Transdermal Scopolamine for the Prevention of Postoperative Nausea and Vomiting: A Systematic Review and Meta-Analysis

Transdermal Scopolamine for the Prevention of Postoperative Nausea and Vomiting: A Systematic Review and Meta-Analysis
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DOI:
10.1016/j.clinthera.2010.11.014
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发表时间:
2010-11-01
影响因子:
3.2
通讯作者:
Kranke, Peter
Kranke, Peter
中科院分区:
医学3区
文献类型:
--
作者:
Apfel, Christian C.;Zhang, Kun;Kranke, Peter

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背景:透皮东莨菪碱(TDS)是一种潜在的长效预防性止吐药,最初是为了预防晕动病而开发的。 TDS 是一种中枢性抗胆碱能药物,于 2001 年被美国食品和药物管理局批准用于预防术后恶心和呕吐 (PONV)。尽管据报道 TDS 在预防 PONV 方面在临床上有效,但一些不良事件 (AE),如镇静、口干、视力模糊、中枢胆碱能综合征和精神错乱(特别是患有轻度认知障碍的老年患者)是潜在的问题。 目的:本研究的目的是探讨 TDS 在预防成人 PONV 中的疗效和耐受性。 2009 年 3 月对 PubMed、EMBASE 和 Cochrane 图书馆进行了成人随机对照试验的系统检索,比较了 TDS 和安慰剂对术后恶心、呕吐和 PONV 的影响,并于 2010 年 7 月进行了更新。在没有任何语言限制的情况下,使用以下术语进行了检索:术后、术后、术后*、术后*、 麻醉后*、麻醉后*、麻醉、麻醉、手术、手术、手术、恶心、呕吐、呕吐、干呕、东莨菪碱和东莨菪碱。然后手动检索已确定的研究以获取进一步的相关文献。结果:分析了 25 项随机对照试验的数据 (N = 3298)。在麻醉后监护室,与安慰剂相比,TDS 与术后恶心风险显着降低相关(相对风险 [RR] = 0.77;95% CI,0.61-0.98;P = 0.03)。 TDS 还与术后恶心(RR = 0.59;95% CI,0.48-0.73;P < 0.001)、术后呕吐(RR = 0.68;95% CI,0.61-0.76;P < 0.001)和 PONV(RR = 0.73;95% CI,0.60-0.88;P)风险显着降低相关。 = 0.001) 在麻醉开始后的前 24 小时内。与安慰剂相比,当治疗前一天晚上(早期应用)(RR = 0.56;95% CI,0.41-0.75;P < 0.001)或手术当天(晚期应用)(RR = 0.61;95% CI,0.47-0.79;P < 0.001)开始治疗时,TDS 似乎能有效预防术后恶心。与安慰剂相比,TDS 与 24 至 48 小时内视觉障碍的发生率较高相关(RR = 3.35;95% CI,1.78-6.32)。混乱和其他 AE 的分析并未显示与 TDS 存在显着关联。结论:在这项系统评价和荟萃分析中,在麻醉开始后的前 24 小时内,无论是早期还是晚期贴片应用,TDS 都与 PONV 的显着减少相关。与安慰剂相比,TDS 与术后 24 至 48 小时内较高的视觉障碍发生率相关,但与其他 AE 无关。 (Clin Ther. 2010;32:1987-2002) (C) 2010 Elsevier HS Journals, Inc.
Background: Transdermal scopolamine (TDS) is a potential long-acting prophylactic antiemetic initially developed to prevent motion sickness. TDS is a centrally acting anticholinergic agent that was approved in 2001 by the US Food and Drug Administration for the prevention of postoperative nausea and vomiting (PONV). Although TDS has been reported to be clinically efficacious in the prevention of PONV, several adverse events (AEs), such as sedation, dry mouth, blurred vision, central cholinergic syndrome, and confusion (particularly in elderly patients with mild cognitive impairment), are potential concerns.Objective: The aim of this study was to explore the efficacy and tolerability of TDS in the prevention of PONV in adults.Methods: A systematic search of PubMed, EMBASE, and the Cochrane Library for randomized controlled trials in adults that compared the effects of TDS and placebo on postoperative nausea, vomiting, and PONV was conducted in March 2009, and an update was conducted in July 2010. Without any language restrictions, a search with the following terms was performed: postoperative, postoperative, postanesthe*, postanaesthe*, post-anesthe*, post-anaesthe*, anesthesia, anaesthesia, surgery, surgeries, surgical, nausea, vomiting, emesis, retching, scopolamine, and hyoscine. Identified studies were then hand-searched for further relevant literature.Results: Data from 25 randomized controlled trials were analyzed (N = 3298). In the postanesthesia care unit, TDS was associated with a significantly reduced risk for postoperative nausea compared with placebo (relative risk [RR] = 0.77; 95% CI, 0.61-0.98; P = 0.03). TDS was also associated with a significantly reduced risk for postoperative nausea (RR = 0.59; 95% CI, 0.48-0.73; P < 0.001), postoperative vomiting (RR = 0.68; 95% CI, 0.61-0.76; P < 0.001), and PONV (RR = 0.73; 95% CI, 0.60-0.88; P = 0.001) during the first 24 hours after the start of anesthesia. TDS appeared to be effective compared with placebo in the prevention of postoperative nausea when treatment was initiated the night before (early application) (RR = 0.56; 95% CI, 0.41-0.75; P < 0.001) or on the day of surgery (late application) (RR = 0.61; 95% CI, 0.47-0.79; P < 0.001). TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours compared with placebo (RR = 3.35; 95% CI, 1.78-6.32). Analyses of confusion and other AEs did not show a significant association with TDS.Conclusions: In this systematic review and meta-analysis, TDS was associated with significant reductions in PONV with both early and late patch application during the first 24 hours after the start of anesthesia. TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours after surgery, but no other AEs, compared with placebo. (Clin Ther. 2010;32:1987-2002) (C) 2010 Elsevier HS Journals, Inc.