Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

Methods

Multicentre, assessor blinded, cluster randomised clinical trial.

多中心、评估者盲法、群组随机临床试验。

28 French hospitals, 19 January 2016 to 16 December 2021.

研究涉及28家法国医院，研究时间跨度为2016年1月19日至2021年12月16日。

Index cases; adults and children weighing >15 kg with scabies, confirmed by dermoscopy.

研究对象为成人和体重超过15公斤的儿童，患有疥疮，通过皮肤镜检查确诊。

Index cases were randomly assigned to the ivermectin group or permethrin group (1:1 ratio).

索引病例被随机分配到伊维菌素组或珀芬净组（1:1的比例）。

Each member of the cluster, defined as the household of each index case, received the same treatment as the index case, except for children weighing <15 kg who were prescribed topical 5% permethrin.

每个聚集病例，定义为每个索引病例的家庭成员，除了体重<15公斤的儿童被开处外用5%的珀芬净外，都接受了与索引病例相同的治疗。

All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10.

所有参与者在第0天和第10天口服伊维菌素200 µg/kg或使用5%的苯甲酸苄酯霜。

Permethrin cream was applied to the whole body, from head to toe.

苯甲酸苄酯霜从头到脚涂抹全身。

The primary outcome was clinical cure of the cluster on day 28 (ie, disappearance of clinical signs and symptoms of scabies for all cluster members).

主要结果是第28天时群体的临床治愈（即所有群体成员的疥疮临床症状和体征消失）。

Secondary outcomes were index case and individual level analyses and safety.

次要结果是对索引病例和个体水平的分析以及安全性评估。

Dermatologists were used as assessors and were masked to the treatment.

皮肤科医生被用作评估者，并且对治疗方案不知情。

Results

507 participants in 142 households (clusters) were treated with ivermectin and 568 participants in 147 households received permethrin.

在142个家庭（群组）中，有507名参与者接受了伊维菌素治疗，而在147个家庭中，有568名参与者接受了吡虫啉治疗。

Cluster level cure rates were 71.8% versus 88.5% (-16.7 percentage point difference, 95% confidence interval(CI) -26.3 to -7.1) for ivermectin versus permethrin.

群组水平的治愈率分别为71.8%对比88.5%（差异-16.7个百分点，95%置信区间（CI）为-26.3至-7.1），伊维菌素对比除虫菊酯。

Secondary outcome percentage point differences also showed the inferiority of ivermectin compared with 5% permethrin for index cases (76.6% v 91.5%; percentage point difference -14.9, 95% CI -23.6 to -6.2) and participants (85.3% v 94.2%; -9.2 percentage point difference, -14.9 to -3.5).

次要结果的百分点差异也显示了伊维菌素与5%除虫菊酯相比的劣势，对于索引病例（76.6%对比91.5%；百分点差异-14.9，95%置信区间（CI）为-23.6至-6.2）和参与者（85.3%对比94.2%；百分点差异-9.2，95%置信区间（CI）为-14.9至-3.5）。

Intraclass correlation coefficients were higher for permethrin than ivermectin for all clusters (0.68, 95% CI 0.61 to 0.75 v 0.46, 0.37 to 0.56) and for cluster size >1 (0.67, 0.60 to 0.74 v 0.47, 0.37 to 0.56).

对于所有簇，与伊维菌素相比，拟除虫菊酯的组内相关系数更高（0.68，95% 置信区间 0.61 至 0.75 对比 0.46，0.37 至 0.56），对于簇大小>1，组内相关系数也更高（0.67，0.60 至 0.74 对比 0.47，0.37 至 0.56）。

Cutaneous adverse events were found in 11.9% and 15.6% of participants treated with ivermectin and permethrin, respectively.

分别有 11.9% 和 15.6% 接受伊维菌素和拟除虫菊酯治疗的参与者出现了皮肤不良事件。

Conclusions

The results of this cluster randomised trial of classic scabies, confirmed by dermoscopy, did not show the non-inferiority of oral ivermectin compared with 5% permethrin cream, given on days 0 and 10, in achieving clinical cure of scabies on day 28 in index cases and their household members.

该经典疥疮群组随机试验结果表明，通过皮肤镜检查确认，口服伊维菌素与在第0天和第10天使用5%苯甲酸苄酯乳膏相比，在第28天实现索引病例及其家庭成员疥疮临床治愈方面，并未显示出非劣效性。

Conversely, the trial showed the statistical superiority of 5% permethrin cream.

相反，试验结果表明5%苯甲酸苄酯乳膏在统计上具有优越性。

trial_registration

NCT02407782.

NCT02407782。