Palmer S C, Nand K, Strippoli G F
University of Otago, Department of Medicine, Christchurch School of Medicine and Health Sciences, PO Box 4345, Christchurch, New Zealand.
Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD001537. doi: 10.1002/14651858.CD001537.pub4.
Steroids have been used widely since the early 1970s for the treatment of adult-onset minimal change disease. The response rates to immunosuppressive agents in adult minimal change disease, especially steroids, are more variable than in children. The optimal agent, dose, and duration of treatment for the first episode of nephrotic syndrome, or for disease relapse(s) has not been determined.
To determine the benefits and harms of interventions for the nephrotic syndrome in adults caused by minimal change disease.
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, reference articles and abstracts from conference proceedings, without language restriction. Search date: January 2007.
Randomised controlled trials (RCTs) and quasi-RCTs of any intervention for minimal change disease in adults over 18 years with the nephrotic syndrome were included. Studies comparing different routes, frequencies, and duration of immunosuppressive agents were selected. Studies comparing non-immunosuppressive agents were also assessed.
Two authors independently assessed study quality and extracted data. Statistical analyses were performed using the random effects model and results were expressed as a relative risk (RR) for dichotomous outcomes, or mean difference (WMD) for continuous data with 95% confidence intervals (CI).
Three RCTs (68 participants) were identified. All treatment comparisons contained only one study. No significant difference was found between prednisone compared with placebo for complete (RR 1.44, CI 0.95 to 2.19) and partial remission (RR 1.00, CI 0.07 to 14.45) of the nephrotic syndrome due to minimal change disease. There was no difference between intravenous methylprednisolone plus oral prednisone compared with oral prednisone alone for complete remission (RR 0.74, CI 0.50 to 1.08). Prednisone, compared with short-course intravenous methylprednisolone, increased the number of subjects who achieved complete remission (RR 4.95, CI 1.15 to 21.26). The lack of statistical evidence of efficacy associated with prednisone therapy was based on data derived from a single study that compared 'alternate-day prednisone' to no immunosuppression' with only a small number of participants in each group. No RCTs were identified comparing regimens in adults with a steroid-dependent or relapsing disease course or comparing treatments comprising alkylating agents, cyclosporine, tacrolimus, levamisole, or mycophenolate mofetil.
AUTHORS' CONCLUSIONS: Further comparative studies are required to examine the efficacy of immunosuppressive agents for achievement of sustained remission of nephrotic syndrome caused by minimal change disease. Studies are also needed to evaluate treatments for adults with steroid-dependent or relapsing disease.
自20世纪70年代初以来,类固醇已被广泛用于治疗成人起病的微小病变病。成人微小病变病对免疫抑制剂的反应率,尤其是对类固醇的反应率,比儿童更具变异性。肾病综合征首次发作或疾病复发时的最佳治疗药物、剂量和疗程尚未确定。
确定针对微小病变病所致成人肾病综合征干预措施的益处和危害。
我们检索了Cochrane对照试验中央注册库、MEDLINE、EMBASE、会议论文的参考文献和摘要,无语言限制。检索日期:2007年1月。
纳入对18岁以上患有肾病综合征的成人微小病变病进行任何干预的随机对照试验(RCT)和半随机对照试验。选择比较免疫抑制剂不同给药途径、频率和疗程的研究。也评估比较非免疫抑制剂的研究。
两位作者独立评估研究质量并提取数据。使用随机效应模型进行统计分析,结果以二分类结局的相对危险度(RR)或连续数据的平均差(WMD)及95%置信区间(CI)表示。
共识别出3项RCT(68名参与者)。所有治疗比较仅包含一项研究。微小病变病所致肾病综合征的完全缓解(RR 1.44,CI 0.95至2.19)和部分缓解(RR 1.00,CI 0.07至14.45)方面,泼尼松与安慰剂相比无显著差异。静脉注射甲泼尼龙加口服泼尼松与单纯口服泼尼松相比,完全缓解率无差异(RR 0.74,CI 0.50至1.08)。与短疗程静脉注射甲泼尼龙相比,泼尼松使实现完全缓解的受试者数量增加(RR 4.95,CI 1.15至21.26)。泼尼松治疗缺乏疗效的统计学证据是基于一项将“隔日泼尼松”与“无免疫抑制”进行比较的单一研究数据,每组参与者数量较少。未识别出比较类固醇依赖或复发病程成人治疗方案的RCT,也未识别出比较包含烷化剂、环孢素、他克莫司、左旋咪唑或霉酚酸酯治疗的RCT。
需要进一步的比较研究来检验免疫抑制剂对微小病变病所致肾病综合征实现持续缓解的疗效。还需要开展研究评估类固醇依赖或复发疾病成人的治疗方法。