一种基于聚二甲基硅氧烷的高效杀虱剂：随机观察者盲法对照试验
A highly efficacious pediculicide based on dimeticone: randomized observer blinded comparative trial.
作者信息
Heukelbach Jorg, Pilger Daniel, Oliveira Fabíola A, Khakban Adak, Ariza Liana, Feldmeier Hermann
机构信息
Department of Community Health, School of Medicine, Federal University of Ceará, Fortaleza, Brazil.
出版信息
BMC Infect Dis. 2008 Sep 10;8:115. doi: 10.1186/1471-2334-8-115.
BACKGROUND
Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA(R)), as compared to a 1% permethrin lotion.
METHODS
Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5-15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology.
RESULTS
Overall cure rates were: day 2 - dimeticone 94.5% (95% CI: 86.6% - 98.5%) and permethrin 66.7% (95% CI: 54.6% - 77.3%; p < 0.0001); day 7 - dimeticone 64.4% (95% CI: 53.3% - 75.3%) and permethrin 59.7% (95% CI: 47.5% - 71.1%; p = 0.5); day 9 - dimeticone 97.2% (95% CI: 90.3% - 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group.
CONCLUSION
The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN15117709.
背景
人头虱（头虱属人亚种）感染在全球范围内都有发生。现有的治疗方法有限，并且对常用灭虱药产生抗药性的报道日益增多。在本试验中，我们评估了一种含有高浓度（92%）硅油二甲硅油（成分与NYDA®相同）的产品与1%氯菊酯洗剂相比的疗效。
方法
随机、对照、观察者盲法临床试验。参与者从巴西一个城市贫困社区招募，该社区头虱病高度流行。为尽量减少试验期间的再次感染，参与者（145名5至15岁的头虱感染儿童）被转移到流行区外的一个度假胜地，为期9天。分别进行两次二甲硅油或1%氯菊酯涂抹，间隔7天。结局指标定义为首次涂抹后、第二次涂抹前后的治愈情况（无存活头虱）、瘙痒程度、美容可接受性及临床病理学情况。
结果
总体治愈率为：第2天 - 二甲硅油94.5%（95%可信区间：86.6% - 98.5%），氯菊酯66.7%（95%可信区间：54.6% - 77.3%；p < 0.0001）；第7天 - 二甲硅油64.4%（95%可信区间：53.3% - 75.3%），氯菊酯59.7%（95%可信区间：47.5% - 71.1%；p = 0.5）；第9天 - 二甲硅油97.2%（95%可信区间：90.3% - 99.7%），氯菊酯67.6%（95%可信区间：55.4% - 78.2%；p < 0.0001）。两组瘙痒程度均有类似减轻。与氯菊酯组相比，二甲硅油组的美容可接受性显著更好（p = 0.01）。二甲硅油组发生了两起与产品相关的轻微事件。
结论
二甲硅油产品是一种安全且高效的灭虱药。由于其物理作用方式（中断虱子中枢神经系统的氧气供应），不太可能产生抗药性。
试验注册
当前受控试验ISRCTN15117709 。
Zotero 插件