Oh Jung Mi, Kyun Jinok, Cho Sung Won
Graduate School of Clinical Pharmacy, Sookmyung Women's University, Seoul, Korea.
Pharmacotherapy. 2002 Oct;22(10):1226-34. doi: 10.1592/phco.22.15.1226.33479.
To evaluate the effects and safety of 52-week lamivudine therapy in Korean patients with chronic hepatitis B virus (HBV), with and without cirrhosis.
Long-term retrospective study.
Ajoo University Medical Center, Soowon, Korea.
Twenty-seven men and two women who had received oral lamivudine 100 mg/day for 52 weeks for treatment of biopsy-proven chronic HBV; 11 patients had cirrhosis, 18 did not.
All 29 patients were positive for HBV DNA and hepatitis B surface antigen (HBsAg) before treatment began; 25 (86%) patients were positive for hepatitis B e antigen (HBeAg). Lamivudine therapy suppressed serum HBV DNA to undetectable levels in 26 (90%) patients within a median of 4 weeks. Serum HBV DNA of 28 patients (97%) fell significantly to undetectable levels within 12 weeks and remained undetectable in 24 (83%) patients after 52 weeks, and HBeAg had converted to negative in 10 (40%) of the 25 patients who were positive. Mean serum alanine aminotransferase (ALT) levels of the 29 patients decreased to within the normal range by 12 weeks and remained at 33-48 IU/L thereafter. Differences in responses of HBV DNA and ALT to lamivudine therapy in HBeAg-positive and -negative patients were negligible (p = 0.786 and p = 0.225, respectively). Pretreatment HBV DNA and ALT levels had no effect on the efficacy of lamivudine (p = 0.9116). Furthermore, differences in responses of HBV DNA (p = 0.641), HBeAg seroconversion (p = 0.386), and ALT (p = 0.689) and in development of drug resistance (p = 0.617) between patients with and without cirrhosis were negligible. No serious adverse effects were reported.
Lamivudine is an effective and well-tolerated therapeutic agent for treating chronic HBV in patients with and without cirrhosis.
评估52周拉米夫定治疗对韩国慢性乙型肝炎病毒（HBV）患者（无论有无肝硬化）的疗效及安全性。
长期回顾性研究。
韩国水原市阿朱大学医学中心。
27名男性和2名女性，因经活检证实为慢性HBV而接受每日100毫克拉米夫定治疗52周；11例患者有肝硬化，18例没有。
所有29例患者在治疗开始前HBV DNA和乙肝表面抗原（HBsAg）均为阳性；25例（86%）患者乙肝e抗原（HBeAg）为阳性。拉米夫定治疗在中位时间4周内使26例（90%）患者的血清HBV DNA降至检测不到的水平。28例患者（97%）的血清HBV DNA在12周内显著降至检测不到的水平，52周后24例（83%）患者仍检测不到，25例HBeAg阳性患者中有10例（40%）转为阴性。29例患者的平均血清丙氨酸氨基转移酶（ALT）水平在12周时降至正常范围内，此后维持在33 - 48 IU/L。HBeAg阳性和阴性患者中HBV DNA及ALT对拉米夫定治疗反应的差异可忽略不计（分别为p = 0.786和p = 0.225）。治疗前HBV DNA和ALT水平对拉米夫定疗效无影响（p = 0.9116）。此外，有肝硬化和无肝硬化患者之间在HBV DNA反应（p = 0.641）、HBeAg血清学转换（p = 0.386）、ALT反应（p = 0.689）及耐药发生方面（p = 0.617）的差异可忽略不计。未报告严重不良反应。
拉米夫定是治疗有或无肝硬化的慢性HBV患者的一种有效且耐受性良好的治疗药物。
