Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes

Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes
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DOI:
10.1186/s13071-016-1490-9
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发表时间:
2016-04-13
影响因子:
3.2
通讯作者:
Rowland, Mark
Rowland, Mark
中科院分区:
医学2区
文献类型:
--
作者:
Tungu, Patrick;Kirby, Matthew;Rowland, Mark

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背景:长效杀虫蚊帐(LN)是预防疟疾的有效工具。世界卫生组织农药评价计划制定了评价标准,以方便登记供公众使用。根据世界卫生组织的第三期程序,在坦桑尼亚进行了一项家庭随机试验,以评估高效氯氰菊酯涂层拦截器(R) LN (BASF)的三年使用情况。结果根据II期实验小屋试验的结果进行校准。方法:对934户随机发放拦截剂LN (200 mg/m(2)高效氯氰菊酯)和常规处理蚊帐CTN (40 mg/m(2)高效氯氰菊酯)。每隔6个月进行一次住户调查,记录净使用量、耐用性、不良影响、用户接受程度和洗涤习惯。同时,收集了每种蚊帐30个,并在锥形和隧道生物测定法中对冈比亚按蚊进行了击倒和杀死试验。每年对蚊帐的高效氯氰菊酯含量进行评估。结果:12个月时,97%的截止剂LN符合锥或隧道试验的疗效标准;这一通过率在24个月时下降到90%,在36个月时下降到87%。相比之下,只有63%的CTN在12个月时达到疗效标准,24个月时为14%,36个月时为0%。36个月时,拦截器LN上的高效氯氰菊酯含量为初始含量的20% (42 +/- 13 mg/m(2)),而CTNs上仅为4% (1.3 +/- 1.6 mg/m(2))。据报道,LN拦截器全年使用,每年清洗4.3次。一些人回忆说,在使用的头几天,面部有刺痛感,但这并没有阻止他们使用。36个月平均钻孔数为18个,孔面积为229 cm(2),孔指数为332。使用36个月后,LN和CTN的杀虫剂含量和锥体生物功效与早期II期小屋试验中使用的LN和CTN相似,但在实验小屋中测试的20次洗涤LN提供了足够的个人保护,而20次洗涤CTN则没有。结论:超过80%的拦截器LN在36个月时达到了世卫组织的III期标准,因此获得了世卫组织的完全推荐。36个月时的III期结果预期为20次标准化洗涤后的II期结果。
Background: Long-lasting insecticidal nets (LN) are an effective tool for malaria prevention. The World Health Organization Pesticide Evaluation Scheme has established evaluation criteria to facilitate registration for public use. A household randomised trial was conducted in Tanzania according to WHOPES Phase III procedures to evaluate the alpha-cypermethrin coated Interceptor (R) LN (BASF) over three years' use. Outcomes were calibrated against results of Phase II experimental hut trials.Methods: Interceptor LN (200 mg/m(2) alpha-cypermethrin) and conventionally treated nets CTN (40 mg/m(2) alpha-cypermethrin) were randomly distributed to 934 households. At 6-monthly intervals, household surveys recorded net use, durability, adverse effects, user acceptance and washing practices. Concurrently, 30 nets of each type were collected and tested for knock-down and kill of Anopheles gambiae mosquitoes in cone and tunnel bioassays. Alpha-cypermethrin content of nets was assessed annually.Results: At 12 months 97 % of Interceptor LN met the efficacy criteria by cone or tunnel test; this pass rate declined to 90 % at 24 months and 87 % at 36 months. In contrast only 63 % of CTN met the efficacy criteria at 12 months, 14 % at 24 months and 0 % at 36 months. The alpha-cypermethrin content at 36 months on Interceptor LN was 20 % (42 +/- 13 mg/m(2)) of the initial content but on CTNs only 4 % (1.3 +/- 1.6 mg/m(2)) remained. Interceptor LN was reported to be used year-round and washed 4.3 times/year. A few recalled facial tingling during the first days of use but this did not deter usage. The average number of holes at 36 months was 18, hole area per net was 229 cm(2) and hole index was 332. Insecticide content and cone bioefficacy of LN and CTN after 36 months' use were similar to that of LN and CTN used in earlier Phase II hut trials, but while the 20 times washed LN tested in experimental huts gave adequate personal protection the 20 times washed CTN did not.Conclusions: More than 80 % Interceptor LN fulfilled the WHOPES Phase III criteria at 36 months and thus the LLIN was granted full WHO recommendation. Phase III outcomes at 36 months were anticipated by Phase II outcomes after 20 standardized washes.