沃普利克斯((r))在择期手术中的安全性和耐受性。

Safety and tolerability of volplex((r)) in elective surgery.

机构信息

Peninsula Medical School, University of Plymouth, Plymouth, UK.

出版信息

Clin Drug Investig. 2004;24(2):73-9. doi: 10.2165/00044011-200424020-00002.

DOI:10.2165/00044011-200424020-00002

PMID:17516693

Abstract

OBJECTIVE

Succinylated gelatin is widely used in the management of hypovolaemic conditions. Volplex((R)) is a new presentation of succinylated gelatin in a flexible, collapsible bag, which is sterilised at 121 degrees C. This study aimed to document the safety and tolerability of Volplex((R)), using Gelofusine((R)) as a control, in elective surgery.

DESIGN AND PATIENTS

The study was a single-centre, open-label, randomised, parallel-group trial that included patients aged 18-75 years who were, in the opinion of the investigator, likely to need an infusion of a colloid as part of their surgical management. The patients were randomised to receive either Volplex((R)) or Gelofusine((R)) in a 2 : 1 ratio in favour of Volplex((R)). Three assessments, preoperative, perioperative and 24 hours following anaesthetic induction, were performed. All statistical testing was two-sided and performed at a 5% level of significance.

RESULTS

76 patients (52 receiving Volplex((R)) and 24 receiving Gelofusine((R))) were included in the intent-to-treat population. The volumes of fluids infused were 1154mL and 1115mL for the Volplex((R)) and Gelofusine((R))groups, respectively, of which 962mL was Volplex((R)) and 958mL was Gelofusine((R)), respectively. Patients also received crystalloids and blood and there were no significant differences between groups in the amounts received. Eighteen Volplex((R)) recipients (35%) and 12 Gelofusine((R)) recipients (50%) reported at least one adverse event. Of the 27 events reported for Volplex((R)), 15 (56%) were considered not related and 12 (44%) possibly related to Volplex((R)). In the case of Gelofusine((R)), 17 events were reported, and of these eight (47%) were considered not related and nine (53%) possibly related to Gelofusine((R)). None of the reported adverse events were considered probably related to either colloid. One serious adverse event, mild hypothermia, was reported in the Gelofusine((R)) group. The unexpected length of surgery was stated as the causal factor. There were no significant differences between Volplex((R)) and Gelofusine((R)) with regard to the number of patients with out-of-range laboratory values postoperatively. Urine output for both groups was reduced postoperatively, but there were no major differences between the groups observed.

CONCLUSION

This small, open-label study showed that Volplex((R)), a new presentation of succinylated gelatin, was comparable to a well-established brand, Gelofusine((R))when used in the management of patients undergoing elective surgery.

摘要

目的

琥珀酰明胶被广泛用于低血容量状态的治疗。Volplex((R)) 是一种新型的琥珀酰明胶制剂，采用柔软、可折叠的袋子包装，并在 121°C 下进行灭菌。本研究旨在评估 Volplex((R)) 在择期手术中的安全性和耐受性，以 Gelofusine((R))为对照。

设计和患者

这是一项单中心、开放标签、随机、平行组试验，纳入了年龄在 18-75 岁之间的患者，研究者认为这些患者可能需要输注胶体以作为其手术治疗的一部分。患者按 2:1 的比例随机接受 Volplex((R))或 Gelofusine((R))治疗，Volplex((R))组为优势组。在麻醉诱导前、围手术期和术后 24 小时进行了 3 次评估。所有统计检验均为双侧检验，显著性水平为 5%。

结果

76 例患者（52 例接受 Volplex((R))，24 例接受 Gelofusine((R)))纳入意向治疗人群。Volplex((R))组和 Gelofusine((R))组输注的液体量分别为 1154mL 和 1115mL，其中 962mL 为 Volplex((R))，958mL 为 Gelofusine((R))。患者还输注了晶体液和血液，两组之间的输注量没有显著差异。18 例 Volplex((R))接受者（35%）和 12 例 Gelofusine((R))接受者（50%）报告了至少 1 次不良事件。在报告的 27 例与 Volplex((R))相关的事件中，15 例（56%）被认为与 Volplex((R))无关，12 例（44%）可能与 Volplex((R))有关。在 Gelofusine((R))组中，报告了 17 例事件，其中 8 例（47%）被认为与 Gelofusine((R))无关，9 例（53%）可能与 Gelofusine((R))有关。报告的不良事件均与任何一种胶体无关。Gelofusine((R))组有 1 例严重不良事件，轻度低体温，原因是手术时间意外延长。两组术后实验室值超出范围的患者数量均无显著差异。两组术后尿量均减少，但无明显差异。