未经评估:本回顾性研究对不良事件(AE)进行了初步定性评估,重点关注妇科手术中使用的三种止血剂的盆腔和腹部AE以及患者结局。
未经评估:氧化再生纤维素粉(ORC)的利用率,多糖粉末(PSP),从2018年1月1日至2020年9月30日,通过PremierHealthcare数据库从医院获得了纤维蛋白密封剂溶液(FSS),用于所有外科手术。所有报告的病例均从食品和药物管理局(FDA)制造商和用户设施设备经验(MAUDE)数据库中提取,用于ORC和PSP,并从FDA不良事件报告系统(FAERS)数据库中提取。评估每种产品的按解剖部位(MAUDE/FAERS)和按专业(Premier)的外科手术程序的AE分布。将病例数以及AE的数量和类型与每种产品的总利用率进行比较。
未经评估:PSP是分析期间使用最多的产品(n=126,509次使用),其次是FSS(n=80,628次使用),和ORC(n=41,583次使用)。在止血剂之间,解剖部位的外科手术分布显着变化(p<0.001)。与PSP和FSS相比,ORC与更多的AEs患者病例和报告的AEs数量相关(p<0.001)。ORC的感染数量高于PSP(p<0.001)和FSS(p<0.001)。
UNASSIGNED:这些研究结果表明,与非ORC止血剂相比,在腹部和盆腔手术中使用ORC可能导致更多的术后并发症。需要进一步的前瞻性随机研究来比较这些产品的疗效和安全性。
UNASSIGNED: This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery.
UNASSIGNED: Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product.
UNASSIGNED: PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001).
UNASSIGNED: These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.