Department of Gastroenterology, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Ministry of Education Key Laboratory of Child Development and Disorders; China International Science and Technology Cooperation Base of Child Development and Critical Disorders; Chongqing Key Laboratory of Pediatrics, Chongqing, China.
Indian J Pediatr. 2020 Jan;87(1):17-25. doi: 10.1007/s12098-019-03098-w. Epub 2019 Dec 12.
To evaluate the efficacy and safety of nitazoxanide in intestinal parasitic infections in children.
Four databases, PubMed, EMBASE, Web of Science and Cochrane Library, have been systematically searched from the inception of each database up to March 1st, 2019. The enrolled studies were limited to randomized clinical trials in children, comparing nitazoxanide with placebo or other antiparasitic drugs. The data extraction and quality assessment of pooled studies were conducted by two reviewers independently. For meta-analysis, Stata12.0 was used and a randomized effect model or a fixed effect model was selected according to the outcomes of heterogeneity test.
A total of 1645 subjects in 13 randomized controlled trials (RCTs) were enrolled, including 768 cases in the trial group and 877 cases in the control group. The effect of nitazoxanide vs. placebo and other antiparasitic drugs on the excretion rate of pathogens was uncertain (OR = 2.06, 95%CI [1.01,4.20], P = 0.047; I = 84.7%; very low quality evidence). Compared with placebo, subgroup analysis suggested that nitazoxanide could significantly improve the excretion rate of pathogens (OR = 7.01, 95%CI [1.82,26.94], P = 0.005; I = 79.1%; moderate quality evidence), while it made little or no difference compared with antiparasitic drugs (OR = 0.72, 95%CI [0.47,1.09], P = 0.124; I = 33.1%; low quality evidence). Meanwhile, nitazoxanide might increase the remission rate of diarrhea with OR = 5.12, 95%CI [2.00,13.08], P = 0.001; I = 72.3%; low quality evidence). However, it might also increase the rate of adverse events (OR = 1.47, 95%CI [1.05,2.07], P = 0.026; I = 44.7%; low quality evidence).
The authors are uncertain whether or not nitazoxanide could improve the excretion rate of pathogens. Based on low-certainty evidence, nitazoxanide may improve the remission rate of diarrhea in children with intestinal parasite infections, but it may be associated with an increased risk of adverse reactions. Hence, more RCTs with a low risk of bias are still needed to assess the efficacy and safety of nitazoxanide.
评估硝唑尼特治疗儿童肠道寄生虫感染的疗效和安全性。
系统检索了 PubMed、EMBASE、Web of Science 和 Cochrane Library 数据库，检索时间均从各数据库建库起至 2019 年 3 月 1 日。纳入比较硝唑尼特与安慰剂或其他抗寄生虫药物治疗儿童肠道寄生虫感染的随机对照试验。由 2 名评价员独立进行资料提取和质量评价。采用 Stata12.0 软件进行 Meta 分析，根据异质性检验结果选择固定效应模型或随机效应模型。
共纳入 13 项随机对照试验的 1645 例受试者，试验组 768 例，对照组 877 例。与安慰剂相比，硝唑尼特可能提高寄生虫的排虫率（OR=2.06，95%CI[1.01,4.20]，P=0.047；I²=84.7%；极低质量证据），但对改善寄生虫的清除率的作用不确定（OR=7.01，95%CI[1.82,26.94]，P=0.005；I²=79.1%；中等质量证据）；与抗寄生虫药物相比，硝唑尼特可能提高寄生虫的排虫率（OR=0.72，95%CI[0.47,1.09]，P=0.124；I²=33.1%；低质量证据），但对改善寄生虫的清除率的作用不确定（OR=0.72，95%CI[0.47,1.09]，P=0.124；I²=33.1%；低质量证据）。同时，硝唑尼特可能提高腹泻的缓解率（OR=5.12，95%CI[2.00,13.08]，P=0.001；I²=72.3%；低质量证据），但可能增加不良反应发生率（OR=1.47，95%CI[1.05,2.07]，P=0.026；I²=44.7%；低质量证据）。
目前作者尚不能确定硝唑尼特是否能提高寄生虫的排虫率。基于低质量证据，硝唑尼特可能提高儿童肠道寄生虫感染的腹泻缓解率，但可能增加不良反应风险。因此，仍需要更多设计良好、低偏倚风险的随机对照试验来评估其疗效和安全性。
