Watrowski Rafał, Jäger Christoph, Forster Johannes
Department of Gynecology and Obstetrics, St. Josefskrankenhaus, Teaching Hospital of the University of Freiburg, Freiburg, Germany
Department of Gynecology and Obstetrics, St. Josefskrankenhaus, Teaching Hospital of the University of Freiburg, Freiburg, Germany.
In Vivo. 2017 Mar-Apr;31(2):251-258. doi: 10.21873/invivo.11053.
To assess the impact of the use of intraoperative hemostatic gelatin-thrombin matrix (HM) (Floseal®, Baxter Healthcare) on transfusion rates and short-term perioperative outcomes in gynecological surgery.
In this retrospective, single-center study, we evaluated data of 215 patients (83 cases and 132 controls) undergoing extensive gynecological surgery (e.g. oncological procedures) with and without intraoperative HM application.
Cases and controls did not differ according to age, preoperative hemoglobin (Hb) concentration, and Hb or C-reactive protein (CRP) levels at discharge. Patients receiving HM had significantly reduced operative (168 vs. 199 min, p=0.02) and hospitalization (9 vs. 14 days, p<0.001) times. The mean postoperative Hb drop (3.33 vs. 4.51 g/dl, p<0.001), and the mean postoperative increase in CRP (94.9 vs. 149.1 mg/l, p<0.001) were significantly less pronounced within the HM group. Despite more prevalent coagulopathy (48 vs. 31%, p=0.02), e.g. due to anticoagulant use (15.7 vs. 3%, p<0.001), patients treated using HM needed less frequent transfusions of packed red blood cells [odds ratio (OR)= 0.13, 95% confidence interval (CI)=0.07-0.24) and fresh frozen plasma (OR=0.51, 95% CI=0.24-1.05). In comparison to controls, the need for surgical revisions (OR 0.1, CI 95% 0.02-0.42) and intensive-care unit admissions (OR 0.15, 95% CI=0.08-0.30) was lower in patients treated with HM.
To our knowledge, our study is the largest case-control study focusing on Floseal® use in gynecology. The use of HM was associated with significantly better short-term perioperative outcomes. Due to its local action, HM seems to be particularly useful in patients in which anticoagulant medication cannot be paused.
评估术中使用止血明胶-凝血酶基质(HM)(弗洛塞尔,百特医疗)对妇科手术输血率和围手术期短期结局的影响。
在这项回顾性单中心研究中,我们评估了215例患者(83例病例组和132例对照组)的数据,这些患者均接受了广泛的妇科手术(如肿瘤手术),其中部分患者术中应用了HM,部分未应用。
病例组和对照组在年龄、术前血红蛋白(Hb)浓度以及出院时的Hb或C反应蛋白(CRP)水平方面无差异。接受HM治疗的患者手术时间(168分钟对199分钟,p = 0.02)和住院时间(9天对14天,p < 0.001)显著缩短。HM组术后平均Hb下降幅度(3.33 g/dl对4.51 g/dl,p < 0.001)以及术后CRP平均升高幅度(94.9 mg/l对149.1 mg/l,p < 0.001)明显更小。尽管凝血功能障碍更为普遍(48%对31%,p = 0.02),例如由于抗凝药物的使用(15.7%对3%,p < 0.001),但使用HM治疗的患者输注浓缩红细胞[比值比(OR)= 0.13,95%置信区间(CI)= 0.07 - 0.24]和新鲜冰冻血浆(OR = 0.51,95% CI = 0.24 - 1.05)的频率更低。与对照组相比,接受HM治疗的患者进行手术修正的需求(OR 0.1,95% CI 0.02 - 0.42)和入住重症监护病房的需求(OR 0.15,95% CI = 0.08 - 0.30)更低。
据我们所知,我们的研究是聚焦于弗洛塞尔在妇科应用的最大规模病例对照研究。使用HM与围手术期短期结局显著改善相关。由于其局部作用,HM似乎对无法停用抗凝药物的患者特别有用。