背景:土壤传播的蠕虫类圆圆线虫感染影响全球多达6亿人,他们大多数生活在卫生条件差的农村地区。如果未经治疗,感染导致长期发病,甚至可能危及生命。莫昔克丁可能是伊维菌素的有希望的替代品,目前唯一推荐的单剂量治疗。我们旨在评估与伊维菌素相比,莫昔克丁在疗效和安全性方面是否不逊色。
方法:在这个随机的,双盲,平行组,非自卑,在老挝和柬埔寨的社区进行2b/3阶段试验,通过六重复定量Baermann测定,对18-65岁的成年人的粪便中是否存在胸骨S幼虫进行了筛查。使用计算机生成的组分配(按感染强度分层的区组随机化),在寄生虫学(两个或两个以上的阳性Baermann检测)和临床上符合条件的参与者被随机分配(1:1)接受单次口服剂量的莫西丁(8mg)和伊维菌素匹配的安慰剂,或伊维菌素(200μg/kg体重)和莫西丁匹配的安慰剂。主要终点是治疗后14-21天评估的治愈率,使用根据意向治疗原则分析的可用病例人群。如果差异的双侧95%CI的下限大于-10个百分点的非劣效性,则认为莫昔克丁不劣于伊维菌素。在治疗前评估安全性终点,在2-3小时,24h,治疗后14-21天。该试验在ClinicalTrials.gov注册,NCT04056325和NCT04848688。
结果:在2020年12月6日至2022年5月21日之间,筛选了4291名参与者,其中726人被纳入并随机分配到莫西丁(n=363)或伊维菌素(n=363)。对于具有主要结果数据的参与者,我们观察到莫西丁组的治愈率为93·6%(95%CI90·5至96·0;346名参与者中的324名),伊维菌素组的治愈率为95·7%(93·0至97·6;350名参与者中的335名),导致组间差异为-2·1个百分点(95%CI-5·5至1·3)。最常见的不良事件是腹痛(32[9%]的363与34[9%]的363与伊维菌素)和头痛(25[7%]与30[8%]),主要是轻度和短暂的。
结论:莫昔克丁治疗圆线虫病的疗效不劣于伊维菌素。此外,两种药物的安全性相似.与伊维菌素相比,莫西丁的固定剂量和较低的成本使其成为有价值的替代品。
背景:瑞士国家科学基金会。
BACKGROUND: Infection with the soil-transmitted helminth Strongyloides stercoralis affects up to 600 million people globally, most of whom live in rural areas with poor sanitation. If untreated, infection leads to long-lasting morbidity and might even be life-threatening. Moxidectin might be a promising alternative to ivermectin, the only currently recommended single-dose treatment. We aimed to assess whether moxidectin is non-inferior in terms of efficacy and safety compared with ivermectin.
METHODS: In this randomised, double-blind, parallel-group, non-inferiority, phase 2b/3
trial in communities in Laos and Cambodia, adults aged 18-65 years were screened for the presence of S stercoralis larvae in their stool via sextuplicate quantitative Baermann assays. Using computer-generated group allocation (block randomisation stratified by infection intensity), parasitologically (two or more positive Baermann assays) and clinically eligible participants were randomly assigned (1:1) to receive single oral doses of either moxidectin (8 mg) and ivermectin-matched placebo, or ivermectin (200 μg/kg bodyweight) and moxidectin-matched placebo. The primary endpoint was cure rate assessed at 14-21 days after treatment, using the available-case population analysed according to intention-to-treat principles. Moxidectin was considered non-inferior to ivermectin if the lower limit of the two-sided 95% CI of the difference was greater than the non-inferiority margin of -10 percentage points. Safety endpoints were assessed before treatment, and at 2-3 h, 24 h, and 14-21 days after treatment. This
trial is registered at ClinicalTrials.gov, NCT04056325 and NCT04848688.
RESULTS: Between Dec 6, 2020, and May 21, 2022, 4291 participants were screened, 726 of whom were enrolled and randomly assigned to moxidectin (n=363) or ivermectin (n=363). For the participants with primary outcome data, we observed a cure rate of 93·6% (95% CI 90·5 to 96·0; 324 of 346 participants) in the moxidectin group and 95·7% (93·0 to 97·6; 335 of 350 participants) in the ivermectin group, resulting in a between-group difference of -2·1 percentage points (95% CI -5·5 to 1·3). The most common adverse events were abdominal pain (32 [9%] of 363 with moxidectin vs 34 [9%] of 363 with ivermectin) and headache (25 [7%] vs 30 [8%]), which were predominantly mild and transient.
CONCLUSIONS: Moxidectin was non-inferior to ivermectin in terms of efficacy in the treatment of
strongyloidiasis. Additionally, both drugs had a similar safety profile. The fixed dose and lower cost of moxidectin compared with ivermectin make it a valuable alternative for people with
strongyloidiasis.
BACKGROUND: Swiss National Science Foundation.