评估N-乙酰半胱氨酸在缩短轮状病毒感染性胃肠炎病程及减少发作频率方面的疗效：一项初步的随机、安慰剂对照、双盲临床试验。
Evaluating the efficacy of N-acetylcysteine in diminishing the duration and frequency of rotavirus-induced gastroenteritis: a preliminary randomized, placebo-controlled, double-blind clinical trial.
作者信息
Heydari Behrooz, Aflatonian Majid, Bagherizadeh Mina, Hoseinzade Farahnaz, Saghafi Fatemeh
机构信息
Department of Clinical Pharmacy, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran.
Department of Pediatrics, School of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
出版信息
BMC Pediatr. 2025 Mar 12;25(1):186. doi: 10.1186/s12887-025-05534-7.
BACKGROUND
Globally, gastroenteritis stands as a primary contributor to child mortality, annually taking the lives of 3 million children under the age of 5 years. Rotavirus, a major factor in viral diarrhea among children aged 6 months to 2 years, presents with severe symptoms such as watery diarrhea and vomiting. Although mortality rates have decreased due to supportive care and vaccines, promising alternatives like N-acetylcysteine (NAC) show potential benefits in laboratory studies, indicating a possible supplementary strategy for managing rotavirus infections by reducing the duration and antigen excretion in feces.
METHODS
During this double-blind clinical trial, 71 patients, confirmed to have gastroenteritis resulting from rotavirus using a rapid diagnostic strip, were randomly allocated to two groups. One group was prescribed NAC at a dosage of 60 mg/kg/day, while the other received a placebo. The patient's progress was monitored daily until their gastroenteritis improved, and details regarding the duration of diarrhea and the frequency of bowel movements were recorded for each participant.
RESULTS
The average duration of diarrhea in the NAC group and the placebo group was 2 and 3 days, respectively, with a level of p = 0.121. During the diarrhea period, the number of bowel movements in the NAC group was recorded at 28.1 ± 21.6 times, whereas in the placebo group, it was 35.3 ± 33.1 times, yielding a p-value of 0.409.
CONCLUSIONS
Even though the effects of NAC were observed in lowering the duration of the period and decreasing the frequency of bowel movements in gastroenteritis, these results did not reach statistical significance. Hence, the data from this study suggest that NAC may not effectively reduce the duration of diarrhea and the frequency of bowel movements linked to gastroenteritis caused by rotavirus.
TRIAL REGISTRATION
IRCT20181208041882N13, 14-10-2023 ( https://irct.behdasht.gov.ir/trial/68259 ).
背景
在全球范围内，肠胃炎是导致儿童死亡的主要原因之一，每年有300万5岁以下儿童因此丧生。轮状病毒是6个月至2岁儿童病毒性腹泻的主要因素，会出现水样腹泻和呕吐等严重症状。尽管由于支持性护理和疫苗，死亡率有所下降，但像N-乙酰半胱氨酸（NAC）这样有前景的替代药物在实验室研究中显示出潜在益处，表明通过缩短粪便中病毒持续时间和抗原排泄量，可能是一种管理轮状病毒感染的补充策略。
方法
在这项双盲临床试验中，71名经快速诊断试纸确诊为轮状病毒引起肠胃炎的患者被随机分为两组。一组患者服用剂量为60mg/kg/天的NAC，另一组接受安慰剂。每天监测患者的病情进展，直到肠胃炎好转，并记录每位参与者腹泻持续时间和排便频率的详细信息。
结果
NAC组和安慰剂组的平均腹泻持续时间分别为2天和3天，p值为0.121。腹泻期间，NAC组的排便次数记录为28.1±21.6次，而安慰剂组为35.3±33.1次，p值为0.409。
结论
尽管观察到NAC在缩短肠胃炎病程和减少排便频率方面有效果，但这些结果未达到统计学显著性。因此，本研究数据表明，NAC可能无法有效缩短与轮状病毒引起的肠胃炎相关的腹泻持续时间和排便频率。
试验注册
IRCT20181208041882N13，2023年10月14日（https://irct.behdasht.gov.ir/trial/68259）
Zotero 插件