舒洛地特联合辛伐他汀治疗糖尿病下肢血管病变有效性和安全性系统评价和Meta分析

Systematic evaluation and Meta-analysis of the efficacy and safety of sulodexide combined with simvastatin in the treatment of lower-extremity arterial disease

目的:系统评价和Meta分析舒洛地特(sulodexide,SDX)联合辛伐他汀(simvastatin)用于糖尿病下肢血管病变治疗有效性和安全性。方法:计算机检索中国期刊全文数据库、万方数据库、维普数据库、SinoMed数据库、PubMed数据库、Cochrane Library数据库、EMbase数据库、Web of Science数据库,搜集舒洛地特联合辛伐他汀治疗糖尿病下肢血管病变的有效性和安全性的随机对照研究(RCT),检索时间均从建库至2019年8月31日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.3软件进行Meta分析。结果:共纳入9篇RCTs,包括781例患者。Meta分析结果显示:与单纯使用舒洛地特组相比,舒洛地特联合辛伐他汀治疗组能提高行走无痛距离、最长行走距离、血流速度(Vm)、搏动指数(PI),降低血流阻力指数(RI)及不良反应发生率。结论:当前纳入文献表明,舒洛地特联合辛伐他汀对糖尿病下肢血管病变治疗的有效性和安全性较高。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective:To systematically evaluate the efficacy and safety of sulodexide(SDX)combined with simvastatin in the treatment of lower-extremity arterial disease.Methods:CNKI,WanFang Data,and VIP,PubMed,The Cochrane Library,EMbase and databases were electronically searched to collect cohort studies on the efficacy and safety of sulodexide combined with simvastatin in the treatment of lower-extremity arterial disease.The retrieval time is from the establishment of the database to August 31,2019.After the two researchers independently screened the literature,extracted the data and evaluated the bias risk included in the study,the Meta analysis was carried out by RevMan 5.3.Results:A total of 9 articles of RCTs were included,including 781 patients.The results of Meta analysis show that:Compared with the group treated with sulodexide alone,the group treated with sulodexide combined with Simvastatin could increase the painless distance,the longest distance of walking,the mean glow velocity(Vm),the pulsatility index(PI),and decrease the blood flow resistance index(RI)and the incidence of adverse reactions.Conclusion:The current literature shows that Sulodexide combined with Simvastatin is relatively effective and safe in the treatment of lower-extremity arterial disease.Limited by the quantity and quality of included studies,the above conclusions need to be verified by more high-quality studies.