不同剂量非布司他与别嘌醇治疗痛风有效性和安全性的系统评价与Meta分析

Systematic Evaluation and Meta-analysis of Efficacy and Safety of Different Doses of Febustrinol and Allopurinol in the Treatment of Gout

目的:系统评价非布司他80、40 mg/d与别嘌醇300 mg/d相互对比治疗痛风的有效性和安全性,以为临床治疗提供循证参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、中国期刊全文数据库、万方数据、中国生物医学文献数据库(CBM),检索时限为建库起至2019年3月,收集非布司他80 mg/d(试验组)、40 mg/d(观察组)与别嘌醇300 mg/d(对照组)治疗痛风的疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取后,采用Cochrane系统评价员手册5.1.0进行质量评价,采用Rev Man 5.1、Stata 13.0软件对血尿酸降低水平、血尿酸浓度达标率、肝功能异常发生率、肾功能异常发生率、消化道反应发生率、急性痛风发作频率进行Meta分析。结果:共纳入17项RCT,合计1816例患者。Meta分析结果显示,试验组患者血尿酸降低水平[MD=-70.17,95%CI(-97.41,-42.93),P<0.001]、血尿酸浓度达标率[RR=1.58,95%CI(1.20,2.08),P=0.001]显著高于观察组,血尿酸降低水平[MD=-34.68,95%(-61.35,-8.00),P=0.01]、血尿酸浓度达标率[RR=1.39,95%CI(1.04,1.85),P=0.03]显著高于对照组,急性痛风发作频率[RR=1.54(1.02,2.31),P=0.04]显著高于观察组;观察组患者肝功能异常发生率[RR=0.71,95%CI(0.52,0.99),P=0.04]显著低于对照组,以上差异均有统计学意义。其余各组指标比较,差异均无统计学意义(P>0.05)。结论:非布司他80 mg/d对比非布司他40 mg/d和别嘌醇300 mg/d治疗痛风在降低痛风患者血尿酸水平方面效果较好。

OBJECTIVE:To systematically evaluate the efficacy and safety of febustrin(80 mg/d and 40 mg/d)and allopurinol(300 mg/d)in the treatment of gout,and to provide evidence-based reference for clinical treatment.METHODS:Retrieved from PubMed,Embase,Cochrane library,CJFD,Wanfang database and CBM during from database establishment to Mar.2019,randomized controlled trial(RCT)about efficacy and safety of febustrin 80 mg/d(trial group),40 mg/d(observation group)and allopurinol 300 mg/d(control group)in the treatment of gout were collected.After extracting data of clinical studies met inclusion criteria and quality evaluation with Cochrane system evaluator manual 5.1.0,Meta-analysis was conducted for blood uric acid decrease level,the compliance rate of serum uric acid concentration,incidence of liver dysfunction,incidence of renal dysfunction,incidence of digestive tract reaction and frequency of acute gout attack with Rev Man 5.1 software and Stata 13.0 software.RESULTS:A total of 17 RCTs were included,involving 1816 patients.Meta-analysis results showed that,the serum uric acid decrease level of patients in trial group[MD=-70.17,95%CI(-97.41,-42.93),P<0.001]and the compliance rate of serum uric acid concentration[RR=1.58,95%CI(1.20,2.08),P=0.001]were higher than observation group;the decrease of serum uric acid level[MD=-34.68,95%(-61.35,-8.00),P=0.01]and the compliance rate of serum uric acid concentration[RR=1.39,95%CI(1.04,1.85),P=0.03]in trial group were significantly higher than control group;the frequency of acute gout attack[RR=1.54(1.02,2.31),P=0.04]in trial group was significantly higher than observation group.The incidence of liver dysfunction in observation group[RR=0.71,95%CI(0.52,0.99),P=0.04]was significantly lower than control group,with statistical significance.There was no statistical significance in other indexes among other indexes(P>0.05).CONCLUSIONS:Compared with febulostat 40 mg/d and allopurinol 300 mg/d,the efficacy of febulostat 80 mg/d is superior in reducing uric acid levels of gout patients.