS的有效方法。
Objective To observe the clinical efficacy and safety of low-dose tacrolimus (TAC) combined with tripterygium glycosides (TW) in the treatment of steroid-resistant nephrotic syndrome (SRNS). Methods The patients were diagnosed as mesangial proliferative glomerulonephritis (MesPGN) and focal segmental glomerulosclerosis (FSGS) by renal biopsy and combined with clinical diagnosis. The patients were treated with prednisone [1 mg / (kg · d), maximal 60 mg / d ] Treatment 3 months invalid patients were randomly divided into two groups. Low-dose TAC + TW group: TAC was first treated with 0.05 mg / (kg.d) twice daily for 12 h at 2 h after meal. TAC concentrations were measured after 3 d of administration. The plasma concentration of TAC was maintained at 1.5-4 ng / ml; at the same time with TW treatment dose 60 mg / d, 3 times before meals orally. TW group: single TW, the therapeutic dose of 60 mg / d, 3 times before meals orally. The curative effect, adverse reaction and the concentration of TAC in each group were observed. Results (1) A total of 20 SRNS patients, 11 low-dose TAC + TW patients and 9 patients in the TW group were eligible. The baseline age, gender distribution, onset time, blood pressure, 24h urinary protein, serum albumin, creatinine, cholesterol, triglyceride, fasting blood glucose, pathological type of kidney and the time of taking prednisone had no significant difference. (2) Urine protein began to decline after 1 month of treatment in low-dose TAC + TW group, 8 cases were completely relieved (72.7%) at 12 months follow-up, 2 cases partially relieved (18.2%) and 1 case ineffective ), The total efficiency (90.9%). However, urinary protein began to decrease in the TW group after 1 month of treatment, but only 2 cases achieved complete remission (22.2%) at 12 months, 4 cases (44.5%) partially relieved and 3 (33.3%) ineffective Effective (66.7%). Follow-up to the end of low-dose TAC + TW group, the complete remission rate was higher than the TW group. (3) Plasma protein in patients with low-dose TAC + TW group was significantly increased after treatment, and plasma protein returned to normal level at 6 months after treatment; however, plasma protein in TW group was not obvious. Serum creatinine levels in both groups before and after treatment did not change significantly. (4) the incidence of adverse reactions no significant difference between the two groups. Conclusion Low-dose TAC + TW can effectively reduce proteinuria in patients with SRNS, the clinical remission rate is high; and patients with good tolerance, is an effective method for the treatment of SRNS.