OBJECTIVETo elucidate the relationship between HBV core promoter mutation and clinical features as well as its effects on serum e system and viral replication.

METHODSSemi-nested mutation specific PCR (msPCR) was employed for detecting core promoter mutation at nt 1 762-1 764 in 97 patients with HBV infection.

RESULTSThe msPCR method was demonstrated to be specific and reliable for the mutation detection by sequencing the PCR products. The detection ratio of the mutation in patients with acute hepatitis, mild, moderate and severe chronic hepatitis and liver cirrhosis was 2/5, 7/43, 10/31, 1/3 and 7/15, respectively. The detection rate of the mutation in liver cirrhosis was significantly higher than that in light chronic hepatitis (P < 0.025). In 92 patients with chronic HBV infection, HBeAg positive rate in wild (25/92), mutant (42/92) and mixed (25/92) strain infection was 80.0%, 56.0% and 64.3%, HBV DNA level was (4.4 +/- 8.5) x 10(8), (1.1 +/- 1.6) x 10(9) and (1.4 +/- 1.8) x 10(9) copies/ml, the rate of abnormal ALT was 44.0%, 52.0% and 42.6%; ALT level was (58.6 +/- 79.0), (57.1 +/- 75.2) and (62.6 +/- 90.3) IU/L, respectively (P > 0.05).

CONCLUSIONSThe msPCR method for detecting core promoter mutation at nt 1 762-1 764 is specific and reliable. Core promoter mutation is associated with the severity of liver disease, but neither related to the status of e system in serum nor to the virus replication.