新型人纤维蛋白原治疗获得性纤维蛋白原减少症的随机、双盲、阳性药物平行对照、多中心临床试验

Randomized,double-blind,parallel-controlled,multi-center clinical trial of modified human fibrinogen in the treatment of acquired hypofibrinogenaemia

目的评价新型人纤维蛋白原治疗获得性纤维蛋白原减少症的有效性及安全性。方法用随机、双盲、阳性药物平行对照、多中心研究试验设计。将240例获得性纤维蛋白原减少症患者随机分为对照组121例和试验组119例。2组患者予以不同企业生产的人纤维蛋白,每次3 g,静脉滴注,qd。2组疗程均为1～3 d。比较2组患者首次治疗后纤维蛋白原升高值,并进行安全性分析。结果试验组和对照组首次注射2 h后纤维蛋白原升高值分别为(1. 00±0. 42)和(0. 71±0. 38) g·L^(-1),差异有统计学意义(P <0. 05)。试验组和对照组的药物不良反应发生率分别为4. 3%和17. 4%,差异有统计学意义(P <0. 05)。用药90 d后未发现新发病毒感染,安全性好。结论试验组较对照组治疗获得性纤维蛋白原减少症有效且安全。

Objective To evaluate the efficacy and safety of a modified human fibrinogen in the treatment of acquired hypofibrinogenaemia.Methods A randomized,double-blind,multi-center study of parallel-control of positive drugs was conducted.Two hundred and forty patients with acquired hypofibrinogenaemia were randomly divided into control group(n=121 cases)and treatment group(n=119 cases).Two groups were treated with human fibrinogen by different enterprises with 3 g every time,intravenous drip,qd.The increase of 2-hour fibrinogen concentrate after the first dose and safety were compared between two groups.Results The increase of 2-hour fibrinogen concentrates after the first dose was(1.00±0.42)g·L-1 for treatment group and(0.71±0.38)g·L-1 for control group with significant difference(P<0.05).The study revealed lower rate of adverse events in treatment group(4.3%)than control group(17.4%)with significant difference(P<0.05).No new viral infection was found within 90-day follow up period.Conclusion The modified human fibrinogen is more effective and safety than the control.