利伐沙班预防关节置换术后深静脉血栓效果的文献计量分析

目的总结近年来国内外在关节置换术后应用利伐沙班预防深静脉血栓(DVT)效果的文献计量分析。方法以关键词"利伐沙班、关节置换"为检索词,利用中国知网和万方数据库,检索语言为中文,检索时间2008年1月至2013年9月,计算机共检索出文献40篇;以"Rivaroxaban、arthroplasty"为关键词在Pubmed中检索,文献检索语种限制为英文,检索的研究对象为人类,检索时间限制在2008年1月至2013年9月,检索文献82篇。结果在2008²013年中文文献分布中,已发表的中文文献有40篇,2009年最少,为0篇,2011年最多,前3年所发表的论文为5篇。从PubMed搜索到的关于利伐沙班预防关节置换术后静脉血栓的外文期刊有47种,符合检索条件的共78篇,发表文献最多的期刊是Lancet,有5篇,所占比例是6.41%。结论利伐沙班在关节置换术后预防DVT的疗效和安全性比一般药物好,建议在关节置换术后使用利伐沙班。     

不同抗凝药物对妇科肿瘤术后深静脉血栓预防作用的临床对比研究

目的:探究不同抗凝药物对妇科肿瘤术后深静脉血栓预防效果。方法:选取自2013年2月至2015年4月间本院收治的妇科肿瘤进行手术的患者90例,按照随机分组对照原则将本组患者分成研究I组、研究II组和对照组,每组各有患者30例。对照组患者不予以抗凝药物治疗,研究I组的患者应用利伐沙班进行术后深静脉血栓的预防性治疗,而研究II组则采用低分子肝素进行治疗。然后对比观察三组患者的血清学指标、血流指标、下肢周径、凝血酶原时间以及术后并发症的发生情况。结果:结果显示,研究组中深静脉血栓发生率为13.33%,对照组为20.0%,比较差异具有显著性(P0.05),具有统计学意义。研究II组的血清学指标、血流指标、下肢周径、凝血酶原时间均较研究I组及对照组优,差异具有统计学意义(P0.05)。且研究组不良反应较对照组少,差异具有统计学意义(P0.05)。结论:研究表明,利伐沙班与低分子肝素均对术后深静脉血栓形成有预防作用,但比较而言,低分子肝素预防效果更佳,不良反应更少。     

利伐沙班预防全膝关节置换术后静脉血栓栓塞症的临床研究

目的探讨利伐沙班和那曲肝素在预防人工膝关节表面置换术（TKA）术后静脉血栓栓塞症（VTE）的疗效和抗凝并发症方面的差异。方法接受初始单侧膝关节表面置换手术的骨关节炎患者75例,随机分为利伐沙班组（n=50）和那曲肝素组（n=25）。监测术后1、3、5 d血常规并记录异体血输血率和输血量,测量术前和术后1、3和5 d大腿周径,了解肢体肿胀程度。观察切口愈合情况,记录切口并发症。同时,根据肢体肿胀程度查下肢血管超声诊断或排除VTE。结果利伐沙班组发生1例股深静脉血栓（2.00%）,那曲肝素组无VTE发生,VTE发生率无组间统计学差异（P〉0.05）。两组均无大出血事件发生。利伐沙班组5例发生小出血事件,那曲肝素组为2例,小出血事件发生率无组间统计学差异（P〉0.05）。利伐沙班组2例切口乙级愈合,那曲肝素组全部甲级愈合,切口感染率无组间统计学差异（P〉0.05）。利伐沙班异体输血率54.00%,输血量（286.00±302.38）ml,相对那曲肝素组无统计学差异（P〉0.05）。利伐沙班组与那曲肝素组患者术后大腿周径变化总体无组间统计学差异（P〉0.05）。结论本组数据显示利伐沙班预防TKA术后VTE的疗效和出血并发症与那曲肝素大致相当。     

髋膝关节置换围手术期下肢深静脉血栓形成与 D-二聚体及抗凝药的关系

目的：探索髋膝关节置换围手术期下肢深静脉血栓形成与 D-二聚体升高关系及使用不同抗凝药的有效性和安全性评估。方法前瞻性分析70例行髋膝关节置换的患者,根据术后双下肢彩色多普勒超声结果,分为血栓组（11例）和非血栓组（59例）,记录两组在术前及术后D-二聚体浓度并进行统计分析。同时按照使用抗凝药不同分为低分子肝素（速碧林）预防组和利伐沙班预防组,记录并比较二者DVT发生率和术后伤口引流量关系。结果血栓组术前D-二聚体浓度与非血栓组术前D-二聚体的浓度相比较有显著性差异（P＜0.01）,血栓组较非血栓组增高。血栓组与非血栓组术后第7天的D-二聚体浓度比较则无显著性差异（P＞0.05）,血栓组与非血栓组各自组内比较,术后与术前的D-二聚体浓度比较均有显著性差异（P＜0.01）,术后浓度较术前均有增高。在使用抗凝药物情况下DVT的发病率为15.71％,利伐沙班与低分子肝素（速碧林）干预后DVT发生的情况无显著性差异（ P＞0.05）。术后伤口引流量无统计学差异（ P＞0.05）。结论研究发现D-二聚体对DVT预测不是特异性指标;髋膝关节置换术后使用抗凝药物情况下 DVT发生情况明显下降,利伐沙班与低分子肝素对于预防DVT作用上无显著性差异。     

