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成人肿瘤溶解综合征中的尿酸酶:系统评价和荟萃分析。

Rasburicase in tumor lysis syndrome of the adult: a systematic review and meta-analysis.

机构信息

Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.

出版信息

Am J Kidney Dis. 2013 Sep;62(3):481-92. doi: 10.1053/j.ajkd.2013.02.378. Epub 2013 May 14.

DOI:10.1053/j.ajkd.2013.02.378
PMID:23684124
Abstract

BACKGROUND

The use of rasburicase has been evaluated extensively in children, but not in adults. We review the current literature to evaluate its effect on adults.

STUDY DESIGN

Systematic review and meta-analysis.

SETTING & POPULATION: Adults receiving rasburicase for tumor lysis syndrome (TLS).

SELECTION CRITERIA FOR STUDIES

Electronic databases, regulatory documents, and websites were searched up to August 7, 2012. Reference lists of published articles were examined for additional relevant references. Any controlled trial or observational studies (controlled before and after) were included. Studies considering children only or mixing data for children and adults were excluded.

INTERVENTION

Rasburicase for TLS.

OUTCOMES

The primary outcome was TLS development. Secondary outcomes included percentage of patients improving, total adverse events, acute kidney failure, deaths, and serum uric acid and creatinine levels.

RESULTS

21 studies (24 publications) reported data for 1,261 adult patients, 768 receiving rasburicase for either the treatment or prophylaxis of TLS; these comprised 4 controlled trials and 17 observational studies. No statistically significant differences in clinical TLS development were observed in the controlled trials between the rasburicase and control groups. For the observational studies, 7.4% of patients developed clinical TLS after rasburicase (95% CI, 1.7%-16.7%), 93.4% of patients achieved normalized serum uric acid levels after rasburicase treatment (95% CI, 91.7%-94.6%), 4.4% developed acute kidney injury (95% CI, 3.0%-6.0%), and 2.6% died (95% CI, 0.95%-5.0%). The mean reduction in serum uric acid levels ranged from 5.3-12.8 mg/dL, and for serum creatinine levels, from 0.10-2.1 mg/dL.

LIMITATIONS

Controlled trials differed in outcomes reported; meta-analysis was not performed.

CONCLUSIONS

Rasburicase is effective in reducing serum uric acid levels in adults with TLS but at a significant cost, and evidence currently is lacking in adults to report whether rasburicase use improves clinical outcomes compared with other alternatives. Until new evidence is available, use of rasburicase may be limited to adult patients with a high risk of TLS.

摘要

背景

拉布立酶已在儿童中广泛评估,但尚未在成人中进行。我们综述目前的文献以评估其在成人中的疗效。

研究设计

系统评价和荟萃分析。

研究场所和人群

接受拉布立酶治疗肿瘤溶解综合征(TLS)的成人。

研究选择标准

电子数据库、监管文件和网站检索至 2012 年 8 月 7 日,对已发表文章的参考文献进行了进一步相关文献的检索。纳入所有对照试验或观察性研究(治疗前和治疗后对照)。仅考虑儿童或混合儿童和成人数据的研究被排除。

干预

拉布立酶治疗 TLS。

主要结局

TLS 发生情况。次要结局包括患者改善比例、总不良事件、急性肾损伤、死亡以及血清尿酸和肌酐水平。

结果

21 项研究(24 篇文献)报告了 1261 例成年患者的数据,768 例接受拉布立酶治疗 TLS,其中包括 4 项对照试验和 17 项观察性研究。对照试验中,拉布立酶组与对照组在临床 TLS 发生方面无统计学差异。对于观察性研究,拉布立酶治疗后有 7.4%(95%CI,1.7%-16.7%)的患者发生临床 TLS,93.4%(95%CI,91.7%-94.6%)的患者血清尿酸水平恢复正常,4.4%(95%CI,3.0%-6.0%)发生急性肾损伤,2.6%(95%CI,0.95%-5.0%)死亡。血清尿酸水平平均降低 5.3-12.8mg/dL,血清肌酐水平平均降低 0.10-2.1mg/dL。

局限性

对照试验报告的结局不同,未进行荟萃分析。

结论

拉布立酶可有效降低 TLS 成人的血清尿酸水平,但费用高昂,目前缺乏成人使用拉布立酶与其他替代方法相比是否能改善临床结局的证据。在新证据出现之前,拉布立酶的使用可能仅限于有高 TLS 风险的成年患者。

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