Application of a Poisson distribution quality control measure to the analysis of two human hookworm drug treatment studies in Ghana.

Application of a Poisson distribution quality control measure to the analysis of two human hookworm drug treatment studies in Ghana.
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应用泊松分布质量控制措施分析加纳的两项人类钩虫药物治疗研究。

DOI:
10.1016/j.ijpddr.2014.01.001
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发表时间:
2014
期刊:
International journal for parasitology. Drugs and drug resistance
影响因子:
--
通讯作者:
Cappello,Michael
Cappello,Michael
中科院分区:
--
文献类型:
--
作者:
Kotze,AndrewC;Dobson,RobertJ;Humphries,Debbie;Wilson,Michael;Cappello,Michael

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我们检查了2007年(研究1)和2010年(研究2)在加纳对钩虫感染者进行的粪卵减少试验(FECRT),以探索测试分析的各个方面。一些受试者在药物治疗后表现出FEC增加。这主要发生在EPG治疗前的FEC受试者中。我们寻求了一种方法,从FECRT分析中删除“错误的”药物疗效阴性病例。对药物疗效阴性病例的治疗前和治疗后的FEC进行检查,以确定它们是否代表单个随机分布样本的重复,即它们是否符合泊松分布。如果处理后的FEC和处理前样本取自单一随机分布的鸡蛋,则其FEC大于预期的情况被排除在FECRT之外。我们认为,这些病例很可能代表了粪便中虫卵的非随机分布、虫卵排泄的逐日变化,或者药物治疗后虫子开始开放,因此不是药物疗效的准确测量。这导致排除了最极端的药物疗效阴性病例,研究1(81.6%比89.2%)和研究2(86.7%比89.4%)的总体药物疗效显著增加。从分析中排除FEC<150人也增加了研究1的有效性(81.6%比88.9%),然而,这导致45%的研究对象被排除在外,而使用泊松分布方法只排除了5%。虽然低FEC受试者被排除在牲畜FECRT之外,但此类受试者在人类FECRT中的显著流行率表明,将它们排除在外可能是不切实际的。因此,我们建议,通过使用简单的泊松分布分析来排除“错误的”负效应病例,可以最大限度地减少低FEC的影响。
We examined faecal egg count reduction tests (FECRTs) conducted with hookworm-infected humans in Ghana in 2007 (study 1) and 2010 (study 2) in order to explore aspects of the test analysis. Some subjects showed increased FEC following drug treatment. This occurred mostly in <150 epg pre-treatment FEC subjects. We sought a means to remove ‘erroneous’ negative drug efficacy cases from the FECRT analysis. Pre- and post-treatment FECs from negative drug efficacy cases were examined to determine whether they represented replicates from a single randomly distributed sample, that is, if they were consistent with a Poisson distribution. Cases where the post-treatment FEC was greater than that expected if it and the pre-treatment sample had been taken from a single random distribution of eggs were excluded from the FECRT. We suggest that these cases most likely represent non-random distribution of eggs in stools, day-to-day variations in egg excretion, or worm patency onset after drug treatment, and hence are not accurate measurements of drug efficacy. This led to exclusion of the most extreme negative drug efficacy cases, with significant increases in overall drug efficacy for study 1 (81.6% vs 89.2%) and study 2 (86.7% vs 89.4%). Excluding FEC <150 individuals from the analysis also increased the study 1 efficacy (81.6% vs 88.9%), however, this resulted in the exclusion of 45% of the study subjects, compared to the exclusion of just 5% using the Poisson distribution method. While low FEC subjects are excluded from livestock FECRTs, the significant prevalence of such subjects in human FECRTs suggests that their exclusion may not be practical. Hence, we suggest that the influence of low FECs can be minimised by excluding ‘erroneous’ negative efficacy cases using a simple Poisson distribution analysis.
简单随机抽样对观察到的粪便卵数变化的贡献。
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