A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor

A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor
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DOI:
10.1111/j.1708-8305.2006.00036.x
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发表时间:
2006-05-01
影响因子:
25.7
通讯作者:
Boulware, DR
Boulware, DR
中科院分区:
医学2区
文献类型:
--
作者:
Boulware, DR

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背景。水母蜇伤在世界各地的海洋游客中很常见,每年估计有 1.5 亿人被水母蜇伤。每年都会发生死亡和住院事件,特别是在印度太平洋地区。一种基于小丑鱼粘液层的新型外用水母蜇伤抑制剂可在实验室环境中防止 85% 的水母蜇伤。现场效果未知。目的是评估水母蜇伤抑制剂 Safe Sea (TM) 的现场功效。方法。一项双盲、随机、安慰剂对照试验在美国佛罗里达州干龟国家公园和伯利兹人心果礁进行。参与者是健康志愿者,计划浮潜 30 至 45 分钟。游泳前十分钟,直接观察每位参与者在身体一侧涂抹 Safe Sea(Nidaria Technology Ltd,约旦谷,以色列)的盲样,并在对侧涂抹 Coppertone (R)(先灵葆雅,凯尼尔沃思,新泽西州,美国)盲样,作为安慰剂对照。 Safe Sea SPF15 和 Coppertone (R) SPF15 的 26 g 遮盖样品装在相同的容器中,以达到 2 mg/cm(2) 的覆盖率。双方由参与者随机选择。水母蜇伤的发生率是主要的结果指标。这是通过参与者访谈和受试者离开水面时的检查来评估的。结果。总共观察到 82 次水暴露事件。研究期间发生了 13 起水母蜇伤事件,发生率为 16%。使用安慰剂时发生了 11 例水母蜇伤,使用蜇抑制剂时发生了 2 例,相对风险降低了 82%(95% 置信区间:21%-96%;p = 0.02)。没有发生海泳者的喷发或副作用。结论。 Safe Sea 是一种外用隔离霜,在现实条件下可有效防止 80% 以上的水母蜇伤。
Background. Jellyfish stings are a common occurrence among ocean goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. Anew topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. The objective is to evaluate the field efficacy of the jellyfish sting inhibitor, Safe Sea (TM).Methods. A double-blind, randomized, placebo-controlled trial occurred at the Dry Tortugas National Park, FL, USA and Sapodilla Cayes, Belize. Participants were healthy volunteers planning to snorkel for 30 to 45 minutes. Ten minutes prior to swimming, each participant was directly observed applying a blinded sample of Safe Sea (Nidaria Technology Ltd, Jordan Valley, Israel) to one side of their body and a blinded sample of Coppertone (R) (Schering-Plough, Kenilworth, NJ, USA) to the contralateral side as placebo control. Masked 26 g samples of both Safe Sea SPF15 and Coppertone (R) SPF15 were provided in identical containers to achieve 2 mg/cm(2) coverage. Sides were randomly chosen by participants. The incidence of jellyfish stings was the main outcome measure. This was assessed by participant interview and examination as subjects exited the water.Results. A total of 82 observed water exposures occurred. Thirteen jellyfish stings occurred during the study period for a 16% incidence. Eleven jellyfish stings occurred with placebo, two with the sting inhibitor, resulting in a relative risk reduction of 82% (95% confidence interval: 21%-96%; p = 0.02). No seabather's eruption or side effects occurred.Conclusions. Safe Sea is a topical barrier cream effective at preventing > 80% jellyfish stings under real-world conditions.