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发表于 2003-12-1 18:00
今年10月14-28在麻省波士顿召开的美国第54届肝脏病会议上专家提出. 拉米夫丁和乙肝疫苗合用治疗能够加快清楚HBV, 特别是病毒含量很高的病人.
我们都知道, 拉米夫丁对于HBV复制具有强劲的抑制能力. 而且重要的是它能够重组慢性乙肝患者的细胞免疫答应. 激发靶标病毒的T细胞是我们终止乙肝感染的有效途径. 据陈述, 乙肝疫苗在这方面有作用.
他们所作的试药表明, 这个论点是正确的. 拉米夫丁+乙肝疫苗联合治疗能够加快排除HBV, 并对突破性肝炎有控制作用. 进一步的用药方案和原理需要进一步研究. 不过它给治疗乙肝带来光明.
54th Annual Meeting of the American Association for the Study of Liver Diseases
October 24 - 28, 2003, Boston, MA
[B]Combination Therapy with Epivir-HBV (lamivudine) and HBV Vaccine May Accelerate Eradication of HBV, Especially in Patients with High Viral Loads[/B]
Epivir-HBV (lamivudine/LAM) has a potent antiviral activity against HBV by directly inhibiting viral DNA synthesis, and has been shown to restore a cellular immune response in patients with chronic hepatitis B (CH-B). Boosting the virus-specific T cell response has been proposed as an means of terminating persistent HBV infection efficiently, and HB vaccine is reportedly effective for this purpose.
The aim of this study was to assess the efficacy of combination therapy with Epivir-HBV (lamivudine) and HB vaccine in patients with chronic HBV infection.
Fifty-five patients with CH-B, 35 with HBeAg+ and 20 with HBeAg-, were enrolled in the study, and randomized to receive either LAM monotherapy or the combination therapy of LAM and HB vaccine.
Twenty-eight patients (18 with HBeAg+ and 10 with HBeAg-) received LAM 100 mg/d alone, and 27 patients (17 with HBeAg+ and 10 with HBeAg) received the combination therapy.
In the combination therapy group, 100 mg/d of LAM was administered as a baseline treatment, and 10 μg of HB vaccine (HBsAg including preS2) was injected subcutaneously every month for 6 times starting at 2 months after the start of LAM administration. Serum HBV DNA levels (TMA method), HBV serologic status (HBsAg, HBsAb, HBeAg, HBeAb), and serum ALT levels were monitored before and at 2, 5, 8, 12 months after starting LAM. All patients were treated with LAM at least for 8 months.
Study Results
In the HBeAg- group, most of the patients responded well to the treatment, and their serum HBV DNA became negative within 2 months after starting LAM administration, except for one patient on monotherapy. None of them developed breakthrough hepatitis during the observation period (8 to 16 months). There were no differences between two groups with regard to serum levels of ALT and HBV markers during treatment.
In the HBeAg+ group, undetectable levels of HBV DNA were observed in 29 % of the combination therapy group, and in 27% of the monotherapy group at 2 months after LAM administration. There was no difference between the two groups with regard to the ratio of HBV DNA negativity at this time point.
However, it became significantly higher in the combination therapy group (81%) than in the monotherapy group (41%, p<0.05) at 5 months after LAM administration (3 months after vaccine administration). And the ratio of HBV DNA negativity tended to be higher in the combination therapy group throughout the observation period. Furthermore, breakthrough hepatitis was observed less frequently in the combination therapy group (27%) than in the monotherapy group (47%).
The levels of serum HBeAg were decreased in both groups. However, they were not different between two groups at each time point. The serum HBsAg levels were unchanged during treatment in both groups.
Conclusions
The authors conclude, “The use of HB vaccine in combination with LAM may accelerate the eradication of HBV especially in the patients with high viral loads, and the combination therapy may be effective in controlling the occurrence of breakthrough hepatitis. The establishment of the protocol with higher efficacy in the combination therapy is required, and the detailed mechanism of action in the combination therapy should be analyzed.”
11/26/03
Reference
T Ishikawa and others (Aichi Medical University School of Medicine, Aichi, Japan). COMBINATION THERAPY OF LAMIVUDINE AND HB VACCINE FOR THE TREATMENT OF CHRONIC HEPATITIS B. Abstract 1165 (poster). Hepatology 38:4 (Suppl). October 2003. (54th Annual Meeting of the American Association for the Study of Liver Diseases. October 24-28, 2003. Boston, MA.)
[此贴子已经被作者于2003-12-1 4:00:50编辑过]
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