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硝唑尼特与利福昔明预防肝性脑病复发的随机双盲对照试验。

Nitazoxanide versus rifaximin in preventing the recurrence of hepatic encephalopathy: A randomized double-blind controlled trial.

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

出版信息

J Hepatobiliary Pancreat Sci. 2021 Oct;28(10):812-824. doi: 10.1002/jhbp.947. Epub 2021 Apr 15.

Abstract

BACKGROUND/PURPOSE: Hepatic encephalopathy (HE) is a neuropsychiatric complication of liver cirrhosis. HE is associated with poor survival and detrimental effects on quality of life (QOL). The drawbacks of the long-term use of rifaximin in HE necessitates searching for alternative therapies. In this context, our study aimed at evaluating the safety and efficacy of nitazoxanide (NTZ) as compared to rifaximin (RFX) in preventing the recurrence of HE and assessing its impact on QOL.

PATIENTS AND METHODS

This prospective, randomized, double-blind controlled study included 60 patients who were randomly assigned to receive either rifaximin 550 mg twice daily (group 1; n = 30) or nitazoxanide 500 mg twice daily (group 2; n = 30) for 24 weeks. During the study period, the patients' neurological symptoms, mental status, and performance were monitored. The serum levels of HE triggers (ammonia, TNF-α, and octopamine) were assessed. The patients' health-related quality of life was also evaluated.

RESULTS

Six months after treatment, patients on NTZ therapy showed a statistically significant improvement in CHESS score and mental status. NTZ provided 136 days of remission vs 67 days of remission for patients on RFX (P  = .0001) and significant reduction in Child score (P  = .018). Additionally, NTZ showed a statistically significant decrease in serum ammonia, TNF-α, and octopamine levels as compared to rifaximin. Regarding QOL, NTZ group showed an improvement in total Chronic Liver Disease Questionnaire (CLDQ) score. Both groups experienced minor controllable side effects.

CONCLUSION

Nitazoxanide may represent a suitable and safe alternative therapy to rifaximin in preventing the recurrence of hepatic encephalopathy.

摘要

背景/目的:肝性脑病(HE)是肝硬化的一种神经精神并发症。HE 与生存率降低和生活质量(QOL)受损有关。由于长期使用利福昔明治疗 HE 存在诸多弊端,因此需要寻找替代疗法。在这种情况下,我们的研究旨在评估硝唑尼特(NTZ)与利福昔明(RFX)预防 HE 复发的安全性和有效性,并评估其对 QOL 的影响。

患者和方法

这是一项前瞻性、随机、双盲对照研究,共纳入 60 例患者,他们被随机分为两组,分别接受利福昔明 550mg,每日两次(第 1 组,n=30)或硝唑尼特 500mg,每日两次(第 2 组,n=30)治疗 24 周。在研究期间,监测患者的神经症状、精神状态和表现。评估 HE 触发因素(氨、TNF-α 和章鱼胺)的血清水平。还评估了患者的健康相关生活质量。

结果

治疗 6 个月后,接受硝唑尼特治疗的患者 CHESS 评分和精神状态有显著改善。与接受 RFX 治疗的患者相比,接受 NTZ 治疗的患者缓解期延长 136 天,缓解期为 67 天(P=0.0001),Child 评分显著降低(P=0.018)。此外,与利福昔明相比,硝唑尼特可显著降低血清氨、TNF-α 和章鱼胺水平。关于 QOL,硝唑尼特组慢性肝病问卷(CLDQ)总分有所改善。两组均出现轻微可控的副作用。

结论

硝唑尼特可能是预防肝性脑病复发的一种合适且安全的利福昔明替代疗法。

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