Efficacy and Safety of Valganciclovir in Congenital Cytomegalovirus Infection with Isolated Intrahepatic Cholestasis: A Randomized Controlled Trial.

IF 1.3 Q3 PEDIATRICS Pediatric Gastroenterology, Hepatology & Nutrition Pub Date : 2024-09-01 Epub Date: 2024-09-09 DOI:10.5223/pghn.2024.27.5.298
Salahuddin Mahmud, Tanzila Farhana, Ataul Mustufa Anik, Fayaza Ahmed, Mashud Parvez, Madhabi Baidya, Rafia Rashid, Farhana Tasneem, Ahmed Rashidul Hasan, Mohammad Jahangir Alam, Shafi Ahmed Muaz
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引用次数: 0

Abstract

Purpose: Cytomegalovirus (CMV) infection affects the hepatic, neurologic, hematopoietic, respiratory, gastrointestinal, and other organs, resulting in a high mortality rate and long-term sequelae. It may cause acute or chronic hepatitis, or even lead to hepatic cirrhosis. Valganciclovir (VGCV) is an effective, safe, and well-tolerated treatment for congenital CMV infection, without any serious adverse effects. This study was conducted to evaluate the clinical, biochemical, and virological profiles of infants with CMV with intrahepatic cholestasis and to determine the outcomes with or without treatment with VGCV.

Methods: Twenty infants aged <6 months diagnosed with congenital CMV infection with evidence of intrahepatic cholestasis were included in this study. Randomization was used to divide the study participants into 2 groups. The control group (n=10) was treated with only supportive management, and the intervention group (n=10) was treated with oral VGCV at 16 mg/kg/dose 12 hours a day for 6 weeks plus supportive treatments. Physical examinations and biochemical, serological, and virological tests were performed at the time of diagnosis and at the end of 6 weeks and 6 months.

Results: The control and intervention groups were compared in terms of clinical and laboratory parameters such as jaundice, dark urine, pale stool, hepatomegaly, total bilirubin, aminotransferases, gamma-glutamyl transferase, alkaline phosphatase, and CMV polymerase chain reaction load, which showed a significant reduction after treatment in the intervention group (p<0.05) with oral VGCV, with very few side effects, whereas the control group showed no significant changes.

Conclusion: Oral VGCV can be used to effectively treat CMV infection with intrahepatic cholestasis without notable side effects.

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缬更昔洛韦治疗先天性巨细胞病毒感染伴孤立性肝内胆汁淤积症的有效性和安全性:随机对照试验
目的:巨细胞病毒(CMV)感染会影响肝脏、神经系统、造血系统、呼吸系统、胃肠道和其他器官,导致高死亡率和长期后遗症。它可能引起急性或慢性肝炎,甚至导致肝硬化。缬更昔洛韦(VGCV)是治疗先天性巨细胞病毒感染的有效、安全、耐受性良好的药物,且无任何严重不良反应。本研究旨在评估患有 CMV 并伴有肝内胆汁淤积症的婴儿的临床、生化和病毒学特征,并确定使用或不使用 VGCV 治疗的结果:方法:20 名年龄为 6 个月的婴儿:对照组和干预组在黄疸、深色尿液、苍白粪便、肝肿大、总胆红素、转氨酶、γ-谷氨酰转移酶、碱性磷酸酶和CMV聚合酶链反应载量等临床和实验室指标方面进行了比较,结果显示干预组治疗后CMV载量显著降低(p):口服 VGCV 可有效治疗 CMV 感染合并肝内胆汁淤积症,且无明显副作用。
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来源期刊
CiteScore
3.90
自引率
0.00%
发文量
43
期刊介绍: Pediatric Gastroenterology, Hepatology and Nutrition (Pediatr Gastroenterol Hepatol Nutr), an official journal of The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition, is issued bimonthly and published in English. The aim of Pediatr Gastroenterol Hepatol Nutr is to advance scientific knowledge and promote child healthcare by publishing high-quality empirical and theoretical studies and providing a recently updated knowledge to those practitioners and scholars in the field of pediatric gastroenterology, hepatology and nutrition. Pediatr Gastroenterol Hepatol Nutr publishes review articles, original articles, and case reports. All of the submitted papers are peer-reviewed. The journal covers basic and clinical researches on molecular and cellular biology, pathophysiology, epidemiology, diagnosis, and treatment of all aspects of pediatric gastrointestinal diseases and nutritional health problems.
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