Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled study
Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled study
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DOI：
10.1016/j.fertnstert.2006.12.084
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发表时间：
2007-11-01
影响因子：
6.7
通讯作者：
diZerega, Gere S.
中科院分区：
文献类型：
--
作者：
Brown, Colin B.;Luciano, Anthony A.;diZerega, Gere S.
目的：评价Adept的有效性和安全性（4%艾考糊精溶液）在腹腔镜妇科手术（包括粘连松解术）后减少粘连的作用。设计：多中心、前瞻性、随机、双盲研究，比较Adept与乳酸林格氏液（LRS）。患者：402例患者在术中随机分配至Adept（n = 203）或LRS（n = 199）组，在4-8周内返回进行第二次腹腔镜检查。两种情况下均测定粘连的发生率、严重程度和程度。主要结果指标：美国食品和药物管理局定义的主要疗效指标是粘连治疗取得临床成功的患者数量。其他指标包括发病率和美国生育学会（AFS）scores. Results（s）：有显著性差异的是，Adept患者比LRS患者获得临床成功（49%对38%）。在不孕症患者中，与LRS相比，Adept表现出特别的临床成功率（55% vs. 33%）。这反映在AFS评分降低的患者数量（53% vs. 30%）和中度/重度AFS分类评分较少的患者（43% vs. 14%）。两组的安全性相当。大多数事件与手术有关，在Adept组中短暂性唇水肿增加。结论：这是第一个随机，双盲试验的粘连减少剂。说明Adept是一种安全有效的腹腔镜手术减黏剂。
Objective: To evaluate the efficacy and safety of Adept (4% icodextrin solution) in reducing adhesions after laparoscopic gynecological surgery involving adhesiolysis.Design: Multicenter, prospective, randomized, double-blind study comparing Adept with lactated Ringer's solution (LRS).Patient(s): Four hundred two patients randomized intraoperatively to Adept (n = 203) or LRS (n = 199) returned for second laparoscopy within 4-8 weeks. Incidence, severity, and extent of adhesions were determined on both occasions.Main Outcome Measure(s): The primary efficacy measure defined by the Food and Drug Administration was the number of patients achieving clinical success with adhesion treatment. Other measures included incidence and American Fertility Society (AFS) scores.Result(s): Significantly more Adept patients achieved clinical success than did LRS patients (49% vs. 38%). In infertility patients, Adept demonstrated particular clinical success compared with LRS (55% vs. 33%). This was reflected in the number of patients with a reduced AFS score (53% vs. 30%) and in fewer patients with a moderate/severe AFS category score 43% vs. 14%). Safety was comparable in both groups. Most events were related to the surgery, with an increase in transient labial edema in the Adept group.Conclusion(s): This is the first randomized, double-blind trial of an adhesion reduction agent. It demonstrated that Adept is a safe and effective adhesion reduction agent in laparoscopy.