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目的观察吗替麦考酚酯(MMF)分散片联合泼尼松治疗难治性肾病综合征(RNS)的疗效性及安全性。方法采用前瞻性多中心对照方法,10个中心共142例患者入选。治疗组87例,对照组55例。治疗组以MMF分散片(每日30～40mg/kg)联合泼尼松(每日0.5～1mg/kg)治疗,服MMF6个月后,如无效应者停药,有效者减量维持治疗6个月,维持剂量每日10～20mg/kg;对照组以环磷酰胺(CTX)冲击,每2周连用2d,每日10mg/kg联合泼尼松治疗,疗程3个月,随后第4,7,10个月的第1天分别给予CTX500mg/m2,静脉点滴1次。泼尼松服用2～3个月开始减量。定期检测尿蛋白、肝肾功能及药物副作用。观察随访期共1年。结果MMF治疗组87例中58例获完全效应,16例部分效应,9例表现为早期效应,4例治疗失败,治疗总有效率95.4%,尿蛋白转阴67例(77%);CTX组55例中35例获完全效应,9例部分效应,1例早期效应,10例治疗失败,治疗总有效率81.8%,尿蛋白转阴36例(65.4%)。两组尿蛋白转阴率统计学差异无显著性,有效率MMF治疗组较CTX组高,而且有统计学意义(P<0.01)。尿蛋白转阴天数、低蛋白血症恢复天数、尿量恢复时间、高脂血症、水肿消退时间等方面MMF明显优于CTX。MMF治疗组用药期间主要副作用有一过性转氨酶升高3例次、感染32例次、消化道症状11例次、月经紊乱、肌肉颤动各1例次;对照组发生转氨酶升高9例次、感染30例次、消化道症状15例次、血红蛋白降低4例次、白细胞降低2例次、脱发7例次。结论结果表明,推荐MMF每日20～35mg/kg联合泼尼松0.5～1mg/kg治疗难治性肾病综合征,尿蛋白转阴率不劣于CTX,而且起效时间较CTX短,药物副作用少。
Objective To observe the efficacy and safety of mycophenolate mofetil (MMF) dispersible tablets combined with prednisone in the treatment of refractory nephrotic syndrome (RNS). Methods A prospective, multicenter, controlled trial of 142 patients in 10 centers was performed. 87 cases in the treatment group and 55 cases in the control group. Treatment group MMF dispersible tablets (daily 30 ~ 40mg / kg) combined with prednisone (daily 0.5 ~ 1mg / kg) treatment, MMF 6 months, if no effect was discontinued, the effective reduction of maintenance treatment 6 Month, the maintenance dose daily 10 ~ 20mg / kg; control group with cyclophosphamide (CTX) impact, once every 2 weeks for 2d, daily 10mg / kg combined with prednisone for 3 months, followed by 4, The first 10 days were given CTX500mg / m2, intravenous drip once. Prednisone take 2 to 3 months to start reducing. Regular testing urine protein, liver and kidney function and drug side effects. The follow-up period was observed for 1 year. Results In the MMF treatment group, 58 of 58 patients achieved complete effect, 16 of them were partial effect, 9 of them showed early effect, 4 failed of treatment, the total effective rate was 95.4% and urinary protein was negative in 67 (77%). CTX group In 55 cases, 35 cases achieved complete effect, 9 partial effects, 1 early effect and 10 failed treatment. The total effective rate was 81.8% and urine protein negative was 36 (65.4%). There was no significant difference in urinary protein negative rate between the two groups, the effective rate of MMF treatment group was higher than that of CTX group, and there was statistical significance (P <0.01). MMF was significantly better than CTX in the days of urinary protein negative conversion, hypoproteinemia recovery days, urine output recovery time, hyperlipidemia and edema regression. The main side effects of MMF treatment group were transient transaminase elevated in 3 cases, infection in 32 cases, gastrointestinal symptoms in 11 cases, menstrual disorders, muscle fibrillation in 1 case; control group occurred aminotransferase increased 9 cases, infection 30 cases, 15 cases of gastrointestinal symptoms, hemoglobin decreased 4 cases, leukopenia 2 cases, hair loss 7 cases. Conclusion The results suggest that MMF 20 ~ 35mg / kg daily combined with prednisone 0.5 ~ 1mg / kg refractory nephrotic syndrome is recommended, urine protein negative rate is not worse than CTX, and the onset time shorter than CTX, drug side effects less.