他克莫司与环磷酰胺联合激素治疗特发性膜性肾病的疗效比较

目的:比较他克莫司( Tacrolimus,TL)与环磷酰胺( Cyclophosphamide,CTX)联合激素治疗特发性膜性肾病(idiopathic membranous nephropathy,IMN)的疗效及安全性.方法:选择本院原发性肾病综合征经肾活检确诊为IMN的30例患者,排除继发性膜性肾病,随机分为两组,分别给予TL联合激素治疗TL组,0.07～0.1mg·kg-1·d-1,n=15]或CTX联合激素治疗CTX组,0.75～1.0 g/m2,1次/月,n=15],疗程为6个月.主要观察治疗前后24小时尿蛋白、血清白蛋白、血脂、血糖、肝肾功的变化和不良反应发生率,以及治疗后的完全缓解率、部分缓解率.结果:TL或CTX治疗6个月后疗效指标均出现明显的改善.TL组1月后24小时蛋白尿、血清白蛋白和血脂出现明显缓解,而CTX组2月后才出现明显缓解.治疗6个月后TL组完全缓解率高于CTX组(40.0％ vs 13.3％),总缓解率高于CTX组(93.3％ vs 60.0％).TL组副作用主要有:胃肠不适2例(13.3％),血糖升高1例(6.7％)、细菌性肺炎1例(6.7％)、带状疱疹1例(6.7％),血清肌酐升高1例(6.7％)、轻度肝转氨酶升高1例(6.7％)、脱发2例(13.3％).CTX组的副作用:胃肠道不适2例(13.3％),肺部感染2例(13.3％),带状疱疹1例(6.7％),骨髓抑制2例(13.3％),肝功能损害3例(20.0％),化学性膀胱炎2例(13.3％),脱发6例(40.0％).结论:TL联合激素治疗膜性肾病是有效和安全的.与CTX相比,TL能迅速缓解膜性肾病患者蛋白尿,并有更高的IMN缓解率.

Efficacy and safety of tacrolimus versus cyclosporine in adults with idiopathic membranous nephropathy

AIM: To compare the clinical efficacy and side-effects in patients with idiopathic membranous nephropathy who received Tacrolimus(TL) or Cyclophosphamide(CTX).METHODS: 30 patients with primary nephrotic syndrome admitted to our hospital,diagnosed by renal biopsy in IMN,excluded in the diagnosis of secondary membranous nephropathy,were randomly divided into Tacrolimus combined with glucocorticoid treatment(TL group,0.07-0.1 mg·kg-1·d-1,n=15) or CTX combined with glucocorticoid treatment(CTX group,0.75-1.0 g/m2 body surface area,every month for 6 months,n=15).All patients received variable doses of prednisolone concomitant with TL or CTX therapy,at a dose of 1.0 mg·kg-1·d-1 initially and maintained at 0.2-0.3 mg·kg-1·d-1.The planned duration of study to assess treatment efficacy was at least 6 months.The effect of TL was observed by the change of 24 h urinary protein,serum albumin,blood lipid,blood glucose,liver and kidney function and its adverse effects in each group,and complete response rate and partial remission rate.RESULTS:Significant clinical improvement in IMN patients was observed after TL or CTX treatment and the most noticeable effect was found at 6 months of therapy.TL significantly alleviate proteinuria,serum albumin and blood lipids a month later,while CTX need two months.At the end of 6 months,the complete remission rate and total remission rate in TL group was significantly higher than these in the CTX group(40.0% vs 13.3%,93.3% vs 60.0%,respectively).Adverse effects in the TL group: gastrointestinal discomfort(13.3%),glucose intolerance(6.7%),bacterial pneumonia(13.3%),shingles(6.7%),serum creatinine increased(6.7%),transaminase increased(6.7%),alopecia(13.3%).In the CTX group: gastrointestinal discomfort(13.3%),bacterial pneumonia(13.3%),shingles(6.7%),myelosuppression(13.3%),transaminase increased(20.0%),chemical cystitis(13.3%),alopecia(40.0%).CONCLUSION: The study suggests that a 6-month course of TL is a safe and effective treatment of IMN.As compared with CTX treatment,TL possibly results in a faster resolution of proteinuria and a higher remission rate of IMN.