Samuels J A, Strippoli G F M, Craig J C, Schena F P, Molony D A
Nephrology / Pediatric Nephrology, UT-Houston Health Science Center, 6431 Fannin Street, MSB 4-148, Houston, TX 77030, USA.
Cochrane Database Syst Rev. 2003(4):CD003965. doi: 10.1002/14651858.CD003965.
IgA nephropathy (IgAN) is a world-wide disease and the cause of end-stage renal failure (ESRF) in 15 to 20% of patients within 10 years and in 30 to 40% of individuals within 20 years from the apparent onset of disease. No specific treatment has yet been established but many approaches have been investigated.
To assess the benefits and harms of immunosuppressive treatment for IgAN.
We searched The Cochrane Renal Group's specialized register (May 2003), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2002) MEDLINE (1966 - September 2002), EMBASE (1988 - September 2002) and handsearched reference lists of retrieved articles and conference proceedings.
Randomized controlled trials (RCTs) and quasi-RCTs comparing treatment of IgAN with immunosuppressive agents against placebo, no treatment, other immunosuppressive or non-immunosuppressive agents.
Two reviewers independently assessed trial quality and extracted data. Statistical analyses were performed using the random effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes, with 95% confidence intervals (CI).
Thirteen eligible RCTs involving 623 patients were identified. All identified RCTs had a placebo, no treatment or warfarin/dipyridamole control group. Seven trials used steroids, three used alkylating agents/cyclosporin and three used combinations of steroids and alkylating agents/cyclosporin. No trial directly compared steroids versus alkylating agents/cyclosporin. Quality was sub-optimal. Steroids were associated with a lower risk of progression to ESRF (RR 0.44, 95% CI 0.25 to 0.80) and lower urinary protein excretion (WMD -0.49 g/24h, 95% CI -0.72 to -0.12). Urinary protein excretion was lower for patients treated with alkylating agents/cyclosporin compared to placebo/no treatment (WMD -0.94 g/24h, 95% CI -1.43 to -0.46). There was no significant reduction of urinary protein excretion with combination treatment of steroids and alkylating agents compared with placebo/no treatment.
REVIEWER'S CONCLUSIONS: The optimal management of IgAN remains uncertain. The RCTs identified were small, of sub-optimal methodological quality and tended to only report favorable and surrogate outcomes without a thorough reporting of treatment harms. All outcomes favor the use of immunosuppressive interventions, with steroids appearing to be the most promising. Further study, in the form of RCTs, is necessary to ascertain which patients would benefit from these interventions, whether they are the ones with early signs of renal dysfunction or those with more advanced renal impairment.
IgA 肾病（IgAN）是一种全球性疾病，15%至 20%的患者在发病 10 年内、30%至 40%的患者在发病 20 年内会发展为终末期肾衰竭（ESRF）。目前尚未确立特异性治疗方法，但已对多种治疗方法进行了研究。
评估免疫抑制治疗 IgA 肾病的获益与危害。
我们检索了考克兰肾脏组专门注册库（2003 年 5 月）、考克兰对照试验中央注册库（CENTRAL）（《考克兰图书馆》，2002 年第 3 期）、医学期刊数据库（MEDLINE，1966 年至 2002 年 9 月）、荷兰医学文摘数据库（EMBASE，1988 年至 2002 年 9 月），并手工检索了所获文章的参考文献列表及会议论文集。
比较免疫抑制剂治疗 IgA 肾病与安慰剂、未治疗、其他免疫抑制剂或非免疫抑制剂治疗的随机对照试验（RCT）和半随机对照试验。
两名评价员独立评估试验质量并提取数据。采用随机效应模型进行统计分析，二分类结局结果以相对危险度（RR）表示，连续性结局结果以加权均数差（WMD）表示，并给出 95%置信区间（CI）。
共纳入 13 项符合条件的 RCT，涉及 623 名患者。所有纳入的 RCT 均设有安慰剂、未治疗或华法林/双嘧达莫对照组。7 项试验使用了类固醇，3 项试验使用了烷化剂/环孢素，3 项试验使用了类固醇与烷化剂/环孢素的联合用药。没有试验直接比较类固醇与烷化剂/环孢素。研究质量欠佳。类固醇与进展为 ESRF 的风险较低相关（RR 0.44，95%CI 0.25 至 0.80），且尿蛋白排泄较低（WMD -0.49 g/24 小时，95%CI -0.72 至 -0.12）。与安慰剂/未治疗相比，接受烷化剂/环孢素治疗的患者尿蛋白排泄较低（WMD -0.94 g/24 小时，95%CI -1.43 至 -0.46）。与安慰剂/未治疗相比，类固醇与烷化剂联合治疗后尿蛋白排泄无显著降低。
IgA 肾病的最佳治疗方案仍不确定。所纳入的 RCT 规模较小，方法学质量欠佳，且倾向于仅报告有利和替代结局，而未全面报告治疗危害。所有结局均支持使用免疫抑制干预措施，其中类固醇似乎最有前景。有必要开展进一步的 RCT 研究，以确定哪些患者能从这些干预措施中获益，是肾功能不全早期迹象的患者还是肾功能损害更严重的患者。
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