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用 4%二甲基硅油洗剂治疗头虱:在土耳其农村的一项随机对照试验中比较两种配方。

Treatment of head lice with dimeticone 4% lotion: comparison of two formulations in a randomised controlled trial in rural Turkey.

机构信息

Celal Bayar University Medical School, Department of Parasitology, Manisa, Turkey.

出版信息

BMC Public Health. 2009 Dec 1;9:441. doi: 10.1186/1471-2458-9-441.

Abstract

BACKGROUND

Dimeticone 4% lotion was shown to be an effective treatment for head louse infestation in two randomised controlled trials in England. It is not affected by insecticide resistance but efficacy obtained (70-75%) was lower than expected. This study was designed to evaluate efficacy of dimeticone 4% lotion in a geographically, socially, and culturally different setting, in rural Turkey and, in order to achieve blinding, it was compared with a potential alternative formulation.

METHODS

Children from two village schools were screened for head lice by detection combing. All infested students and family members could participate, giving access to treatment for the whole community. Two investigator applied treatments were given 7 days apart. Outcome was assessed by detection combing three times between treatments and twice the week following second treatment.

RESULTS

In the intention to treat group 35/36 treated using dimeticone 4% had no lice after the second treatment but there were two protocol violators giving 91.7% treatment success. The alternative product gave 30/36 (83.3%) treatment success, a difference of 8.4% (95% CI -9.8% to 26.2%). The cure rates per-protocol were 33/34 (97.1%) and 30/35 (85.7%) respectively. We were unable to find any newly emerged louse nymphs on 77.8% of dimeticone 4% treated participants or on 66.7% of those treated with the alternative formulation. No adverse events were identified.

CONCLUSION

Our results confirm the efficacy of dimeticone 4% lotion against lice and eggs and we found no detectable difference between this product and dimeticone 4% lotion with nerolidol 2% added. We believe that the high cure rate was related to the lower intensity of infestation in Turkey, together with the level of community engagement, compared with previous studies in the UK.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN10431107.

摘要

背景

二甲基硅油 4%洗剂在英国的两项随机对照试验中已被证明是治疗头虱感染的有效方法。它不受杀虫剂耐药性的影响,但获得的疗效(70-75%)低于预期。本研究旨在评估二甲基硅油 4%洗剂在地理、社会和文化背景不同的土耳其农村地区的疗效,并为达到盲法效果,将其与一种潜在的替代制剂进行比较。

方法

通过检测梳理从两所乡村学校的儿童中筛选出头虱。所有受感染的学生和家庭成员都可以参与进来,为整个社区提供治疗。两位调查员相隔 7 天分别使用两种处理方法进行治疗。在两次治疗之间进行三次检测梳理,并在第二次治疗后两周进行两次检测,以评估结果。

结果

在意向治疗组中,36 名使用二甲基硅油 4%的患者中,有 35 名在第二次治疗后没有虱子,但有两名违反方案的患者,成功率为 91.7%。替代产品的成功率为 36 名中的 30 名(83.3%),差异为 8.4%(95%CI-9.8%至 26.2%)。按方案治愈的比例分别为 34 名中的 33 名(97.1%)和 35 名中的 30 名(85.7%)。我们在 77.8%的二甲基硅油 4%处理的参与者和 66.7%的使用替代制剂处理的参与者身上没有发现新出现的虱卵。没有发现任何不良事件。

结论

我们的结果证实了二甲基硅油 4%洗剂对头虱和虱卵的疗效,并且我们没有发现这种产品与添加了橙花醇 2%的二甲基硅油 4%洗剂之间存在可检测的差异。我们认为,高治愈率与土耳其的感染强度较低有关,同时也与英国以前的研究相比,社区参与度较高有关。

试验注册

当前对照试验 ISRCTN82656454。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7a1/2794865/90ced6a556dd/1471-2458-9-441-1.jpg

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