A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery
A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery
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DOI：
10.1093/humrep/17.4.1031
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发表时间：
2002-04-01
影响因子：
6.1
通讯作者：
Brown, CB
中科院分区：
文献类型：
--
作者：
diZerega, GS;Verco, SJS;Brown, CB
背景：粘连相关的再入院是妇科手术的常见后遗症。通过分离愈合的腹膜表面来防止粘连的尝试包括特定部位的屏障和滴注溶液的水浮。快速吸收限制了林格氏乳酸盐(RLS)等溶液的有效性。这项初步研究评估了4%二十碳糊精的非粘滞性、耐受性和初步有效性。二十碳糊精是一种在腹膜内滞留时间较长的α-1，4葡萄糖聚合物，用于减少腹腔镜妇科手术后的粘连。方法：年龄大于或等于18岁，需要进行腹腔镜附件手术的妇女(n=62)，进入一项随机、开放、评估、盲法、多中心研究，比较4%icodextrin和RLS。治疗被编码成四个一组的区块，每个组都是平等随机的，并预先分配给连续编号的患者。术中灌洗至少100ml/30min，术后滴注L 1支。按方案分析包括所有符合条件的患者(n=53)；重组分析要求一个或多个基线粘连(n=42)。术后6~12周复查腹腔镜术，评估术后粘连的发生率、程度和严重程度。程序被录制下来，供第三方使用，盲目评估。结果：安全性和耐受性(实验室变量、不良事件、临床随访)良好，不同治疗之间没有差异。对发生率排序的粘连(n=53)进行的偏移分析显示，服用二十碳糊精的患者比服用RLS的患者有明显改善(37%比15%；不显著)。在接受二十碳糊精治疗的患者中，粘连评分降低(n=42)比接受RLS治疗的患者更常见：发生率(52vs32%)、程度(52vs47%)和严重程度(65vs37%)。尽管有更多的基线粘连，但服用二十碳糊精后的中位数重建率(24%)低于RLS(60%)。先导性研究小组的规模并不具有统计学意义。结论：在这项初步研究中，4%icodextrin灌洗加滴注耐受性良好，减少了妇科腹腔镜手术后粘连的形成和重塑。第三阶段的关键研究目前正在进行中。
Background: Adhesion-related readmissions are frequent sequelae to gynaecological surgery. Attempts to prevent adhesions by separating healing peritoneal surfaces include site-specific barriers and hydroflotation by instilled solutions. Rapid absorption limits the effectiveness of solutions such as Ringer's lactated saline (RLS). This pilot study assessed the safety, tolerability and preliminary effectiveness of a non-viscous, iso-osmolar solution of 4% icodextrin, an alpha-1,4 glucose polymer with prolonged intraperitoneal residence, in reducing adhesions after laparoscopic gynaecological surgery. Methods: Women aged greater than or equal to18 years, requiring laparoscopic adnexal surgery (n=62), were entered into a randomized, open-label, assessor-blinded, multicentre study to compare 4% icodextrin with RLS. Treatments were coded in blocks of four with equal randomization to each group, and pre-allocated to consecutively numbered patients. At least 100 ml per 30 min was used for intra-operative lavage, with 1 l instilled post-operatively. Per protocol analysis included all eligible patients (n=53); reformation analysis required one or more baseline adhesion (n=42). Incidence, extent and severity of post-operative adhesions were assessed at second-look laparoscopy after 6-12 weeks. Procedures were video-taped for third party, blinded assessment. Results: Safety and tolerability (laboratory variables, adverse events, clinical follow-up) were good with no difference between treatments. A shift analysis of incidence-ranked adhesions (n=53) showed apparent improvements in more patients with icodextrin than RLS (37 versus 15%; not significant). Adhesion score reduction (n=42) was more frequent in icodextrin-than RLS-treated patients: incidence (52 versus 32%), extent (52 versus 47%), and severity (65 versus 37%). Despite greater baseline adhesions, median reformation was less after icodextrin (24%) than RLS (60%). The pilot study group sizes were not powered for statistical significance. Conclusions: In this preliminary study, 4% icodextrin lavage plus instillation was well tolerated and reduced adhesion formation and reformation following laparoscopic gynaecological surgery. A Phase III pivotal study is currently in progress.