Rossignol Jean-François, Kabil Samir M, Said Mohammed, Samir Hatem, Younis Azza M
The Romark Institute for Medical Research, Tampa, Florida 33607, USA.
Clin Gastroenterol Hepatol. 2005 Oct;3(10):987-91. doi: 10.1016/s1542-3565(05)00427-1.
BACKGROUND & AIMS: The aim of this study was to evaluate the efficacy of nitazoxanide for the treatment of diarrhea and enteritis associated with Blastocystis hominis as the sole identified pathogen in children and adults from the Nile delta of Egypt.
Two prospective, randomized, double-blind, placebo-controlled studies were conducted. Nitazoxanide 500 mg (as a 500-mg tablet) was administered twice daily for 3 days in patients aged 12 years or older, 200 mg (as 10 mL of an oral suspension) was administered twice daily for 3 days in patients aged 4-11 years, and 100 mg (as 5 mL of an oral suspension) was administered twice daily for 3 days in patients aged 1-3 years.
Four days after the completion of therapy, 36 (86%) of the 42 patients who received nitazoxanide showed resolution of symptoms compared with 16 (38%) of 42 patients who received placebo (P<.0001). Thirty-six (86%) of the 42 patients who received nitazoxanide were free of B hominis organisms in each of 3 posttreatment stool samples compared with only 5 (12%) of 42 patients who received placebo (P<.0001). Response rates in patients receiving the tablets and the suspension were identical.
These findings suggest that B hominis is pathogenic in some patients and can be treated effectively with nitazoxanide. Alternatively, the possibility that nitazoxanide is effective in treating other unidentified causes of persistent diarrhea and enteritis warrants further study.
本研究旨在评估硝唑尼特治疗埃及尼罗河三角洲地区儿童和成人腹泻及肠炎的疗效，这些患者仅检测出人芽囊原虫这一病原体。
开展了两项前瞻性、随机、双盲、安慰剂对照研究。12岁及以上患者每日服用2次500毫克硝唑尼特（500毫克片剂），共3天；4至11岁患者每日服用2次200毫克（10毫升口服混悬液），共3天；1至3岁患者每日服用2次100毫克（5毫升口服混悬液），共3天。
治疗结束4天后，接受硝唑尼特治疗的42例患者中有36例（86%）症状缓解，而接受安慰剂治疗的42例患者中只有16例（38%）症状缓解（P<0.0001）。接受硝唑尼特治疗的42例患者中有36例（86%）在治疗后3次粪便样本中均未检测到人芽囊原虫，而接受安慰剂治疗的42例患者中只有5例（12%）未检测到（P<0.0001）。接受片剂和混悬液治疗的患者的缓解率相同。
这些研究结果表明，人芽囊原虫在一些患者中具有致病性，硝唑尼特可有效治疗。此外，硝唑尼特对持续性腹泻和肠炎的其他不明病因有效的可能性值得进一步研究。
