Combined Oral Ivermectin and 5% Permethrin Cream to Treat Severe Scabies.

A combination of standard-dose oral ivermectin and topical scabicides is recommended for treatment.

推荐使用标准剂量的口服伊维菌素和局部杀螨剂联合治疗。

However, data from randomized clinical trials are lacking, and the probability of cure is uncertain.

然而，缺乏随机临床试验的数据，治愈的可能性不确定。

Ivermectin at higher doses has been effective in the treatment of some parasitic diseases.

在治疗某些寄生虫病方面，较高剂量的伊维菌素已被证明是有效的。

Methods

We conducted a blinded randomized trial involving adults with severe scabies (i.e., profuse or crusted), as confirmed by parasitologic or dermoscopic assessment.

我们开展了一项双盲随机试验，研究对象为经寄生虫学或皮肤镜检查确诊的成年严重疥疮（即大量或结痂型）患者。

The patients were assigned in a 1:1 ratio to receive oral ivermectin (to be taken with food) at a dose of 400 μg per kilogram of body weight (higher-dose group) or 200 μg per kilogram (standard-dose group) on days 0, 7, and 14, combined with head-to-toe application of 5% permethrin cream on days 0 and 7 and daily application (as recommended) of an emollient cream.

患者按1:1的比例分配，分别接受口服伊维菌素治疗（与食物同服），剂量为每公斤体重400微克（高剂量组）或200微克（标准剂量组），分别在第0天、第7天和第14天服用，同时在第0天和第7天全身涂抹5%的吡硫翁霜，并按推荐每日涂抹润肤霜。

The primary end point was cure of severe scabies, which was defined as the absence of mites and mite-related products (i.e., eggs and feces), as confirmed by parasitologic or dermoscopic assessment on days 18 and 21, and the absence of active clinical lesions on physical examination on day 28.

主要终点是治愈重症疥疮，定义为在第18天和第21天通过寄生虫学或皮肤镜检查确认无螨虫及其相关产物（即卵和粪便），以及在第28天的体格检查中无活动性临床病变。

Results

A total of 132 patients (66 in each group) were included in the main analysis.

共有132名患者（每组66人）被纳入主要分析。

Cure was observed in 75% of the patients in the higher-dose group and in 82% of those in the standard-dose group (odds ratio for cure, 0.64; 95% confidence interval, 0.25 to 1.67).

在高剂量组中，75%的患者观察到治愈，而在标准剂量组中，82%的患者观察到治愈（治愈的几率比为0.64；95%置信区间为0.25至1.67）。

No safety issues were identified.

未发现任何安全问题。

Conclusions

Among adults, the 400-μg-per-kilogram dose of ivermectin plus 5% permethrin cream was not superior to the standard 200-μg-per-kilogram dose of ivermectin plus 5% permethrin cream in curing severe scabies.

在成人中，400微克/千克剂量的伊维菌素加上5%的吡硫翁乳膏并不优于标准的200微克/千克剂量的伊维菌素加上5%的吡硫翁乳膏治疗重症疥疮。

(Funded by the French Ministry of Health and French Society of Dermatology; ClinicalTrials.gov number, NCT02841215.).

(由法国卫生部和法国皮肤科学会资助；ClinicalTrials.gov编号，NCT02841215。)