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不同剂量纤维蛋白密封剂减少全膝关节置换术后出血的疗效比较。

Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty.

作者信息

Notarnicola Angela, Moretti Lorenzo, Martucci Antonio, Spinarelli Antonio, Tafuri Silvio, Pesce Vito, Moretti Biagio

机构信息

Orthopaedics Section, Department of Neuroscience and Organs of Sense, University General Hospital, Bari, Italy.

出版信息

Blood Coagul Fibrinolysis. 2012 Jun;23(4):278-84. doi: 10.1097/MBC.0b013e3283518846.

Abstract

In recent years, the application of fibrin sealant has been shown to be efficacious in the management of intraoperative and postoperative hemostasis. We designed a prospective randomized controlled clinical trial to assess the efficacy of two different dosages of fibrin sealant (5 and 10 ml) in patients undergoing total knee arthroplasty, as compared with the untreated control group. A total of 90 patients entered the study, randomly assigned to one of the three groups: treatment with 5 ml fibrin sealant (30 patients), with 10 ml fibrin sealant (30 patients) or no treatment (30 patients). A statistically significant difference in the mean reduction of hemoglobin concentrations was found on the first postoperative day in the treated groups as compared with the controls: 5 ml fibrin sealant (2.6 mg/dl) and 10 ml fibrin sealant (2.5 mg/dl) vs. controls (3.7 mg/dl) (P = 0.024). The mean number of blood transfusions was significantly lower in the treated groups: 5 ml (0.5) and 10 ml (0.3) of fibrin sealant vs. controls (1) (P = 0.0019). Functional recovery was also better in the treated groups: on the seventh day, the joint ROM (range of motion) was statistically superior in the 5 ml group (96.5°) and 10 ml group (98.8°) as compared with the controls (75.5°) (P < 0.0001). This study supports the efficacy of administering fibrin sealant in the perioperative management of bleeding after total knee arthroplasty and shows that a 5 ml dosage yields a comparable outcome to the 10 ml dosage previously reported in the literature.

摘要

近年来,纤维蛋白密封剂已被证明在术中及术后止血管理中有效。我们设计了一项前瞻性随机对照临床试验,以评估两种不同剂量(5毫升和10毫升)的纤维蛋白密封剂在全膝关节置换术患者中的疗效,并与未治疗的对照组进行比较。共有90名患者进入研究,随机分为三组之一:接受5毫升纤维蛋白密封剂治疗(30例患者)、接受10毫升纤维蛋白密封剂治疗(30例患者)或不接受治疗(30例患者)。与对照组相比,治疗组术后第一天血红蛋白浓度平均降低有统计学显著差异:5毫升纤维蛋白密封剂组(2.6毫克/分升)和10毫升纤维蛋白密封剂组(2.5毫克/分升)对比对照组(3.7毫克/分升)(P = 0.024)。治疗组的平均输血次数显著更低:5毫升(0.5次)和10毫升(0.3次)纤维蛋白密封剂组对比对照组(1次)(P = 0.0019)。治疗组的功能恢复也更好:在第七天,5毫升组(96.5°)和10毫升组(98.8°)的关节活动度(ROM)在统计学上优于对照组(75.5°)(P < 0.0001)。本研究支持在全膝关节置换术后围手术期出血管理中使用纤维蛋白密封剂的有效性,并表明5毫升剂量产生的结果与文献中先前报道的10毫升剂量相当。

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