Division of Gastroenterology & Hepatology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
Trans R Soc Trop Med Hyg. 2012 Mar;106(3):167-73. doi: 10.1016/j.trstmh.2011.11.007. Epub 2012 Jan 31.
We conducted a double-blind, placebo-controlled clinical trial to demonstrate the efficacy of nitazoxanide suspension for the treatment of presumed infectious diarrhea in children. Eligible patients must have had diarrheal illness lasting 3-29 days. Patients were randomized to receive either nitazoxanide or placebo twice daily for three days. The primary endpoint was time from first dose to resolution of symptoms. One hundred children mean age 3.3 years were enrolled. The median time to resolution of symptoms for nitazoxanide treated patients was 23 hours (IQR 4-48 hours) vs 103.5 hours (IQR 63->168 hours) for placebo (p<0.001). An analysis by disease subset indicated nitazoxanide treated patients had statistically shorter durations of diarrheal illness associated with Giardia lamblia (n=32, p<0.001) and those with no identified enteropathogen (n=38, p=0.008), when compared to placebo. The study medication was well tolerated. Overall, nitazoxanide was effective at reducing the duration of diarrheal illness associated with multiple etiologies, including patients with no identified enteropathogen. These results suggest nitazoxanide may be a viable therapeutic option for the empiric treatment of diarrheal illness in children where the etiology is unknown or presumed to be of infectious origin. Clinical trial registry number NCT01326338.
我们进行了一项双盲、安慰剂对照的临床试验，旨在证明硝唑尼特悬浮液治疗儿童疑似感染性腹泻的疗效。合格的患者必须患有持续 3-29 天的腹泻病。患者随机分为每日两次接受硝唑尼特或安慰剂治疗三天。主要终点是从首次用药到症状缓解的时间。100 名平均年龄为 3.3 岁的儿童入组。硝唑尼特治疗组症状缓解的中位数时间为 23 小时（IQR 4-48 小时），安慰剂组为 103.5 小时（IQR 63-168 小时）（p<0.001）。按疾病亚组分析表明，与安慰剂相比，硝唑尼特治疗组患有蓝氏贾第鞭毛虫相关腹泻的患者（n=32，p<0.001）和无明确病原体的患者（n=38，p=0.008）的腹泻持续时间明显缩短。研究药物的耐受性良好。总体而言，硝唑尼特可有效缩短多种病因引起的腹泻持续时间，包括无明确病原体的患者。这些结果表明，硝唑尼特可能是一种可行的治疗选择，用于经验性治疗病因不明或疑似感染性的儿童腹泻。临床试验注册号 NCT01326338。