人工髋关节置换术后下肢深静脉血栓的预防

目的预防人工髋关节置换术后下肢深静脉血栓的形成。方法选择本院骨科人工髋关节置术后患者108例,将其随机分为观察组（54例）与对照组（54例）,全部患者运用人工髋关节手术治疗,术后观察组选用利伐沙班和复方丹参滴丸联合预防下肢深静脉血栓形成,对照组单选用利伐沙班预防,比较两组的治疗效果。结果观察组中D-2聚体为（271.0±12.0）ng/mL,与对照组的（350.0±20.2）ng/mL相比差异有高度统计学意义（P〈0.01）,观察组中未出现D-2聚体〉300 ng/mL的患者。结论利伐沙班和复方丹参滴丸联合预防人工髋关节置换术后患者下肢静脉血栓的形成效果显著,值得推广。     

Monitoring direct FXa-inhibitors and fondaparinux by Prothrombinase-induced Clotting Time (PiCT): relation to FXa-activity and influence of assay modifications

Introduction

FXa-activity can be measured by the Prothrombinase induced Clotting time (PiCT). The manufactured assay uses bovine FXa as component and employs a incubation period before re-calcification. Its use with new direct FXa-inhibitors is challenged by reports on decreased sensitivity.

Methods

Blood was incubated with 3 investigational, structurally related (oxazolidinones) direct FXa-inhibitors including the recently approved agent rivaroxaban (0 - 2.0 µM), with the structurally distinct direct FXa-inhibitor DX 9065a (0 - 18 µM) and with the indirect inhibitor fondaparinux (0 - 0.6 µM). We tested modifications of PiCT regarding the source of FXa (bovine or human) and the incubation step (incubation before re-calcification = 2-step, no incubation =1-step), and compared results with inhibition of human or bovine FXa-activity.

Results

The bovine 2-step PiCT showed a paradoxical decrease with all direct FXa-inhibitors, this effect is surmounted only at high concentrations and is not seen with the bovine 1-step PiCT. The decrease in PiCT is not observed in antithrombin-depleted plasma. The humanized PiCT (1 or 2 step) showed a consistent prolongation under all direct inhibitors. Fondaparinux prolonged PiCT with either assay. The correlation between PiCT and corresponding FXa-activity was significant both for humanized 2-step PiCT or bovine 1 step PiCT (r2 = 0.80), but the 95% prediction interval was large and covered a span of 40% FXa-activity between one agent and another.

Conclusions

The customary bovine PiCT should only be used to monitor direct FXa-inhibitors when modified as 1-step procedure. PiCT is not suitable to assess similarity of FXa-inhibition when different agents are interchanged.     

Evaluating the efficacy and safety of rivaroxaban as a warfarin alternative in chronic thromboembolic pulmonary hypertension patients undergoing pulmonary endarterectomy: A randomized clinical trial

Background and aimChronic thromboembolic pulmonary hypertension (CTEPH) is caused by the obstruction of the main pulmonary artery due to thrombosis and vascular remodeling. Regarding the need for anticoagulant therapy in CTEPH patients, this study aimed to compare rivaroxaban with warfarin in terms of its efficacy and safety in patients undergoing endarterectomy surgery.MethodsThe study was a parallel clinical trial in patients who underwent endarterectomy following CTEPH. A total of 96 patients were randomly selected and assigned to two groups: warfarin-treated (control) and rivaroxaban-treated (intervention). Patients were clinically assessed for re-thrombosis, re-admission, bleeding, and mortality in the first, third, and sixth months after surgery.ResultsThere was no significant difference in the occurrence of thrombosis between the two groups within the first, third-, and sixth-months post-surgery (p=0.52, 1, 0.38 respectively). Moreover, the mortality rate (p=0.9), bleeding rate (p=0.06), and re-admission rate (p=0.15) showed no significant differences between the two groups.ConclusionRivaroxaban may be as effective as warfarin in treating CTEPH patients after endarterectomy in the short term and can be used as an anticoagulant in these patients. However, studies with long-term follow-ups are needed to consolidate the strategy of treating these patients with rivaroxaban.     

利伐沙班片经鼻胃管给药方式的体外试验研究

目的：以利伐沙班为例,对临床上需鼻饲管给药的品种,建立体外药学研究的方法,以指导自制制剂与参比制剂在特定给药条件下的药学行为的一致性。方法：模拟临床给药,对影响给药的项目：沉降试验、粒径分析试验和回收试验进行研究。结果：沉降试验、粒径分析试验及回收试验结果可靠,表明本次所选自制制剂与参比制剂经鼻饲管给药过程中,沉降体积一致、粒度分布一致、回收结果一致。结论：所选方法可指导同类品种鼻胃管给药的体外研究。