吲哚布芬用于预防静脉血栓形成的有效性与安全性的系统评价与Meta分析

Clinical Efficacy and Safety of Indobufen in the Prevention of Venous Thrombosis:A Systematic Review and Meta-Analysis

目的:评价吲哚布芬在预防静脉血栓形成中的有效性与安全性。方法:在PubMed、Embase、the Cochrane Library、ClinicalTrial.gov、中国知网、万方数据库和中国生物医学文献数据库中检索,纳入吲哚布芬用于预防静脉血栓形成的随机对照试验(干预措施为吲哚布芬单药或联合其他常规用药治疗;对照措施为其他阳性对照药单药或联合其他常规用药治疗),检索时间截至2023年5月。2名评价者按照事先制定的纳入与排除标准筛选文献,提取资料,并对纳入研究的方法学质量进行评价,采用RevMan 5.3软件进行Meta分析。结果:最终纳入15项RCT研究,共2164例患者,其中吲哚布芬组1117例,对照组1047例。有效性结局显示,吲哚布芬在心房颤动(AF)血栓预防、骨科大手术后血栓预防和特发性膜性肾病血栓预防方面有足够的循证证据进行Meta分析,结果均不劣于华法林或其他抗凝血药;在AF合并缺血性心脑血管疾病、肾病综合征和下肢浅静脉曲张术后血栓预防方面,吲哚布芬也具有一定的证据,但尚不足以进行定量分析。安全性结果显示,吲哚布芬在预防AF血栓形成中造成出血(RR=0.18,95%CI=0.09~0.38,P<0.00001)和轻微出血(RR=0.17,95%CI=0.05~0.52,P=0.002)的发生率显著低于华法林,差异均有统计学意义。结论:吲哚布芬在预防静脉血栓形成方面已积累了一定的循证证据,其临床有效性不劣于传统治疗方案,在安全性方面更优。

OBJECTIVE:To evaluate the efficacy and safety of indobufen in the prevention of venous thrombosis.METHODS:PubMed,Embase,the Cochrane Library,ClinicalTrial.gov,CNKI,Wanfang Data and CBM were searched electronically for randomized controlled trial(RCT)of indobufen in the prevention of venous thrombosis(the interventions were indobuprofen alone or in combination with other conventional drugs,while the control measures were other positive control drugs alone or in combination with other conventional drugs)up to May 2023.Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data,and assessed the methodological quality of the included literature.Meta-analysis was performed by using RevMan 5.3 software.RESULTS:A total of 15 RCT with 2164 patients were included.There were 1117 patients in the indobufen group and 1047 patients in the control group.Efficacy results showed that the there was sufficient evidence-based evidence for Meta-analysis of indobufen in thromboprophylaxis of atrial fibrillation(AF),thromboprophylaxis after major orthopedic surgery,and thromboprophylaxis of idiopathic model nephropathy,and the results were not worse than warfarin or other anticoagulants.In the prevention of thrombosis after AF combined with ischemic cardio-cerebrovascular disease,nephrotic syndrome and superficial varices of lower extremities,indobufen also had some evidence,yet it was not enough for quantitative analysis.Safety outcomes showed that the incidences of bleeding(RR=0.18,95%CI=0.09-0.38,P<0.00001)and minor bleeding(RR=0.17,95%CI=0.05-0.52,P=0.002)induced by indobufen in prevention of AF thrombosiswas were significantly lower than those in warfarin,with statistically significant differences.CONCLUSIONS:Indobufen has accumulated a certain amount of evidence-based evidence in the prevention of venous thrombosis.The clinical efficacy of indobufen in the prevention of venous thrombosis is not inferior to that of conventional therapy,and the safety of indobufen is better.