目的研发中央随机分配管理系统(web-based central randomization management system,WCRMS)。方法采用软件研发中的生命周期法,将整个系统开发过程划分为系统规划、系统分析、系统设计、系统实施以及系统维护5个阶段进行系统研制。基...目的研发中央随机分配管理系统(web-based central randomization management system,WCRMS)。方法采用软件研发中的生命周期法,将整个系统开发过程划分为系统规划、系统分析、系统设计、系统实施以及系统维护5个阶段进行系统研制。基于国际临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)标准进行数据库设计,采用模型-视图-控制器(Model View Controller,MVC)模式架构,web服务器采用稳定的tomcat,数据库连接池技术采用Proxool。结果我们成功的研制了中央随机分配管理系统,并且经过多次测试,证明该系统具有稳定性、可靠性和实时性。目前该系统正稳定运行中,它可以支持多个研究设计(多中心/单中心、盲法/非盲)、样本量大小不一的临床研究同时进行,支持设盲研究紧急揭盲、动态药物管理。结论基于CDISC标准的数据库设计,保证了数据标准化与规范化,使系统能更好地与电子数据采集EDC系统进行对接。利用本系统,可使得随机分配隐藏更加可靠,也可使项目管理员通过实时监测项目各分中心进度,采取对应措施,缩短临床研究周期、保证试验质量,从而提高整个研究的效率。展开更多
Aims: Although embolic protection devices reduce complications during saphenous vein graft(SVG) stenting, adverse events still occur in ～10%of patients. IIb/IIIa antagonists have not been proven effective during SVG ...Aims: Although embolic protection devices reduce complications during saphenous vein graft(SVG) stenting, adverse events still occur in ～10%of patients. IIb/IIIa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. Methods and results: In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. IIb/IIIa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for IIb/IIIa inhibitor use(n=345) had higher baseline risk, with increased 30-day major adverse cardiac events(MACE, 13.0 vs. 8.0%, P=0.03). GuardWire assigned patients treated with IIb/IIIa inhibitors had higher 30-day MACE compared with those not treated with IIb/IIIa inhibitors(16.0 vs. 6.3%, P=0.007). In contrast, MACE in high-risk FilterWire patients treated with IIb/IIIa inhibitors were similar to their lower risk, untreated counterparts(9.9 vs. 9.5%, P=0.89). Multivariable analysis detected a borderline significant(P=0.056) interaction for lower MACE between FilterWire and IIb/ IIIa inhibitor use. Adjustment by the propensity to use IIb/IIIa inhibitors resulted in a significant(P=0.023) interaction for lower MACE rates. IIb/IIIa inhibition in conjunction with FilterWire was associated with less abrupt closure, no reflow, or distal embolization. Conclusion: IIb/IIIa antagonists may improve procedural outcome during SVG stenting in high risk patients, utilizing filter-based embolic protection devices.展开更多
文摘Aims: Although embolic protection devices reduce complications during saphenous vein graft(SVG) stenting, adverse events still occur in ～10%of patients. IIb/IIIa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. Methods and results: In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. IIb/IIIa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for IIb/IIIa inhibitor use(n=345) had higher baseline risk, with increased 30-day major adverse cardiac events(MACE, 13.0 vs. 8.0%, P=0.03). GuardWire assigned patients treated with IIb/IIIa inhibitors had higher 30-day MACE compared with those not treated with IIb/IIIa inhibitors(16.0 vs. 6.3%, P=0.007). In contrast, MACE in high-risk FilterWire patients treated with IIb/IIIa inhibitors were similar to their lower risk, untreated counterparts(9.9 vs. 9.5%, P=0.89). Multivariable analysis detected a borderline significant(P=0.056) interaction for lower MACE between FilterWire and IIb/ IIIa inhibitor use. Adjustment by the propensity to use IIb/IIIa inhibitors resulted in a significant(P=0.023) interaction for lower MACE rates. IIb/IIIa inhibition in conjunction with FilterWire was associated with less abrupt closure, no reflow, or distal embolization. Conclusion: IIb/IIIa antagonists may improve procedural outcome during SVG stenting in high risk patients, utilizing filter-based embolic protection devices.
