The PERFECT Study (PEnnel Real liFe Efficacy Clinical Trial), a Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined with Garlic Oil in Patients with Transaminase Elevated Chronic Liver Disease / 대한내과학회지

BACKGROUND/AIMS: Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients. METHODS: A total of 237 patients with chronic liver disease were randomized into three groups; 100 patients were administered pennel, 102 patients Legalon as an active-control and 35 patients placebo for 12 weeks. The primary endpoint was the rate of alanine aminotransferase (ALT) normalization. We assessed differences in ALT levels and malondialdehyde (MDA) as an oxidative biomarker between 0 and 12 weeks, the improvement in quality of life using a chronic liver disease questionnaire (CLDQ) and the incidence of adverse events. RESULTS: Among 237 patients, there were 157 patients with non-alcoholic fatty liver disease, 36 patients with alcoholic liver disease, and 28 patients with chronic hepatitis B and C. The incidence of ALT normalization at 12 weeks was 89% for the pennel group, 18.6% for the active-control group, and 22.9% for the placebo-control group (p < 0.001). The difference in serum ALT level between 0 and 12 weeks was significantly higher in the pennel group (p < 0.001) and the level of MDA was decreased in the pennel group, statistically (p < 0.001). There was no difference in incidence of adverse events among groups. The pennel group showed significant improvement based on the CLDQ (p < 0.001). CONCLUSIONS: Pennel can effectively improve the rate of ALT normalization and the quality of life with a safety profile in chronic liver disease.

The PERFECT Study (PEnnel Real liFe Efficacy Clinical Trial), a Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined with Garlic Oil in Patients with Transaminase Elevated Chronic Liver Disease / 대한내과학회지

BACKGROUND/AIMS: Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients. METHODS: A total of 237 patients with chronic liver disease were randomized into three groups; 100 patients were administered pennel, 102 patients Legalon as an active-control and 35 patients placebo for 12 weeks. The primary endpoint was the rate of alanine aminotransferase (ALT) normalization. We assessed differences in ALT levels and malondialdehyde (MDA) as an oxidative biomarker between 0 and 12 weeks, the improvement in quality of life using a chronic liver disease questionnaire (CLDQ) and the incidence of adverse events. RESULTS: Among 237 patients, there were 157 patients with non-alcoholic fatty liver disease, 36 patients with alcoholic liver disease, and 28 patients with chronic hepatitis B and C. The incidence of ALT normalization at 12 weeks was 89% for the pennel group, 18.6% for the active-control group, and 22.9% for the placebo-control group (p < 0.001). The difference in serum ALT level between 0 and 12 weeks was significantly higher in the pennel group (p < 0.001) and the level of MDA was decreased in the pennel group, statistically (p < 0.001). There was no difference in incidence of adverse events among groups. The pennel group showed significant improvement based on the CLDQ (p < 0.001). CONCLUSIONS: Pennel can effectively improve the rate of ALT normalization and the quality of life with a safety profile in chronic liver disease.

Two Cases of Hemobilia Associated with Common Bile Duct Stones / 대한소화기내시경학회지

Hemobilia is a disease caused by injury or conditions that cause the abnormal communication between intrahepatic blood vessels and biliary tract, resulting in leakage of blood into the biliary tract. In the past, trauma had been the most common cause of hemobilia. However, with the increasing invasive procedures in the hepatobiliary tract, iatrogenic origin has become the major cause of hemobilia. Also, non-traumatic etiologies of hemobilia include vascular malformation such as aneurysm, gallstone, inflammation, biliary tumor, hepatocellular carcinoma and coagulopathy. Among these non-traumatic etiologies, choledocholithiasis is a rare cause of hemobilia. The authors have experienced two cases of hemobilia caused by choledocholithiasis, which was diagnosed by abdominal ultrasonography, abdominal CT and duodenoscopy. Both patients were treated by the endoscopic sphincterotomy and stone removal with basket.

A Case of Combined Hepatocellular-Cholangiocarcinoma with Sarcomatous Transformation and Second Primary Colon Cancer / 대한간학회지

Combined hepatocellular-cholangiocarcinoma is a rare form of primary liver cancer, featuring both hepatocellular and biliary epithelial differentiations. An intrahepatic tumor may be considered as a metastatic lesion. It has been suggested in the literature that the likelihood of metastasis in the cirrhotic liver is lower than that in the non-cirrhotic liver. A rare case of combined hepatocellular-cholangiocarcinoma and second primary colon adenocarcinoma in a 67-year-old male patient with liver cirrhosis is presented. Histologically, the intrahepatic mass was composed of a spindle cell sarcomatous component; a hepatocellular carcinoma component; and a cholangiocarcinoma component. There were focal transitional regions among the different components. Immunohistochemically, the cholangiocarcinoma component of the intrahepatic mass showed positive reactions for CK-7 but negative reactions for CK-20. The adenocarcinoma of the colon showed positive reactions for CK-20 but negative reactions for CK-7.

The Anaylsis of Mortality Rate According to CTP Score and MELD Score in Patients with Liver Cirrhosis / 대한간학회지

BACKGROUND/AIMS: The Model for End-Stage Liver Disease (MELD) consists of serum bilirubin and creatinine levels, International Normalized Ratio (INR) for prothrombin time, and etiology of liver disease. The MELD score is a reliable measurement of mortality risk and is suitable for a disease severity index in patients with end-stage liver disease. We examined the validity of the MELD as a disease severity index for patients with end-stage liver disease. METHODS: We investigated the 379 patients with liver cirrhosis hospitalized between January 1995 and May 2001. We retrospectively reviewed the hospital records to verify the diagnosis of cirrhosis and to collect exact patient information about their demographic data, portal hypertensive complications and laboratory data. The ability to classify patients with liver cirrhosis according to their risk of death was examined using the concordance c-statistic. RESULTS: The MELD score performed well in predicting death within 3 months with a c-statistic of 0.73 with etiology and 0.71 without etiology. The significant clinical, laboratory variables on 3 month survival in patients with liver cirrhosis are serum bilirubin, ascites and hepatic encephalopathy. The addition of portal hypertensive complications to the MELD score did not improve the accuracy of the MELD score. CONCLUSIONS: The MELD score is a useful disease severity index for the patients with end-stage liver disease and provides reliable measurement of short term survival over a wide range of liver disease severity and diverse etiology.

Novel Maintenance Therapy with Lamivudine in Patients with Chronic Active Viral Hepatitis B / 대한간학회지

BACKGROUND/AIMS: This study was conducted to determine the effect of novel long-term maintenance treatment with lamivudine by gradual lengthening of the medication interval in patients with chronic active viral hepatitis B. METHOD: All patients were non-responder, relapsed or intolerable patients to previous interferon therapy. Patients were divided into a drug-interval changing study and a daily continual medication control group. Drug-interval changing protocol with gradual lengthening of the medication interval after conversion to undetectable HBV-DNA in serum and reduction of serum aminotransferase to normal level was monitored monthly. RESULTS: Before treatment, 15 patients of the drug-interval change group and 11 patients of the daily medication group were similar in laboratory and pathologic findings. Mean follow-up periods were 12.8 moths and 11.4 months respectively. HBeAg seroconversion rate was higher in patients in the daily medication group (86.7% vs. 40.0%, p<0.05). The odds of loss of HBeAg, development of anti-HBe, and suppression of HBV-DNA are about 11 times, 7 times, and 8 times higher in the drug-interval change group compared with the daily medication group, respectively (p<0.05). CONCLUSION: Drug-interval lengthening method was effective in long-term suppression of viral replication with low cost.