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狼疮性肾炎的治疗:临床试验的荟萃分析

Treatment of lupus nephritis: a meta-analysis of clinical trials.

作者信息

Bansal V K, Beto J A

机构信息

Division of Renal Disease and Hypertension, Loyola University Medical Center, Maywood, IL 60153, USA.

出版信息

Am J Kidney Dis. 1997 Feb;29(2):193-9. doi: 10.1016/s0272-6386(97)90029-9.

DOI:10.1016/s0272-6386(97)90029-9
PMID:9016889
Abstract

The best therapeutic choice in lupus nephritis remains shrouded in a body of controversial literature. The purpose of this review was to assess and compare by meta-analysis the efficacy of therapeutic agents used in the treatment of lupus nephritis using outcomes of end-stage renal disease (ESRD) and total mortality. An exhaustive search was performed using MEDLINE (1970 to 1995) and manual search of bibliographic notations and nonindexed sources. Twenty prospective controlled trials with treatment allocation by random assignment or consecutive enrollment were identified using diagnostic evidence of systemic lupus erythematosus based on American Rheumatism Association (ARA) criteria and clinical/biopsy evidence of lupus nephritis. One trial was excluded, resulting in 19 trials (n = 440) using treatment groups of oral prednisone alone, azathioprine with and without concomitant prednisone, oral cyclophosphamide with prednisone, azathioprine and oral cyclophosphamide with prednisone, and intravenous cyclophosphamide with prednisone. Crude risk data was pooled. An adjusted pooled risk was calculated using the random effects model of DerSimonian and Laird. Two measures of clinical effectiveness were used to compare treatments: absolute risk differences and number needed to treat. Analysis was completed between treatment groups as follows: oral prednisone compared with all immunosuppressive agents with prednisone and all treatment groups compared with one another. When compared with oral prednisone alone, immunosuppressive agents used in conjunction with oral prednisone were found to be statistically more effective for both total mortality and ESRD (absolute risk differences, 13.2% and 12.9%, respectively). When treatment groups were compared, intravenous cyclophosphamide in conjunction with oral prednisone was found to be statistically more effective than oral prednisone alone for both total mortality and ESRD (absolute risk differences, 19.9% and 16.2%, respectively). The simultaneous use of azathioprine and oral cyclophosphamide concomitant with oral prednisone was found to be 16.9% more effective than oral prednisone alone in reducing incidence of ESRD. No difference was seen in total mortality and data represented only two studies (n = 30). No immunosuppressive agent was found to be statistically more effective than another for either total mortality or ESRD. Future prospective studies are needed to control for numerous variables and renal function changes to provide more definitive answers.

摘要

狼疮性肾炎的最佳治疗选择仍笼罩在大量有争议的文献中。本综述的目的是通过荟萃分析,使用终末期肾病(ESRD)和总死亡率的结果,评估和比较用于治疗狼疮性肾炎的治疗药物的疗效。使用MEDLINE(1970年至1995年)进行了详尽的检索,并对手抄的书目注释和未编入索引的来源进行了检索。根据美国风湿病协会(ARA)标准的系统性红斑狼疮诊断证据以及狼疮性肾炎的临床/活检证据,确定了20项采用随机分配或连续入组进行治疗分配的前瞻性对照试验。排除了一项试验,最终得到19项试验(n = 440),其治疗组包括单独口服泼尼松、硫唑嘌呤联合或不联合泼尼松、口服环磷酰胺联合泼尼松、硫唑嘌呤和口服环磷酰胺联合泼尼松以及静脉注射环磷酰胺联合泼尼松。汇总了原始风险数据。使用DerSimonian和Laird的随机效应模型计算调整后的汇总风险。使用两种临床有效性指标来比较治疗方法:绝对风险差异和需治疗人数。在治疗组之间进行了如下分析:单独口服泼尼松与所有联合泼尼松的免疫抑制剂比较,以及所有治疗组之间相互比较。与单独口服泼尼松相比,联合口服泼尼松使用的免疫抑制剂在总死亡率和ESRD方面在统计学上更有效(绝对风险差异分别为13.2%和12.9%)。当比较各治疗组时,静脉注射环磷酰胺联合口服泼尼松在总死亡率和ESRD方面在统计学上比单独口服泼尼松更有效(绝对风险差异分别为19.9%和16.2%)。发现同时使用硫唑嘌呤和口服环磷酰胺联合口服泼尼松在降低ESRD发生率方面比单独口服泼尼松有效16.9%。在总死亡率方面未发现差异,且数据仅代表两项研究(n = 30)。未发现任何免疫抑制剂在总死亡率或ESRD方面在统计学上比另一种更有效。未来需要进行前瞻性研究以控制众多变量和肾功能变化来提供更明确的答案。

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