Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled trial
Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled trial
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DOI：
10.1016/s0140-6736(02)11401-2
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发表时间：
2002-11-02
期刊：
影响因子：
168.9
通讯作者：
Kelly, P
中科院分区：
文献类型：
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作者：
Amadi, B;Mwiya, M;Kelly, P
背景：发展中国家儿童隐孢子虫病导致持续腹泻和营养不良，并与死亡率增加有关，但没有有效的治疗方法。我们的目的是评估硝唑昔酮-一种新的广谱抗寄生虫药物对赞比亚儿童因小隐孢子虫腹泻的发病率和死亡率的影响。方法2000年11月至2001年7月在赞比亚卢萨卡大学教学医院就诊的隐孢子虫腹泻患儿，经父母同意接受HIV检测，随机给予硝唑昔尼（100 mg，每日2次，口服3天）或安慰剂。主要终点是治疗开始后第7天的临床反应。次要终点包括第10天的寄生虫学反应和第8天的死亡率。分析的目的是治疗，排除随后发现在基线时细小C阴性或合并感染的患者。根据HIV血清学对试验进行分层。研究招募了50名hiv血清阳性和50名hiv血清阴性的儿童，其中4名随后被排除在外。在hiv血清阴性的儿童中，25名接受硝唑尼特治疗的儿童中有14名（56%）腹泻缓解，22名接受安慰剂治疗的儿童中有5名（23%）腹泻缓解（差异33%，95% CI 7-59; p=0.037）。25名服用硝唑昔尼特的患者中有13名（52%）根除了粪便中的细小疟原虫，22名服用安慰剂的患者中有3名（14%）根除了粪便中的细小疟原虫（38%,95% CI 14-63; p=0.007）。安慰剂组22名儿童中有4名（18%）在第8天死亡，而硝唑昔尼特组25名儿童中没有死亡（-18%，34至2；p=0-041）。hiv血清阳性的儿童没有从硝唑尼特中获益。Nitazoxanide与两层的不良事件均无显著相关。结论硝唑昔尼特3天疗程可显著改善腹泻的消退、寄生虫的根除和疾病的治疗。以及艾滋病毒血清阴性而非艾滋病毒血清阳性儿童的死亡率。
Background Cryptosporidiosis in children in developing countries causes persistent diarrhoea and malnutrition and is associated with increased mortality, but there is no effective treatment. We aimed to assess the effect of nitazoxanide-a new broad-spectrum antiparasitic drug-on morbidity and mortality in Zambian children with diarrhoea due to Cryptosporidium parvum.Methods Children with cryptosporidial diarrhoea who were admitted to the University Teaching Hospital, Lusaka, Zambia, between November, 2000, and July, 2001, and whose parents consented to their having an HIV test were randomly assigned nitazoxanide (100 mg twice daily orally for 3 days) or placebo. The primary endpoint was clinical response on day 7 after the start of treatment. Secondary endpoints included parasitological response by day 10 and mortality at day 8. Analysis was by intention to treat, with exclusion of patients subsequently found to be negative for C parvum or co-infected at baseline. The trial was stratified by HIV serology.Findings 50 HIV-seropositive and 50 HIV-seronegative children were recruited for the study, four of whom were subsequently excluded. In HIV-seronegative children, diarrhoea resolved in 14 (56%) of 25 receiving nitazoxanide and 5 (23%) of 22 receiving placebo (difference 33%, 95% CI 7-59; p=0.037). C parvum was eradicated from stool in 13 (52%) of 25 receiving nitazoxanide and three (14%) of 22 receiving placebo (38%, 95% CI 14-63; p=0.007). Four children (18%) of 22 in the placebo group had died by day 8, compared with none of 25 in the nitazoxanide group (-18%, 34 to 2; p=0-041). HIV-seropositive children did not benefit from nitazoxanide. Nitazoxanide was not significantly associated with adverse events in either stratum.Interpretation A 3-day course of nitazoxanide significantly improved the resolution of diarrhoea, parasitological eradication,. and mortality in HIV-seronegative, but not HIV-seropositive, children.