在坦桑尼亚的实验棚中,通过阿拉伯按蚊的死亡率来衡量胡椒基丁醚Yorkool® G3驱虫蚊帐与Olyset®Plus驱虫蚊帐的优劣。

IF 2.4 3区 医学 Q3 INFECTIOUS DISEASES
Olukayode G Odufuwa, Masudi Suleiman Maasayi, Emmanuel Mbuba, Watson Ntabaliba, Rose Philipo, Safina Ngonyani, Ahmadi Bakari Mpelepele, Isaya Matanila, Hassan Ngonyani, Jason Moore, Yeromin P Mlacha, Jennifer C Stevenson, Sarah Jane Moore
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引用次数: 0

摘要

背景:世界卫生组织(WHO)建议进行非劣效性试验,以证明保健产品具有与现有标准护理产品相当的功效。作为世界卫生组织全球疟疾计划(GMP)疟疾病媒控制产品评估程序的一部分,必须根据蚊子死亡率证明第二类驱虫蚊帐不劣于第一类产品。第一类除虫菊酯-胡椒基丁醚(PBO)驱虫蚊帐 Olyset® Plus 对公共卫生的影响已在有抗药性蚊虫的地区进行的流行病学试验中得到证实,但仍有必要确定其他除虫菊酯-胡椒基丁醚驱虫蚊帐的功效,以确保蚊帐及时上市,从而增加获取驱虫蚊帐的机会。根据世界卫生组织的非劣效性试验指南,在坦桑尼亚的实验棚中对溴氰菊酯-PBO驱虫蚊帐Yorkool® G3与Olyset® Plus的非劣效性进行了昆虫学评估:这两种拟除虫菊酯-PBO驱虫蚊帐的试验是在坦桑尼亚卢皮罗的实验棚中进行的,采用了 7 × 7 拉丁方形随机区组设计。这项研究在 14 个茅屋中进行了 49 个夜晚,评估野生、自由飞翔、抗除虫菊酯的阿拉伯疟蚊的死亡率和吸血情况。采用非劣效法,比较了未清洗和经过 20 次野外清洗的除虫菊酯-PBO Yorkool® G3 ITNs 与同类产品 Olyset® Plus 的疗效(主要终点是 24 小时的蚊虫死亡率,次要终点是吸血量),以及纯除虫菊酯 ITNs PermaNet® 2.0 的疗效:根据蚊子死亡率[51% vs. 39%,OR 1.68 (95% CI 1.50-1.88)],实验性小屋试验表明,Yorkool® G3 与 Olyset® Plus 相比并无劣势和优势[51% vs. 39%,OR 1.68 (95% CI 1.50-1.88)],因为较低的 95% CI 超过了 0.74(delta 为 39%)和无差别边缘 (1)。所有经处理的驱虫蚊帐的食血抑制率都很高(> 90%),Yorkool® G3 的抑制率不劣于 Olyset® Plus [4% vs. 2%,OR 1.81 (95% CI 1.46-2.39)],因为 95% CI 上限小于 4.85(delta 为 4%)。从蚊子的死亡比例和吸血情况来看,拟除虫菊酯-PBO驱虫蚊帐优于仅使用拟除虫菊酯的 PermaNet® 2.0 蚊帐(p 值 结论):根据对抗除虫菊酯的阿拉伯疟蚊的死亡率和噬血抑制率,Yorkool® G3驱虫蚊帐不劣于一流的Olyset® Plus驱虫蚊帐,也优于标准的仅使用除虫菊酯的驱虫蚊帐PermaNet® 2.0。Yorkool® G3驱虫蚊帐是控制新陈代谢型抗杀虫剂疟疾病媒的潜在工具,它们的上市将有助于疟疾控制计划以具有成本效益的方式选择驱虫蚊帐,从而提高人们获得驱虫蚊帐的机会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The non-inferiority of piperonyl-butoxide Yorkool® G3 insecticide-treated nets compared to Olyset®Plus measured by Anopheles arabiensis mortality in experimental huts in Tanzania.

Background: Non-inferiority trials are recommended by the World Health Organization (WHO) to demonstrate that health products show comparable efficacy to that of existing standard of care. As part of the WHO Global Malaria Programme (GMP) process of assessment of malaria vector control products, a second-in-class insecticide-treated net (ITN) must be shown to be non-inferior to a first-in-class product based on mosquito mortality. The public health impact of the first-in-class pyrethroid-piperonyl butoxide (PBO) ITN, Olyset® Plus, has been demonstrated in epidemiological trials in areas with insecticide-resistant mosquitoes, but there is a need to determine the efficacy of other pyrethroid-PBO nets to ensure timely market availability of nets in order to increase access to ITNs. The non-inferiority of a deltamethrin-PBO ITN Yorkool® G3 was evaluated entomologically against Olyset® Plus in experimental huts in Tanzania, following WHO guidelines for non-inferiority trials.

Methods: The trial of the two pyrethroid-PBO ITNs was conducted in experimental huts in Lupiro, Tanzania, using a randomized 7 × 7 Latin square block design. The study ran for 49 nights in 14 huts assessing the mosquito mortality and blood-feeding of wild, free-flying, pyrethroid-resistant Anopheles arabiensis. Using the non-inferiority approach, the comparative efficacy (primary endpoint was mosquito mortality at 24 h and secondary endpoint was blood-feeding) of unwashed and 20 times field-washed pyrethroid-PBO Yorkool® G3 ITNs, were compared with the first-in-class product Olyset® Plus and against a pyrethroid-only ITN, PermaNet® 2.0 ITNs, as a standard comparator.

Results: The experimental hut trial demonstrated non-inferiority and superiority of Yorkool® G3 to Olyset® Plus based on mosquito mortality [51% vs. 39%, OR 1.68 (95% CI 1.50-1.88)], given that lower 95% CI exceeded 0.74 (delta of 39%) and the margin of no difference (1). Blood-feeding inhibition was high for all treated ITNs (> 90%) and Yorkool® G3 was non-inferior to Olyset® Plus [4% vs. 2%, OR 1.81 (95% CI 1.46-2.39)], given that upper 95% CI was less than 4.85 (delta of 4%). The pyrethroid-PBO ITNs were superior to the pyrethroid-only net, PermaNet® 2.0, as determined by both the proportion of mortality and blood-feeding of mosquitoes (p-value < 0.05).

Conclusion: Yorkool® G3 ITNs demonstrated non-inferiority to the first-in-class Olyset® Plus and superiority over the standard pyrethroid-only ITN, PermaNet® 2.0 as measured by mortality and blood-feeding inhibition of wild pyrethroid-resistant An. arabiensis mosquitoes. Yorkool® G3 ITNs are potential tools for the control of metabolic insecticide-resistant malaria vectors, and their market availability will contribute to the cost-effective selection of ITNs by malaria control programmes to improve population access to ITNs.

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来源期刊
Malaria Journal
Malaria Journal 医学-寄生虫学
CiteScore
5.10
自引率
23.30%
发文量
334
审稿时长
2-4 weeks
期刊介绍: Malaria Journal is aimed at the scientific community interested in malaria in its broadest sense. It is the only journal that publishes exclusively articles on malaria and, as such, it aims to bring together knowledge from the different specialities involved in this very broad discipline, from the bench to the bedside and to the field.
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