Abstract:

Objective　To compare the effects of fondaparinux sodium injection and nadroparin calcium injection in preventing thrombotic disease in fracture patients after surgery. Methods　This study was a randomized controlled trial. A total of 130 patients who underwent fracture surgery in Northwest University First Hospital from January 2022 to January 2024 were selected and were divided into two groups with 65 patients in each group by the random number table method. In the fondaparinux sodium group, there were 38 males and 27 females, the age was (52.37±12.71) years old, and the body mass index (BMI) was (26.5±3.2) kg/m². In the nadroparin calcium group, there were 39 males and 26 females, the age was (53.19±13.20) years old, and the BMI was (26.7±3.1) kg/m². In the fondaparinux sodium group, subcutaneous injection of fondaparinux sodium was immediately started after surgery at a dose of 2.5 mg, once a day, lasting for 14 days. In the nadroparin calcium group, subcutaneous injection of nadroparin calcium was given every 12 hours at a dose of 4 100 AXaIU each time for 14 days. The deep vein thrombosis (DVT), pulmonary embolism (PE), swelling and pain of lower limbs, coagulation function indicators, and incidence of adverse reactions were compared between the two groups. Statistical methods used were t test and χ² test. Results　There were no statistically significant differences in the incidences of DVT and PE between the fondaparinux sodium group and the nadroparin calcium group [13.84% (9/65) vs. 10.76% (7/65), 3.07% (2/65) vs. 1.53% (1/65)] (χ²=0.29 and 0.34, both P>0.05). There was no statistically significant difference between the two groups in terms of postoperative swelling and pain in lower limbs (both P>0.05). The prothrombin time (PT) was (9.49±1.21) s in the fondaparinux sodium group and (9.47±1.08) s in the nadroparin calcium group before surgery, and (14.61±1.09) s and (14.27±1.12) s on the 14th day after surgery; the thrombin time (TT) was (9.05±1.20) s in the fondaparinux sodium group and (9.07±1.23) s in the nadroparin calcium group before surgery, and (13.24±1.33) s and (15.22±1.29) s on the 14th day after surgery; the PT and TT after surgery were higher than those before surgery in both groups (all P<0.05). The hypersensitive C-reactive protein (hs-CRP) in the nadroparin calcium group was lower than that in the fondaparinux sodium group on the 14th day after surgery [(13.82±1.77) mg/L vs. (17.71±1.53) mg/L], with a statistically significant difference (t=13.40, P<0.05). The incidence of adverse reactions was 7.69% (5/65) in the fondaparinux sodium group and 10.76% (7/65) in the nadroparin calcium group, with no statistically significant difference (χ²=0.37, P>0.05). Conclusion　Fondaparinux sodium injection and nadroparin calcium injection have similar effects and safety in preventing postoperative thrombotic disease in fracture patients after surgery, which can provide a certain reference for clinical practice.

Key words:

Fracture, Coagulation, Thrombus, Fondaparinux sodium, Nadroparin calcium

摘要：

目的　比较磺达肝葵钠注射液与那屈肝素钙注射液在预防骨折患者术后发生血栓性疾病的效果。方法　选取西北大学第一医院2022年1月至2024年1月行骨折手术治疗的130例患者进行随机对照试验，通过随机数字表法分为两组，各65例。磺达肝葵钠组：38例男性、27例女性；年龄（52.37±12.71）岁；体重指数（BMI）为（26.5±3.2）kg/m²；术后皮下注射磺达肝葵钠，剂量为2.5 mg，1次/d，持续14 d。那屈肝素钙组：39例男性、26例女性；年龄（53.19±13.20）岁；BMI为（26.7±3.1）kg/m²；术后每12 h皮下注射1次那屈肝素钙，每次4 100 AXaIU，持续14 d。比较两组术后深静脉血栓（DVT）、肺栓塞（PE）、双下肢肿胀及疼痛情况、凝血功能指标、不良反应发生率。统计学方法采用t检验、χ²检验。结果　磺达肝葵钠组与那屈肝素钙组DVT及PE发生率比较［13.84%（9/65）比10.76%（7/65）、3.07%（2/65）比1.53%（1/65）］，差异均无统计学意义（χ²=0.29、0.34，均P>0.05）。两组术后双下肢的肿胀及疼痛情况差异均无统计学意义（均P>0.05）。术前磺达肝葵钠组和那屈肝素钙组的凝血酶原时间（PT）分别为（9.49±1.21）s、（9.47±1.08）s，术后14 d分别为（14.61±1.09）s、（14.27±1.12）s；术前磺达肝葵钠组与那屈肝素钙组凝血酶时间（TT）分别为（9.05±1.20）s、（9.07±1.23）s，术后14 d分别为（13.24±1.33）s、（15.22±1.29）s；两组术后PT、TT均较术前增高（均P<0.05）。术后14 d那屈肝素钙组超敏C反应蛋白（hs-CRP）低于磺达肝葵钠组［（13.82±1.77）mg/L比（17.71±1.53）mg/L］，差异有统计学意义（t=13.40，P<0.05）。磺达肝葵钠组的不良反应发生率为7.69%（5/65），那屈肝素钙组为10.76%（7/65），差异无统计学意义（χ²=0.37，P>0.05）。结论　磺达肝葵钠注射液与那屈肝素钙注射液在预防骨折患者术后血栓性疾病方面具有相似的效果和安全性，可为临床提供一定的参考。

关键词:

骨折, 凝血, 血栓, 磺达肝葵钠, 那屈肝素钙