[논문]Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study

Jun, Dae Won; Kim, Byung Ik; Cho, Yong Kyun; Kim, Hong Ju; Kwon, Young Oh; Park, Soo Young; Han, Sang Young; Baek, Yang Hyun; Jung, Yong Jin; Kim, Hwi Young; Kim, Won; Heo, Jeong; Woo, Hyun Young; Hwang, Seong Gyu; Rim, Kyu Sung; Choi, Jong Young; Bae, Si Hyun; Lee, Young Sang; Lim, Young Suck; Cheong, Jae Youn; Cho, Sung Won; Lee, Byung Seok; Kim, Seok Hyun; Sohn, Joo Hyun; Kim, Tae Yeob; Paik, Yong Han; Kim, Ja Kyung; Lee, Kwan Sik

doi:10.3350/cmh.2013.19.2.165

Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study 원문보기

Clinical and molecular hepatology, v.19 no.2, 2013년, pp.165 - 172

Jun, Dae Won (Department of Internal medicine, Hanyang University College of Medicine, Seoul, Korea.) , Kim, Byung Ik (Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.) , Cho, Yong Kyun (Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.) , Kim, Hong Ju (Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.) , Kwon, Young Oh (Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University College of Medicine, Daegu, Korea.) , Park, Soo Young (Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University College of Medicine, Daegu, Korea.) , Han, Sang Young (Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.) , Baek, Yang Hyun (Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.) , Jung, Yong Jin (Department of Internal M) , Kim, Hwi Young , Kim, Won , Heo, Jeong , Woo, Hyun Young , Hwang, Seong Gyu , Rim, Kyu Sung , Choi, Jong Young , Bae, Si Hyun , Lee, Young Sang , Lim, Young Suck , Cheong, Jae Youn , Cho, Sung Won , Lee, Byung Seok , Kim, Seok Hyun , Sohn, Joo Hyun , Kim, Tae Yeob , Paik, Yong Han , Kim, Ja Kyung , Lee, Kwan Sik

Abstract ▼ AI-Helper

Background/AimsCarnitine and vitamin complex (Godex®) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients.Methods130 treatment-naïve patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months.ResultsAmong the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-γ secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment.ConclusionsALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.

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참고문헌 (16)

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Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study 원문보기

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