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Safety and efficacy of a 100?% dimethicone pediculocide in school-age children

机译：100 %%二甲硅油杀虫剂对学龄儿童的安全性和有效性

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Background Head lice most commonly affect children, ages 3 to 11. Concerns exist about the safety and efficacy of pesticide-based treatments. Published studies suggest dimethicone is a potentially safe and effective non-toxic treatment, but have not evaluated 100?% dimethicone in a pediatric population. The objectives were to evaluate the efficacy and safety of 100?% dimethicone for the treatment of head lice in children, monitored by school nurses. Methods This was a multi-site, open-label study of a 100?% dimethicone gel for the treatment of head lice in a pediatric population. Children (ages 3–12) suspected of infestation with head lice were evaluated by school nurses at six schools and daycare programs in New York and New Jersey. Inclusion criteria were presence of at least three live lice, or one live louse and 10 viable eggs (eggs found within 1.27?cm of the scalp) and no use of any head lice treatment within four weeks of enrollment. Counts of live lice and viable eggs found in 58 subjects were tracked at baseline (Day 0) and on Day 1, Day 7, and Day 14 after treatment. Results After 1?day of treatment with 100?% dimethicone, 98.30?% of subjects were free of live lice and 55.20?% were free of viable eggs. On day 14, 96.50?% were still free of live lice, and 80.70?% were free of viable eggs. All subjects were monitored by the school nurse at baseline and throughout the study period for adverse effects, including scalp erythema, excoriation, flaking and edema. There was one adverse event of skin irritation lasting 10?min, and no serious adverse events reported. Overall, scalp conditions improved from the baseline: 10 subjects (17.5?%) reported mild to moderate scalp erythema on day 1, compared with only one subject (1.7?%) on day 14; 8 subjects (14.3?%) reported mild scalp excoriation on day 1, with none reporting on day 14. Conclusions 100?% dimethicone was found to be a safe and highly effective treatment for pediatric head lice. Because dimethicone avoids pesticide exposure and resistance issues, dimethicone should be considered as a first-line treatment for head lice. Trial Registration NCT02213055 Date of registration: August 8, 2014 Standards of reporting The CONSORT 2010 Checklist was consulted during the review of this manuscript. Please note that sections pertaining specifically to randomized controlled trials (RCT’s) were not applicable.
机译：背景头虱最常影响3至11岁的儿童。人们对基于农药的治疗的安全性和有效性存在担忧。已发表的研究表明，二甲硅油是一种潜在的安全有效的无毒治疗方法，但尚未评估儿科人群中100％的二甲硅油。目的是评估由学校护士监测的100 %%二甲硅油治疗儿童头虱的疗效和安全性。方法这是一项针对100 %%二甲硅油凝胶的多部位，开放标签研究，用于治疗儿科人群的头虱。纽约和新泽西的六所学校和日托计划的学校护士对怀疑患有头虱的儿童（3至12岁）进行了评估。纳入标准为至少有3个活虱子或1个活虱和10个活卵（在头皮的1.27？cm范围内发现的卵），入选后4周内未使用任何头虱治疗。在治疗后的基线（第0天）和第1、7、14天对58名受试者的活虱和活卵计数进行了追踪。结果用100 %%的二甲聚硅氧烷治疗1天后，有98.30％的受试者没有活虱，有55.20％的受试者没有活卵。在第14天，仍有96.50％的动物没有活虱子，有80.70％的动物没有卵子。由学校护士在基线和整个研究期间对所有受试者进行监控，以检查不良影响，包括头皮红斑，剥落，剥落和浮肿。有一个不良反应持续了10分钟，并且没有严重的不良反应发生。总体而言，头皮状况较基线有所改善：第1天有10名受试者（17.5％）报告轻度至中度头皮红斑，而第14天只有一名受试者（1.7 %%）; 8名受试者（14.3％）在第1天报告了轻度头皮exc除，而在第14天没有报告。结论发现100 %%的二甲硅油是一种安全有效的小儿头虱治疗方法。由于聚二甲基硅氧烷避免了农药暴露和耐药性问题，因此应将聚二甲基硅氧烷视为头虱的一线治疗方法。试用注册NCT02213055注册日期：2014年8月8日报告标准在审阅本手稿时，查阅了CONSORT 2010清单。请注意，专门针对随机对照试验（RCT）的部分不适用。

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