Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection

查看全文 作　　者：JS [1]Rajkumar;MG [1]Sekar;SK [2]Mitra

机构地区：[1]Lifeline Rigid Hospitals, Kilpauk, Chennai, Tamilnadu 600010, India;[2]The Himalaya Drug Company, Bangalore 562123, Karnataka, India

出　　处：《World Journal of Gastroenterology》索引2007年第13卷第30期,共5页

摘　　要：AIM: To investigate the safety and efficacy of the formulation HD-03/ES capsules in the management of patients with chronic hepatitis B infection. METHODS: A total of 25 patients were recruited to the study and were given HD-03/ES, two capsules twice daily for six months. Clinical assessment of symptoms and signs were done using the 'clinical observation table' once a month before and after the treatment. Biochemical investigations of total bilirubin, ALT, AST, serum protein for liver function tests were done every month after initiating treatment. Serum was analyzed for HBV markers for HBsAg, HBeAg and HBV DNA at baseline, 4 and 6 mo after therapy using ELISA kits from Roche. RESULTS: After 6 mo of therapy with HD-03/ES, a significant reduction of ALT values from 66.5 ± 11.1 to 39.1 ± 5.2 (P < 0.01) and a significant HBsAg loss (52%, P < 0.001), HBeAg loss (60%, P < 0.05) and HBV DNA loss (60%, P < 0.05) was observed. Adverse effects were mild and never warranted withdrawal of the drug. CONCLUSION: The results of this pilot study indicate that HD-03/ES might be a safe and effective treatment for chronic hepatitis B infection and a long-term multicentric comparator trial is warranted and under way. 关键词：乙型肝炎病毒治疗方法临床效果

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Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection

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