Burgess Ian F, Kay Katrina, Burgess Nazma A, Brunton Elizabeth R
Medical Entomology Centre, Insect Research and Development Limited, Cambridge.
Med Devices (Auckl). 2011;4:35-42. doi: 10.2147/MDER.S17551. Epub 2011 Mar 11.
This was a randomized, assessor-blind, controlled comparison of a soya oil- based medical device shampoo with a medicinal permethrin lotion in an alcohol vehicle for treatment of head louse infestation to generate data suitable for a regulatory submission to achieve reimbursable status for the shampoo product.
We treated 91 children and adults, divided between two sites, on two occasions 9 days apart. Participants washed their hair and towel-dried it before treatment. The shampoo was used twice for 30 minutes each time. The lotion was used for 30 minutes followed by rinsing. Assessments were made by dry detection combing on days 2, 9, 11, and 14 after the first treatment. According to present knowledge, this combing technique does not influence the overall head louse populations or outcome of treatment.
The soya oil shampoo was significantly (P < 0.01) more effective than the lotion for both intention to treat (62.2% versus 34.8% successful treatment) and per-protocol (74.3% versus 36.8% success) groups. Post-treatment assessments showed the necessity for repeat treatment, but that a 9-day interval was too long because if eggs hatched after the first treatment, the lice could grow old enough to lay eggs before the second treatment.
The soya oil-based shampoo was more effective than the permethrin lotion, more cosmetically acceptable, and less irritant.
这是一项随机、评估者盲法、对照比较研究,比较一种以大豆油为基础的医用器械洗发水与一种含酒精载体的药用氯菊酯洗剂治疗头虱感染的效果,以生成适合监管申报的数据,使洗发水产品获得报销资格。
我们在两个地点对91名儿童和成人进行了治疗,分两次进行,间隔9天。参与者在治疗前洗头并用毛巾擦干。洗发水每次使用两次,每次30分钟。洗剂使用30分钟后冲洗。在首次治疗后的第2、9、11和14天通过干检梳发进行评估。根据目前的知识,这种梳发技术不会影响头虱总数或治疗结果。
对于意向性分析集(治疗成功比例分别为62.2%和34.8%)和符合方案集(治疗成功比例分别为74.3%和36.8%),大豆油洗发水均显著(P < 0.01)比洗剂更有效。治疗后评估显示有必要进行重复治疗,但9天的间隔太长,因为如果在首次治疗后卵孵化,虱子可能在第二次治疗前长大到足以产卵。
以大豆油为基础的洗发水比氯菊酯洗剂更有效,在美容方面更易接受,刺激性更小。