摘要
目的评价痛风/高尿酸血症患者应用非布司他或别嘌醇的心血管安全性,探讨亚洲和非亚洲患者心血管安全性的差异。方法检索国内外有关数据库(截至2021年10月),收集非布司他(试验组)与别嘌醇(对照组)治疗痛风/高尿酸血症患者心血管安全性比较的随机对照试验(RCT)和队列研究,结局指标包括急性失代偿性心力衰竭(ADHF)、脑卒中、急性冠状动脉综合征(ACS)、冠状动脉(冠脉)血运重建、心血管病因和全因死亡的发生率。分别采用Cochrane偏倚风险评估工具和纽卡斯尔-渥太华量表对纳入的RCT和队列研究进行质量评价。采用RevMan 5.4软件进行meta分析,效应值为相对危险度(RR)及其95%置信区间(CI)。结果纳入分析的RCT为9项,队列研究7项,共包括385700例患者,试验组123565例,对照组262135例。质量评价结果显示,9项RCT中低风险偏倚和偏倚风险不确定者分别为4和5项;7项队列研究中高和中等质量者分别为2和5项。对RCT的meta分析结果显示,试验组ADHF发生率低于对照组,差异有统计学意义[1.37%(77/5620)比2.21%(102/4607),RR=0.74,95%CI:0.55~0.99,P=0.04]。对队列研究的meta分析结果显示,亚洲试验组脑卒中发生率与对照组比较差异无统计学意义[0.87%(519/59559)比0.90%(810/89836),RR=0.94,95%CI:0.75~1.17,P=0.58];非亚洲试验组脑卒中发生率低于对照组,差异有统计学意义[1.49%(377/25306)比1.70%(1305/76864),RR=0.88,95%CI:0.78~0.98,P=0.02];亚洲试验组心血管病因死亡发生率高于对照组,差异有统计学意义[0.96%(473/49373)比0.68%(335/49368),RR=1.41,95%CI:1.23~1.62,P<0.01]。结论非布司他致ADHF的发生风险低于别嘌醇,致非亚洲患者脑卒中的发生风险低于别嘌醇,致亚洲患者心血管病因死亡的发生风险高于别嘌醇。
Objective To evaluate the cardiovascular safety of febuxostat and allopurinol in patients with gout/hyperuricemia,and to explore the difference in cardiovascular safety between Asian and non-Asian patients.Methods Randomized controlled trials(RCTs)and cohort studies of comparision of cardiovascular safety between febuxostat(the trial group)and allopurinol(the control group)in the treatment of gout/hyperuricemia were collected by searching related databases at home and abroad(up to October,2021).The outcome indicators were the incidences of acute decompensated heart failure(ADHF),stroke,acute coronary syndrome(ACS),coronary revascularization,death from cardiovascular causes,and all-cause death.The Cochrane collaboration risk of bias risk tool and Newcastle Ottawa Scale were used to evaluate the quality of the RCTs and the cohort studies,respectively.RevMan 5.4 software was used for meta-analysis,and the effect sizes were relative risk(RR)and its 95%confidence interval(CI).Results A total of 9 RCTs and 7 cohort studies were enrolled in the analysis and 385700 patients were involved,including 123565 in the trial group and 262135 in the control group.The results of quality evaluation showed that there were 4 and 5 RCTs with low and uncertain bias risk in 9 RCTs,respectively;among the 7 cohort studies,2 and 5 were of high and medium quality,respectively.The result of meta-analysis of RCTs showed that the incidence of ADHF in the trial group was significantly lower than that in the control group[1.37%(77/5620)vs.2.21%(102/4607),RR=0.74,95%CI:0.55-0.99,P=0.04].The result of meta-analysis of cohort studies showed that the incidence of stroke in Asian patients in the trial group was lower than that in the control group[0.87%(519/59559)vs.0.90%(810/89836),RR=0.94,95%CI:0.75-1.17,P=0.58];the incidence of stroke in non-Asian patients in the trial group was lower than that in the control group,and the difference was statistically significant[1.49%(377/25306)vs.1.70%(1305/76864),RR=0.88,95%CI:0.78-0.98,P=0.02];the incidence of
作者
邓健浩
张家兴
庄茜
Deng Jianhao;Zhang Jiaxing;Zhuang Qian(Department of Pharmacy,Longyan Second Hospital,Fujian Province,Longyan 364000,China;Department of Pharmacy,Guizhou Provincial People's Hospital,Guiyang 550002,China;Department of Pharmacy,Fujian Medical University Union Hospital,Fuzhou 350001,China)
出处
《药物不良反应杂志》
CSCD
2022年第5期239-245,共7页
Adverse Drug Reactions Journal
