摘要
目的 探讨国产拉米夫定治疗慢性乙型肝炎(CHB)少年患者的疗效及安全性。方法 随机对105例12～16岁的CHB病毒感染者予以口服国产拉米夫定片剂100 mg/d,共52周,基线丙氨酸氨基转移酶(ALT)水平异常者为第1组,基线ALT水平正常者为第2组。评价治疗前后患者血清乙型肝炎病毒(HBV)DNA、HBV标志物、ALT变化,同时记录不良事件。结果 治疗52周时血清HBV DNA阴转率第1组为92.0％,第2组为76.1％;第1组在治疗12、24、52周时ALT复常率分别为59.0％、66.7％和76.0％;HBV DNA阴转伴ALT复常率分别为44.9％、64.1％与70.7％。治疗52周时,第1组乙型肝炎e抗原(HBeAg)血清转换率为23.9％,HBeAg血清转换并有HBV DNA阴转率为22.5％,第2组均为14.2％,两组比较差异无显著性;在治疗期间发生的不良事件中,仅有6例次可能与拉米夫定有关,无严重不良事件发生。结论 有HBV活动复制的CHB少年患者,用国产拉米夫定治疗52周安全有效,能迅速抑制HBV复制,并使大多数患者ALT正常化,部分患者发生HBeAg阴转或血清转换且有随基线ALT水平升高而增加的趋势。
Objective To analysis the efficacy and safety of lamivudine(made in China) therapy for 52 weeks in adolescent patients with chronic hepatitis B(CHB). Methods One hundred and five teenage CHB patients were treated with lamivudine 100mg once daily for 52 weeks. Patients with elevated ALT at baseline were in group 1 and those with normal ALT were in group 2. The changes of HBV DNA, HBV seromarkers and ALT at the end of 12, 24 and 52 weeks after lamivudine therapy were compared with those at baseline. Adverse events were recorded and evaluated. Results At the end of 52 weeks of lamivudine therapy, HBV DNA-ve, HBeAg loss and anti-HBe seroconversion were observed in 92.0%, 24.4% and 22.0% in group 1 patients and 76.1%, 14.2% and 14.2% in group 2 patients respectively. No significant differences were found between two groups. At 12, 24 and 52 weeks, normalization rates of ALT were 59.0%, 66.7% and 76.0%, normal ALT with undetectable HBV DNA were 44.9%, 64.1% and 70.7% at the same time. During 52 weeks lamivudine treatment 26 mild adverse events were observed in 18 patients. Conclusions Lamivudine can inhibit HBV replication rapidly and normalize ALT in majority adolescent CHB patients. HBeAg loss or seroconversion of antiHBe was observed in some of these patients. All patients in this study were safety and well tolerated.
出处
《中华肝脏病杂志》
CAS
CSCD
2004年第7期429-431,共3页
Chinese Journal of Hepatology
