非布司他与别嘌呤醇治疗痛风随机对照试验系统评价  

RCT Review of Febuxostat vs Allopuinol in Treating Gout and Hyperuricemia

作　　者：方芳[1] 王鹏[1] 

机构地区：[1]核工业四一六医院,四川成都610051

出　　处：《中国药业》2016年第11期13-19,共7页China Pharmaceuticals

摘　　要：目的评价非布司他治疗痛风的安全性与有效性。方法检索Pubmed,The Cochrane Library,EMbase,中文科技期刊全文数据库（CNKI）,中国生物医学文献服务系统（Sino Med）,维普中文科技期刊数据库（VIP）和万方数据库,纳入非布司他治疗痛风的随机对照试验（RCT）。由2位研究人员依据纳入与排除标准独立筛选文献,提取数据,评估偏倚风险,并交叉核对结果,最后采用Revman 5.3软件进行Meta分析。结果共纳入7篇文献。分析结果显示,非布司他40 mg,80 mg,120 mg组血尿酸（s UA）达标率分别为45.8%[RR=1.28,95%CI为1.13~1.46,P=0.000 1],65.8%[RR=1.73,95%CI为1.61~1.86,P=0.000 1],79.3%[RR=2.11,95%CI为1.87~2.38,P〈0.000 01],与剂量呈正相关趋势,与别嘌呤醇组的差异具有显著性;非布司他（40~120 mg）降低s UA的效果均优于别嘌呤醇[非布司他40 mg组,MD=1.82,95%CI为0.39~3.25,P=0.01;80 mg组,MD=10.21,95%CI为8.93~11.49,P〈0.000 01;120 mg组,MD=18.33,95%CI为16.23~20.43,P〈0.000 01];预防期非布司他120 mg组与别嘌呤醇组的痛风发生率有显著性差异[RR=1.65,95%CI为1.36~2.02,P〈0.000 01],非布司他组的痛风发生率显著高于别嘌呤醇组,80 mg组、非预防期120 mg组与别嘌呤醇组差异无显著性;非布司他组的不良反应发生率明显低于别嘌呤醇组[RR=0.95,95%CI为0.91~0.99,P=0.03]。而在肝功能损害及严重不良反应发生率方面各组均无显著性差异。结论非布司他疗效与安全性均优于别嘌呤醇。Objective To evaluate the safety and effectiveness of febuxostat versus allopuinol for the treatment of gout and hyperuricemia. Methods The randomized controlled trials（RCT） were got by searching the database including PubMed, the cochrane library, EMbase, CNKI, SinoMed, VIP, and Wanfang. Two investigator independently screened literature, extrcated data and assessed methodological quality of the studies. Then, the data extracting from RCTs were analyzed by the RevMan 5.3. Results 7 RCTs were included in total. The result of meta analysis demonstated that, a significantly greater proportion of subjects receiving febuxostat at any dose achieved the primary end point of sUA levels 〈 6.0 mg/dl than subjects receiving allopurinol （45.8% [ RR = 1.28, 95% CI： 1.13 - 1.46, P =0.000 1], 65.8% [ RR = 1.73, 95% CI： 1.61 - 1.86, P = 0. 000 1 ], 79.3% [ RR = 2. 11, 95% CI： 1.87 - 2. 38, P 〈 0. 000 01 ] ）; at the final visit, all febuxostat doses produced significantly greater percent decreases in serum urate levels from baseline compared with aUopurinol[febuxostat 40 rag, MD = 1.82, 95% CI： O. 39- 3.25, P =0.01; febuxostat 80 mg, MD = 10. 21, 95% CI： 8.93- 11.49, P 〈 0. 000 01; febuxostat 120 mg, MD = 18. 33, 95% CI： 16. 23 -20. 43, P 〈 0. 000 01]. The incidence rate of gout in the prophylaxic period of febuxostat 120 mg had statistical ditherence with alloparinol group[ RR = 1.65, 95% CI： 1.36- 2.02, P 〈 0. 000 01]. There were no statistically significant differences in the proportion of subjects requiring treatment for gout flares in febuxostat 80 mg and no prophylaxis peroid of febuxostat 120 mg. Moreover, the adverse events incidence of febuxostat was lower than those of allopurinol[RR =0. 95, 95% CI： 0. 91-0.99, P=0. 03]. The incidence of liver function lesion, serious adverse events were similar in all treatment groups. Conclusion Based on current clinical evidence, the safety and effictiveness of febuxostat were better than allopurinol.

关 键 词：非布司他 别嘌呤醇 痛风 高尿酸血症 系统评价 

分 类 号：R969.4[医药卫生—药理学] R971.1[医药卫生—药学]